Patent Publication Number: US-11382507-B2

Title: Structured tailoring

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     The present application is a divisional of U.S. patent application Ser. No. 12/818,930 filed Jun. 18, 2019, which is a continuation in part of U.S. patent application Ser. No. 12/643,415 filed Dec. 21, 2009, now U.S. Pat. No. 9,659,037, which claims priority to U.S. Provisional Application Ser. No. 61/140,270 filed Dec. 23, 2008, all of which are incorporated by reference herein in their entirety. 
    
    
     TECHNICAL FIELD 
     Embodiments disclosed herein are directed to behavior modification methods and systems and particularly to self-administered, behavior modification facilitated through a structured tailoring method and system thereof. 
     BACKGROUND 
     Behavior modification programs are known and typically require an individual to follow a predetermined and/or clinician determined series of steps and/or milestones in order to achieve lifestyle changes necessary to maintain his or her health or recover from ailments or medical procedures. However, changing behavior is difficult. Although many behavior modification programs do an adequate job in setting up goals and suggestions for users to monitor progress, they fall short when the user begins to fail in adhering or continuing through the behavior modification. For many users, changing behavior can only be accomplished once an individual has internalized the behavior needing to be changed. 
     SUMMARY 
     It is against the above background that the embodiments of the invention provide a self-administered, behavior modification program facilitated through a structured tailoring method and system thereof which accelerates and enhances the internalization process of the individual, and which provides help when the individual begins to fail in adhering or continuing with the behavior modification. 
     In one embodiment, a method of performing a structured collection procedure of an individual which helps the individual change a current behavior to a target behavior is disclosed. The method comprises providing a structured collection procedure and program instructions, and executing the program instructions on a device which cause a processor of the device to: personalize the structured collection procedure by requesting goals from the individual to define for events to be accomplished in the structured collection procedure one or more adherence criteria that the processor uses to determine whether each event was accomplished successfully and to define an exit criterion for ending the structured collection procedure; request intervention preferences from the individual; initiate automatically a schedule of the events defined in the structured collection procedure upon one or more entry criteria being met at some unknown time; provide intervention according to the intervention preferences when the one or more adherence criteria for one of the events is not met; and end automatically the structured collection procedure upon the one or more exit criteria being met at some unknown time. 
     In another embodiment, the program instructions further cause the processor to perform an initial assessment of the individual to tailor both the events as well as the interventions provided by the structured collection procedure. In another embodiment, the initial assessment is based on answers to catalog questions provided to the individual. In another embodiment, the initial assessment cover areas of readiness for change, current health, and activity level of the individual. In another embodiment, the program instructions further cause the processor to provide a recommendation based on the input received from the individual concerning the initial assessment. In another embodiment, the program instructions further cause the processor to use the recommendation as the one or more entry criteria. In another embodiment, the program instructions further cause the processor permit the individual to tailor the recommendation to his or her individual abilities and availability. In another embodiment, the program instructions further cause the processor to permit the individual to define the goals as short term goals, midterm goals, and a long-term goal. In another embodiment, the program instructions further cause the processor to automatically cycle through each of the goals defined by the individual upon successfully completion of a previous goal. In another embodiment, the program instructions further cause the processor to provide a recommendation based on the input received from the individual concerning the initial assessment, and to define one of the goals as a short-term goal that is based on the results from the assessment and the recommendation. In another embodiment, the program instructions further cause the processor to provide upon request an education module which provides education material. In another embodiment, the education material contains health and behavior education in relation to the targeted behavior. In another embodiment, the education material include a skill assessment and skill development activities. In another embodiment, the program instructions further cause the processor to assess if the individual possesses the proper level of skill before moving into a new structured collection procedure. In another embodiment, the program instructions further cause the processor to provide skill development activities for the individual to complete in order to gain the skill for the new structured collection procedure if assess by the processor as not have the proper level of skill. In another embodiment, the program instructions further cause the processor to provide a behavior support assessment to ascertain from the individual what barriers and motivators in the past have assisted in success or failures when it comes to performing the target behavior. In another embodiment, the program instructions further cause the processor to provide a behavior-support intervention module in which the individual picks one or more pre-defined interventions based on the barriers and motivators ascertained from the individual. In another embodiment, the pre-defined interventions are selected from electronic alarms, reminders, messages, and prompting social support networks for help. In another embodiment, the program instructions further cause the processor to provide a validation module which ascertains whether an appropriate level of intervention is assigned due to an associated risk if one of the events fail to meet the one or more adherence criteria. In another embodiment, the schedule of events define how often progress will be monitored by the procedure. In another embodiment, the program instructions further cause the processor to monitor compliancy of the individual with the events by assessing whether the one or more adherence criteria have been met by the individual when performing each one of the events. In another embodiment, the program instructions further cause the processor to check whether there is an indication that the structured collection procedure is not working if the exit criteria are not met. In another embodiment, the indication is provided to the processor by the individual or is shown in collected data associated with each one of the events. In another embodiment, where the indication is present, then the program instructions further cause the processor to query the individual as to whether the individual believes the procedure is working, whether the individual is following the intervention, or whether the individual is lacking in a skill or understanding of how attain the goals. In another embodiment, wherein the program instruction further cause the processor to perform a health and behavior support assessment in order to work through the process of providing a new personalized collection procedure if the collection procedure is indicated as not working, to request again the intervention preferences from the individual if the individual indicates that the intervention is not being followed, and to provide education material or start a skill assessment module if the individual indicates a lack in skill or understanding. In another embodiment, the program instructions further cause the processor to stop the structured collection procedure if the one or more adherence criteria are not met and instructs the individual to contact a clinician. 
     In still another embodiment, a system for performing a structured collection procedure of an individual which helps the individual change a current behavior to a target behavior is disclosed. The system comprises memory; a processor connected to the memory; and program instructions which when executed by the processor causes the processor to: personalize the structured collection procedure by requesting goals from the individual to define for events to be accomplished in the structured collection procedure one or more adherence criteria that the processor uses to determine whether each event was accomplished successfully and to define an exit criterion for ending the structured collection procedure, and requesting intervention preferences from the individual; initiate automatically a schedule of the events defined in the structured collection procedure upon one or more entry criteria being met at some unknown time, store in the memory data collected in accordance to the schedule; provide intervention according to the intervention preferences when the one or more adherence criteria for one of the events is not met; and end automatically the structured collection procedure upon the one or more exit criteria being met at some unknown time. 
     In still another embodiment, a method of structured tailoring which assists an individual in addressing a health related behavior is disclosed. The method comprises providing a master protocol comprising sub-protocols of various structured collection procedures and program instructions, each of the various structured collection procedures address a goal that addresses the health related behavior and comprises entry criteria and exit criteria, wherein entry criteria of some of the various structured collection procedures is met upon exit criteria of previous ones of the various structured collection procedures being met; and executing the program instructions on a device which cause a processor of the device to: use the entry criteria of each of the various structured collection procedures to determine which of the various structured collection procedures are first enabled in the master protocol, run the master protocol with first enabled ones of the various structured collection procedures, end each of the first enabled ones of the various structured collection procedures when the exit criteria of each of the first enabled ones of the various structured collection procedures have been met, and run the master protocol with next ones of the various structured collection procedure having their entry criteria met by the exit criteria of the previous ones of the various structured collection procedures being met. It is to be appreciated that by the above method, the master protocol is dynamically designed depending on which exit criterion is met. 
     In another embodiment, the entry criteria of a sub-protocol comprises at least one of an exit criterion of another sub-protocol and a further entry criterion. In another embodiment, the program instructions further cause the processor to check preferences of the individual as the further entry criterion to determine which of the various structured collection procedures is first enabled in the master protocol. In another embodiment, the program instructions further cause the processor to use calculated skills of the individual as the further entry criteria for one or more of the various structured collection procedures. In another embodiment, the program instructions further cause the processor to use calculated skills of the individual as the further entry criterion for one or more of the various structured collection procedures, wherein each of the one or more of the various structured collection procedures having the entry criteria based on the calculated skill has a different skill level which must be met or exceeded in order to met the entry criteria. In another embodiment, wherein one or more of the various structured collection procedures further comprises adherence criteria, and wherein the program instructions further cause the processor to check the adherence criteria of the structured collection procedures enabled in the master protocol and change which ones of the various structured collection are enabled in the master protocol when the adherence criterion is not met. In another embodiment, the next ones of the various structured collection procedure are automatically run by the processor when their entry criteria are met by the exit criteria of the previous ones of the various structured collection procedures being met. In another embodiment, the program instructions further cause the processor to use calculated skills of the individual as the exit criteria for one or more of the various structured collection procedures. In another embodiment, the program instructions further cause the processor to use calculated skills of the individual as the exit criteria for one or more of the various structured collection procedures, wherein each of the one or more of the various structured collection procedures having the exit criteria based on the calculated skill has a different skill level which must be met or exceeded in order to met the exit criteria. In another embodiment, the exit criterion for one or more of the various structured collection procedures stops their associated structured collection procedure to avoid non-reasonable data input if at least one of an acceptance criterion and an adherence criterion is not met. In another embodiment, the adherence criterion is calculated based on the data related to the behavior of the user and the acceptance criterion is calculated based on data related to the health condition of the user. In another embodiment, at least one of the acceptance criterion and the adherence criterion is calculated based on a single data point or a number of data points. In another embodiment, the exit criterion of a not met acceptance criterion and/or adherence criterion causes the master protocol to run with next ones of the various structured collection procedure having their entry criteria met by that exit criterion and after meeting an exit criterion of that next ones of the various structured collection procedure starting a new protocol or going back to the previous protocol with the exit criterion of a not met acceptance criterion and/or adherence criterion. In another embodiment, after the exit criterion is met for one or more of the structured collection procedures, the program instructions further cause the processor to provide automatically one of a learning tool and a trouble shooting guide before starting the next ones of the structured collection procedures. In another embodiment, the program instructions further cause the processor to present recommended actions and to require active confirmation by the individual for each of the recommended actions. In another embodiment, the device further comprises a user interface in communication with the processor and the active confirmation by the individual is via the user interface. In another embodiment, after the active confirmation by the individual, the program instructions further cause the processor to present automatically one of a web page, or web page link which offers the user selective information with respect to each one of the recommended actions that was confirmed. In another embodiment, the selective information comprises addresses of restaurants located near the individual, sport activities located near the individual, group of people with similar interests located near the individual, training courses located near the individual, or combinations thereof. 
     In still another embodiment, a method of assisting an individual in changing a health related behavior is disclosed. The method comprises requesting on an electronic device a data input of data related to a health condition of a user; calculating a medical need based on that data; calculating a recommended health related behavior change based on the medical need which will lead to an improved health condition of the user; requesting on the electronic device a data input of data related to preferences of the individual regarding events to be accomplished in order to change the health related behavior; providing a structured collection procedure based the calculated health related behavior change, whereby the structured collection procedure is adapted based on entered ones of the preferences of the individual; and executing program instructions on the electronic device which cause a processor of the device to initiate the adapted structured collection procedure which takes the individual preferences of the user into account. 
     In another embodiment, the requesting on the electronic device is via providing a catalogue of questions to the individual. In another embodiment, the structured collection procedure is based on answers to the catalogue questions. In another embodiment, the adapted structured collection procedure comprises of at least one of a learning tool and a trouble shooting guide. In another embodiment, the method further comprises requesting a data input of data related to the behavior of the user in the past. In another embodiment, the method further comprises comparing the data related to the behavior of the user in the past with the data related to the preferences of the individual and calculating based on that comparison the willingness of the individual to do events not indicated as a preference by the individual. In another embodiment, a willingness of the individual is calculated by applying pattern recognition of the data related to the behavior of the user in the past, wherein the pattern recognition can be any suitable conventional pattern recognition software. In another embodiment, the method further comprises requesting intervention preferences from the individual. In another embodiment, the method further comprises assessing whether an appropriate level of intervention has been entered by the individual based on associated risk of non-adherence to the structured collection procedure. In another embodiment, if the appropriate level of intervention has not been entered by the individual, the method further comprises presenting for selection appropriate levels of intervention for the associated risk of non-adherence to the structured collection procedure. In another embodiment, if the appropriate level of intervention has not been entered by the individual, the method further comprises having the device select automatically the appropriate level of intervention for the associated risk of non-adherence to the structured collection procedure. 
     In still another embodiment, a method of assisting an individual in changing a health related behavior is disclosed. The method comprises providing on an electronic device a skill calculation module which calculates the skills of an individual based on a data input of data related to the behavior of the user a structured collection procedure which addresses the health related behavior and comprises an entry criterion having a skill level; receiving on an electronic device a data input of data from the individual related to the behavior of the individual calculating the skill of the individual based on the received input; and permitting the individual access to the structured collection procedure on the electronic device if the entry criterion is met by the calculated skill of the individual meeting or exceeding the skill level. 
     In another embodiment, the method further comprises the device providing training based on the calculated skill of the individual. In another embodiment, the structured collection procedure further comprises exit criteria having a skill level, and said method further comprises having the device end the structured collection procedure if calculated skill of the individual after the training meets the exit criteria by the calculated skill of the individual meeting or exceeding the skill level of the exit criteria. In another embodiment, the method further comprises the device automatically initiating another structured collection procedure having a higher skill level upon meeting the exit criteria. In another embodiment, the received input is pair testing data, and the calculated skill is based on comparing an estimation values with measured values provided in the pair testing data. In another embodiment, the device calculates the skill level of the individual based on input selected from adherence to structured collection procedure after initiation, adherence of one or more previous initiated structured collection procedures, status of a disease of the individual, a classification of the health related behavior, a self-reported skill level, and combinations thereof. 
     In still yet another embodiment, a method for performing a structured collection procedure of an individual which helps the individual change a current behavior to a target behavior is disclosed. The method comprises a master protocol comprising sub-protocols of various structured collection procedures and program instructions, each of the various structured collection procedures address a goal that addresses the target behavior and comprises entry criteria and exit criteria, wherein entry criteria of some of the various structured collection procedures is met upon exit criteria of previous ones of the various structured collection procedures being met; and executing the program instructions on a device which cause a processor of the device to: personalize the structured collection procedure by requesting goals from the individual to define for entry criteria to be accomplished in the structured collection procedure, one or more adherence criteria that the processor uses to determine whether each event was accomplished successfully and to define an exit criterion for ending the structured collection procedure, and requesting intervention preferences from the individual; use the entry criteria based on invention preferences from the individual of each of the various structured collection procedures to determine which of the various structured collection procedures are first enabled in the master protocol, run the master protocol with first enabled ones of the various structured collection procedures, end each of the first enabled ones of the various structured collection procedures when the exit criteria of each of the first enabled ones of the various structured collection procedures have been met, and run the master protocol with next ones of the various structured collection procedure having their entry criteria met by the exit criteria of the previous ones of the various structured collection procedures being met. 
     These and other advantages and features of the various embodiments of the invention disclosed herein, will be made more apparent from the description, drawings and claims that follow. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The following detailed description of the embodiments of the present invention can be best understood when read in conjunction with the following drawings, where like structure is indicated with like reference numerals. 
         FIG. 1  is a diagram showing a care management system for an individual and a clinician along with others having an interest in the care management of the individual according to an embodiment of the present invention. 
         FIGS. 2 and 2A  are diagrams showing embodiments of a system suitable for implementing a structured tailoring method according to an embodiment of the present invention. 
         FIG. 3  shows a block diagram of a collection device embodiment according to the present invention. 
         FIG. 4  shows a depiction in tabular format of a data record embodiment created from using a structured tailoring method on the collection device of  FIG. 3  according to the present invention. 
         FIG. 5A  depicts a method of creating a structured collection procedure. 
         FIGS. 5B and 5C  show parameters defining a structured collection procedure and factors which can be considered to optimize an individual&#39;s therapy using the structured collection procedure, respectively, according to one or more embodiments of the present invention. 
         FIGS. 6A, 6B, 6C, 6D, and 6E  show various structured collection procedures embodiments defined according to the present invention. 
         FIG. 7  conceptually illustrates one example of a pre-defined structured collection procedure, and a method for customizing the pre-defined structured collection procedure according to an embodiment of the present invention. 
         FIG. 8A  shows a method for performing a structured collection procedure according to an embodiment of the present invention. 
         FIGS. 8B and 8C  show a method of implementing a structured collection procedure via a graphical user interface provided on a collection device according to an embodiment of the present invention. 
         FIG. 9  shows a method for performing a structured collection procedure according to another embodiment of the present invention. 
         FIG. 10  conceptually illustrates another example of a pre-defined structured collection procedure, and a method for customizing the pre-defined structured collection procedure according to an embodiment of the present invention. 
         FIG. 11  depicts graphically a behavior change process according to an embodiment of the present invention. 
         FIG. 12  shows a method for performing a structured tailoring process according to an embodiment of the present invention. 
         FIG. 13  depicts graphically embedded goals of the structured tailoring process according to an embodiment of the present invention. 
         FIG. 14  depicts a master protocol of a structured tailoring process according to an embodiment of the present invention. 
     
    
    
     DETAILED DESCRIPTION 
     The present invention will be described below relative to various illustrative embodiments. Those skilled in the art will appreciate that the present invention may be implemented in a number of different applications and embodiments and is not specifically limited in its application to the particular embodiments depicted herein. 
     As used herein with the various illustrated embodiments described below, the following terms include, but are not limited to, the following meanings. 
     The term “biomarker” can mean a physiological variable measured to provide data relevant to an individual such as for example, a blood glucose value, an interstitial glucose value, an HbA1c value, a heart rate measurement, a blood pressure measurement, lipids, triglycerides, cholesterol, and the like. 
     The term “contextualizing” can mean documenting and interrelating conditions that exist or will occur surrounding a collection of a specific biomarker measurement. Preferably, data about documenting and interrelating conditions that exist or will occur surrounding a collection of a specific biomarker are stored together with the collected biomarker data and are linked to it. In particular, a further assessment of the collected biomarker data takes into account the data about documenting and interrelating conditions so that not only the data as such are evaluated but also the link between data to which it is contextualized. The data about documenting and interrelating conditions can include for example information about the time, food and/or exercises which occurs surrounding a collection of a specific biomarker measurement and/or simultaneously thereto. For example, the context of a structured collection procedure according to an embodiment of the present invention can be documented by utilizing entry criteria for verifying a fasting state with the user before accepting a biomarker value during a Basal titration optimization procedure. 
     The term “contextualized biomarker data” can mean the information on the interrelated conditions in which a specific biomarker measurement was collected combined with the measured value for the specific biomarker. In particular, the biomarker data are stored together with the information on the interrelated conditions under which a specific biomarker measurement was collected and are linked thereto. 
     The term “criteria” can mean one criterion or more criteria, and can be at least one or more of a guideline(s), rule(s), characteristic(s), and dimension(s) used to judge whether one or more conditions are satisfied or met to begin, accept, and/or end one or more procedural steps, actions, and/or values. 
     The term “adherence” can mean that a person following a structured collection procedure performs requested procedural steps appropriately. For example, the biomarker data should be measured under prescribed conditions of the structured collection procedure. If then the prescribed conditions are given for a biomarker measurement the adherence is defined as appropriate. For examples, the prescribed conditions are time related conditions and/or exemplarily can include eating of meals, taking a fasting sample, eating a type of meal with a requested window of time, taking a fasting sample at a requested time, sleeping a minimum amount of time, and the like. The adherence can be defined as appropriate or not appropriate for a structured collection procedure or a single data point in particular of a contextualized biomarker data. Preferably, the adherence can be defined as appropriate or not appropriate by a range of a prescribed condition(s) or by a selectively determined prescribed condition(s). Moreover the adherence can be calculated as a rate of adherence describing in which extent the adherence is given for a structured collection procedure or a single data point in particular of a contextualized biomarker data. 
     The term “adherence event” can mean when a person executing a structured collection procedure fails to perform a procedural step. For example, if a person did not collect data when requested by the collection device, the adherence is determined as not appropriate resulting in an adherence event. In another example, adherence criteria could be a first criterion for the individual to fast 6 hours and a second criterion for collecting a fasting bG value at a requested time. In this example, if the individual provides the bG sampling at the requested time but fasted only 3 hours before providing, then although the second adherence criterion is met, the first adherence criterion is not, and hence an adherence event for the first criterion would occur. 
     The term “violation event” is a form of an adherence event in which the person executing the structured collection (testing) procedure (protocol) does not administer a therapeutic at a recommended time, does not administer a recommended amount, or both. 
     The term “adherence criteria” can include adherence and can also mean a basis for comparison (e.g., assessment) of a measured value, a value related to a measured value and/or a calculated value with a defined value or defined range of the value wherein based on the comparison data are accepted with approval and positive reception. Adherence criteria can take into account time related values and/or adherence in one embodiment, but also can take into account noise in other embodiments, and the like. Furthermore, adherence criteria can be applied to contextualized biomarker data so that a biomarker data is accepted depending on a comparison of the contextualized data about documenting and interrelating conditions that exists or occurs surrounding the collection of the specific biomarker. Adherence criteria can be akin to a sanity check for a given piece of information, or group of information. Preferably, the single data point/information or group of data or information is rejected if the acceptance criterion is not fulfilled. In particular, such rejected data are then not used for further calculations which are used to provide a therapy recommendation. Mainly the rejected data are only used to assess the adherence and/or to trigger automatically at least one further action. For example, such a triggered action prompts the user then to follow a structured collection procedure or a single requested action so that based on that the adherence criteria can be fulfilled. 
     The term “data event request” can mean an inquiry for a collection of data at a single point in space-time defined by a special set of circumstances, for example, defined by time-related or not time-related events. 
     The term “decentralized disease status assessment” can mean a determination of the degree or extent of progression of a disease performed by using a biomarker measurement of interest to deliver a value without sending a sample to a laboratory for assessment. 
     The term “medical use case or question” can mean at least one or more of a procedure, situation, condition, and/or question providing an uncertainty about the factuality of existence of some medical facts, combined with a concept that is not yet verified but that if true would explain certain facts or phenomena. Medical use case or question can be already deposited and stored in the system so that the user can select between different medical use cases or questions. Alternatively, the medical use case or question can be defined by the user itself. 
     The term “determining” can mean any method that allows a decision to be made such as, for example, by using an expert solution(s), game theory, quantitatively calculated, extracted from a data source, arrived at by comparison, logically deduced or any other suitable methods of determination. 
     The terms “software” and “program” may be used interchangeably herein. 
       FIG. 1  shows a care management system  10  for an individual  12  and a clinician(s)  14  along with others  16  having an interest in the care management of the individual  12 . Individual  12 , having dysglycemia, may include persons with a metabolic syndrome, pre-diabetes, type 1 diabetes, type 2 diabetes, and gestational diabetes. The others  16  with an interest in the individual&#39;s care may include family members, friends, support groups, and religious organizations all of which can influence the individual&#39;s conformance with a recommend therapy and/or behavioral change. The individual  12  may have access to a personal computer  18 , such as a home computer, which can connect to a public network  50  (wired or wireless), such as the internet, cellular network, etc., and couple to a dongle, docking station, or device reader  22  for communicating with an external portable device, such as a portable collection device  24 . An example of a device reader is shown in the manual “Accu-Chek® Smart Pix Device Reader User&#39;s Manual” (2008) available from Roche Diagnostics. 
     The collection device  24  can be essentially any portable electronic device that can function as an acquisition mechanism for determining and storing digitally a biomarker value(s) according to a structured collection procedure, and which can function to run the structured collection procedure and the method of the present invention. Greater details regarding various illustrated embodiments of the structured collection procedure are provided hereafter in later sections. In a preferred embodiment, the collection device  24  can be a self-monitoring blood glucose meter  26  or a continuous glucose monitor  28 . An example of a blood glucose meter is the Accu-Chek® Active meter, and the Accu-Chek® Aviva meter described in the booklet “Accu-Chek® Aviva Blood Glucose Meter Owner&#39;s Booklet (2007), portions of which are disclosed in U.S. Pat. No. 6,645,368 B1 entitled “Meter and method of using the meter for determining the concentration of a component of a fluid” assigned to Roche Diagnostics Operations, Inc., which is hereby incorporated by reference. An example of a continuous glucose monitor is shown in U.S. Pat. No. 7,389,133 “Method and device for continuous monitoring of the concentration of an analyte” (Jun. 17, 2008) assigned to Roche Diagnostics Operations, Inc., which is hereby incorporated by reference. 
     In addition to the collection device  24 , the individual  12  can use a variety of products to manage his or her diabetes including: test strips  30  carried in a vial  32  for use in the collection device  24 ; software  34  which can operate on the personal computer  18 , the collection device  24 , a handheld computing device  36 , such as a laptop computer, a personal digital assistant, and/or a mobile phone; and paper tools  38 . Software  34  can be pre-loaded or provided either via a computer readable medium  40  or over the public network  50  and loaded for operation on the personal computer  18 , the collection device  24 , the clinician computer/office workstation  25 , and the handheld computing device  36 , if desired. In still other embodiments, the software  34  can also be integrated into the device reader  22  that is coupled to the computer (e.g., computers  18  or  25 ) for operation thereon, or accessed remotely through the public network  50 , such as from a server  52 . 
     The individual  12  can also use for certain diabetes therapies additional therapy devices  42  and other devices  44 . Additionally, therapy devices  42  can include devices such as an ambulatory infusion pump  46 , an insulin pen  48 , and a lancing device  51 . An example of an ambulatory insulin pump  46  include but not limited thereto the Accu-Chek® Spirit pump described in the manual “Accu-Chek® Spirit Insulin Pump System Pump User Guide” (2007) available from Disetronic Medical Systems AG. The other devices  44  can be medical devices that provide data such as blood pressure, fitness devices that provide data such as exercise information, and elder care device that provide notification to care givers. The other devices  44  can be configured to communicate with each other according to standards planned by Continua® Health Alliance. 
     The clinicians  14  for diabetes are diverse and can include e.g., nurses, nurse practitioners, physicians, endocrinologists, and other such health care providers. The clinician  14  typically has access to a clinician computer  25 , such as a clinician office computer, which can also be provided with the software  34 . A healthcare record system  27 , such as Microsoft® HealthVault™ and Google™ Health, may also be used by the individual  12  and the clinician  14  on computers  18 ,  25  to exchange information via the public network  50  or via other network means (LANs, WANs, VPNs, etc.), and to store information such as collection data from the collection device  24  to an electronic medical record of the individual e.g., EMR  53  ( FIG. 2A ) which can be provided to and from computer  18 ,  25  and/or server  52 . 
     Most individuals  12  and clinicians  14  can interact over the public network  50  with each other and with others having computers/servers  52 . Such others can include the individual&#39;s employer  54 , a third party payer  56 , such as an insurance company who pays some or all of the individual&#39;s healthcare expenses, a pharmacy  58  that dispenses certain diabetic consumable items, a hospital  60 , a government agency  62 , which can also be a payer, and companies  64  providing healthcare products and services for detection, prevention, diagnosis and treatment of diseases. The individual  12  can also grant permissions to access the individual&#39;s electronic health record to others, such as the employer  54 , the payer  56 , the pharmacy  58 , the hospital  60 , and the government agencies  62  via the healthcare record system  27 , which can reside on the clinician computer  25  and/or one or more servers  52 . Reference hereafter is also made to  FIG. 2 . 
       FIG. 2  shows a system embodiment suitable for implementing a structured tailoring method according to an embodiment of the present invention, which in another embodiment can be a part of the care management system  10  and communicate with such components, via conventional wired or wireless communication means. The system  41  can include the clinician computer  25  that is in communication with a server  52  (e.g., data server, web server, combination thereof) as well as the collection device  24 . Communications between the clinician computer  25  and the server  52  can be facilitated via a communication link to the public network  50 , to a private network  66 , or combinations thereof. The private network  66  can be a local area network or a wide are network (wired or wireless) connecting to the public network  50  via a network device  68  such as a (web) server, router, modem, hub, and the likes. 
     In one embodiment, the server  52  can be a central repository for a plurality of structured collection procedures (or protocols)  70   a ,  70   b ,  70   c ,  70   d , in which the details of a few exemplary structured collection procedures are provided in later sections. The server  52 , as well as the network device  68 , can function also as a data aggregator for completed ones of the structured collection procedures  70   a ,  70   b ,  70   c ,  70   d . Accordingly, in such an embodiment, data of a completed collection procedure(s) from a collection device of the individual  12  can then be provided from the server  52  and/or network device  68  to the clinician computer  25  when requested in response to retrieval for such data. 
     In one embodiment, one or more of the plurality of structured collection procedures  70   a ,  70   b ,  70   c ,  70   d  on the server  52  can be provided over the public network  50 , such as through a secure web interface  55  ( FIG. 2A , showing another embodiment of the system  41 ) implemented on personal computer  18 , the clinician computer  25 , and/or the collection device  24 . In another embodiment, the clinician computer  25  can serve as the interface (wired or wireless)  72  between the server  52  and the collection device  24 . In still another embodiment, the structured collection procedures  70   a ,  70   b ,  70   c ,  70   d , as well as software  34 , may be provided on a computer readable medium  40  and loaded directly on personal computer  18 , the clinician computer  25 , and/or the collection device  24 . In still another embodiment, the structured collection procedures  70   a ,  70   b ,  70   c ,  70   d  may be provided pre-loaded (embedded) in memory of the collection device  24 . In still other embodiments, new/updated/modified structured collection procedures  70   a ,  70   b ,  70   c ,  70   d  may be sent between personal computer  18 , the clinician computer  25 , server  52  and/or the collection device  24  via the public network  50 , the private network  66 , via a direct device connection (wired or wireless)  74 , or combinations thereof. Accordingly, in one embodiment the external devices e.g., computer  18  and  25 , can be used to establish a communication link  72 ,  74  between the collection device  24  and still further electronic devices such as other remote Personal Computer (PC), and/or servers such as through the public network  50 , such as the Internet and/or other communication networks (e.g., LANs, WANs, VPNs, etc.), such as private network  66 . 
     The clinician computer  25 , as a conventional personal computer/workstation, can include a processor  76  which executes programs, such as software  34 , and such as from memory  78  and/or computer readable medium  40 . Memory  78  can include system memory (RAM, ROM, EEPROM, etc.), and storage memory, such as hard drives and/or flash memory (internal or external). The clinician computer  25  can also include a display driver  80  to interface a display  82  with the processor  76 , input/output connections  84  for connecting user interface devices  86 , such as a keyboard and mouse (wired or wireless), and computer readable drives  88  for portable memory and discs, such as computer readable medium  40 . The clinician computer  25  can further include communication interfaces  90  for connections to the public network  50  and other devices, such as collection device  24  (wired or wireless), and a bus interface  92  for connecting the above mentioned electronic components to the processor  76 . Reference hereafter is now made to  FIG. 3 . 
       FIG. 3  is a block diagram conceptually illustrating the portable collection device  24  depicted in  FIG. 2 . In the illustrated embodiment, the collection device  24  can include one or more microprocessors, such as processor  102 , which may be a central processing unit comprising at least one more single or multi-core and cache memory, which can be connected to a bus  104 , which may include data, memory, control and/or address buses. The collection device  24  can include the software  34 , which provides instruction codes that causes a processor  102  of the device to implement the methods of the present invention that are discussed hereafter in later sections. The collection device  24  may include a display interface  106  providing graphics, text, and other data from the bus  104  (or from a frame buffer not shown) for display on a display  108 , by which the processor  102  can instruct/provide instructions/information/questions/guidance to a user. The display interface  106  may be a display driver of an integrated graphics solution that utilizes a portion of main memory  110  of the collection device  24 , such as random access memory (RAM) and processing from the processor  102  or may be a dedicated graphic processing unit. In another embodiment, the display interface  106  and display  108  can additionally provide a touch screen interface for providing data to the collection device  24  in a well-known manner. 
     Main memory  110  in one embodiment can be random access memory (RAM), and in other embodiments may include other memory such as a ROM, PROM, EPROM or EEPROM, and combinations thereof. In one embodiment, the collection device  24  can include secondary memory  112 , which may include, for example, a hard disk drive  114  and/or a computer readable medium drive  116  for the computer readable medium  40 , representing for example, at least one of a floppy disk drive, a magnetic tape drive, an optical disk drive, a flash memory connector (e.g., USB connector, Firewire connector, PC card slot), etc. The drive  116  reads from and/or writes to the computer readable medium  40  in a well-known manner. Computer readable medium  40 , represents a floppy disk, magnetic tape, optical disk (CD or DVD), flash drive, PC card, etc. which is read by and written to by the drive  116 . As will be appreciated, the computer readable medium  40  can have stored therein the software  34  and/or structured collection procedures  70   a ,  70   b ,  70   c , and  70   d  as well as data resulting from completed collections performed according to one or more of the collection procedures  70   a ,  70   b ,  70   c , and  70   d.    
     In alternative embodiments, secondary memory  112  may include other means for allowing the software  34 , the collection procedures  70   a ,  70   b ,  70   c ,  70   d , other computer programs or other instructions to be loaded into the collection device  24 . Such means may include, for example, a removable storage unit  120  and an interface connector  122 . Examples of such removable storage units/interfaces can include a program cartridge and cartridge interface, a removable memory chip (e.g., ROM, PROM, EPROM, EEPROM, etc.) and associated socket, and other removable storage units  120  (e.g. hard drives) and interface connector  122  which allow software and data to be transferred from the removable storage unit  120  to the collection device  24 . 
     The collection device  24  in one embodiment can include a communication module  124 . The communication module  124  allows software (e.g., the software  34 , the collection procedures  70   a ,  70   b ,  70   c , and  70   d ) and data (e.g., data resulting from completed collections performed according to one or more of the collection procedures  70   a ,  70   b ,  70   c , and  70   d ) to be transferred between the collection device  24  and an external device(s)  126 . Examples of communication module  124  may include one or more of a modem, a network interface (such as an Ethernet card), a communications port (e.g., USB, firewire, serial, parallel, etc.), a PC or PCMCIA slot and card, a wireless transceiver, and combinations thereof. The external device(s)  126  can be the personal computer  18 , the clinician computer  25 , the handheld computing devices  36 , such as a laptop computer, a personal digital assistance (PDA), a mobile (cellular) phone, and/or a dongle, a docking station, or device reader  22 . In such an embodiment, the external device  126  may provided and/or connect to one or more of a modem, a network interface (such as an Ethernet card), a communications port (e.g., USB, firewire, serial, parallel, etc.), a PCMCIA slot and card, a wireless transceiver, and combinations thereof for providing communication over the public network  50  or private network  66 , such as with the clinician computer  25  or server  52 . Software and data transferred via communication module  124  can be in the form of wired or wireless signals  128 , which may be electronic, electromagnetic, optical, or other signals capable of being sent and received by communication module  124 . For example, as is known, signals  128  may be sent between communication module  124  and the external device(s)  126  using wire or cable, fiber optics, a phone line, a cellular phone link, an RF link, an infrared link, other communications channels, and combinations thereof. Specific techniques for connecting electronic devices through wired and/or wireless connections (e.g. USB and Bluetooth, respectively) are well known in the art. 
     In another embodiment, the collection device  24  can be used with the external device  132 , such as provided as a handheld computer or a mobile phone, to perform actions such as prompt an individual to take an action, acquire a data event, and perform calculations on information. An example of a collection device combined with such an external device  126  provided as a hand held computer is disclosed in U.S. patent application Ser. No. 11/424,757 filed Jun. 16, 2006 entitled “System and method for collecting patient information from which diabetes therapy may be determined,” assigned to Roche Diagnostics Operations, Inc., which is hereby incorporated by reference. Another example of a handheld computer is shown in the user guide entitled “Accu-Chek® Pocket Compass Software with Bolus Calculator User Guide” (2007) available from Roche Diagnostics. 
     In the illustrative embodiment, the collection device  24  can provide a measurement engine  138  for reading a biosensor  140 . The biosensor  140 , which in one embodiment is the disposable test strip  30  ( FIG. 1 ), is used with the collection device  24  to receive a sample such as for example, of capillary blood, which is exposed to an enzymatic reaction and measured by electrochemistry techniques, optical techniques, or both by the measurement engine  138  to measure and provide a biomarker value, such as for example, a blood glucose level. An example of a disposable test strip and measurement engine is disclosed in U.S. Patent Pub. No. 2005/0016844 A1 “Reagent stripe for test strip” (Jan. 27, 2005), and assigned to Roche Diagnostics Operations, Inc., which is hereby incorporated by reference. In other embodiments, the measurement engine  138  and biosensor  140  can be of a type used to provide a biomarker value for other types of sampled fluids or analytes besides or in addition to glucose, heart rate, blood pressure measurement, and combinations thereof. Such an alternative embodiment is useful in embodiments where values from more then one biomarker type are requested by a structured collection procedure according to the present invention. In still another embodiment, the biosensor  140  may be a sensor with an indwelling catheter(s) or being a subcutaneous tissue fluid sampling device(s), such as when the collection device  24  is implemented as a continuous glucose monitor (CGM) in communication with an infusion device, such as pump  46  ( FIG. 1 ). In still another embodiments, the collection device  24  can be a controller implementing the software  34  and communicating between the infusion device (e.g., ambulatory infusion pump  46  and electronic insulin pen  48 ) and the biosensor  140 . 
     Data, comprising at least the information collected by the biosensor  140 , is provided by the measurement engine  138  to the processor  102  which may execute a computer program stored in memory  110  to perform various calculations and processes using the data. For example, such a computer program is described by U.S. patent application Ser. No. 12/492,667, filed Jun. 26, 2009, titled “Method, System, and Computer Program Product for Providing Both an Estimated True Mean Blood Glucose Value and Estimated Glycated Hemoglobin (HbA1C) Value from Structured Spot Measurements Of Blood Glucose,” and assigned to Roche Diagnostics Operations, Inc., which is hereby incorporated by reference. The data from the measurement engine  138  and the results of the calculation and processes by the processor  102  using the data is herein referred to as self-monitored data. The self-monitored data may include, but not limited thereto, the glucose values of a individual  12 , the insulin dose values, the insulin types, and the parameter values used by processor  102  to calculate future glucose values, supplemental insulin doses, and carbohydrate supplement amounts as well as such values, doses, and amounts. Such data along with a date-time stamp  169  for each measured glucose value and administered insulin dose value is stored in a data file  145  of memory  110  and/or  112 . An internal clock  144  of the collection device  24  can supply the current date and time to processor  102  for such use. 
     The collection device  24  can further provide a user interface  146 , such as buttons, keys, a trackball, touchpad, touch screen, etc. for data entry, program control and navigation of selections, choices and data, making information requests, and the likes. In one embodiment, the user interface  146  can comprises one or more buttons  147 ,  149  for entry and navigation of the data provided in memory  110  and/or  112 . In one embodiment, the user can use one or more of buttons  147 ,  149  to enter (document) contextualizing information, such as data related to the everyday lifestyle of the individual  12  and to acknowledge that prescribed tasks are completed. Such lifestyle data may relate to food intake, medication use, energy levels, exercise, sleep, general health conditions and overall well-being sense of the individual  12  (e.g., happy, sad, rested, stressed, tired, etc.). Such lifestyle data can be recorded into memory  110  and/or  112  of the collection device  24  as part of the self-monitored data via navigating through a selection menu displayed on display  108  using buttons  147 ,  149  and/or via a touch screen user interface provided by the display  108 . It is to be appreciated that the user interface  146  can also be used to display on the display  108  the self monitored data or portions thereof, such as used by the processor  102  to display measured glucose levels as well as any entered data. 
     In one embodiment, the collection device  24  can be switched on by pressing any one of the buttons  147 ,  149  or any combination thereof. In another embodiment, in which the biosensor  140  is a test-strip, the collection device  24  can be automatically switched on when the test-strip is inserted into the collection device  24  for measurement by the measurement engine  138  of a glucose level in a sample of blood placed on the test-strip. In one embodiment, the collection device  24  can be switched off by holding down one of the buttons  147 ,  149  for a pre-defined period of time, or in another embodiment can be shut down automatically after a pre-defined period of non-use of the user interface  146 . 
     An indicator  148  can also be connected to processor  102 , and which can operate under the control of processor  102  to emit audible, tactile (vibrations), and/or visual alerts/reminders to the individual of daily times for bG measurements and events, such as for example, to take a meal, of possible future hypoglycemia, and the likes. A suitable power supply  150  is also provided to power the collection device  24  as is well known to make the device portable. 
     As mentioned above previously, the collection device  24  may be pre-loaded with the software  34  or by provided therewith via the computer readable medium  40  as well as received via the communication module  124  by signal  128  directly or indirectly though the external device  132  and/or network  50 . When provided in the latter matter, the software  34  when received by the processor  102  of the collection device  24  is stored in main memory  110  (as illustrated) and/or secondary memory  112 . The software  34  contains instructions, when executed by the processor  102 , enables the processor to perform the features/functions of the present invention as discussed herein in later sections. In another embodiment, the software  34  may be stored in the computer readable medium  40  and loaded by the processor  102  into cache memory to cause the processor  102  to perform the features/functions of the invention as described herein. In another embodiment, the software  34  is implemented primarily in hardware logic using, for example, hardware components such as application specific integrated circuits (ASICs). Implementation of the hardware state machine to perform the feature/functions described herein will be apparent to persons skilled in the relevant art(s). In yet another embodiment, the invention is implemented using a combination of both hardware and software. 
     In an example software embodiment of the invention, the methods described hereafter can be implemented in the C++ programming language, but could be implemented in other programs such as, but not limited to, Visual Basic, C, C#, Java or other programs available to those skilled in the art. In still other embodiment, the program  34  may be implemented using a script language or other proprietary interpretable language used in conjunction with an interpreter. Reference hereafter is also made to  FIG. 4 . 
       FIG. 4  depicts in tabular form a data file  145  containing data records  152  of self-monitored data  154  resulting from a structured collection procedure according to an embodiment of the present invention. The data records  152  (e.g., rows) along with the self-monitoring data  154  (e.g., various one of the columns) can also provide associated therewith contextual information  156  (e.g., other various ones of the columns as well as via row and column header information). Such contextual information  156  can be collected either automatically, such as for example via input received automatically from the measurement engine, the biosensor, and/or any one of the other devices, or via input received from the user interface which was manually enter by the individual in response to a collection request (e.g., a question displayed by the processor  102  on the display  108 ) during the structured collection procedure. Accordingly, as such contextual information  156  can be provided with each data record  152  in a preferred embodiment, such information is readily available to a physician and no further collection of such information is necessarily needed to be provided again by the individual either manually or orally after completing the structured collection procedure. In another embodiment, if such contextual information  156  and/or additional contextual information is collected after completion of a structured collection procedure according to the present invention, such information may be provided in the associated data file and/or record  145 ,  152  at a later time such as via one of the computers  18 ,  25 . Such information would then be associated with the self-monitored data in the data file  145 , and thus would not need to be provided again orally or manually. Such a process in the latter embodiment may be needed in the situation where the structured collection procedure is implemented as or partly as a paper tool  38  which is used with a collection device incapable of running the software  34  implementing such a structured collection procedure. 
     It is to be appreciated that the date file  145  (or portions thereof, such as only the self-monitored data  154 ) can be sent/downloaded (wired or wireless) from the collection device  24  via the communication module  124  to another electronic device, such the external device  132  (PC, PDA, or cellular telephone), or via the network  50  to the clinician computer  25 . Clinicians can use software provided on the clinician computer  25  to evaluate the received self-monitored data  154  as well as the contextual information  156  of the individual  12  for therapy results. An example of some of the functions which may be incorporated into the software and which is configured for a personal computer is the Accu-Chek® 360 Diabetes Management System available from Roche Diagnostics that is disclosed in U.S. patent application Ser. No. 11/999,968 filed Dec. 7, 2007, titled “METHOD AND SYSTEM FOR SETTING TIME BLOCK,” and assigned to Roche Diagnostics Operations, Inc., which is hereby incorporated by reference. 
     In a preferred embodiment, the collection device  24  can be provided as portable blood glucose meter, which is used by the individual  12  for recording self-monitored data comprising insulin dosage readings and spot measured glucose levels. Examples of such bG meters as mentioned above previously include but are not limited to, the Accu-Chek® Active meter and the Accu-Chek® Aviva system both by Roche Diagnostics, Inc. which are compatible with the Accu-Chek® 360° Diabetes management software to download test results to a personal computer or the Accu-Chek® Pocket Compass Software for downloading and communication with a PDA. Accordingly, it is to be appreciated that the collection device  24  can include the software and hardware necessary to process, analyze and interpret the self monitored data in accordance with predefined flow sequences (as described below in detail) and generate an appropriate data interpretation output. In one embodiment, the results of the data analysis and interpretation performed upon the stored data by the collection device  24  can be displayed in the form of a report, trend-monitoring graphs, and charts to help individuals manage their physiological condition and support patient-doctor communications. In other embodiments, the bG data from the collection device  24  may be used to generated reports (hardcopy or electronic) via the external device  132  and/or the personal computer  18  and/or the clinician computer  25 . 
     The collection device  24  can further provide the individual and/or his or her clinician with at least one or more of the capabilities comprising: a) editing data descriptions, e.g. the title and description of a record; b) saving records at a specified location, in particular in user-definable directories as described above; c) recalling records for display; d) searching records according to different criteria (date, time, title, description etc.); e) sorting records according to different criteria (e.g., values of the bG level, date, time, duration, title, description, etc.); f) deleting records; g) exporting records; and/or h) performing data comparisons, modifying records, excluding records as is well known. 
     As used herein, lifestyle can be described in general as a pattern in an individual&#39;s habits such as meals, exercise, and work schedule. The individual additionally may be on medications such as insulin therapy or orals that they are required to take in a periodic fashion. Influence of such action on glucose is implicitly considered by the present invention, and the control of which can be the one of the long term goal of the individual. 
     It is to be appreciated that the processor  102  of the collection device  24  can implement one or more structured collection procedures  70  provided in memory  110  and/or  112 . Each structured collection procedure  70  in one embodiment can be stand-alone software, thereby providing the necessary program instructions which when executed by the processor  102  causes the processor to perform the structured collection procedure  70  as well as other prescribed functions. In other embodiments, each structured collection procedure  70  can be part of the software  34 , and can be then be selectively executed by the processor  102  either via receiving a selection from a menu list provided in the display  108  from the user interface  146  in one embodiment or via activation of a particular user interface, such as a structured collection procedure run mode button (not shown) provided to the collection device  24  in another embodiment. It is to be appreciated that the software  34 , likewise, provides the necessary program instructions which when executed by the processor  102  causes the processor to perform the structured collection procedure  70  as well as other prescribed functions of the software  34  discussed herein. One suitable example of having a selectable structured collection procedure provided as a selectable mode of a collection meter is disclosed by in U.S. patent application Ser. No. 12/491,523, filed Jun. 25, 2009, titled “Episodic Blood Glucose Monitoring System With An Interactive Graphical User Interface And Methods Thereof,” assigned to Roche Diagnostics Operations, Inc., which is hereby incorporated by reference. 
     In still another embodiment, a command instruction can be sent from the clinician computer  25  and received by the processor  102  via the communication module  124 , which places the collection device  24  in a collection mode which runs automatically the structured collection procedure  70 . Such a command instruction may specify which of the one or more structured collection procedures to run and/or provide a structured collection procedure to run. In still another embodiment, a list of defined medical use cases or medical questions can be presented on the display  108  by the processor  102 , and a particular structured collection procedure  70  can be automatically chosen by the processor  102  from a plurality of structured collection procedures (e.g., procedures  70   a ,  70   b ,  70   c , and  70   d ) depending on the selection of the defined medical use cases or medical questions received by the processor  102  via the user interface  146 . 
     In still another embodiment, after selection, the structured collection procedure(s)  70  can be provided through the computer readable medium e.g.,  40  and loaded by the collection device  24 , downloaded from computer  18  or  25 , the other device(s)  132 , or server  52 . Server  52 , for example, may be a healthcare provider or company providing such pre-defined structured collection procedures  70  for downloading according to a selected defined medical use case or question. It is to be appreciated that the structured collection procedure(s)  70  may be developed by a healthcare company (e.g. company  64 ) and implemented via the public network  50  through a webpage which can be accessed via standard browser and run on the device  24  (if web enabled) and personal computer  18  and/or clinician computer  25 , and/or made available for downloading on server  52 , such as illustrated in  FIG. 2 . In still other embodiments, notices that a new structured collection procedure  70  is available for use on the collection device  24  to help address a particular use case/medical question that a user (e.g., healthcare provider and patient) may have can be provided in any standard fashion, such for via postal letters/cards, email, text messaging, tweets, and the likes. 
     In still another embodiment, the software  34  can be implemented on the continuous glucose monitor  28  ( FIG. 1 ). In this manner, the continuous glucose monitor  28  can be used to obtain time-resolved data. Such time-resolved data can be useful to identify fluctuations and trends that would otherwise go unnoticed with spot monitoring of blood glucose levels and standard HbA1c tests. Such as, for example, low overnight glucose levels, high blood glucose levels between meals, and early morning spikes in blood glucose levels as well as how diet and physical activity affect blood glucose along with the effect of therapy changes. 
     In addition to collection device  24  and software  34 , clinicians  14  can prescribe other diabetes therapy devices for individuals  12  such as an ambulatory insulin pump  46  as well as electronically based insulin pen  48  ( FIG. 1 ). The insulin pump  46  typically includes configuration software such as that disclosed in the manual “Accu-Chek® Insulin Pump Configuration Software” also available from Disetronic Medical Systems AG. The insulin pump  46  can record and provide insulin dosage and other information, as well as the electronically based insulin pen  48 , to a computer, and thus can be used as another means for providing biomarker data as requested by the structured collection procedure  70  ( FIG. 2 ) according to the present invention. 
     It is to be appreciated that one or more of the method steps discussed hereafter can be configured as a paper tool  38  ( FIG. 1 ) e.g. as a form, checklist, journal, etc., but preferably all the method steps are facilitated electronically on system  41  ( FIG. 2 ) or on any electronic device/computer, such as collection device  24 , having a processor and memory as a program(s) residing in memory. As is known, when a computer executes the program, instructions codes of the program cause the processor of the computer to perform the method steps associated therewith. In still other embodiments, some or all of the method steps discussed hereafter can be configured on computer readable medium  40  storing instruction codes of a program that, when executed by a computer, cause the processor of the computer to perform the method steps associated therewith. These method steps are now discussed in greater detail hereafter with reference made to  FIGS. 5A and 5B . 
     Create a Structured Collection Procedure 
       FIG. 5A  depicts a method  200  of creating a structured collection procedure  70  illustrated by  FIG. 5B  for a medical use case or question which may be implemented in any one of the above described devices  18 ,  24 ,  25 ,  26 ,  28 ,  36 ,  52  as stand alone software, as part of the diabetes software  34  or portions there of as part of paper tool  38 . In step  202 , a medical use case or question, hereafter referred to generally as use case(s), is selected and/or can be defined. It is to be appreciated that a use case may be, for example, one selected from the following medical use cases or questions: a desire to know the effects of eating a particular food; a desire to know the best time to take medication before and/or after with a meal; and a desire to know the effects of exercise on bG levels. Other use cases may be questions concerning finding a diagnosis, how best to initialize therapy for an individual, finding a determination of status of an individual&#39;s disease progression, finding the best ways to optimize an individual&#39;s therapy, change an individual&#39;s current behavior to a targeted behavior, and the like. Still other examples can be providing such structured collection procedures  70  which can be used to help address medical questions regarding fasting blood glucose, pre-prandial glucose values, postprandial glucose values, and the like. Other medical questions can be to control the biomarker in a predefined context, to optimize the biomarker in a predefined context, related to therapy onset, type of therapy, oral mono-therapy, oral combination therapy, insulin therapy, lifestyle therapy, adherence to therapy, therapy efficacy, insulin injection or inhalation, type of insulin, split of insulin in basal and bolus, and the likes. The selected use case can be assigned to a medical use case parameter  220  depicted in  FIG. 5B . 
     In step  204 , the situation or problem surrounding the selected use case can be defined. This can be accomplished via looking at all the factors which may affect a change in the use case. For example, in the use case of desiring to know how best to optimize the individual&#39;s therapy and/or to change a current behavior, some factors to look at may include stress, menstrual cycle, pre-dawn effect, background insulin, exercise, bolus timing with respect to a meal, basal rate, insulin sensitivity, post-prandial behavior, and the like such as shown by  FIG. 5C . 
     In step  206 , a determination can be made as to what kinds of analysis can be used to address or shed light on the situation or the problem. Such analysis may be, for example, selected from the following: evaluating the change in fasting blood glucose (FPG) values over the course of the collection procedure  70 , monitoring one or more particular value over the duration of the collection procedure  70 , determining an insulin to carbohydrate (I:C) ratio, determining insulin sensitivity, determining best time for administering a drug with respect to another variable, such as meal(s), and the like. In step  208 , a sampling group determination can be made as to which information has to be collected, such as what biomarker(s) and the context(s) in which the biomarkers shall be collected, as well as when this information needs to be collected to conduct the analysis. For example, the sampling group can be defined as a string of data objects, each of which consists of: target type, e.g., time based which can use a target time (e.g., used for an alerting feature), a lower time window bound, an upper time window bound, etc., or data based which defines a data type (single, aggregate, or formula), the conditions for accepting the data (e.g., none, below a value, above a value, a formula, etc.), the type of collection (e.g., user input, sensor, data, etc.), as well as any reminder screen text (e.g., static, and/or dynamic in both formatting and value insertion) for each collection. The result of this process is a schedule of collection events  222  ( FIG. 5B ) containing one or more events  237 . It is to be appreciated that the schedule of collection events  222  of the structured collection procedure  70  for some uses cases can be a simple data collection schedule e.g., one which presents as an event  237  questions to the patient  12  as to whether or not a desire action was accomplished as scheduled, such as in the use case of changing a behavior of the patient to a target behavior, e.g., exercising for a desired period of time per day, not smoking for a period of time each day, not eating particular foods after a certain time of day, eating particular foods at each meal per day, and the likes. For other uses cases, the schedule of collection events  222  in the structured collection procedure  70  can be a complex data collection which requires multiple actions and biomarker inputs from the patient  12  to be accomplished as scheduled. 
     Next in step  210 , the manner in which each event  237  or a group of the schedule of collection events  222  is/are to be conducted in order to be useful for addressing the situation or problem of the selected use case is then determined. This results in one or more adherence criteria  224 . In addition to and/or instead of the manner for performing a collection, the adherence criteria  224  may also be based on one or more biomarker values falling into a pre-defined range or is equal to a certain pre-defined value. In other embodiments, the adherence criteria can be a formula(s) which uses a biomarker datum or group of such data to determine if the resulting value falls into the pre-defined range or is equal to a certain pre-defined value. 
     For example, adherence criteria  224  can describe the parameters around the events  237  that the individual  12  needs to perform such as tests within a certain window, fasting for a given amount of time, sleeping for a given amount of time, exercise, low stress, not menstruating, etc. As such, adherence criteria  224  can establish the context of the information about to be provided. Adherence criteria  224  can also be used as mentioned above previously in another context to provide an assessment of whether the data is acceptable and when used in such a context may be referenced to as “acceptance” criteria. For example, before a sample is taken, the adherence criteria  224  can establish whether steps leading up to taking of the sample are accomplished. For example, the processor  102  in response to a request  240  displays the question, “Have you been fasting for the last 8 hours?”, wherein a “Yes” response received by the processor via the user interface  146  meets the adherence criteria  224  for this step. In another example, after the sample is taken, the processor  102  can assess the received data for reasonableness using other adherence (acceptance) criteria. For example, based on prior data, a fasting bG sample should be between 120-180 mg/dl, but the received value was of 340 mg/dl, and thus fails such adherence (acceptance) criteria since being out of the predefined range for an acceptable value. In such an example, an adherence event  242  occurs wherein the processor  102  could prompt for an additional sample. In such a case, if the re-sampling fails too (i.e., not between 120-180 mg/dl), the assessment provided by the processor  102  is that the individual  12  has not fasted, and thus the processor  102  as instructed by the adherence criteria upon a failing of the re-sampling extend automatically the events  237  in the schedule of events  222  accordingly. 
     Next in step  212 , the condition(s) and context(s) in which the schedule of events  222  is to be started and ended can be determined. This results in one or more entry criteria  226  and exit criteria  228  being provided for the schedule of events  222  as well as possibly for a group of other schedule of events to which the schedule of events  222  belongs if providing a package of structured collection procedures, e.g., procedures  70   a ,  70   b ,  70   c , and  70   d , which may run concurrently and/or sequentially one after the other. 
     For example, the entry criteria  226  can be used to determine whether the individual meets the conditions to use the collection procedure by the processor  102  checking that, for example, the individual  12  meets the entry criteria  226  based on current age being in a range, HbA1c being in a range, that the individual has a particular disease, has had the disease over a minimum period of time, has a Body Mass Index (BMI) in a range, had a Fasting Plasma Glucose (FPG) in a range, had a particular drug sensitivity, is taking a particular drug, taking a particular drug dosage, meets one or more prerequisites of another structured collection procedure, has completed one or more of another structured collection procedure, does not have one or more particular pre-conditions, e.g., pregnant, not fasting, or contraindications, e.g., feeling ill, feverish, vomiting, etc., and combinations thereof. Entry criteria  226  can also initiate the schedule of events  222  by an initiation event such as a time of day, a time of week, meal, taking a meal with a time offset, exercise, and exercise with a time offset, use of a therapeutic drug, use of a therapeutic drug with time offset, physiological circumstances, biomarker range, and biomarker within a predetermined range calculated as an offset from a prior biomarker value. Example of a physiological circumstance can be that entry criteria will be met to start a structured collection procedure when a pre-determined number of a physiological event, e.g., hyperglycemia, hypoglycemia, a certain temperature at a certain of day, and the like, occur within a pre-defined amount of time, e.g., hours, day, weeks, etc. Accordingly, the entry criteria can be used to support the use of need to met prerequisites, indications for usage, and/or contraindications for usage. For example, an entry criteria  226  could define a prerequisite condition which in order for the structured collection procedure  70  to run an Insulin Sensitivity optimization, the processor  102  must verify first that a structured collection procedure for a Basal titration is completed and/or has a desired result and/or as well as another structured collection procedure for an insulin to carbohydrate ratio is completed and/or has a desired result. In another example, an entry criteria  226  could be defined with needing to meet certain indications for usage in which certain structured collection procedures could provide segregated uses for diabetics who are Type 1 vs. Type 2 as well as types of structured collection procedures which can be used to titrate for specific drugs. In another example, the entry criteria  226  could be defined with needing to meet certain contraindications for usage, in which for example, certain structured collection procedures  70  will not run if the individual  12  is pregnant, sick, etc. 
     Examples of the exit criteria  228  can be based on the processor  102  determining that a particular value is reached, that a mean average of the primary samples values are in a range, that a particular event(s) and/or condition(s) have or have not occurred, and combinations thereof. Other conditions when the procedure may stop can include adverse events such as a hypoglycemic event, the individual is sick, the individual undergoes a therapy change, etc. Additional detail may also by provided by the processor  102  on the display  108  to the individual  12  based on what the specific exit criteria has been met. For example, in one example, if the individual  12  measures a glucose value indicating hypoglycemia, upon exiting the procedure, the processor  102  run automatically another alternative procedure which instructs the individual  12  to ingest carbohydrates and measure his blood glucose value every half an hour until the blood glucose exceeds 120 mg/dL. For this alternative procedure, the individual  12  can also be requested by the processor  102  to document his meals, activity, stress, and other relevant details to ensure that the conditions that led to hypoglycemia are recorded. The individual  12  may also be instructed by the processor  102  to contact the clinician  14  in this and other such special cases as deemed fit. Exit criteria can also include, for example, criteria for ending such as exiting after a successful completion, or exiting after an indeterminate completion, such as expiration of a predetermined timeout (logistical end), e.g., no result after n days, where n=1 to 365 days, or by termination e.g., exit with unsuccessful termination due to a fail-safe. It is to be appreciated that the structured collection procedure  70  can also be defined to end automatically not only based on meeting the exit criteria  228 , but also when the individual  12  fails to perform a request to an acceptable level of compliance and/or when an individual&#39;s physiological state has changed such that the individual is should not carry out the schedule of events  222 , thereby failing adherence criteria  224 , wherein the adherence event  242  is to end the structured collection procedure. 
     In step  214 , guidance  230  for the user during collection can be determined as well as any options  232  for customizing the collection. For example, for guidance  230 , the clinician  14  can use a default list of messages, or tailor messages to guide the individual  12  during execution of the collection procedure  70 . As an example, one message could be provided on a successful data acquisition (i.e., meets the adherence criteria  224 ) would read, “Thank you. Your next scheduled measurement is at 1230 pm.” Alarms, such as provided by indicator  148 , can also be associated with the collection procedure  70  that remind the individual  12  to take a measurement and can include a snooze functionality should the individual  12  need additional time to conduct the measurement. The snooze functionality as well as other device features are discussed further in later sections. 
     The result of steps  208 - 214  is the structured collection procedure  70  being created in step  216  which associates together the use case parameter  220 , the scheduled of events  222 , the adherence criteria  224 , the entry criteria  226 , the exit criteria  228 , guidance  230 , and the options  232 . In one embodiment, at the time of generating a collection procedure  70  the clinician  14  also generates printed material that explains to the individual the following aspects (at a minimum): the purpose of the collection procedure  70  and expected ideal outcome, i.e., setting a goal for the collection procedure  70 ; the collection procedure  70  design and the number of measurements needed; the entry criteria  226  that the individual  12  must satisfy before initiating the collection procedure  70  and before taking each reading; and the exit criteria  228  under which the individual  12  should cease to continue the collection procedure  70 . Such printed material as well as the guidance  230  that can be provided during the execution of the collection procedure  70  ensures that the individual is fully aware of why the data collection procedure is being carried out. 
     Examples, of the structured collection procedure  70  may be, for example, a structured collection procedure for determining an insulin-to-carbohydrate ratio, for determining bolus timing in respect to meal start, and for determining an exercise equivalent to ingested carbohydrates. In step  218 , the structured collection procedure  70  is then made available for implementation and use in the system  41 , such as in any of the above discussed manners mentioned with regards to  FIGS. 1, 2, and 3 . A structured collection procedure  70  accordingly may be provided via the above process, such as by either the medical community or healthcare companies  64 , to help the clinician  14  address and/or investigate a defined medical use case or problem. 
       FIG. 5B  shows the interactions of the parameters  222 ,  224 ,  226 , and  228  of the structured collection procedure  70  for obtaining contextualized biomarker data from a diabetic patient to address a medical use case upon which the structured collection procedure is based. As mentioned above, the use case parameter  220  may be provided to identify the medical use case or question to which the parameters  222 ,  224 ,  226 , and  228  address. For example, the processor  76  of the clinician computer  25 , the processor  102  of the collection device  24 , and/or the server  52  may read the medical use case parameters  220  from a plurality of structured collection procedures  70   a ,  70   b ,  70   c ,  70   d  ( FIG. 2 ), such as provided on these devices and/or within the system  41 , and provide a list of the available structured collection procedures, such as on the display  82  of the clinician computer  25  or the display  108  of the collection device  24 . Additionally, the clinician computer  25 , the personal computer  18 , and/or the server  52  can use the medical use case parameter  220  for locating/sorting/filtering such structured collection procedures according to a medical use case(s). 
     As mentioned above, the entry criteria  226  establishes the requirements for initiating the structured collection procedure  70  to obtain data which includes biomarker data, particularly, collected in a predefined context. In one embodiment, the processor  102  of the collection device  24  can use the entry criteria  226  to determine when an associated structured collection procedure  70  is appropriate for the individual&#39;s physiological context and to ensure that all of the necessary inputs to the associated structured collection procedure have been established. Therefore, it is to be appreciated that the start date and/time of a structured collection procedure may dynamically change automatically by the processor  102  of the collection device  24  if the predefined condition(s) of the entry criteria  226  is not satisfied. Accordingly, until the entry criteria  226  is satisfied, the start date and/time of the associated structured collection procedure  70  can be at some unknown time in the future. 
     For example, in one embodiment, a structured collection procedure  70  can be chosen automatically by the processor  102  from a plurality of structured collection procedures  70   a ,  70   b ,  70   c ,  70   d , such as provided in memory  110  of the collection device  24 , memory of the computer  18 ,  25  and/or from server  52 , based on satisfying the condition(s) of a defined entry criteria  226  for an associated structured collection procedure. For example, in one embodiment, a first structured collection procedure, such as procedure  70   d , is useful for showing trends in blood glucose levels (“bG Level Trending”). Therefore, an entry criteria  226  for the first structured collection procedure  70   d  may be for the individual to have a bG level mean which has elevated over a defined period (e.g., a past number of days, weeks, and months from the current date) above a certain pre-defined rate. For a second structured collection procedure, such as procedure  70   a , its entry criteria  226  may require a particular number of bG measurement for a pre-breakfast measurement over a defined period (e.g., a past number of days, weeks, months, from the current date) being below a pre-defined bG value. In such an example, the processor  102  upon start up in one embodiment when commanded, such as via input received via the user interface, in another embodiment, or at a scheduled time as programmed by the software  34  in another embodiment, can run through the various entry criteria  226  provided by the various structured collection procedures  70   a  and  70   d  that are, for example, provided in memory  110  of the collection device  24  and determine whether the stated condition(s) for the entry criteria  226  of a particular procedure  70  is satisfied. In this example, the processor  102  determines that the historical data from past measurements in memory  110  indicate that the individual&#39;s bG level mean has been elevating, and that the entry criteria  226  for the first collection procedure  70   d  has been met, but not the entry criteria for the second collection procedure  70   a . In this example, the processor  102  then automatically selects and starts the first structured collection procedure  70   d  based on the above-mentioned analysis. 
     It is also to be appreciated that the use of the entry criteria  226  can help to reduce the misallocation of medical expenses by assuring that the indications of use for the structured collection procedure  70  have been met before starting the schedule of collection events  222 . The entry criteria  226  as well can help assure that any requests to perform multiple structured collection procedures do not overlap if incompatible, are not unnecessary repeats of each other, or provide a significant burden on the individual. In this manner, many of the noted problems in which an individual may avoid any further attempts to diagnose their chronic disease or to optimize therapy can be both addressed and avoided automatically by the processor  102  of the collection device  24  via use of the entry criteria  226 . 
     As shown by  FIG. 5B , the entry criteria  226  can include context specific entry criteria  234 , procedure specific entry criteria  236 , and combination thereof. Examples of context specific entry criteria  234  can include one or more variables to identify meals, low blood glucose events, insulin type and dosage, stress, and the like. In another example, the context specific entry criteria  234  can be defined such as in the form of a specific question(s), to which the processor  102  requires a specific answer to be received from patient via input from the user interface  146 . For example, the processor  102  in executing the entry criteria  226  may display on the display  108  the question of whether the individual is willing and able to perform the structured collection procedure  70  over the required period. If the individual responses affirmatively via the user interface  146 , then the entry criteria  226  has been satisfied and the processor  102  continues automatically with performing the collection events  237  according to the their associated timing as defined in the structured collection procedure  70 . If the individual responses in the negative to the displayed question, then the processor  102  will not continue with the structured collection procedure  70 , and may for example, re-schedule the asking of such a question to a future time, such as if designated by an options parameter. 
     Examples of procedure specific entry criteria  236  can include one or more variables to identify disease state, disease status, selected therapy, parameter prerequisites, insulin to carbohydrate ratio prior to testing insulin sensitivity, incompatible collection procedures, and the like. The procedure specific entry criteria  236  can be defined such that the processor  102  will continue automatically with the structured collection procedure  70  with one of three initiators—the individual  12 , the clinician  14 , or data, e.g., if the condition(s) of the entry criteria  226  is satisfied. For example, the procedure specific entry criteria  236  can be satisfy if the clinician  14  has prescribed the structured collection procedure  70 , such as via an authorized user entering via the user interface  146  a valid password to unlock the particular structured collection procedure for use, in one embodiment. In another embodiment, the clinician  14  can send the password or an authorization code from clinician computer  25  and/or server  52  to the collection device  24  which prescribes (authorizes) the collection procedure  70  for use by the individual  12  on the collection device  24 . It is to be appreciated that one or more structured collection procedure  70  can be provided in memory  110  of the collection device  24  which cannot be used by the individual  12 , and which can be also hidden from being viewed on the display  108 , such as in a selection list, by the individual until authorized by the clinician  14 . 
     The procedure specific entry criteria  236  can be satisfy by a user for example, by the user selecting a particular structured collection procedure  70  from a listing of structured collection procedures  70   a ,  70   b ,  70   c ,  70   d  provided on the display  108 . An example of a data initiated procedure for criteria  236  would be that a biomarker measurement(s) provided to the processor  102  indicates a certain condition which must have occurred or be present in order for the entry criteria  226  for the particular structured collection procedure to be satisfied. Such a condition, for example, can be the occurrence of a single event, such as a severe hypoglycemic event, or a series of events, such as hypoglycemic events within a given, a predetermined time frame, such as in 24 hours from a start time, in one week from a start time, etc, a calendar date-time, and the like. 
     Accordingly, the entry criteria  226  can be a single criterion or multiple criteria that establish context and/or condition of the individual&#39;s physiology that are relevant to the medical use case being addressed by the structured collection procedure  70 . In another embodiment, the entry criteria  226  can be assessed after data has been collected, such as, on historical data. 
     The schedule of events  222  specifies one or more events  237  which each comprises at least one or more variables defining a performance time  238 , the guidance  230  to perform the event, requests  240  for patient actions, which may include a request for information from the individual and/or a request for collection of at least one type of biomarker data from the individual, and combinations thereof. For performance time  238 , the schedule of events  222  can specify timing of each event  237 , such as for a biomarker sampling at a particular time on three consecutive work days, or one sample at time of wake-up, one sample thirty minutes later, and another sample one hour later. 
     The guidance  230  for each event  237  and for any criteria  224 ,  226 ,  228  may include, for example, providing electronic reminders (acoustic, visual) to start, end and/or wake up at a particular time, to perform a bG collection at a particular time, to ingest a particular meal or food(s) at a particular time, to perform a certain exercise(s) at a particular time, take medication at a particular time, and the like. Guidance  230  may also include information, questions and requests to record particular information about physiology, health, sense of well-being, etc., at a particular time, suggestion to improve compliancy with the collection procedure, encouragement, and positive/negative feedback. 
     It is to be appreciated that the events  237  define all the steps that are necessary to be preformed in advance of as well as after a biomarker sampling according to a request  240 , such that a reproducible set of circumstances, i.e., context before and/or after the sampling, is created in the biomarker data for the biomarker sampling. Examples of such biomarker data, in the context of diabetes, include fasting blood glucose values, pre-prandial glucose values, postprandial glucose values, and the like. Examples of a set of circumstances can include data associated with the biomarker value which identifies collected information in the data about meals, exercises, therapeutic administration, sleep, hydration, and the likes. 
     Each of the events  237  in the schedule of events  222  can be time-based, event-based, or both. An event  237  can also be a start of a meal, a wake-up time, start of exercise, a therapeutic administration time, a relative offset used with a prior glucose value, or a time indicating movement above or below a predetermined biomarker value threshold. The events  237  can also include any required patient actions necessary to be performed in advance of and during biomarker sampling such that reproducible circumstances are created at the time of biomarker sampling. This can includes one or more of meals, exercise, therapeutic administration, sleep, hydration, and the like. Additionally, the events  237  in the schedule of events  222  can be adjusted (number, types, timing, etc.), to accommodate work schedule, stressors, and the like of the individual  12 . 
     As mentioned above previously, the adherence criteria  224  is used to assess qualitatively whether an event  237  performed according to the schedule of events  222  provided data which is acceptable to addressing the medical use case upon which the structured collection procedure  70  is based. In particularly, the adherence criteria  224  can provide variables and/or values used to validate data from a performed event  237 . For example, an adherence criteria  224  can be a check performed by the processor  102  of the collection device  24  that a value collected in response to an event  237  is within a desired range, or is above, below, or at a desired value, wherein the value may be a time, a quantity, a type, and the like. The same or different adherence criteria  224  may be associated with each of the events  237  within the schedule of events  222  as well with the entry criteria  226  in one embodiment, and as being the exit criteria  228  in another embodiment, such as illustrated by  FIG. 6D  (i.e., “stop exercising when bG back in target range” which defines both the adherence and exit criteria). In one embodiment, one or more events  237  in the schedule of events  222  may be modified (e.g., added, deleted, delayed, etc.) if a particular event or events fail to met the adherence criteria  224  for the particular event or events. In one embodiment, the failure of the adherence criteria  224  can trigger an adherence event  242 . In one embodiment, upon occurrence of an adherence event  242  due to the associated adherence criteria  224  for an event  237  not being met or satisfied, the processor  102  may be required one or more additional actions as a consequence. For example, the processor  102  may prompt on the display  108  additional information to the individual, and/or prompt a question to determine whether the individual  12  is sick, stressed, or unable to perform the request e.g., eat the meal, or exercise. If the individual answers “Yes”, e.g., via the user interface  146 , then as part of the adherence event  242  the processor  102  can provide a delay to the schedule of event (i.e. suspend). In one embodiment, the delay can continue until the individual indicated that he or she is better in response to another question prompter by the processor  102 , such as the next day or after a predefined amount of time as also part of the adherence event. For example, the individual  12  is prompted by the processor  102  to administer a drug, but the individual is not at home, such as for example, where his/her insulin is located. The individual  12  can select the delay via the user interface  146 , wherein the processor  102  re-prompts the individual after a predetermined amount of time. This delay may also have an upper limit in which if the schedule of events is not re-started within a certain amount of the time, the structured collection procedure  70  in such a circumstance may just end. In another embodiment, another form of an adherence event is a violation event, which results when the person executing a structured collection procedure  70  fails to make a recommended change in response to a request. For example, the request may be for the individual to adjust a drug dosage from 10 U to 12 U, wherein the individual answers in the negative to a question on the displayed on the display  108  asking if the individual will or has complied with such a change. In response to such a violation event, the processor  102  may also send a message and/or provide a delay as previously discussed above concerning the adherence event. 
     In another example and in one embodiment, a bG measurement must be collected before each meal in order for a structured collection procedure  70  to provide data that is useful in addressing the medical use case or question for which it was designed, such as identified by the use case parameter  220 . If, in this example, the individual fails to take a bG measurement for the lunch meal in response to a request  240  for such a collection according to the schedule of the event  222 , and hence the adherence criteria  224  for that event  237  fails to be satisfied, the processor  102  in response to the associated adherence event  242  can be programmed according to instructions in the collection procedure  70  to cancel all remaining events  237  in the schedule of events  222  for that day, mark the morning bG measurement stored in the data file (such as data file  145  ( FIG. 4 ) as invalid, and reschedule for the schedule of event  222  for the next day. Other examples of further actions in which the processor  102  may take in response to an adherence event  242  may be to dynamically change the structured collection procedure by switch to a secondary schedule of event, which may be easier for the individual to perform, provide additional events for measurements to make up the missing data, change the exit criteria from a primary to a secondary exit criterion providing modified criterion(s), change the adherence criteria from a primary to a secondary adherence criterion, fill in the missing data for the failing event with (an estimate from) historical data, perform a particular calculation to see if the structured collection procedure  70  can still be successfully performed, send a message to a particular person, such as a clinician, of the failing event, provide a certain indication in the associated data record  152  to either ignore or estimate the missing data point, and the likes. In still another embodiments, the adherence criteria  224  can be dynamically assessed, such as for example, based on one or more biomarker values and/or input received from the user interface in response to one or more questions, via an algorithm which determines whether the collected data provides a value which is useful in addressing the medical use case or case. In this example, if the calculated adherence value is not useful, for example, does not fall into a desired range or meet a certain pre-define value, then further processing as defined by the resulting adherence event would then take place, such as any one or more of the processes discussed above. 
     The exit criteria  228  as mentioned previously above establishes the requirements for exiting or completing the structured collection procedure  70 , so that the structured collection procedure  70  has adequate contextual data to answer the medical question addressed by the structured collection procedure  70 . The exit criteria  228  can help increase the efficiency of the structured collection procedure  70  by minimizing the number of required samples needed to address the medical use case. By “addressing”, it is meant that sufficient data has been collected in which the clinician  14  may render an assessment to the medical use case. In other embodiments, the assessment may be indicated by a given confidence interval. A confidence interval is a group of discrete or continuous values that is statistically assigned to the parameter. The confidence interval typically includes the true value of the parameter at a predetermined portion of the time. 
     As with the entry criteria  226 , the exit criteria  228  can comprise one or more of context specific exit criteria  244 , procedure specific exit criteria  246 , and combinations thereof. Examples of context specific exit criteria  244  can include one or more variables to identify mood, desired blood glucose events (i.e., blood glucose level), to indicate stress, illness, contraindications, such as for example, hyperglycemia, hypoglycemia, vomiting, a fever, and the likes. Examples of procedure specific exit criteria  246  can include one or more variables to identify a number of events meeting the adherence criteria, biomarker values being in a desired pre-determined range and/or at a desired pre-determined value, a desired disease state, desired disease status, no change in the biomarker after a pre-determined period, or no significant progress over a pre-determined period to a desired biomarker value, and the like. It is to be appreciated that in one embodiment the exit criteria  228  can establish the condition(s) needed to be met for entry criteria  226  of a second structured collection procedure  70 . For example, upon having a suitable Insulin-to-Carbohydrate (I:C) determined with a first collection procedure, such as for example, structured collection procedure  70   b  ( FIG. 6B ), running a structured test for determining the best time for administering a bolus in regards to a start of a meal, such as for example, procedure  70   c  ( FIG. 6C ), which needs a current I:C ratio, can be conditioned such that the processor  102  can implement automatically a schedule of events of the second structured collection procedure  70   c  upon meeting the exit criteria of the first structured collection procedure  70   b  at some unknown time. In other embodiment, for example, the exit criteria  228  of a first structured collection procedure  70  that is being run by the processor  102  according to the schedule of events  222  and the entry criteria  226  of the second structured collection procedure  70  both can be based on the same one or more contraindications, such as mentioned above. In such an embodiment, upon occurrence of a contraindication being provided to and/or detected by the processor  102 , such as via the user interface  146  and/or the biosensor  140 , respectively, which in this example meets the exit criteria  228  of the first structured collection procedure  70 , the processor  102  would automatically start the schedule of events of the second structured collection procedure  70  as the entry criteria  226  of the second structured collection procedure  70  has also been met. An example of such a second structured collection procedure  70  which can be started via exiting a first structured collection procedure can be one which has a schedule of events  222  which requests a biomarker samplings at a routine interval, e.g., every 30 minutes, every hour, every day at a particular time, etc., until the contraindication(s) clears (e.g., biomarker value(s) reaches a desire range or value, individual  12  indicates to processor  102  via user interface  146  no longer having a contraindication(s), expiration of a predefined period, etc.). Such an embodiment is useful if recording the context and values of the events after the occurrence of the contraindication(s) is a desire and in which the first collection procedure should be exited when a contraindication(s) occurs. 
     The exit criteria  228  can be a single criterion or multiple criteria that establish the conditions to exit the structured collection procedure  70 . The conditions are provided in a preferred embodiment such to ensure that adequate contextualized biomarker data has been obtained to answer the medical question being addressed by the collection method. For example, such that a predetermined number of valid samples have been acquired, or that the variability in the samples is below a predetermined threshold. Therefore, it is to be appreciated that the end date and/time of the collection procedure  70  may be dynamic and be changed automatically by the processor  102  if the predefined condition(s) of the exit criteria  228  is not satisfied. Likewise, the conditions of the exit criteria  228  may be dynamic and be changed automatically be the processor  102  such for example if a particular adherence criteria  224  is satisfied or not satisfied. For example, in one embodiment if adherence criteria  224  for a particular collection event  237  is met, then the processor  102  is instructed to use a first exit criterion and if not met, then the processor  102  is instructed to use a second exit criterion that is different from the first exit criterion. Accordingly, until the exit criteria  228  is satisfied, the end date and/time of the structured collection procedure  70  can be at some unknown time in the future. In another embodiment, the exit criteria  228  can be assessed after data has been collected, such as, on historical data. 
     It is to be appreciated that the entry and exit criteria  226 ,  228  together with the adherence criteria  224  can help to reduce both the time to perform the structured collection procedure  70  and the expense associated with the collection by defining one or more of the acceptable conditions, values, structure and context needed to perform the schedule of events  222  in an effort to make every collection event  237  count and/or reduce consumption of test strips  30  with unneeded collections that do not help address the medical use case or question. Hereafter reference is made to  FIGS. 6A-6E . 
     Structured Collection Procedure Examples 
       FIGS. 6A-E  illustrate examples of some structured collection procedures  70   a ,  70   b ,  70   c , and  70   d  depicting their functions which can easily be translated by one of ordinary skill in the related art into instruction code which may be implemented on any one of the devices the above described devices  18 ,  24 ,  25 ,  26 ,  28 ,  36 ,  52 . Therefore, for brevity, no discussion is provided in regard to pseudo-code or actual code relating to these illustrated functions. 
       FIG. 6A  diagrammatically illustrates an embodiment of a structured collection procedure  70   a  used to obtain contextualized biomarker data from a diabetic patient. The horizontal axis shows the performance times  238  of the various events  237 , and the vertical axis shows adherence criteria  224  without values. In the illustrated embodiment, the events  237  can include recording information regarding a meal  248  and sleep  250  in which to provide context  252  for the five-biomarker samplings  254  also events  237  that are part of the schedule of events  222 . In this example, the adherence criteria  224  for the meal  248  can be a value which must be greater than a minimum value, e.g., for a carbohydrate amount. The entry criteria  226 , for example, can comprise a biomarker value being above a particular value such as required to meet contextualization requirements to begin the structured collection procedure  70   a . The exit criteria  228  as well can comprise a biomarker values being below a particular value such as also required to meet contextualization requirements to end the structured collection procedure  70   a . Such a structured collection procedure  70  is useful for helping to address a number of medical use cases. 
     Another example is diagrammatically depicted by  FIG. 6B  which shows a structured collection procedure  70   b  which has a defined medical use case parameter  220  indicating that the procedure can be helpful for determining suitability of an insulin to carbohydrate (I:C) ratio. As illustrated, the entry criteria  226  is defined as having the individual simply acknowledge guidance  230  of selecting a fast-acting meal, to note that the insulin dose is calculated with the current I:C ratio as well as agreeing not to exercise, take additional food or insulin during the testing period. For example, the processor  102  can present on the display  108  such guidance  230 , which the user can then acknowledge after reading with either a “Yes” or a “No” entered via using the user interface  146  for the desired entry choice. If the user enters “Yes”, then the entry criteria  226  is satisfied, and the processor  102  automatically starts the schedule of events  222  defined in the structured collection procedure  70   b . In another embodiment, the entry criteria  226  may be or include satisfying a request  237  for selecting a fast-acting meal. For example, the request  237  for selection can be the processor  102  displaying on the display  108  a selection menu providing a listing of fast-acting meals to which input of such a selection via the user interface  146  is needed. For example, selection of a fast-acting meal may be made via a press of one of the buttons  147 ,  149  or via the touch screen interface if provided by display  108 . Such a selection can then be stored in memory  110  of the collection device  24  such as setup data  163  ( FIG. 4 ) which may be part of the data file  145  ( FIG. 4 ) for the structured collection procedure  70   b . In an alternative embodiment, a particular fast-acting meal may be recommended by the structured collection procedure  70   b.    
     As shown, the schedule of events  222  can comprise one or more events, such as the plurality of events  237   a - k  illustrated and with each having associated performance times  238   a - k  and requests for action  240   a - k . As shown, the requests for action  240   a - c , and  240   f - k  are requests for the user to take a bG level measurement, request  240   d  is to take an insulin dose, and request  240   e  is to eat the fast acting meal. Also shown is that events  238   f - k  each have an adherence criteria  224 , which must be met if the data for events  238   f - k  are to be recorded in the data file  145 . In this example, the adherence criteria  224  requires that the actions  240   f - k  be completed within ∀20 minutes of their corresponding performance times  238   f - k  in order for a data record  152  recording the received value(s) for the corresponding event  237   f - k  to count towards completing the collection procedure  70   b . In one embodiment, the processor  102  will make each of the requests  240   a - k  at their associated performance times  238   a - k  in order to obtain resulting data values e.g., data values  256   a - k  ( FIG. 4 ) at the time the requests are performed. 
     For example, the processor  102  can prompt the individual  12  with a request  240   a  to take a bG level (biomarker) measurement at performance time  238   a . The resulting measurement when received by the processor  102 , such as automatically from the measurement engine  138  after reading the test strip (biosensor)  140  for the desired biomarker, is then recorded automatically by the processor  102  in the date file  145  as a corresponding data value  256   a  for the associated event  237   a . For actions  240   d  and  240   e , at a required time, the processor  102  can automatically prompt the individual  12  to take the prescribed action at the required time, and again automatically prompt the individual thereafter to confirm that the required action has been taken, or that a predefine status has been achieved. A date-time stamp  169  can also be provided in the date record  152  automatically by the processor  102  upon triggering of the requests  240   a - k , acknowledgement of the requests  240   a - k , upon completion of the event  237   a - k , upon receiving a data value  256   a - k  for the event  237   a - k , and combinations thereof. Additionally, in another embodiment, the individual  12  can record data values  256   a - k  for one or more events  237   a - k  by entering the data directly into the device  24  via the user interface  146 , wherein the processor  102  stored the entered data values/information in the associated data record  152  for the event  237   a - k , or in other embodiments can record a voice message with the information for later transcription into digital data. In still other embodiments, the individual  12  can be guided by the collection device  24  to record data for an event  237   a - k  using a paper tool  38 . 
     As mentioned previously above, each event  237  can be a recording of a biomarker value, or a request for a required patient action that is necessary in order to create a context for the biomarker value, such as for example, meals, exercise, therapeutic administration, and the like. In the illustrated embodiment, the context  252  for completing events  237   a - c  is to establish a pre-prandial baseline and a no-trend condition, and for events  237   f - k  to establish a post-prandial excursion and tail. Such context  252  for these events may also be associated with the corresponding data records  152  for each event as contextual information  156  ( FIG. 4 ). Such information is useful later when reconstructing the data and/or when there is a desire to know the context for which the data record was created. 
     It is to be appreciated that any patient action taken outside of the required requests for patient actions  240   a - k  can also be recorded by the processor  102  but will not be considered by the processor  102  as part of the collection procedure  70   b . Data  256   a - k  for events  237   a - k  that are prospective can be identified based on a type of event, the time of the event, the trigger of the event, and combination thereof. Each of the performance times  238   a - k  can be fixed or variable based on prior data. Some of the event  237   a - k  in other embodiments can also be a past, current, or a future event such as for meals, exercise, and the like, or data values such as for hypoglycemic events, hyperglycemic events, or data of a specific value of interest. In some embodiments, the events  237   a - k  can be identified via a paper tool  38  that is procedure based. 
     As also shown, the structured collection procedure  70   b  will end if the condition of the exit criteria  228  is satisfied. In this example, the exit criteria  228  is satisfied if at least three of the actions  240   f - k  met the adherence criteria  224 . For example, the processor  102  may provide a unique identifier (e.g. an incremental count)  167  ( FIG. 4 ) in the data file  145  for each event  237   a - k  performed and to which satisfied the adherence criteria  224  if required. In the illustrated embodiment of  FIG. 4 , events  237   a - c  and  237   e - k  each receive a unique identifier but not event  237   d , e.g., &lt;null&gt;, since not satisfying an associated adherence criteria (not shown). In addition, analysis logic  258  and resulting recommendations  260  can also be provided in the structured collection procedure  70   b  which the processor  102  may apply automatically to the data collected upon satisfying the exit criteria  228  in one embodiment. 
     Similar features are also provided in the examples illustrated by  FIGS. 6C and 6D , wherein  FIG. 6C  depicts a structured collection procedure  70   c  which has a defined medical use case parameter  220  indicating that the procedure is helpful for determining suitability of a bolus in regards to a meal start. Likewise,  FIG. 6D  depicts a structured collection procedure  70   d  which has a defined medical use case parameter  220  indicating that the procedure is helpful for determining suitability of an exercise equivalent to a carbohydrate intake. In addition to the above examples, other such structured collection procedures may be designed to address other various medical use cases such as, for example, the following: determining the effects of eating a particular food on a biomarker level of an individual; determining the best time to take medication before and/or after a meal; and determining the affect of a particular drug on a biomarker level of an individual. Still other structured collection procedures can be provided which may be useful in addressing questions concerning how best to initialize therapy for an individual, finding a determination of status of an individual&#39;s disease progression, finding the best ways to optimize an individual&#39;s therapy, and the like. For example, the clinician  14  can define and/or use a pre-defined structured collection procedure  70  which looks at factors which may have an effect on the therapy of the individual. Such factors can include, for example, stress, menstrual cycle, pre-dawn effect, background insulin, exercise, bolus timing with respect to a meal, basal rate, insulin sensitivity, post-prandial behavior, and the like. 
       FIG. 6E  shows a diagram structured collection procedure  70  comprising one or more multiple sampling groupings  262  each comprising a recurring schedule of events  222  provided between the entry criteria  226  and the exit criteria  228 . In this example, the schedule of events  222  comprises one or more events  237  occurring each day at consistent times of day. As the structured collection procedure  70  in the process of obtaining contextualized biomarker data from a diabetic individual  12  can span over multiple days, even week and/or months before the exit criteria  228  is met, one or more checks  264 , such as for parameter adjustment, and/or evaluation of whether to re-run the sampling groupings  262 , can also be provided between the entry and exit criteria  226 ,  228  in one embodiment. The duration between such checks  264  can be used for physiological system equilibration, evaluation of treatment efficacy, or convenience. For example, either between each sample grouping  262  or after a predefined number such sampling grouping  262  (as shown), an analysis for the check  264  can be performed by the processor  102  to determine whether an adjustment to any parameter in the collection procedure  70  is needed. 
     For example, such analysis may be either for a parameter optimization or efficacy assessment. For the parameter optimization, the processor  102  can run calculations on the samples provided within a previous schedule of events  222  or sample grouping  262 , using information from prior optimizations, clinician set parameters, and a collection or therapy strategy, recommends a new parameter value. For the efficacy assessment, the processor  102  can evaluate data not utilized by the optimization analysis. Additionally, it is to be appreciated that after a group of samples, i.e., sampling group  262 , are taken the processor  102  can also evaluate the data from the sampling group  262 , such as if such data is need in order to alter/optimize a person&#39;s therapy. Adherence criteria  224  can be applied to the perform this evaluation to the data of the sampling group  262 . For example, a first adherence criteria  224  can be used by the processor  102  to assess whether a minimum amount of data is provided by the sampling group  262  and if not, for example, the alteration/optimization of the individual&#39;s therapy will not take place. Another adherence criteria  224  could permit the processor  102  assess whether the data is acceptable to permit an adjustment called for by the check  264 , such as looking at spread of the data, whether these is too much variability (noise), as well as other data attributes to use the data. In this example, if meeting such adherence criteria, then processor  102  has assessed that there is minimum risk that adjusting a parameter of the procedure could readily result in a severe event, e.g., hyper- or hypoglycemic event. Lastly, an adherence criteria can be used by the processor to assess the exit criteria  228  based on the data of sampling group, for example, the exit criterion is met when the data from the sampling group  262  satisfies the adherence criteria, such as for example, discussed above, for the sampling group. 
     It is to be appreciated that collection or therapy strategies can be categorized into scale based (sliding or fixed) assessments or formula based assessments. As input to the collection or therapy strategy, the processor  102  in one embodiment can utilize the data collected from a predetermined number of prior sample grouping(s)  262 . This data can be either used as individual points (only the formula based collection or therapy strategies), or combined with filtering for use in a scale based assessment. In another embodiment, for example, the result of a check  264  performed by the processor  102  can also result in a status or recommendation being provided by the processor  102  automatically. Such status or recommendation may be e.g., a status of continuing with current parameter values, a recommendation to change particular parameters, a recommendation to change the adherence and/or exit criteria, a status that the processor  102  switched to a secondary adherence and/or exit criteria based on the analysis performed on the data from a prior schedule of events or prior sample grouping, or a recommendation to terminate the collection procedure, and the likes. 
     Customizing a Structured Collection Procedure 
       FIG. 7  conceptually illustrates one example of a pre-defined structured collection procedure  70 , which has a defined medical use case parameter  220  indicating that the procedure is helpful for medical use cases or questions which need to know the trends in blood glucose (bG) levels of an individual and/or the relationships between blood glucose values and time of day, meal size, and energy level. As mentioned above previously, the use case parameter  220  can be used as an identity tag in which the processor  102  may locate the associated structured collection procedure  70  in response to a search query, such as, for entered use case or question. For example, the search query can be entered into the collection device  24  via the user interface  146  and/or received from the clinician computer  25 . Such a search query may result from a desire to know which uses case can be addressed by the structured collection procedures  70  currently available on the collection device  24 , or to know which structured collection procedure  70  would be useful to address a particular use case or question. Therefore, the use case parameter  220  in one embodiment permits a structured collection procedure  70  to be automatically chosen by the processor  102  from a plurality of structured collection procedures  70   a - d , such as provided in memory  110 , memory  78 , computer readable medium  40 , and/or server  52  based on a selection, such as from a displayed list on the display  108  provided by the processor  102 , or from input received by the processor  102  from the user interface of a defined medical question. In other embodiments, the use case parameter  220  may also indicate the structured collection procedure  70  is also useful for showing relationships between bG level values and time of day, meal size, and/or energy level. 
     In one embodiment, the pre-defined parameters of the structured collection procedure  70  can be displayed for modification/customization by the processor  102  of the collection device  24  on the display  108  and/or by the processor  76  of the clinician computer  25  on the display  82  by an authorized user. Such an authorized user may be identified, for example, on the collection device  24  and/or the clinician computer  25  by a password entered via the user interface  146 ,  86 , respectively. In such an embodiment, the pre-define parameters of structured collection procedure  70  can be displayed on the display  108 ,  82  in which customizable parameters can provide editable or selectable variables via drop-down boxes with various selection choices, radio buttons, check boxes, formatted fields requesting a specific type of information (mm-dd-yyyy, number, letter, etc.), text boxes to enter messages to be displayed, and the likes. The structured collection procedure  70  can be displayed for editing in tabular format (as illustrated) in one embodiment or in a sequential manner listing one parameter at a time in a scroll-through fashion in another embodiment. In still another embodiment, structured collection procedures can be provided which cannot be modified. 
     As shown by  FIG. 7 , the structured collection procedure  70  may further comprise parameters defining one or more criteria setting the conditions needing to be met by the individual  12  to start of the structured collection procedure, i.e., entry criteria  226 , to end the structured collection procedure i.e., exit criteria  228 , and combinations thereof. In one embodiment, the processor  102  of the collection device  24  uses the one or more criteria to automatically start, evaluate, and end the structured collection procedure  70  if the condition(s) defined by the structured collection procedure are met. In still another embodiment, adherence criteria  224 , which are the conditions needing to be met in order for the collected datum/data to be accepted, can also be provided in the structured collection procedure  70 . 
     As also shown in  FIG. 7 , the structured collection procedure  70  further comprise parameters defining one or more (collection) events  237  which together form the schedule of events  222 . Each of the events  237  comprises one or more requests  240 , e.g., for a measurement from the measurement engine  138  of a biomarker value for a sample provided to the biosensor  140 , and/or for information to be entered by the individual via the user interface  146  such as in response to a question presented by the processor  102  on the display  108 . In the illustrated embodiment, the requests  240  are for a bG measurement, a meal size indication (S, M, or L), and an energy level indication (1, 2, 3, 4, 5), in which 1 is lowest and 5 is highest. Other such requests  240  can include indicating whether the individual exercised, indicating a particular food that was consumed, indicating which medicine was administered, indicating dosage of the medicine administered, and the like may also be provided in other structured collection procedures  70 . In the illustrated embodiment, the collection events can be customized by selecting which request  240  the processor  102  should perform via a yes/no selection box. 
     The structured collection procedure  70  may also include guidance  230  and timing or performance time  238  associated with each of the collection events  237  as well as with each of the entry, exit, and adherence criteria  226 ,  228 , and  224 . Such guidance  230  is provided by the processor  102  to the display  108  upon the occurrence of the associated collection event  237  or other parameters. For example, a collection event  237  for a bG measurement before breakfast may also have a request  240  for an indication of the energy level of the individual. Therefore, in this example, the associated guidance  230  which states, “Please indicate energy level” is provided on the display  108  by the processor  102 . It is to be appreciated that the guidance  230  is a text box, field, area, which enables for information to be provided to the individual to help the individual in performance of the structured collection procedure  70 . In this example, selection of a number from 1 to 5 may be made via press of one of the buttons  147 ,  149  or via the touch screen interface if provided by display  108  as a data entry for such a request  237 , which is then stored by the processor  102  in memory  110  of the collection device  24  as part of a data file  145  ( FIG. 4 ) for the structured collection procedure  70 . 
     The timing parameter  238  of the structured collection procedure  70  is used to specify for any one of the associated collection event  237 , the entry, exit, and adherence criteria  226 ,  228 ,  224 , either a specific date and/or time (mm-dd-yyyy, hh:mm), or a period (n) after a preceding collection event in which to perform the associated collection event. The periods n 1 , n 2 , n 3  in the illustrated embodiment for the respective collection events  237  indicate hours, but in other embodiments can be indicated in minutes or seconds. In another embodiment, the timing or performance time parameter  238  for an associated collection event  237  and for the entry, exit, and adherence criteria  226 ,  228 ,  224  can be modified by another collection event and/or by the criteria. 
     For example, in the illustrate embodiment, the entry criteria  226  is modified by the adherence criteria  224  by adding a day if the guidance  230  provided in the form of a question “Are you willing to conduct a test over 3 consecutive days?” is not affirmed by the individual  12  e.g., via a “No” selection provided on the collection device  24 . In this illustrated example, the “Affirms guidance” may be a drop down selection provided in a combo box for customizing the adherence criteria  224  of the associated collection event  237 , which when selected causes the processor  102  to wait for the accepted/not accepted input (e.g., via buttons  147 ,  149 ) before executing the remaining logic (“if not add 1 day to timing”) of the adherence criteria  224 . Still further in this example, the processor  102  in accordance with the logic provided in the adherence criteria  224  associated with the exit criteria  228 , can set the timing or performance time parameter  238  of the exit criteria  228  to the date (mm-dd-yyyy) that is 3 days after completing the entry criteria  226 . It is to be appreciated that the various possible combinations of logic statements which may be performed by the structured collection procedure  70  can be pre-defined and selected by a drop down box in order to be customized in one embodiment, and/or logic statements can be built in another embodiment. 
     The structured collection procedure  70  can also includes an options parameter  232  associated with each of the collection events  237  as well as with each of the entry, exit, and adherence criteria  226 ,  228 ,  224 . The options parameter  232  can have a customizable value(s) to govern whether the data and/or results of the associated collection event  237  or any of the other parameters e.g., entry, exit, and adherence criteria  226 ,  228 ,  224 , in the structured collection procedure  70  meets a particular condition such that still further processing may be carried out by the processor  102  if such a condition(s) is meet. For example, such options can be to have the processor  102  automatically send a message to the physician indicating that the individual has started the structured collection procedure  70  via satisfying the entry criteria  226 , or to provide a message to the individual and/or the physician if the individual fails a collection event  237  by not satisfying an adherence criteria, or to provide a message to the physician when the individual completes the structured collection procedure  70  when the exit criteria  228  is satisfied, or combinations thereof. For example, such an options parameter  232  can have a global list of such actions which is selected on the display  108 , for example, by a selected value from a range of values associated with each option. For example, the options for each parameter can be customized via selecting from a drop down box having option choices (e.g., 1, 2, 3, 4, 5, . . . , A, B, C, etc.) and in which, for example, Option 1 of having the processor  102  provide a message to the physician if the individual fails a collection event  237  (e.g., by not satisfying an adherence criteria), is shown selected for the before breakfast collection event  237 . An example in the context of individual  12  being diabetic is provided hereafter to illustrate further such features provided on a collection device  24  according to the present invention. 
     A typical patient with Type 2 diabetes may measure his/her blood glucose once per day after waking up in the morning. At a routine office visit, the individual&#39;s HbA1C result is found to be elevated. The physician recommends that the person goes through three days of intensified glucose monitoring, and selects the structured collection procedure which is useful for this purpose. The structured collection procedure  70  is then customized as discussed above such that during these three days collection events  237  are defined with a number bG measurement requests  240  such that the individual can be requested by the processor  102  to measure his/her blood glucose before and two hours (e.g., n 1 =2) after breakfast, before and two hours (n 2 =2) after lunch, before and two hours (n 3 =2) after supper, and at bedtime. Additionally, the individual  12  can be requested via other associated requests  240  for each collection event  237  to provide an assessment of the relative size of the ingested meals at the appropriate times as well as an indication how he/she feels with regard to energy level. In the illustrate embodiment of  FIG. 7B , the processor  102  can request the indication of energy level with each collection event  237  and the assessment of the relative size of the ingested meals every other collection event  237  (i.e., after the meal). Furthermore, the physician has provided a condition via adherence criteria  224  of having to perform the meal assessment within ±30 minutes of period (n) of the associated collection event  237  in order for such information to be useful in the assessment. Such information is useful to contextualize the collected data and for the analysis performed on the collected data. 
     Additionally, the physician would like to be notified when the individual has failed to complete the “before breakfast” collection event  237 . Therefore, to facilitate the notification option, the physician customizes the structured collection procedure  70  by set the options parameter  232  associated with the “before breakfast” collection event, via a drop down box to “Send a message to the physician if adherence criteria fails.” All other collection events  237  have their associated options parameter  232  default to indicate that the processor  102  is not to take any additional action with regards to the options parameter. It is to be appreciated that the above described features and arrangements illustrated embodiment of  FIG. 7 , provides a simply and convenient interface and method for customizing a structured collection procedure. 
     Implementing and Performing a Structured Collection Procedure 
       FIG. 8A  shows a flowchart of the method for implementing and performing a structured collection procedure  70  to obtain contextualized biomarker data from a individual  12  according to an embodiment of the invention. It is to be appreciated that a number of structured collection procedures  70   a - d  ( FIG. 2 ) may be stored in memory  110  ( FIG. 3 ) of the device  24  and selected for execution at any desired time. For example, upon pressing a certain combination of the buttons  147 ,  149 , the individual can select a desired structured collection procedures  70   a - c  and the date when to start a collection i.e., a set mode function. For example, a date range to choose from may be to begin the testing tomorrow and end at today +90 days, which the processor  102  can also recorded in the data file  145  ( FIG. 4 ) as part of the setup data  163 . In such an implementation, the processor  102  as instructed by the software  34  reads the setup data  163  for the selected procedure  70  and indicates on the display  108  that the device  24  is the structured tailoring mode, for example, a day before the chosen start date. 
     It should be appreciated that multiple structured collection procedures  70   a - d  can be executed sequentially or simultaneously at any given time. However, in one embodiment, the software  34  permits the user only to schedule another structured collection procedure  70  if the start date is later than the end date of the current structured collection procedure  70  being executed. The software  34  also permits the user to override a scheduled date for a structured collection procedure  70 . If a structured collection procedure  70  is scheduled and the user enters the set mode function again, the software  34  causes the processor  102  to display the scheduled date on the display  108  as the default date; if the user exits the set mode without modifying the date, the previously scheduled date stays active. If a structured collection procedure  70  has started, the software  34  permits the user to enter the set mode and cause the processor  102  to cancel the current structured collection procedure  70 . Upon cancellation, in one embodiment, the software  34  causes the processor  102  to de-tag (e.g., null the unique identifiers  167 ) the data records  152  in the data file  145  for the data collected for the cancelled structured collection procedure  70 . 
     Upon reaching the procedure start in step  316  ( FIG. 8A ), the processor  102  evaluates the whether entry criteria  226  is met in step  318  to begin the structured collection procedure  70  selected to obtain biomarker data to address a predefined use case or question (e.g., use case parameter  220 ). In step  320 , the processor  102  specifies requests  240  according to their associated timing  238  for each event  237  in the schedule of events  222  for the structured collection procedure  70 . It is to be appreciated that the schedule of events  222  provides a sampling plan for biomarker data collection that is performed by the processor  102  to obtain biomarker data in a predefined context. In performing the schedule of events  222  in step  320 , the software  34  causes the processor  102  to assign a unique identifier (e.g. incremental count)  167  in a date record  152  which corresponds to each event  237  in the structured collection procedure  70 . Optionally, each criteria  226 ,  228 ,  224  may also be provide with a date time stamp  169  to indicate when such criteria was satisfied, if desired. 
     Adherence criteria  224  is then applied to the input received (e.g., biomarker data or information) in response to an request  240  to determine whether the input received meets the adherence criteria  224 . When a structured collection procedure  70  has started, all data collected according to requests  240  in the structured collection procedure  70  and which satisfy the adherence criteria  224 , if required in step  322 , are then assigned (tagged) in the data file  145  by the processor  102  with the unique identifier  167  in step  324 . It is to be appreciated that the unique identifier also serves to associates the collected data e.g., data values  256  with their event  237 , the request  240 , and a date-time stamp  169  to indicate when the collection in response to the request  240  was received by the processor  102 . While a structured collection procedure  70  is being executed, in one embodiment the software  34  permits the user to perform a measurement on the device  24  at any time without interfering with the episode. 
     In one embodiment, the software  34  permits reminders for biomarker measurements to be ‘snoozed’ as mentioned above for a period, such as for example, 15 minutes and up to a number of times, for non-critical measurements. In another embodiment, biomarker measurements or data entries that are performed close enough in time to a request  240  in step  320  are designed as valid measurements or data entry for the request  240  by the software  34 . As such, the processor  102  will tag the associated data record  152  for the event  237  with the unique identifier  167  for such a biomarker measurement or data entry accordingly. In the case of biomarker measurements, if the measurement is accepted as valid for the request  240 , the software  34  causes the processor  102  to prompt the user to input additional information if needed by the structured collection procedure  70  to provide context  252  for data resulting from the request  240 . Such additional input, may include, for example, a rating of energy level from 1 to 5, where 1 is low and 5 is high; meal size from 1 to 5 where 1 is small and 5 is large, and exercises from yes or 1 to mean over 30 minutes, and no or 2 to mean less than 30 minutes. Such additional information or contextual information  156  when inputted via the user interface  146  is stored by the processor  102  in the data file  145  associated with the unique identifier  167  for the data event request  240  requiring the additional information also in step  324 . 
     In one embodiment, biomarker measurements determined by the processor  102  as not being close enough in time to the data event request  240  defined by the structured collection procedure  70  will not be tagged with a unique identifier  167  in the data file  145  by the processor  102 . Such is illustrated in the shown data file  145  with request  240   d  and data values  256   d  not being associated with a unique identifier  167  e.g., &lt;null&gt;. An example of a definition of ‘close enough in time to the collection procedure’ as instructed by the structured collection procedure  70  and/or software  34  to cause the processor  102  to make such a determination may be defined as being relative to a prescheduled time or a snoozed time. For example, for pre-prandial measurements up to 15 minutes in anticipation is acceptable; for post-prandial measurements, up to 10 minutes in anticipation is acceptable; and for bedtime measurements, up to 15 minutes in anticipation is acceptable. Other definitions may be provided in other structured collection procedures  70  and/or software  34 . 
     In step  326 , the processor  102  then evaluates whether the exit criteria  228  for the selected structured collection procedure  70  is satisfied. If not, then the processor  102  continues with performance the schedule of events  222  until the exit criteria  228  is satisfied. Upon satisfying the exit criteria  228 , the collection procedure  70  ends in step  328 . In one embodiment, the structured collection procedure  70  may also end if in step  318 , the entry criteria  226  is also not met. 
     In some embodiments, the structured collection procedure  70  can be configured for performance as a paper tool  38 ; diabetes software  34  integrated into a collection device  24  such as a blood glucose meter  26 ; diabetes software  34  integrated into the computing device  36 , such as a personal digital assistant, handheld computer, or mobile phone; diabetes software  34  integrated into a device reader  22  coupled to a computer; diabetes software  34  operating on a computer  18 ,  25  such as a personal computer; and diabetes software  34  accessed remotely through the internet, such as from a server  52 . When diabetes software  34  is integrated into a collection device  24  or a computing device  36 , the diabetes software  34  can prompt the individual to record diary information such as meal characteristics, exercise, and energy levels. The diabetes software  34  can also prompt the individual to obtain biomarker values such a blood glucose values. 
     GUI Interface Providing a Selectable Structured Collection Procedure 
       FIG. 8B  shows a method of implementing the structured collection procedure via a graphical user interface provided on a collection device  24 , which when executed on the collection device, cause the processor  102  to perform the following steps. Upon pressing a certain combination of the buttons  147 ,  149 , the individual  12  can scroll to the structured collection procedure  70  available for selection in a list  329  provided by the processor  102  on the display  108  of the collection device  24  in step  330 . If desiring to start the structured collection procedure, the individual  12 , for example, selects via pressing an OK button  151  in step  332 , the desired structured collection procedure  70 . In this example, the entry criteria  226  ( FIG. 7 ) of the structured collection procedure  70  provides information in step  334  which the processor  102  displays to the user on the display  108 . After reading the displayed information, the user presses any button in step  336  in which the next procedure in the entry criteria  226  is performed by the processor  102 . In this illustrated example, as part of the entry criteria  226 , a question is then asked in step  338  by the processor  102 . If the individual  12  is still desirous of starting the structured collection procedure, the individual  12  selects the OK button  151  in step  340 ; otherwise, any other press via button  147 ,  149  will cause the processor to go back to the list  329 , thereby stopping the set-up procedure for the structured collection procedure  70 . 
     After the individual  12  presses the OK button  151 , the processor  102  in step  342  will provide on the display  108  an alarm clock  343  for setting the time to begin the selected structured collection procedure  70 . It is to be appreciated that all the required events  237  for biomarker sampling, patient information, etc., is automatically schedule by the processor  102  in accordance with the schedule of events  222  for the structured collection procedure  70  in which timing, values, questions, etc., therein may have been adjusted as discussed previously above in reference to  FIG. 7 . Therefore, other than entering the start time as permitted by the entry criteria  226 , no other parameter adjustments in the structured collection procedure  70  is required by the individual  12  (or permitted in one embodiment). 
     In the illustrated embodiment, the individual in step  344  can adjust the start time of the structured collection procedure for the next day, e.g., Day 1, via buttons  147 ,  149 . Upon confirming the start time in step  346  via pressing the OK button  151 , the start time is recorded in memory  110  as part of the setup data  163  in the data file  145  ( FIG. 4 ) for the structured collection procedure  70  by the processor  102 . The processor  102  then displays the selection list  329  on the display  108  in step  348 , thereby completing the set-up procedure, which satisfies the entry criteria  226 , and indicates on the display  108  that the collection device  24  is in a structured tailoring mode  349 . 
     It should be appreciated that in one embodiment multiple structured collection procedures can be executed sequentially or simultaneously at any given time, and hence in one embodiment the mode  349  provided on the display  108  will indicated which structured tailoring is being performed. However, in one preferred embodiment, the software  34  does not permits the user to schedule another structured collection procedure, unless the start date is later than the end date of the current structured collection procedure being executed via the user interface  146 . It is to be appreciated that processor  102  may re-schedule the following structured collection procedures automatically if the current structured procedure is still running due to the exit criteria  228  not being met. The software  34  in another embodiment may also permit the user to override a scheduled date for a structured collection procedure. If a structured collection procedure is scheduled and the user enters the set mode function again, the software  34  causes the processor  102  to display the scheduled date on the display  108  as the default date; if the user exits the set mode without modifying the date, the previously scheduled date stays active. If a structured collection procedure has started, the software  34  permits the user to enter the set mode and cause the processor  102  to cancel the current structured collection procedure, if desired. 
     In step  350 , an alarm condition  351  can be provided by the processor  102  the next day (as indicated by the symbol Day 1) as was set in the above-mentioned procedure the previous day (as indicted by the symbol Start Up). Upon the user selecting any button  147 ,  149 ,  151  in step  352 , the processor  102  as instructed by schedule of events  222 , provides a first scheduled event  237  which is information  353  to be displayed on display  108  in step  354 , which the individual  12  acknowledges with any button  147 ,  149 ,  151  being pressed in step  356 . Next in step  358 , the processor  102  is instructed by the schedule of events  222  to execute a second scheduled event, which is to display on the display  108  a question  359  for the individual, which the individual  12  acknowledges with any button  147 ,  149 ,  151  pressed in step  360 . In the illustrated embodiment, the individual in step  362  indicates the start time of breakfast in minutes from the wake up alarm  351  previously acknowledged in step  352 . Upon confirming the meal start time in step  364  to the processor  102 , via pressing the OK button  151 , the meal start time is recorded in memory  110 . For example, the meal start time is recorded in the data file  144  in the associated data record  152  as data for the event  237  by the processor  102 . Additionally, in step  366 , the processor  102  displays to the individual  12  the information regarding the timing for the next schedule event as a reminder. In step  368 , upon reaching the next scheduled event indicted by the schedule of events  222 , the processor  102  provides a request  240  on the display  108  for the individual to take a measurement, e.g., a blood glucose measurement. Additionally, in step  370 , the processor  102  also makes a request  240  for information on the size of the meal that is to be ingested as required by the schedule of events  222  in order to provide contextual information  156  to the measurement value. 
     As mentioned above previously, for each event the software  34  causes the processor  102  to assign a unique identifier (e.g. incremental count)  167  ( FIG. 4 ) to the data of each request  240  provided in the schedule of events  222  which meet the adherence criteria  224  in the associated date record  152  for the event  237 . Therefore, while the structured collection procedure is being executed, the software  34  permits the user to perform a measurement on the collection device  24  at any time out side the schedule of events  222 . Such a measurement since not being performed according to a request  240  will not be evaluated for the adherence criteria  224 , and thus will not be provided with a unique identifier  167  in the date file but will only be provided with a date-time stamp and its measurement value. Such data is still recorded in the data file  145 , as such data may still be useful for another analysis. 
     In another embodiment, the software  34  also permits reminders for biomarker measurements, such as provided in step  238 . For example, in one embodiment, the processor  102  provides an alarm and/or alert message for a reminder via the indicator  148  and/or on the display  108 , respectively, to provide a measurement. For example, at the time  238  of a particular request  240  for taking a biomarker measurement (or reading), the processor  102  prompts the individual  12  by al least displaying on the display the message, “It is now time for your reading.” An audible alarm and/or tactile alarm (vibrations) can be provided by the processor  102  via indicator  148  in another embodiment. For example, in one embodiment, the collection device  24  will provide such a prompt even when already powered on, such as by the individual  12  for another reason, e.g., to conduct a non-scheduled event, when in, for example, a window of time in which to take the requested measurement/reading, or even when powered downed, such as in a standby mode, by waking up to provide the reminder via the prompt. In another embodiment, the provided reminder or prompt can be ‘snoozed’ for a pre-defined period as mentioned above, that still falls within the window of time in which to take the requested (critical) measurement/reading such as for example, 15 minutes or any other such suitable time that falls in the window of time. It is to be appreciated that the snooze feature for a measurement/reading that is considered critical to the procedure  70 , e.g., a measurement/reading needed for helping to address the medical use case or question, needed to meet adherence criteria  224 , and/or needed in subsequent analysis for some determination, etc., the snooze feature will not extend the request  240  beyond the window of time provided by the collection procedure  70  via, e.g., adherence criteria  224  for the request  240 . For example, in one embodiment one or more events  237  in the schedule of events  222  can be pre-defined as critical as well as being a primary sample via use of the options parameter  232  ( FIG. 7 ) provided in the structured collection procedure  70 . For example, an event  237  which is designated as critical is one that cannot be missed, but if missed can be replaced by another sample already in the date file  145 . An event  237  which is designated as a primary sample is one that cannot be missed, and which cannot be replaced by another sample, even if available in the date file  145 . In still another embodiment, the snoozing can be up to a number of times, for non-critical measurements. For example, certain events  237  in the structured collection procedure  70  could be designated as having a non-critical request  240 , which can be snoozed, such as via selecting such an option that is provided as one of the options parameter  232  ( FIG. 7 ). The options parameter  232  in this embodiment could for example provide the snooze option as well as a selectable time interval (e.g., 1-60 minutes, etc.) and a selectable number of times (e.g., 1-5, etc.) that the user is permitted to snooze the request  240 . In still another embodiment, the collection device  24  permits for an alarm shut off i.e., the indicator  148  if providing the reminder (audible, vibratory) can be shut off for the entire window of time via the user interface  146 , but wherein processor  102  still accepts the measurement/reading as long as it is made in the window of time. In still another embodiment, the collection device  24  provides a skip reading option also received by the processor  102  via a selection entered using the user interface  146 , e.g., from a list of selectable options, such as for example, snooze, alarm shut off, skip reading, provided on the display  108 , in which again no reminder/prompt will be provided as individual  12  has indicated to the processor  102  that he/she does not want to take that particular requested measurement/reading. It is to be appreciated that selecting the skip reading selection option can result in an adherence event  242  resulting in further processing, such as discussed previously above in early sections, if adherence criteria  224  had been associated with the event  237  prompting the request  240 . 
     In still another embodiment, the adherence criteria  224  can require biomarker measurements to be performed close enough in time to a data event request  240 . Therefore, if such biomarker measurements are performed within the period specified by the adherence criteria  224 , the processor  102  can indicate that the measurements or data entry for the event is acceptable and tags (i.e., assigns the unique identifier  167 ) the value of the biomarker measurement or data entry in the data file  145  accordingly. In the case of biomarker measurements, if the measurement is accepted as valid for the data event request  240  (i.e., meets the adherence criteria  224 ), the schedule of events  222  may causes the processor  102  to prompt the user to input additional information if needed by the structured collection procedure  70 , such as mentioned above regarding step  370  to provide contextual information  156  (i.e., context) to the measurement received in response to a request  240 . 
     Such contextual information  156  when inputted via the user interface  146  can be stored by the processor  102  in the data file  145  associated with the unique identifier  167  for the data event request  240  requiring the additional information. Biomarker measurements determined by the processor  102  as not being close enough in time to the data event request  240  as defined by the adherence criteria  224  will not be tagged in the data file  145  by the processor  102 . Such is illustrated in the shown data file  145  ( FIG. 4 ) with data event request  240   d  and data values  256   d  not being associated with a unique identifier  167 . An example of a definition of ‘close enough in time to the collection procedure’ as instructed by the adherence criteria  224  to cause the processor  102  to make such a determination may be defined as being relative to a prescheduled time or a snoozed time. For example, for pre-prandial measurements up to 15 minutes in anticipation is acceptable; for post-prandial measurements, up to 10 minutes in anticipation is acceptable; and for bedtime measurements, up to 15 minutes in anticipation is acceptable. Other definitions may be provided in other adherence criteria  224  for other events in the schedule of events  222  as well as in other structured collection procedure. 
     In the illustrated embodiment, the user uses the buttons  147 ,  149  to scroll to a selection, which is entered by the processor in the data record  152  for the associated request  240  via pressing Okay button  151  in step  372 . In one embodiment, the meal size can be indicated via a number range, such as for example, from 1 to 5, where 1 is small and 5 is large. In the illustrated embodiment, additional input for contextual information  156  regarding a rating of energy level from 1 to 5, where 1 is low and 5 is high is requested in step  374 , which is entered in the data file  145  as mentioned previously above via the processor  102  receiving input for the request  240  by using the user interface  146  in step  376 . In other embodiment, other contextual information  156  may include indicating whether the individual exercised and/or how long. For example, the user interface  146  may be use in which yes or 1 to mean over 30 minutes, and no or 2 to mean less than 30 minutes. In the illustrated embodiment, as the exit criteria  228  is now meet via successfully performing steps  368 - 376 , the structured collection procedure  70  ends in step  378 , wherein the processor  102  again displays the list  329 , such that the individual  12  may perform other tasks on the collection device  24  if so desired. 
     Generation, Modification, and Transfer of Collection Procedures 
     Embodiments of the present invention also enable the generation, modification, and transfer of collection procedures  70  to and from the collection device  24 . As the collection procedures  70  stem from and aim to address specific medical use cases or questions, the transfer of the resultant information e.g., data file  145 , from one device to another is carried out in a secure manner. Additionally, a method whereby all of the collection procedure related information (e.g., data file  145 ) for an individual or a group of individuals can be managed in a secure and efficient manner. 
     It is to be appreciated that the discussion provided hereafter includes aspects related to the interaction between the clinician  14  and the individual  12 . In particular, the disclosure hereafter provides details regarding the infrastructure required to manage the generation, transfer, and analysis of the collection procedures  70 . Reference hereafter is also made to the system  41  of  FIG. 2 , as aspects pertaining to the transfer of devices and information (data, reports, etc.) to and from the devices  18 ,  25  and  52  are provided. 
     In one illustrated embodiment, the system  41  can comprise server  52  being a web-server that serves as a repository of a plurality of collection procedures  70   a ,  70   b ,  70   c ,  70   d , as software  34  that resides on the clinician computer  25 , and the collection device  24 , such as provided as a blood glucose meter. Henceforth these components are referred to as the “server”, “software”, and the “meter” respectively. Additionally, the computer  25  where the software  34  resides is termed as the “client”. 
     In one embodiment, the server  52  can serve as a central repository for a number of collection procedures  70   a ,  70   b ,  70   c , and  70   d  that address specific medical questions. Accordingly, one or more collection procedures  70  can be downloaded from the server  52  to the clinician computer  25 . In such an embodiment, all communications between the server  52  and the client computer  25  is done in a secure and web-based format. Additionally, in another embodiment, there is no full two-way data transfer between the computer  25  and the server  52  such that data can never be transferred to the server  52 . Furthermore, in other embodiment, a request for a collection procedure from the server  52  can be made only with a valid identifier. Such an embodiment ensures that only authorized clients are allowed to access the server  52  to download the requested collection procedure(s)  70 . 
     In one embodiment, each collection procedure  70  downloaded from the server  52  can be used only once (e.g., if the completed flag or state is set, the procedure  70  cannot be run again until reauthorized by the clinician  14 ). Each successive download of the collection procedure  70  requires access from an authorized client user with a valid ID  71  ( FIG. 2 ). The server  52  also provides the client computer  25  with updates thereby ensuring that the software is the most recent version. There also exist restrictions on the communication from the client computer  25  to the server  52 . The server  52  can only access information related to the installed version of the software  34 . It is not possible for the server  52  to access any data resident in the client database e.g., memory  78 . Additionally, the data on the client computer  25  is access controlled so that it cannot be used and accessed without the necessary permissions. 
     The software  34  residing on the client computer  25  serves as the interface between the server  52  and the meter  24 . The software  34  at the front end includes a user-friendly interface that provides the clinician  14  with ready information pertaining to the overall practice. This information may include details about all assigned individuals, details about the individuals the clinician  14  is scheduled to see on a given day, as well as the details about individuals that need extra attention. The software  34  also interfaces with a database that includes relevant data that is arranged by an individual patient ID, such as used by and provided in the healthcare record system  27 . The software interface also allows the clinician  14  to access the individual  12  details using the individual identifier. In this manner the software  34  provides the clinician  14  with information about the collection procedure(s)  70  that the individual  12  has already completed (i.e., those with a completed set for the completion flag  257 ), the associated results, and also the collection procedure(s)  70  that the individual  12  is currently performing. All of the data residing on the client computer  25  is secure and access-controlled. The server  52  has no means to access the data. The clinician  14  can access data from all individuals in the practice. In addition, an individual  12  can access his data, such as from a server of the clinicians, using his/her patient identifier in a secure web-based format. This data is downloaded to the database on computer  25  from the meter  24  and associated to the individual  12  using the individual identifier. 
     At the time of data download from the meter  24 , the software  34  also performs an analysis on the data to ensure that the integrity of the data is maintained and no corruption in the data has taken place at the time of transfer. The client computer  25  with the help of the software  34  can also send emails to the individuals and these emails can contain information about an upcoming appointment, reminders on what the individual is supposed to do after an appointment and reports that are results of a completed collection procedure  70 . When the clinician  14  downloads a collection procedure  70  from the server  52  for a particular individual, the collection procedure  70  is associated with the individual identifier. In this way, it is possible to account for what collection procedures  70  are currently underway for each of his patients. 
     A downloaded collection procedure  70  can also be modified by the clinician  14  and/or by the individual (if permitted by the collection procedure  70  such as discussed hereafter in reference to process  700 ) using the software  34  to tailor the collection procedure  70  to each individual&#39;s needs as previously discussed above in earlier sections ( FIG. 7 ). At the time of modification of the collection procedure  70 , the clinician  14  (or individual  12  if so permitted) also has the option to alter the analysis that will be carried out on the modified collection procedure  70 . Additionally, even for standard collection procedures  70  that have not been modified, the clinician  14  has the option to add additional options for analysis. 
     Furthermore, the clinician  14  (or individual  12  if so permitted) can decide and set guidelines as to when the procedure  70  must terminate. For example, the clinician  14 , can decide and set how many adherence violations are allowed, i.e., how many measurements can the individual miss, such as via using the options parameter  232  in the collection procedure  70 . 
     Once a collection procedure  70  is introduced into the meter  24  by the clinician  14  (details discussed in the next section), such clinician defined collection procedure  70  cannot be altered by the individual  12 , i.e., except for those collection procedures which can be personalized by the individual as discussed hereafter in a later section. Additionally, the collection procedure  70  is associated with both the clinician  14  (the prescriber) and the individual identifiers to ensure accounting of the collection procedure  70  and associated data (e.g., data file  145 ). 
     The software  34  also allows the clinician  14  to select the type of report that will be generated once the completed collection procedure  70  has been analyzed. This report is tailored for the device on which it will be viewed. The report could be for a mobile device such as a telephone, a palm device or a meter, or a computer, or a printed format. The software  34  also has the ability to connect with an electronic medical records system to add data and results of analysis performed on the data from a collection procedure  70  to the medical records. 
     The meter  24  serves as the mechanism by which prospective and contextualized data is collected by the individual  12  as recommended by the collection procedure  70 . The meter  24  can be owned by the individual or it can be owned by the clinician  14  and loaned to the individual  12  for the duration of the data collection associated with the collection procedure  70 . The clinician  14  can introduce the collection procedure  70  into the meter  24  by a number of mechanisms. For example, the collection procedure  70  can be downloaded from the server  52  and added to the meter  24  via a connecting cable that links the client computer  25  to the meter  24  in one embodiment. The collection procedure  70  can also be obtained in another embodiment on a chip (e.g., computer readable medium  40 ) that can be inserted into the meter  24 . This collection procedure  70  is then loaded into firmware of the meter  24  where it can be initiated by the individual  12 . The collection procedure  70  can also be introduced using an RFID tagged chip (e.g., computer readable medium) in still another embodiment. 
     Along with the downloaded collection procedure  70 , the meter  24  also has the ability to display instructions to the individual  12  that guide the individual at the time of data collection. Additionally, as discussed above, the collection procedure  70  can introduce into the meter  24  both the individual identifiers as well as the clinician identifier. Similarly, the data collected from the meter  24  can be associated with the individual identifier and clinician identifier, such as part of setup data  163  ( FIG. 4 ) in the data file  145 . Additionally, the setup data  163  in the data file  145  can include information about the meter  24  (i.e., measurement noise, calibration data), as well as strip lot numbers and other information about the strips used for any data collection event  237 . Such information may be helpful at the time of data analysis. 
     At the completion of the collection procedure  70  the meter  24  can be connected to the software  34 . At that time data, such as data file  145 , is transferred securely and stored by the processor  76  of the client computer  25  according to the software  34  running thereon. Once the analysis performed on the data from the collection procedure is completed by the software  34  on the client computer  25 , the device  24  also has the ability to store results of the analysis for later patient reference. 
     In still other structured collection procedure embodiments, at each aspect of running the collection procedure  70 , right from initialization to the end of the execution, some sort of status reporting can be provided in which to aid the individual in executing and completing the structured collection procedure. The types of status reports which can be provided at each of the various aspects of execution of the structured collection procedure  70  is discuss hereafter with reference made to  FIG. 9 , which depicts another method for performing a structured collection procedure. It is to be appreciated that process steps shown in  FIG. 9  having like numbering of process steps discussed in proceeding sections have like function, and thus no further discussion is provided for brevity. 
     Start of the Structured Collection Procedure. 
     In one embodiment, starting information  600  can be provided before the individual  12  initiates the structured collection procedure  70 , or in another embodiment as part of the procedure start in process step  316  ( FIG. 8A ). The starting information  600  in one embodiment conveys to the individual  12  the reason(s) why the structured collection procedure should be carried out and also what results can be expected upon successful completion of the collection procedure  70 . In other embodiments, the starting information  600  can include information regarding the entry criteria  226  that needs to be met in order to start the collection procedure  70  in process step  318 . Additionally, general suggestions regarding the requirements for the adherence criteria  224 , e.g., explaining what constitutes a measurement that cannot be used, e.g., not fasting, the requisite time before a fasting reading, etc., as well as encouragement, e.g., “The better the adherence, the better the results as well as the quicker the overall task will be completed,” can be provided in still other embodiments of the starting information  600 . In still other embodiments, specific information for the clinician  14  can also be included in the starting information  600 , e.g., the intended user groups for the collection procedure  70 , the burden of the collection procedure  70 , and the likes. It is to be appreciated that such starting information  600  can be given as a printed report, can be made available in a secure fashion over the web so that it can be viewed on a computer, such as computer  18 ,  25  ( FIG. 1 ), and/or displayed on the display  108  of the device  24 , or on a display of any other appropriate handheld device. In still other embodiments, the starting information  600  is included as part of the guidance  230  ( FIG. 10 ) provided by the structured collection procedure  70  at startup and/or can be pre-defined in the collection procedure  70  and customized by the clinician  14  as desired. 
     In still other embodiments, the starting information  600  can provide the anticipated total amount of time required to complete the collection procedure and the number of expected measurements. An example of such information provided by the starting information  600  for the total time and measurements may be a message which states “The anticipated amount time is about 4 weeks to complete the collection procedure which requires  30  fasting pre-breakfast measurements.” It is to be appreciated that starting information  600  can be delivered in a number of different ways, in addition to the above mentioned means. For example, a calendar either printed, electronically provided on computer  18 , via the web, and/or on device  24  can be provided which contains the days and times at which a measurement is to be made for performing the associated collection procedure  70 . 
     During the Collection Procedure Execution 
     While the structured collection procedure  70  is being executed, for example, on the device  24 , there are a number of indicators that can be provided to the individual  12  as status updates. These indicators help the individual  12  to know how he/she is performing in the execution of the collection procedure  70  and are also useful in providing guidance under special or adverse conditions that the individual  12  might encounter. Such status indicators include, but not limited thereto, the following examples. 
     Initially, and as stated above in a previous section, the structured collection procedure  70  may end if in step  318 , the entry criteria  226  is also not met. If the entry criteria  226  is not met in step  226 , then in this alternative embodiment a message  601  may be provided which notifies the individual  12  of such a fact and which requests in step  607  whether to re-start the procedure by providing the starting information  600  again. In still other embodiments, the individual  12  can be given feedback on the extent of his or her adherence to the collection procedure  70 . As shown by  FIG. 9 , in this alternative embodiment if after process step  322  the adherence criteria  224  is not met, then a violation counter is incremented in process step  612 . In another embodiment, a violation message  610  may also be provided by the processor  102  on the display to notify the individual  12  that a violation has occurred. It is to be appreciated further that when a violation occurs, the processor  102  can also record the occurrence of the violation in an embodiment of the data file  145  in a violation field  611  for the associated event  237  as depicted by  FIG. 4 . 
     As also depicted by  FIG. 4 , type codes  613  may be provided in the violation field  611  by the processor  102  to indicate what caused the violation (e.g., “A” event performed before window, “B” event performed after window, “C” event skipped, “D” an event performed incorrectly, to provide context to the violation. For example, event  237   d , which did not received a unique identifier  167  due to failing the adherence  224 , from being skipped. As such the processor  102  recorded a “C” type code  613  in the violation field  611 . Such context is information that the clinician and/or a running a process  700  can use in assessing how the collection procedure  70  may be adjusted to better suit the individual  12  in the future. 
     In process step  614 , the number of violations (i.e., violation counter) is checked to see if it exceeds a maximum number of violations permitted (i.e., violation number (VN)) before automatic termination of the collection procedure  70  occurs for excess adherence violations. The violation number (VN(s))  615  can be preset in the collection procedure  70  as depicted by  FIG. 10  and adjusted by the clinician (and/or individual if permitted) as desired. In still other embodiments, a number of violation numbers  615  could also be provided in the collection procedure  70  wherein each violation number would be set for each of the Type Codes  613 , such that if the violation counter for each Type Code  613  exceeded the associated violation number, the collection procedure  70  would terminate due to that specific type violation. In still other embodiments, the violation number  615  could represent the number of violations in a pre-defined period of time instead of an absolute number since the start of the collection procedure  70 . For example, the pre-defined period time could be designed and adjusted by the clinician  14  (and/or individual if permitted) in the collection procedure by a time parameter (t)  619 . For example, in one embodiment the processor  102  in step  612  would also check to see whether the violation counter exceeded the violation number  615  within the associated pre-defined period (t)  619 , or in another embodiment any of the violation numbers associated with each Type Code  613  within their associated pre-defined period (t)  619 . In the illustrated embodiment of  FIG. 9 , if the violation number (VN)  615  is exceeded in process step  614 , i.e. the violation counter “Violations” is greater than the violation number (VN), then a failed message  617  is provided in process step  616  and the procedure ends in process step  328  as discussed previously above in an earlier section. The failed message  617  can be pre-defined in the collection procedure  70  as depicted by the  FIG. 10  and customized by the clinician  14  as desired. The failed message  617  can be provided on the display  108  of the device  24  and/or to the clinician  14  via communication interface  124 . 
     In one embodiment, the individual  12  can be told how many further adherence violations he/she can have before he/she might be forced to quit the structured collection procedure  70 , such as part of the messages provided in the calendar embodiment. For example, the message may be “You have {Violation Counter} of {VN} permitted violations,” or “You have {VN-Violation Counter} permitted violation remaining,” where { } indicates the current parameter value. In other embodiments, after each violation which does not result in termination (e.g., Violation Count&lt;VN in process step  614 ), the device  24  can check to see if the user should be queried, for example, in process step  618 . If the result of process step  618  is no, such as in the case where no query message(s)  621  ( FIG. 10 ) is defined in the structured collection procedure  70 , then the process proceeds to process step  326 . If the result of the process step  618  is yes, then in process step  620  the query message  621  is provided to the individual  12  on display  108  of the device  24 . The query message  621  can be pre-defined in the collection procedure  70  as depicted by the  FIG. 10  and customized by the clinician  14  (and/or individual if permitted) as desired. 
     For example, in one embodiment, the query message  621  may be a question asking the user if he/she understands the structured collection procedure  70 . In the illustrated embodiment depicted by  FIG. 9 , the user may answer the query message  621  via selecting either a “yes” or “no”, e.g., via the user interface  146  ( FIG. 3 ). If “yes”, then the collection procedure  70  would continue, such as at process step  326  ( FIG. 9 ). If “no”, then the device  24  provides helping information  625  in process step  622 . Such helping information  625  may include re-displaying the starting information  600  pertaining to purpose of the collection procedure  70  and the requirements on how the collection procedure needs to be conducted and/or educational material as defined herein after in a later section. If after such information is displayed to the user e.g., on display  108 , the device  24  in other embodiments can query the user further in process step  624  via presenting another query message  621 ′. The query message  621 ′ can be, e.g., a request to see if the individual may need feedback from the clinician  14  to better understand why the violation occurred, to which the individual may answer yes or no via the user interface  146 . If “no”, then the collection procedure  70  would continue, such as at step  326 , and if “yes”, the device  24  could then send a message  627  in process step  626 , e.g. via communication interface  124 , to the clinician  14  to contact the individual due to an adherence violation. The query message  621 ′, the helping information  625 , and the clinician message  627  likewise can be pre-defined in the collection procedure  70  as depicted by the  FIG. 10 , and customized by the clinician  14  as desired. 
     It is to be appreciated that the above mentioned type of querying may help to get the individual  12  back on track with the collection procedure  70  due to minor misunderstandings. In still another embodiments, the adherence violation in process step  628  results in a triage message  629  being sent automatically (e.g., from device  24  to clinician computer  25  via network  50 ) to the clinician  14  to help the clinician  14  identify which individual  12   s  are at risk of not completing the structured collection procedure  70 . Such messaging may prompt the clinician  14  to contact the individual  12  to provide information and further motivation. 
     In still other embodiments, the collection procedure  70  can provide possible ways to reduce the number of accumulated adherence violations through closer adherence. For example, the clinician  14  may at some point during the collection procedure  70  reset the violation counter and/or change the violation number  615 . In still other embodiments, the device  24  can provide a way the individual  12  earns adherence credits based on a successfully completing a period of adherence that would cancel accumulated violations, and/or to earn a reduction in the pending violations by opting into a form of the procedure that provides more guidance on the aspects of the procedure that are the source of the violations. In still another embodiment, the device  24  can permit an individual who is having problems with testing at the correct time, to opt into a version of the procedure  70  that provides more prompting with the upcoming test, such as a reminder at the time of the test and another shortly before the end of the grace period for that test if it has not been performed. In still other embodiments, the number of accumulated adherence violations can be reduced by providing reminders at mealtime of taking post-prandial measurement, by indicating at measurement time, the time/details about next measurement, as well as by providing encouragement during protocol execution. 
     In still other embodiments, when an adherence violation occurs in a particular portion of the collection procedure  70 , the device  24  can recommend that the user seeks help, such as to contact the clinician  14  to gain possible insight or motivation, and/or can provide particular information on where to seek such help. For example, the clinician could designed by the options parameter  232  for which particular events  237  such information is to be provided if a violation occurs. For such an embodiment, the processor  102  in process step  630  then checks to see whether such a designation has been made in the collection procedure  70  via help flag “*” being provided in the options parameter  232  for the event  237 , e.g., for the “N1 hours after breakfast” event as depicted by  FIG. 10 , which in this case caused the violation. If such a help flag “*” is provided, then a help message  631  is in process step  632 . For example, the information provided in the help message  631  can be included in the helping information  625 , and can include, but not limited thereto, web addresses of online help content, and names and numbers of social support networks. The individual  12  in still other embodiments such information may also include suggestions on how to deal with the situation(s) where an adherence violation had occurred. For example, suggestions on what to do when a value of a physiological measurement collected in response to a collection event is out of the expected range can be provided. Such suggestions can be provided as a listing of frequently asked questions (FAQ) and answers. Still other suggestions can ask the individual  12  to make assessments as to whether the violation is a recurring pattern, or a singular data point attributed to a particular acute issues, such e.g., the individual is on vacation and therefore explainable, or chronic where nothing has changed, thereby possibly indicating that something physiological or medicinally has changed, and therefore a change may be needed before continuing. 
     As discussed in the previous sections provided above, when the individual  12  encounters a severe hypoglycemic event, the recommendation provided by the device  24  would be to contact the clinician  14 . However, in still other embodiments, additional guidance can be provided to ensure that such an adverse event does not persist, e.g., eat some carbohydrates, measure again after some time, and the likes. 
     In still other embodiments, after the evaluating the exit criteria  228  in process step  326  ( FIG. 9 ), the processor  102  then checks to see in process step  634  if a defined deviation(s)  635  from an expected behavior is occurring in the execution of the collection procedure  70 , and if so, then the device  24  can suggest that the individual  12  contacts the clinician  14  via displaying a contact message  633  in process step  636 . In one embodiment, the contact message  633  can be the same message as the failed message  617 , or in another embodiment, it can be a customizable message (such as defined by the clinician and/or patient) in the collection procedure  70 . Also, one example of when an individual&#39;s behavior deviates greatly from what is expected is as follows. When the individual  12  undergoes a titration structured collection procedure  70 , if the processor  102  notes that data values  256  of the measured value for blood glucose in the data file  145  ( FIG. 10 ) do not show any lowering of fasting bG values over a pre-defined period of time in spite of increasing dosages of insulin, the contact message  633  will be sent. Other such deviation examples can be pre-defined via logical operations (e.g., Boolean and conditional logic) provided in a deviation parameter  635  ( FIG. 10 ) provided in the options of the collection procedure  70  and which can be customized by the clinician  14  (or individual in some embodiments when permitted by a process for providing a personalized collection procedure, such discussed hereafter in later sections) as desired. 
     Structured Tailoring 
     In still other embodiments, the structured collection procedure  70  can be further expanded to include structured tailoring in order to help improve the success of the individual  12  changing and maintaining health related behavior by individualizing behavior change action plans through the use of the entry, exit, and adherence criteria. It is to be appreciated that structured tailoring is a communication strategy for enhancing the efficacy of health and behavior change messaging. In particular, structured tailoring provides a framework to design and construct a patient specific system of education and action that can maximize the potential benefits for each individual. Structured tailoring uses a combination of relevant content that is intended to reach one specific individual, based on characteristics that are unique to that individual, and derived from an individual assessment. In particular, structured tailoring to assist in behavior change deals with improving the behavior change process (BCP). This is done by monitoring the users success in their behavior change process in terms of the input criteria to events  237 , adherence criteria  224  and exit criteria  228 . As depicted by  FIG. 11 , the idea is that many BCP programs do an adequate job in setting up goals and suggestions for users to monitor progress, but they fall short when the user begins to fail in adhering or continuing through the BCP. The BCP according to a process of the present invention discussed hereafter, provides a structured tailoring processes which systematically and automatically provides goal setting (symbol “03”), coaching through interventions (symbol “06”), and monitoring of the process (symbol “07”), in a cyclical fashion which provides incremental changes with each cycle that the individual  12  has personalize to help internalize acceptance or “buy in” into the BCP. With such internalized acceptance and support provided by the process, the individual then has the willingness and help to attain the desired target behavior. With reference made to  FIGS. 12-14 , an exemplary embodiment of a structured collection procedure suitable for structured tailoring is discussed hereafter. 
     As depicted by  FIG. 12 , a structured tailoring process  700  providing for a behavior change via tailored invention is disclosed, and which can be implemented as software instructions or program which will cause a processor or computer to carry out the following steps. The process  700  starts from the initial assessment  705  of the individual  12  to begin to tailor both the activities as well as the interventions provided to the individual when running the structured collection procedure  70  on the device  24  and/or computer  18  that has been personalized for structured tailoring of the individual. The initial assessment  705  can, for example, cover areas of readiness for change, current health, and activity level of the individual. Next, in process step  710  and in this example, based on the individual&#39;s readiness and current health, suggestions are made for the individual&#39;s particular protocol. For example, if the individual isn&#39;t ready, education, information and skill development (see process step  720 ) and messaging will be suggested and/or provided by the process for further contemplation and preparation for change. If it is deemed that the individual  12  is ready to change their behavior, the process  700  can recommend a starting point based on preselected use cases. This recommendation could be used as the entry criteria  226  of the procedure  70  in one embodiment. 
     Next, in process step  715 , the individual  12  will then take the recommendation resulting from process step  710  and tailor it to his or her individual abilities and availability. Goals are setup in multiple levels from short term (e.g., S 1 , S 2 , S 3 , S 4 , S 5 , S 6 , S 7 , S 8 , S 9 , . . . , SX) to midterm (e.g., M 1 , M 2 , M 3 , . . . , MX), and then to a long-term goal as depicted by  FIG. 13 . The individual  12  can begin with just short-term goals, but as the individual continues to cycle through the process  700 , they will eventually develop midterm and long-term goals. For example, short term goals S 1 , S 2  and S 3  could be intended just to start the change of the individual  12  in a positive direction towards an actual behavior change, in which the short term goals adjust the requirements for reaching the behavior change incrementally or progressively with each cycle of the process  700 . In such an example, a first mid-term goal e.g., M 1  as depicted by  FIG. 13 , can be that by the end of the third cycle of the process  700 , i.e., that successful completion of the short time goals S 1 , S 2 , S 3 , the individual  12  is progressing with the necessary behavior change that will eventually result in the target behavior over a period of time. As depicted, a number of such mid-term goals can be formed of one or more short-term goals, and wherein in the above example, the additional mid-term goals M 2  and M 3  could be that the individual  12  continues with the desired behavior change, via the series of further short term goals (e.g., S 4 -S 9 ), such that at the end of third mid-term goal, the individual  12  has accomplished the target behavior. Upon reaching the target behavior, the long term goal could be that the individual  12  has demonstrated the target behavior for at least X cycles of the process  700 . It is to be appreciated that other variations and combinations of such short term, mid term, and long-term goals can be provided, other than what has been depicted in the illustrative embodiment of  FIG. 13 , as such goals will be customized by the individual to their own preferences via the reiterative nature of the process  700 . 
     At the start of each cycle of the process  700 , each short-term goal will be based on the results from the earlier associated assessment and recommendation processes  705 ,  710 , respectively. For example, in the context of wanting to have the individual exercise more as the behavior change, a typical beginning short-term goal, e.g., S 1 , may be to have the individual just keep track of how much activity he or she is doing for the first week. The next short-term goal, e.g., S 2 , then set by the individual may be to walk for X number of minutes for X number of days. For the next series of short term goals, the minutes and days can increase in duration or the activity could increase in intensity overtime. Such individual defined goals are then used as the adherence criteria  224  e.g., exercising X minutes per day, and the exit criteria  228  e.g., have exercised X minutes per day for X number of days, for the collection procedure  70 . 
     In process step  720 , an education module  724  can be provided by the process  700  which provides education material, and which in other embodiments also can be accessed at any time (from any process step) during execution of the process  700 . The education material may contain any type of health and behavior education in relation to exercise including, benefits of exercise, safety, making time to exercise, making exercise fun, how to do certain exercise, etc., and can be provided by the process  700  as electronic text, images, sounds as well as combinations thereof. The education material can also include a skill assessment as well as skill development activities. For example, the skill assessment permits the process  700  to check and assess if the individual possesses the proper level of skill before moving into a new activity and/or protocol, i.e., a different collection procedure  70 . If not, then the process  700  then provides/recommends the skill development activities for the individual  12  to complete in order to gain the necessary skill level for the new activity and/or collection procedure  70 . 
     Next, in process step  725 , once the individual  12  identifies their goals, the process  700  then begins a behavior support assessment to ascertain from the individual  12  what barriers and motivators in the past have assisted in success or failures when it comes to performing the target behavior, for example, exercising, not smoking, not drinking, etc. These can be psycho-social like being bored (barrier), or having a partner to exercise with (motivator), etc., they can also be physical like being too tired or sick (barriers), or they can be environmental like inclement weather or safety concerns (barriers), or walking in a nice park outdoors (motivators). These motivators and barriers are self selected and configured by the individual based on their experience. 
     In process step  730 , once the individual  12  has completed the behavior support assessment in process step  725 , the process  700  then provides a behavior-support intervention module  732  in which the individual  12  picks a pre-defined intervention(s) based on their individual motivators and/or barriers. These interventions can take multiple forms from basic electronic alarms, reminders, messages, such as those discussed above in previous sections, as well as to elaborate social support networks utilizing GPS (such as when device  24  is a GPS enable device) to recommend available friends to exercise with or suitable places to exercise that are near to the individual. These interventions are self selected and configured by the individual  12  based on his or her preferences. The process  700  also provides a validation module  734  to ascertain that the appropriate level of intervention is assigned due to the associated risk of non-adherence. In one embodiment, if the validation module  734  determines that an appropriate level of intervention has not been assigned, suggested levels of interventions can be presented to the individual for selection, and/or selected for the individual if no other choices are available. Once the individual  12  has designated the desired intervention(s) in step  735  (or which has been automatically assigned by the validation module  734  as previously explained), events  237  which define a plan of action (i.e., the schedule of events  222 ) in the collection procedure  70  for the individual  12  are generated by the process  700 . For example, the events  237  will define how often progress will be monitored (daily/multiple times a week in the beginning). The individual  12  can then customize and/or accept the plan of action (i.e., the schedule of events  222 ) defined by the events  237 . Next, after accepting the plan of action, the individual  12  will then start the procedure  70  with all the agreed upon interventions (alarms, reminders, messages, etc.) upon meeting the entry criteria  226 , e.g., indicating to the device  24  a readiness to change the associated behavior by using the now personalized procedure  70  providing tailored events and interventions for accomplishing a short term goal of changing a current behavior of the individual to a targeted behavior. 
     Next, in process step  735 , the device  24  or computer  18  running the personalized procedure  70  monitors compliancy of the individual with the plan of action i.e., schedule of events  222 , such as discussed previously above with reference to  FIG. 9 , as further modified as discussed hereafter. If activities (i.e., events  237 ) are on track (i.e., adherence criteria  224  is met), then the process  700  checks to see if the defined goal has been achieved by seeing if the exit criteria  228  is met in step  740 , which is similar to step  326  in  FIG. 9 . Likewise, if the goal is not met i.e., exit criteria  228  is not met, then in process step  745 , the process  700  checks to see whether the personalized collection procedure  70  is working which is also similar to process step  634  i.e., checking for a deviation  635 , shown in  FIG. 9 . 
     For example, for this illustrative embodiment of structured tailoring, a deviation  635  used in process step  745  in one embodiment can be an indication provided to the process  700  by the individual (e.g., via a user interface  146 ) and/or a showing in the collected data that the weight of the individual and/or some other physiological value (blood pressure, heart rate, etc.) of the individual is not trending toward an expected predefined value after a predetermined period of time. Still other examples of such a deviation simply may be a question presented to the individual (e.g., via the display  108  or on computer  18 ) asking the individual  12  as to whether the individual believes that the process  700  is working, whether the individual  12  is following their own intervention, or whether the individual  12  is lacking in a skill and/or understanding of how reach/attain the goal. 
     If the personalized procedure  70  is not working to support a positive change in behavior (i.e., a deviation  635  has occurred) a contact message (i.e., message  633 ) can optionally be sent (i.e., process step  636 ), but unlike the collection procedure  70  depicted by  FIG. 9 , in this illustrative embodiment of  FIG. 12 , the individual will be requested by the process  700  to go back to an earlier process step based on the type of deviation. In particular, if the result and/or the procedure  70  are not working in step  745 , then the process  700  will take the individual  12  back to the appropriate area e.g., Health and Behavior Assessment (are they ready for change?), goal setting (input criteria), Education/skills development (are they capable?), or behavior support (are there more barriers or motivators plans necessary for success?), so the individual  12  can re-set the procedure  70  to ensure success. 
     For example, if the personalized collection procedure as a whole is indicated (by either the individual or the collected data) as not working, the process  700  loops to process step  705 , i.e., for another health and behavior support assessment in order to work through the process of providing a new personalized collection procedure  70 . If, however, one or more of the set goals of the procedure  70  are indicated (either by the individual or the collected data) as not working, the process  700  loops back to process step  715  to permit the individual to reset the goal(s) previously recommended. If, however, a skill or understanding of the how to achieve the set goal(s) of the procedure  70  is indicated (either by the individual or the collected data) as lacking, the process  700  loops back to process step  720  to provide the education material and/or start the skill assessment module  724 . If, however, the intervention of the procedure  70  is indicated (either by the individual or the collected data) as not working, the process  700  loops back to process step  725  such that the individual  12  can reassess their barriers and motivators in order to try to develop a better intervention plan/strategy. 
     If, however, in process step  745  the procedure  70  is working, then the process  700  continues with monitoring the procedure  70  in step  735 . If, however, in process step  740 , the goal has been achieved (i.e., exit criteria  228  is met), the process  700  permits the individual  12  to go back to set a new goal(s) that was previously recommended or continue progressing on the originally set goal(s) once again, or to go back to the to process step  705  for a new health and behavior assessment in order to develop a new personalized collection procedure  70  for attaining a new goal(s). Additionally, the process  700  permit the individual  12  to go to process step  720  to access the education information module  724 , if desired. 
     Once the individual  12  has successfully gone through the personalized procedure  70  (i.e., exit criteria  228  has been met, wherein the individual  12  has achieved the short-term goal, the process  700  permits the individual  12  to continue to a next level of the BCP, i.e., short term goal S 2 . As the individual  12  progresses and the targeted behavior become part of the individual&#39;s daily life, in one embodiment the process  700  also permits the individual to choose and add different protocols to a master protocol  800  as depicted by  FIG. 14 . 
     As depicted, the master protocol  800  is a collection of the procedures  70  which the individual  12  can select upon progressing successfully through various short term, mid-term, and/or long term goals. For example, if the individual successfully completes the short term goal for procedure  70   A1 , then the process  700  proceeds automatically to procedure  70   A2  and also permits the individual to select procedure  70   B1 , which can be a mid-term goal e.g., adding another type of procedure, i.e. procedure  70   B1 , to perform simultaneous with the second level procedure  70   A2 . Continuing with this example, should the individual successfully complete procedure  70   A2  and  70   B1 , then the process  700  proceeds automatically to procedure  70   AX ,  70   B2 , as well as permitting the individual to select new procedure  70   X1 , in which selecting one or both of the procedures  70   B2 ,  70   X1  e.g., can be a second mid-term goal, and so on. In this manner, the master protocol  800  provides the individual  12  with a customizable plan by which to progress through various levels and types of procedures  70  (e.g., automatically upon meeting the exit criteria of the previous level), such as those directed to exercise, e.g., procedures  70   A1 ,  70   A2 , . . . ,  70   AX , diet e.g., procedures  70   B1 ,  70   B2 , . . . ,  70   BX , and any other procedures e.g.,  70   X1 ,  70   X2 , . . . ,  70   XX , directed to reducing stress, improving sleep habits, and the likes providing for a behavior change. It is to be appreciated that with each new level and type of procedure  70 , the individual personalizes the procedure  70  via being presented and performing process steps  705 - 730 . An example of a structured tailoring use case is now discussed hereafter. 
     Structured Tailoring Use Case 
     An example of a structured tailoring use case would be a person wanting to begin an exercise program. The process  700  as mentioned above is used for short term, midterm and long term goals. In this use case example, the short term goal is defined as something that can be accomplished with in a few days or a week. For example, in this described exercise example, a starting short term goal could be to begin walking 1 day for 10 minutes the first week. The next week could be 2 days for 10 minutes, the second short term goal, the next could be two days for 15 minutes, the third short term goal, and so on. A series of such short term goals can then constitute a midterm goal. In another example, a first mid term goal could be that in the next 3 months I want to walk on average at least 2 times a week for 30 minutes. After that the first mid term goal, the next (second) midterm goal could be on average 4 times a week for 30 minutes, and so on. The long term goal then could be walking consistently 5 times a week for 30 minutes at a certain pace. Accordingly, it is to be appreciated that the short term goals are embedded in midterm goals which are embedded in long term goals. 
     Continuing with the use case example, the individual  12  will use the process  700  to personalize a first procedure  70  e.g., procedure  70   A1 , of the master protocol  800  via completing an initial assessment, setting an individual goal (say walk 30 minutes a day 3 days a week), identify barriers (too tired at the end of the day) and motivators (I like walking with my spouse), and set a plan for success (walk M-W-F in the morning with my wife). The individual  12  will then start the now personalized procedure  70 , and when meeting the entry criteria (e.g., indicating physically ready and willing to carry out the plan), the process  700  begins monitoring progress of the procedure  70  in step  735  as described above. 
     In this example, if goal is met in step  740 , the individual  12  is asked (e.g., by the processor  102  prompting on the display  108 ) “Do you want to continue this (procedure) or set a different exercise goal (walk 45 minutes 4 times a week), or do something else (work on eating healthier)?” If the goal is not met (e.g., the individual  12  walked only 2 times for 30 minutes), the process  700  in this example will asks the individual in step  745  (e.g., via the processor  102  prompting on the display  108 ) “Is the procedure working?” If the individual  12  indicates (e.g., via the user interface  146 ) that the process  700  is working (i.e., the individual  12  is on track, but hasn&#39;t reached the goal yet), the process  700  continues to monitor progress i.e., for each event  237  meeting the adherence criteria  224  (e.g., walk 30 minutes M-W-F w/spouse in the morning) in process step  735 . If the result and/or the process are not working well (i.e. adherence criterion is not met, affecting exit criteria), then in this example, the process  700  checks whether the individual  12  is correctly utilizing the support intervention correctly (i.e. I wanted to walk with my spouse, but I never asked her). 
     If the process  700  determines that there truly is an adherence issue, it will stop the procedure  70 , and send the individual  12  back to the appropriate area as mentioned previously above in previous section. For example, in response to answering the question “Are you ready for change?” provided by the process in process step  745  (or process step  634  ( FIG. 9 , checking for a deviation  635 ), in which the individual indicated that “Perhaps their health is preventing them from walking” from an answer selection menu presented by the process  700  (e.g., on display  108 ), the process  700  loops to process step  705  in an attempt to re-personalize a new procedure  70  which takes into account the current health of the individual. In another example, if the individual response to the question about wanting to change the goal to another recommended goal, e.g., 2 times a week for 10 minutes, the process  700  loops back to process step  715  to reset the goal. In still another example, if the individual indicated that the procedure  70  is not fully understood and/or that he or she is not sure of the skill level needed, the process  700  loops to the process step  720  such that the individual views educational information learning how to begin the subject exercise program, or to process step  725  to provide behavior support if the individual indicated that he or she needs a reminder to walk, or that their spouse doesn&#39;t want to walk (in which case they may want to walk with someone else). 
     As the individual  12  continues the BCP, the process  700  then allows for other levels and types of procedures to be initiated in the master protocol  800  which go either into more depth or breadth of exercise or into a new BCP area such as diet, diabetes management, sleep, stress management, etc., as previously discussed above in reference to  FIG. 14 . In this example, each of these additional procedures  70   A1 . . . X ,  70   B1 . . . X ,  70   X1 . . . X , etc., can be run individually (linearly) or the individual  12  could have multiples ones of such procedures running in parallel, depending on the skill and motivation of the individual  12 . Examples of typical questions and interventions for exercise (physical activity) which the process  700  can provide in process steps  705 ,  725  and along with an answer selection menu (such as provided on computer  18  and/or device  24 ) by which the individual and process personalizes the procedure  70 , is provided hereafter. 
     In process step  705 , some general considerations that the individual  12  selects are: I prefer to do one type of exercise program for a long period of time; I enjoy changing my exercise routine frequently; I am more successful changing one intervention at a time; and I am more successful when I change multiple behaviors at the same time. The process  700  uses the selected consideration(s) to provide recommendations in step  710 . In process step  725 , the process  700  can present in one embodiment, the following question “What are things that typically stopped/prevented or discouraged you in the past or you could imagine may stop you in the future from participating in physical activity?” The individual  12  can then select from a presented answer list that explorers the individual  12  road blocks to achieving change. 
     In one example, a set of questions each with an answer list which the individual  12  can select from, explorer the internal road blocks and type of tailored intervention desired. Such questions and answer lists are as follows:
     a. “When I experienced negative emotions, e.g. sad, afraid or angry”
       I would like to meet or to connect with people to support me in dealing with my negative emotions
           I will connect to My Social Network (that is created on the same web-site) to designated “supporters” for the list (Action)
               Intervention: message will be sent to the “supporter” as a text message “Bob is staring an exercise program, are you willing to support him?” and then offer to schedule times to talk and call and schedule and appt in the supporter&#39;s calendar to call Bob at a certain time, with a reminder   
               I will call my friend (name)
               Intervention: type in the name of the person and make the call   
               
           I would like to receive more information and techniques on how to change my negative thinking
           Intervention: connect to the CBT training/intervention site, built in the web-site or a separate site   
           I would like to receive encouraging messages
           Intervention: automated text messages to
               cell phone   voice mail   email   pedometer   
               
           
       b. “When I felt tired or sluggish”
       I would like to receive information/tips on increasing my energy. &gt;connect to helpful hints (check your sleep, eating consistently throughout the day, caffeine intake, sick/illness, exercise, stress, time management)   
       c. “When I don&#39;t think I am benefiting”
       I would like to receive information on the benefits of exercise for people like me
           Intervention: tailored research messages sent based on profile (age, weight, fitness level, etc)   Intervention: receive stories showing good outcomes from people like me (based on profile)   
           I would like to be reminded by emails/messages about the benefits of exercise
           Intervention: automated affirmation text messages based on initial outcome expectations to
               cell phone   voice mail   email   pedometer   
               
           
       d. “When I am not enjoying the activity”
       I would like to receive support to increase enjoyment in exercise
           Intervention: list of alternate physical activities based on goal settings (time, frequency, calories burned)   Intervention: chose a buddy to call (select or type in) to exercise with you   Intervention: use or change music, redirect to the Company™ website to download motivating, stimulating music (recommended titles: Show me the money, Caress my motivation etc)   Intervention: Change time and frequency of exercise   Intervention: Competition: connect to Exercise Buddy Network site and set up/sign up competitions   Intervention: exercise in the bright colored Company™ spandex   Intervention: combine old and new activities: watch The Biggest Loser or read magazines while exercising (on stationary bike)   Intervention: DVD game boy, Wii to vary exercise routine   Intervention: exercise in a nicer place (project images of beautiful scenarios, exercise in virtual reality headgear and suit)   
           
       e. “When I don&#39;t plan and prioritize my activities well”
       I would like to receive info on time management and prioritization   
       f. “When I experience physical activity as boring or uninteresting”
       Mindfulness and acceptance education (boring is not necessary bad, no need to feel good constantly)   
       

     In another example, a set of questions each with an answer list which the individual  12  can select from, explorer the social road blocks and type of tailored intervention desired. Such questions and answer lists are as follows:
     a. When I don&#39;t have someone to encourage me to exercise
       Intervention: I would like to receive encouraging messages from Company X
           voice mail   cell phone   email   pedometer   
           Intervention: I will ask (name) to take me to exercise (matching names from Contact list will automatically pop up to select the appropriate contact)   Intervention: I would like to encourage messages from (name) from My Social Network, that will trigger messages from the person (as above)   Intervention: video clips from virtual friends   Intervention: grandkids recording encouraged messages that are played for encouragement   Intervention: virtual puppy whines until one gets up for a walk   
       b. When I don&#39;t have someone to exercise with me
       Intervention: connect to My Social Network   
       c. When my friends and family discourage me by words and example
       Intervention: connect to My Social Network   
       

     In another example, a set of questions each with an answer list which the individual  12  can select from, explorer the environmental road blocks and type of tailored intervention desired. Such questions and answer lists are as follows:
     a. When I don&#39;t have anywhere pleasant to exercise
       I would like to receive information on women-only gyms (Curves in the area)   Intervention: receive a list of gyms and park within walking distance from my house (based on ZIP code)   Intervention: suggestions where to exercise in inclement weather (connect with mall walkers in the area   Intervention: Connect with outers who exercise outdoors improve safety/reduce crime. Connect with Neighborhood Watch and monitor crime activity while exercising, while improving safety in neighborhood   Intervention: exercise group at the church or community center (search by ZIP code for locations)—also ties in with community/social   
       b. When I don&#39;t have the equipment to exercise
       Low budget solutions (mall walkers with canned groceries, church   
       c. When I don&#39;t have transportation to get to exercise (addressed under social, “take me to the park”)   

     In another example, a similar set of questions each with an answer list which the individual  12  can select from, can be provided which explorers the things that typically supported, enabled or encouraged the individual to exercise in the past or which could be possibly helpful in the future in which to help the individual decide on the type of tailored intervention desired. Such questions could be as follows: 
     Internal: 
     
         
         a. When I feel strong and confident 
         b. When I have a clear plan or routine 
         c. When I believe I can do it 
         d. When it makes me feel good 
         e. When I am playing game 
         f. When I feel I am benefiting 
         g. When I reward myself for exercising 
         h. When I think about how this will benefit my friends and family
 
Social:
 
         a. When others encourage me to exercise and compliment me on my improvements 
         b. When someone rewards me for my accomplishments 
         c. When I see or hear about other people like me who benefited from exercise 
         d. When I have a buddy to exercise with me 
         e. When I exercise alone with some instructions 
         f. When I am competing with other people or with a goal 
         g. When I have someone to take me to exercise
 
Environmental
 
         a. When I can exercise on my own terms 
         b. When I can find safe neighborhoods 
         c. When I put reminders in my home or work environment 
         d. When I change my environment to encourage physical activity, such as use public transportation, park farter away from the building or take the stairs 
         e. When I know that what I am doing is helping the environment or I become an advocate for social change 
       
    
     Accordingly, by the above structured tailoring disclosure, in one embodiment, a system implementing the process  700  can help to enhance the success of behavior change of a individual  12  by helping the individual  12  to personalize a collection procedure as well as running and monitoring the personalized collection procedure(s)  70 . The system can be computerized, such as implemented on device  24 , personal computer  18 , and/or web based such as hosted by a server  52  which is accessible by the device  24  and/or personal computer  18  as well as clinician computer  25  via a standard web browser and network  50  ( FIG. 1 ). 
     Although not limited thereto, some of the noted advantages provided by such a structured tailoring based system are: an increase in the personal relevance of health messages, which consequently assist in creating an ideal environment in which persuasion and behavior change can occur; and enhancing the creation of the tailored messages by facilitating the collection and assessment of individual data and then using evidence-based decision rules to create individualized health messages, strategies and action plans. 
     Thus, by the above disclosure embodiments concerning systems and methods managing the execution, data collection, and data analysis of collection procedures running simultaneously on an electronic device are disclosed for the purposes of helping the individual change a current behavior to a target behavior, and/or assisting the individual in addressing/changing a health related behavior. One skilled in the art will appreciate that the teachings can be practiced with embodiments other than those disclosed. The disclosed embodiments are presented for purposes of illustration and not limitation, and the invention is only limited by the claims that follow.