Abstract:
A healthcare data management system includes a central processor and a database accessible by the processor that contains an electronic personal health journal. The journal includes a plurality of fields of information relating to a patient, including health status. A software program installed on the processor is adapted to establish secure communication between a user and the processor to interact with an information field of the journal subject to a predetermined permission level, which is established on the basis of a relationship between the user and the patient and on the basis of user entity and is determinative of the information fields to which the user is permitted access and of the information fields that are amendable by the user. Methods are provided for accessing and maintaining health data, increasing patient compliance, and decreasing duplication of services, healthcare costs, and iatrogenic pharmaceutical interactions.

Description:
CROSS-REFERENCE TO RELATED APPLICATION  
       [0001]     This application claims priority to provisional application Ser. No. 60/468,838, filed May 8, 2003, entitled “Health Information Database Creation and Access System and Method.” 
     
    
     BACKGROUND OF THE INVENTION  
       [0002]     1. Field of the Invention  
         [0003]     The present invention relates to healthcare database systems and methods, and, more particularly, to systems and methods for housing healthcare information, improving patient compliance, and providing secure, role-based access to healthcare databases and protected health information.  
         [0004]     2. Description of Related Art  
         [0005]     Healthcare information databases are known in the art for keeping an insurance plan member&#39;s health-related activity and demographic data. Typically such data are housed by the insurance company so as to be accessible only by an authorized user, such as an employee of the insurance company. If the member leaves that insurance company, his or her records are generally not transferrable to the next insurance company.  
         [0006]     Additionally, if the “plan member” comprises a family, at some point the definition of that family is likely to change, through, for example, a child&#39;s reaching maturity, death, or divorce. With such a change, a part of the family&#39;s data may need to be transferred to another plan.  
         [0007]     Another problem relates to uninsured patients, for whom no database entries may exist. Caring for such patients, especially those with chronic conditions such as diabetes, asthma, heart disease, obesity, depression, and substance abuse, consume a large portion of a hospital&#39;s budget, as well as other governmental funds, such as those of a county Public Health department, Medicare, and Medicaid. Costs associated with these and other chronic diseases consume 60-70% of the healthcare dollar.  
         [0008]     Often uninsured patients use hospital emergency rooms as their source of primary care, leading to often unnecessary and/or preventible emergency room visits. No system is currently in place to assist such patients in managing their diseases; thus the current system is reactive, not proactive.  
         [0009]     Further, since no database entries may exist for such uninsured patients, their personal health data are likely not to be available for review by qualified caregivers for whom such knowledge could significantly improve the care provided.  
         [0010]     Access to records has also been problematic, with privacy issues being paramount. One may desire access to one&#39;s own records to view or update their personal health record electronically with medical data, and need to prove identification, such as voice recognition, personal identification number, a token, or a biometric, for example. In other situations, such as in emergencies, medical personnel may need access to some or all of a member&#39;s data when obtaining conscious permission of the member is not possible.  
         [0011]     The Health Information Protection and Administration Act of 1996 (HIPAA) was enacted to streamline the exchange of information in the healthcare industry and to reduce general administrative tasks while maintaining patient privacy. The three major tenets of this Act include (1) standard X.12 EDI transactions be created and maintained for the healthcare accounting part of the industry; (2) security to protect and electronically share all patient medical history information; and (3) unique identifiers be created and used for all patients, providers, payees, and employees in the healthcare industry for the purpose of providing authorization and accessing personal health data. Providers must have an electronic tracking mechanism in place to document disclosure of individually identified health information, and individuals must give written authorization and/or consent if data are to be shared. As the definition of a “health record” has become increasingly complex, no longer limited to a single physical folder in a doctor&#39;s or hospital&#39;s filing system, a system is required for coordinating healthcare efforts among many facilities and platforms, and for providing patient access.  
         [0012]     Additional problems in the healthcare industry are fraud and waste that can occur if a patient visits more than one facility for the same complaint.  
         [0013]     Therefore, there is a need for a secure infrastructure and patient-centric system that provides electronic healthcare data that are encrypted, can be authenticated, possess a digital signature, and include access and role-based control on a secure basis.  
       SUMMARY OF THE INVENTION  
       [0014]     The system and methods of the present invention integrate secure network management features into an enterprise-wide business application to reduce medical costs while granting individuals access to their health information and to health planning tools to provide improved health and healthcare. The invention reduces duplication, waste, fraud, and abuse in Public Health, and provides tools and technology for secure information sharing among disparate systems to improve the quality and cost-effectiveness of care through information technology and, in some cases, outreach. The system includes a standards-based common communication platform with secure links to an integrated, virtual private network, for hosting a web-based personal health journal for patients. Personal health data can be updated remotely, and clinical information can be shared with authorized healthcare providers and case/care managers based upon consent and authorization. The system complies with HIPAA, having privacy and security provisions built in.  
         [0015]     At the heart of the system is a personal health journal, which is populated by the individual and caregivers, and includes pertinent patient data including protected health data. The personal health journal is not necessarily intended to be comprehensive, but rather to comprise a “snapshot” of the patient&#39;s current medical condition for assisting in delivering immediate care when needed.  
         [0016]     Also provided are user-friendly technology and disease-specific educational information that is accessible by the patient. The patient is encouraged to actively participate in managing his/her own health with assistance from care managers and, in one embodiment, “buddies,” coupled with incentives provided in one or more of a plurality of methods.  
         [0017]     A particular benefit of the system is that security is at the device level, that is, the patient and care givers treating the patient operate with the use of an electronic certificate that is carried with the person, and does not reside on a network at the system level.  
         [0018]     The system and method are designed to increase compliance and reduce healthcare costs, to improve patient care and safety, reduce clinical and clerical errors, and to provide authorized caregivers with timely access to a patient&#39;s clinical information in order to increase compliance and reduce duplication of services.  
         [0019]     In addition, a funding model is presented whereby the system functions as a self-sustaining organization to benefit the healthcare industry and public health.  
         [0020]     The features that characterize the invention, both as to organization and method of operation, together with further objects and advantages thereof, will be better understood from the following description used in conjunction with the accompanying drawing. It is to be expressly understood that the drawing is for the purpose of illustration and description and is not intended as a definition of the limits of the invention. These and other objects attained, and advantages offered, by the present invention will become more fully apparent as the description that now follows is read in conjunction with the accompanying drawing. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0021]      FIG. 1  is a system schematic showing an overview of the system modules.  
         [0022]      FIG. 2  is a schematic diagram of an exemplary embodiment of system information flow.  
         [0023]      FIG. 3  illustrates exemplary screen tabs for a personal health journal.  
         [0024]      FIG. 4  is a flowchart of a first embodiment of a method for improving patient compliance in disease management using electronic communication.  
         [0025]      FIG. 5  is a flowchart of a second embodiment of a method for improving patient compliance in disease management using direct contact with a case manager.  
         [0026]      FIG. 6  is a flowchart of a method for decreasing duplication of services.  
         [0027]      FIG. 7  is a flowchart of a method for reducing a likelihood of adverse drug interactions.  
         [0028]      FIG. 8  is a schematic diagram of the funding and services model of the present invention. 
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0029]     A description of the preferred embodiments of the present invention will now be presented with reference to  FIGS. 1-8 .  
         [0030]     The system  10 , as schematically illustrated in  FIGS. 1 and 2 , comprises a central site  20  housing a database  21  and a library  22  of health information geared for consumers. A processor  23  runs database creation and maintenance applications, and is adapted for network communication, such as over the Internet or other means of signal transmission. The system  10  permits data sharing, for example, among multiple platforms on such networks as wireless wide-area networks and local area networks. Database access (HUB) is gathered through secure Firewall A, which includes a role-based access directory. The broken line signifies bidirectional communication via a firewall. The dotted line signifies bidirectional communication via personal contact.  
         [0031]     A patient  40  initially meets with an intake counselor  44  to enroll in the program and to provide biometric identifier(s) for subsequent access approval and to initially populate a personal health journal (PHJ)  41 . Once enrolled, a patient can access his/her PHJ  41  by providing, for example, biometric data B, such as fingerprint, token, voice print, or eye print, such as via a portable electronic memory device, for example, a “smart card,” “smart token,” or USB dongle, via Firewall A to access the HUB in order to update his/her account and/or retrieve data from the PHJ  41 .  
         [0032]     Included in the PHJ  41  (see, for example, an exemplary screen showing tabs in  FIG. 3 ) are such data as demographic information, family and personal health history, allergies, medications, health activities, caregiver identification, links to laboratory results, and disease-specific information such as diagnoses, procedures, and care plans. An exemplary set of screen tabs is given in  FIG. 3  for access to various sets of data. A scanning function permits the inclusion of images of documents in the PHJ  41 , such as signed authorizations, consent forms, do not resuscitate forms, organ donor forms, and laboratory test results, although these are not intended as limitations. Accumulated health indicator tracking data are also stored in the PHJ  41 , as entered by the patient and caregivers.  
         [0033]     A care manager  50 , which here is intended to include a licensed care giver such as a doctor, nurse, technician, etc., can only communicate electronically with a patient  40  if proper identification is made, such as biometric identification. Once approved for access, limited patient information is available, based upon the consent and/or authorization of the patient, and data on the patient  40  may be updated. The patient  40  controls which data can be viewed, and can change their personal health data. However, they are not permitted to change any data that have been entered by the care manager  50 .  
         [0034]     The patient also has access to a call center  48  for assisting in compliance, reminders for physician visits, and disease-specific education.  
         [0035]     A licensed caregiver (such as a doctor, nurse, pharmacist, or laboratory technician) at sites  30 - 32 , a pharmacy  47 , or testing facility  45  can only review and document or update a patient file if registered within the system  10  and in possession of a security certificate (e.g., PKI) issued through a “trusted authority” C. In a preferred embodiment, all digital certificates are issued to the end user by a certification authority and the registering authority. These certificates are “roaming certificates,” meaning that a certificate holder does not have to be in a predetermined location in order to access data. The certificates are also nonrepudiatable. Upon receiving a certificate, a private digital key D is issued that will provide identification with unique roles within the medical environment and permit access to the HUB for the purpose of updating, signing, and documenting a patient&#39;s record.  
         [0036]     Another feature of the system  10  is the creation of an electronically accessible and visible audit trail, providing data on the identity of anyone who has accessed a patient&#39;s record, what action, if any, was performed, and the date of access for preventing, for example, duplication of services and potential adverse drug interactions.  
         [0037]     An individual electronic ID is assigned to the patient  40  for portability and security and to a specific location having specific functions. Such locations may include, but are not intended to be limited to, a hospital  30 , 31 , a clinic  32 , a physician&#39;s office, laboratory, home care center, pharmacy, prison, ambulance, or not-for-profit center.  
         [0038]     The secure firewall A provides private and authenticated access into the HUB and, based upon one&#39;s unique role, allows information to be shared.  
         [0039]     Medical facilities having processors such as a first  30  and a second  31  hospital and a county clinic or laboratory  32  are adapted for data flow with the central site  20 , such as over the Internet  24 .  
         [0040]     A patient  40 , for example, an uninsured patient, can, at any of the medical facilities  30 - 32  establish an electronic personal healthcare journal  41  with appropriate documentation and authentication. The journal  41  is accessible only by the patient unless privileges are granted to another party, and is housed in the central site&#39;s database  21 . In addition to entering data on the patient&#39;s current health and past health history, such information as organ donor status may also be included. A guardian may also be granted permission to create a journal  41  for the person in his/her care, such as a parent for a child.  
         [0041]     The patient  40  also has access to informational presentations housed in the central site&#39;s library  22 . Such presentations may include educational information and information on disease management, for example, although these are not intended as limitations.  
         [0042]     A care manager  50  assigned to assist the patient  40  can meet with the patient  40  and access limited information at the central site&#39;s database  21 , to which the care manager  50  will have been given privileges, either partial or limited, for and by the patient  40 .  
         [0043]     In addition, a relative, associate, or motivational partner (“buddy”)  42  of the patient  40  may also be given access, which may be limited, to the PHJ with explicit permission from the patient  40 . Such access may also be limited to particular data fields as desired and designated by the patient  40 . Such data fields may include, at a relatively low level, an appointment reminder for a doctor visit. A volunteer “buddy” may be assigned, for example, by a not-for-profit or faith-based organization to provide support via telephone calls, emails, and personal visits. This volunteer serves to encourage patients to self-manage their disease to as great an extent as possible, and to educate the patient  40  in areas such as nutrition, exercise, testing (such as blood glucose, blood pressure, and weight monitoring), and follow-up physical examinations and testing.  
         [0044]     Another particular benefit of the present invention is the portability of healthcare data between facilities and, if present, insurance companies, as physical records are no longer required to be transferred. Rather, the access permissions are changed to reflect the patient&#39;s current relationship(s). Thus the same credentials can be used for all systems and over all platforms without interface problems, so that, for example, Medicare and Medicaid and individual insurance companies can be participants.  
         [0045]     The embodiments of the methods of the present invention are directed to a method for accessing healthcare data, a method for increasing patient compliance in disease management, a method for reducing healthcare costs for all patients, and a method for reducing duplication of services, which particularly impacts the care of uninsured patients. Here the phrase “disease management” is intended to encompass any ongoing condition that has or may have an impact on the patient&#39;s health. For example, obesity is intended to be subsumed under this method. In the case of a patient  40  with a chronic disease, for example, diabetes, careful daily monitoring and medication compliance are extremely important.  
         [0046]     These methods include the steps of, at some point during a treatment cycle, setting up a personal health journal  41  for the patient  40  ( FIG. 4 , block  101 ). The journal  41  is populated with a health history record (block  102 ) that is updated at least during each visit to a medical facility  30 - 32 .  
         [0047]     One aspect of the invention includes a method  100  for improving compliance in disease management ( FIG. 4 ), which also serves to lower healthcare costs. In an exemplary embodiment of this aspect, which is not intended as a limitation, an incentive is provided for compliance. Here a portable telephone  43  is given to the patient (block  103 ). The system  10  automatically telephones the patient  40  at predetermined intervals and queries the patient  40  as to disease management (“Did you take your insulin today?”; “What was your blood sugar reading?”; “How many calories did you consume yesterday?”; “What was your weight today?”; “How do you feel?”) (block  104 ). Voice or other biometric recognition is used to ensure that it is the patient him/herself who is answering. Data corresponding to the patient&#39;s answers are entered into the PHJ  41  (block  105 ), and compliance or noncompliance is automatically recorded (block  106 ). An additional incentive, such as increased time limits on the telephone  43 , is provided for compliance (block  107 ). Noncompliant patients do not receive the incentive (block  108 ). Both the incentives and the telephonic reminders increase compliance. Further, having such a digital record updated on a frequent basis without taking the time of a medical facility  30 - 32  greatly improves the healthcare that medical personnel can offer when the patient  41  does visit, since the medical personnel can access the patient&#39;s PHJ  41  and view the history, and since the patient&#39;s memory is not being relied on to report compliance.  
         [0048]     Other types of incentives can also be contemplated, including, but not intended to be limited to, food coupons, prescription coupons and testing supplies, transportation tokens, movie passes, phone cards, and limited memberships to an exercise facility.  
         [0049]     In another aspect  120  of the present invention ( FIG. 5 ), the function of the care manager  50  is proactive (block  121 ). The care manager  50  can function to assist the patient  40  in keeping his/her care up to date (block  122 ) and by asking similar questions to those above (block  123 ), and can also provide additional motivational support (block  124 ), as with the “buddy” volunteer described above. This can help avoid crises and trips to the hospital. In the embodiment of  FIG. 4 , the patient  40  may be given a device such as a bidirectional personal data assistant (PDA), cell phone, or other electronic/digital device for reporting daily activities to the care manager  50 . Thus the care manager  50  can log the patient&#39;s data and provide a personal support system for the patient  40 .  
         [0050]     A method  140  for achieving a substantial cost savings in treating patients, including uninsured patients, is also addressed by the present invention. In this embodiment ( FIG. 6 ), the patient  40  appears for treatment at the first hospital  30  (block  141 ), is treated (block  142 ), and data are entered into the patient&#39;s PHJ  41  reflecting the date and type of treatment (block  143 ). The patient  40  then appears at the second hospital  31  in an attempt to obtain the same treatment (block  144 ). Personnel at the second hospital  31  access the patient&#39;s PHJ  41  (block  145 ) with permission from the patient  40 , and check for previous treatment(s). If such a visit resulted in a treatment for the same condition for which the patient  40  is seeking help at the second hospital  31  within a predetermined time limit (block  146 ), treatment is denied (block  147 ), thus saving hospital resources. If not, treatment is provided (block  148 ), and a record is entered into the PHJ  41  (block  149 ).  
         [0051]     The present invention also addresses the problem of potentially harmful drug interactions ( FIG. 7 ). Such adverse interactions can occur, for example, if different drugs are prescribed by different doctors who under the current state of the art would not have access to a list of medications being prescribed elsewhere for the patient  40 . The problem is addressed by a method  160  that comprises the steps of receiving at a healthcare facility  30  a request from a patient  40  for treatment for an ailment (block  161 ) and identifying a potential pharmaceutical with which to treat the ailment (block  162 ).  
         [0052]     The facility  30  then receives permission from the patient  40  for secure access to a portion of an electronic healthcare record  41  including patient prescription data (block  163 ) and electronically enters a secure healthcare management system  10  that comprises the database  21  housing prescription data on the patient  40  (block  164 ).  
         [0053]     The facility  30  and the patient  40  must provide electronic certification to the system  10  of a registry of the facility  30  with the system  10  and of the received permission (block  165 ). If the identified pharmaceutical and the patient prescription data meet predetermined criteria (block  166 ), the identified pharmaceutical is prescribed to the patient  40  (block  167 ). Otherwise, the identified pharmaceutical is not prescribed (block  168 ).  
         [0054]     Two exemplary embodiments of this method  160  may be contemplated (block  169 ). In one embodiment, following the electronic certification providing step (block  165 ), the patient prescription data is accessed (block  170 ) and a determination at the healthcare facility  30  is made of an advisability of prescribing the identified pharmaceutical (block  171 ) based upon any other currently prescribed pharmaceutical(s).  
         [0055]     In an alternate embodiment, the healthcare management system  10  includes software for making a determination of a potential for an adverse interaction between the identified pharmaceutical and any currently prescribed pharmaceutical in the patient prescription data (block  172 ).  
         [0056]     A method  60  of funding such a system  10  illustrated in  FIG. 8 , which is believed to represent a significant improvement in achieving better healthcare for the both the insured and the uninsured segments of the population, as well as lowering costs for providing such healthcare. This embodiment of the method  60  of the present invention relies on community-based and/or faith-based initiatives to succeed, although this is not intended as a limitation.  
         [0057]     At the center of  FIG. 8  is the community foundation, depicted as the central site  20 . Fund and information flow is illustrated by arrows leading into and out of the foundation  20 . Those providing funds include, but are not intended to be limited to, in-kind donation partners  61  such as local corporations; investors  62  such as hospitals, county or city governments; donors  63  such as foundations, individuals, philanthropists, corporations, faith-based groups, and pharmaceutical corporations; and other funders such as national charitable organizations  64 . Other, nonmonetary, input may come in the form of advisors  65  such as investors, universities, city or county government, faith-based organizations, doctors, nurses, and care-givers.  
         [0058]     Services provided by the foundation  20  include providing assistance to other entities, such as, but not intended to be limited to, not-for-profit entities, who care for the uninsured with chronic diseases and/or disabilities. Also provided are accountability, that is, fiduciary distribution of funds  67 , a replicable model for other communities to adopt and research, a community-based Advisory Board, and measurable outcomes  69 . A double-blinded database of outcomes  69  can be used to formulate effective case-management techniques, guidelines for success in serving the uninsured, patient satisfaction surveys, fewer emergency room visits, increased patient compliance, nonprofit efficiency, and community reporting. Research may also be utilized by universities to further improve the knowledge base for caregiving.  
         [0059]     The foundation  20  also functions to coordinate the volunteer “buddies” with the patients  40  and to assist in patient enrollment functions.  
         [0060]     In the foregoing description, certain terms have been used for brevity, clarity, and understanding, but no unnecessary limitations are to be implied therefrom beyond the requirements of the prior art, because such words are used for description purposes herein and are intended to be broadly construed. Moreover, the embodiments of the system and methods illustrated and described herein are by way of example, and the scope of the invention is not limited to the exact details disclosed herein.