Patent Abstract:
A method for evaluating sleep disorders in mammals and distributing control information related to the sleep disorders through electronic communication networks. The method includes acquiring analog information related to physiological signals through a mobile device from a mammal user. The mammal user is at a geographic location outside of a sleep laboratory staffed by trained technicians. The mobile device is coupled to a sensing device, which is coupled to monitoring region(s) of the mammal. The method includes converting the analog information into a digital format using a signal processing device and transmitting information related to the physiological signals in the digital format to one or more service computers through an electronic communications network. Each of the service computers is operably coupled to a health information service facility. The method determines if the mammal user has related control information at one of the health information service facilities. The related control information is received through the communication network. The method processes the information related to the physiological signals at one or more of the service computers to provide a report associated with the information related to the physiological signals and the mammal user. The method communicates report information in the report associated with the information related to the physiological signals upon indication of receipt of at least control account information of the mammal user based upon the determining the related account information.

Full Description:
CROSS-REFERENCES TO RELATED APPLICATIONS 
     Not applicable 
     STATEMENT AS TO RIGHTS TO INVENTIONS MADE UNDER FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
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     REFERENCE TO A “SEQUENCE LISTING,” A TABLE, OR A COMPUTER PROGRAM LISTING APPENDIX SUBMITTED ON A COMPACT DISK 
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     BACKGROUND OF THE INVENTION 
     The present invention generally relates to ways of monitoring health related disorders. More particularly, the invention provides a method and system for monitoring and controlling signals of sleep disorders acquired from a mammal user. Merely by way of example, the invention is applied using wide area electronic communication network and computer hardware. But it would be recognized that the invention has a much broader range of applicability such as applicability in an enterprise networks and others. 
     Many diseases afflict humans and other mammals. More than eighty such diseases comprise a class of ills known as sleep disorders. Some sleep disorders pose serious threats to health and well-being, and some are often treatable. Others are believed to be untreatable. As merely an example, sleep disorders are common. Many humans having a sleep disorder are often unaware of their affliction. For example, a single sleep disorder, obstructive sleep apnea, affects 5-15% of American adults and may be reasonably suspected in the 40% of adults who snore and the 5-10% of children who snore. Thus, obstructive sleep apnea is sufficiently common that, ideally, all primary care physicians should perform evaluations for it several times per day and should expect to diagnose it several times per week. Yet, fewer than 1% of patients in primary care carry the diagnosis of sleep apnea (E. M. BALL, et al. Diagnosis and treatment of sleep apnea within the community. The Walla Walla Project. Arch Intern Med. 1997;157(4):419-24.) (N. R. KRAMER, et al. The role of the primary care physician in recognizing obstructive sleep apnea. Arch Intern Med. 1999;159(9):965-8.) (N. C. NETZER, et al. Using the Berlin Questionnaire to identify patients at risk for the sleep apnea syndrome. Ann Intern Med. 1999;131(7):485-91.) (T. YOUNG, et al. Estimation of the clinically diagnosed proportion of sleep apnea syndrome in middle-aged men and women. Sleep. 1997;20(9):705-6.). A major limitation to reducing the public health burden of sleep disorders has been in diagnosing them. 
     Conventional techniques for diagnosing sleep disorders have limitations preventing them from becoming widely used. For example, if the patient&#39;s fundamental problem occurs during sleep, it often follows that observations should be made of the sleeping patient. Such observations are generally not practical in most physician offices. Specialized sleep-monitoring facilities allow assessments of a sleeping patient by collecting a plurality of physiological signals from the patient—a procedure known as “polysomnography.” Polysomnography performed in such facilities, however, is often inconvenient for the patients who sleep there overnight and has proven to be expensive as well. 
     To overcome the limitations of dedicated sleep-monitoring facilities, other conventional techniques may permit collection of physiological signals as the patient sleeps at his or her home. These techniques include a hardware device for recording physiological signals. After recording physiological signals during sleep, the recorded physiological signals are accessed and analyzed, and information related to the analysis is made available to an end-user. Conventional techniques have many limitations in this regard. Logistics surrounding the analysis facility and return of the recording device are a major issue. 
     In some techniques, a physician&#39;s office or other health care facility is an analysis facility. This typically means that the expertise needed to analyze the signals resides within the health care facility. Humans may be the repository of such expertise, but this is problematic because humans ideally need training to performing such analyses, and because human experts are generally expensive. Machines (including software codes running on general purpose computers) may also perform analyses in one or more health care facilities. Such an arrangement places significant burdens on the human caretaker of the machine(s) at each facility. For example, a caretaker should be aware of updates and recalls of the analysis software, and should install updates as they become available. In addition, the caretaker should ensure the computer is properly configured for the software and remains in a validated state, all of which may be challenging, given periodic updates to operating systems, possible corruption of necessary system files, interference from other software, and so on. Physical and usage security also should be maintained around the computer, to prevent accidental or malicious tampering. This is especially difficult for a shared, general-purpose computer. Although some conventional techniques use both humans and machines to perform analyses, such techniques often magnify problems associated with a system, which inherits problems of both humans and machines. 
     Other approaches attempt to centralize the analysis facility. As merely an example, a company called Sleep Solutions Inc. (herein “Sleep Solutions”) sends sleep-monitoring hardware to the patient&#39;s home by post or other delivery service. The hardware records physiological signals and is then returned, by post or other delivery service, to the Sleep Solutions analysis facility. The physiological data are analyzed, and the report is made available to the patient&#39;s physician over the Internet. There are several difficulties with this method. Postal services may be slow. Overnight delivery is possible with some delivery services, but at considerable expense. Furthermore, equipment may be damaged or lost in transit, which adds to expense and may necessitate a repeat study on the patient. This approach may also require considerable expense to support an infrastructure at the analysis facility to receive diagnostic hardware items, prepare them for the next use, and then distribute them. Still another limitation with the Sleep Solutions system arises in making patient reports available on the Internet. Any transmission of medical information must generally be done securely. Sleep Solutions employs the common combination of username and password at the end-user site. A limitation of this system is well known: many human computer-users have a tendency to choose an easily-guessed password and/or write their password somewhere it might be found. 
     Another product is offered by SNAP Laboratories, which also uses a centralized analysis facility. SNAP often uses a digital audio tape (DAT) recorder to capture the sounds made by a sleeping patient. The sounds are recorded onto a DAT cassette tape, and the cassette tape is sent by post or other delivery service to an analysis facility maintained by SNAP. This system has all the problems of the system of Sleep Solutions, and further adds costs of a consumable data storage item (the DAT cassette tape). 
     Other conventional approaches attempt to teach the transmission of physiological data to a remote analysis facility. These approaches, however, often cannot practically be implemented on a large scale, as they contain significant shortcomings, e.g. confidential patient information is open on the network, account information is inadequate, only a portion of information of potential diagnostic utility is transmitted, analysis methods are inflexibly implemented, provisions for technically unsophisticated users are not described, and so on. Depending upon the particular approach, there can also be many other limitations. 
     From the above, it is desirable to have improved techniques for monitoring health related disorders. 
     BRIEF SUMMARY OF THE INVENTION 
     According to the present invention, techniques for monitoring health related disorders are provided. More particularly, the invention provides a method and system for monitoring and controlling signals of sleep disorders acquired from a mammal user. Merely by way of example, the invention is applied using wide area electronic communication network and computer hardware. But it would be recognized that the invention has a much broader range of applicability such as applicability in enterprise networks and others. 
     In a specific embodiment, the invention provides a method for evaluating sleep disorders in mammals and distributing control information related to the sleep disorders through electronic communication networks. The method includes acquiring analog information related to physiological signals through a mobile device from a mammal user. The mammal user is at a geographic location outside of a sleep laboratory staffed by trained technicians (e.g., conventional location for treatment by trained technicians and physicians). The mobile device is coupled to one or more sensing devices, which is/are coupled to one or more monitoring regions of the mammal, e.g. neck, pericardium, suprasternal notch, scalp, etc. The method includes converting the analog information into a digital format using a signal processing device and transmitting information related to the physiological signals in the digital format to one or more service computers through an electronic communications network. Each of the service computers is operably coupled to a health information control facility. Alternatively, one or more of the service computers is coupled to the health information control facility. The method determines if the mammal user has related control information at at least one of the health information control facilities. The related control information is received through a communication network. The method processes the information related to the physiological signals at one or more of the service computers to provide a report associated with the information related to the physiological signals and the mammal user. The method communicates report information in the report associated with the information related to the physiological signals upon indication of receipt of at least control account information of the mammal user based upon the determining the related account information. 
     In an alternative specific embodiment, the invention includes a system for evaluating sleep disorders in mammals and distributing control information related to the sleep disorders through electronic communication networks. The system comprises one or more memories that include computer codes. A code is directed to acquiring analog information related to physiological signals through a mobile device from a mammal user, which is at a geographic location outside of a sleep laboratory staffed by trained technicians. The mobile device is coupled to one or more sensing device(s), which is/are coupled to one or more monitoring regions of the mammal. A code is directed to converting the analog information into a digital format using a signal processing device. A code is directed to transmitting information related to the physiological signals in the digital format to one or more service computers through an electronic communications network. Each of the service computers is operably coupled to a health information control facility. Alternatively, one or more of the service computers is coupled to the health information control facility. A code is directed to determining if the mammal user has related control information at one of the health information control facilities. A code is directed to processing the information related to the physiological signals at one or more of the service computers to provide a report associated with the information related to the physiological signals and the mammal user and a code is directed to communicating report information in the report associated with the information related to the physiological signals upon indication of receipt of at least control account information of the mammal user based upon the determining the related account information. 
     In an alternative specific embodiment, the invention provides a controlled method for evaluating sleep disorders in mammals and distributing information including case data related to the sleep disorders through communication networks. The method includes capturing analog information related to physiological signals through a remote device from a mammal user outside of a sleep laboratory staffed by trained technicians. The method also includes converting the analog information into a digital format using a signal processing device and transmitting information related to the physiological signals in the digital format to one or more service computers through an electronic communications network. The method includes transferring case data information related to the physiological signals to the service center receiving the physiological signals and processing the information related to the physiological signals at one or more of the service facilities to form an output associated with the information and the mammal user. A step of associating a portion of the case data information to the output associated with the physiological signals to form a report is included. The method communicates report information in the report derived from the information related of the physiological signals and case data. 
     In still an alternative specific embodiment, the invention provides a controlled system for evaluating sleep disorders in mammals and distributing information including case data related to the sleep disorders through communication networks. The system comprises one or more memories, which include computer codes. A code is directed to capturing analog information related to physiological signals through a remote device from a mammal user outside of a sleep laboratory staffed by trained technicians. A code is directed to converting the analog information into a digital format using a signal processing device and a code is directed to transmitting information related to the physiological signals in the digital format to one or more service computers through an electronic communications network. A code is directed to transferring case data information related to the physiological signals to the service center receiving the physiological signals. A code is directed to processing the information related to the physiological signals at one or more of the service facilities to form an output associated with the information and the mammal user. A code is directed to associating a portion of the case data information to the output associated with the physiological signals to form a report. The one or more memories also include a code directed to communicating report information in the report derived from the information related of the physiological signals and case data. 
     Various additional objects, features and advantages of the present invention can be more fully appreciated with reference to the detailed description and accompanying drawings that follow. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  shows a simplified diagram of a method for communicating sleep-related data according to an embodiment of the present invention. 
         FIG. 2  shows a configuration of facilities and electronic communication links according to an embodiment of the present invention. 
         FIG. 3  shows a configuration of a patient home according to an embodiment of the present invention. 
         FIG. 4  shows a configuration of an end-user facility according to an embodiment of the present invention. 
         FIG. 5  shows a configuration of a service facility and control facility according to an embodiment of the present invention. 
         FIG. 6  shows a simplified overview of a method according to an embodiment of the present invention. 
         FIG. 7  shows details of the “Consult resources” function according to an embodiment of the present invention. 
         FIG. 8  shows details of the “Prepare to test” function according to an embodiment of the present invention. 
         FIG. 9  shows details of the “Perform test” function according to an embodiment of the present invention. 
         FIG. 10  shows details of transmitting information to service center according to an embodiment of the present invention. 
         FIG. 11  shows details of transmitting information from data marshaling device to network gateway device according to an embodiment of the present invention. 
         FIG. 12  shows details of transferring data from network gateway device to service center according to an embodiment of the present invention. 
         FIG. 13  shows details of processing information related to physiological signals according to an embodiment of the present invention. 
         FIG. 14  shows details of performing a service according to an embodiment of the present invention. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     According to the present invention, techniques for monitoring health related disorders are provided. More particularly, the invention provides a method and system for monitoring and controlling signals of sleep disorders acquired from a mammal user. Merely by way of example, the invention is applied using wide area electronic communication network and computer hardware. But it would be recognized that the invention has a much broader range of applicability such as enterprise networks and others. 
     We have discovered that few diagnostics have been successfully applied on a scale as massive as the one demanded for sleep disorders. Such wide spread diagnostics are termed “population diagnostics.” Examples of successful population diagnostics include, but are not restricted to, the blood pressure cuff (sphygmomanometer), the thermometer, and the weight scale. Population diagnostics are often not routinely applied by physicians, but by ancillary healthcare personnel, such as nursing assistants and the like. Accordingly, performance requirements for a population diagnostic are more stringent that requirements for diagnostics used in less massive numbers. Table 1 shows a partial list of characteristics we found in effective population diagnostics. 
     TABLE 1—CHARACTERISTICS OF A POPULATION DIAGNOSTIC
         Inexpensive:   (a) Equipment (hardware and software) should be inexpensive to acquire (e.g., easily affordable to a primary care physician&#39;s practice);   (b) Per-use cost is low (e.g., a few U.S. dollars at this time) in materials and staff time;   (c) Simple to train ancillary personnel to perform the diagnostic.   Foolproof (i.e., yield trustworthy results almost 100% of the time it is applied):   (a) Few, if any, demands on the patient;   (b) Few, if any, demands on the staff;   (c) Reliable and durable.   Unobtrusive, meaning:   (a) Low-maintenance   (b) Minimal administrative overhead.   (c) Minimal data management overhead.   (d) Not require manually-performed updates or modifications once installed.   Results should be quick (i.e. best available in near real time, at the point of care).   Results must be understandable to the end-user.   Safe.   Reasonably accurate.       

     To achieve some or all of the above, the present invention provides a novel “sleep-data service center” (henceforth “service facility” or “service center”) that communicates electronically with end-user facility(s) and/or the patient&#39;s home. In addition to physiological data, such communication includes, but is not restricted to administrative data, physiological meta-data, clinical data, and several other data types described below. A plurality of data types allows the sleep-data service center to perform many functions of value for both the patient and the end-user(s). A plurality of service functions, in combination with the ease of communication between two or all parties, is a highly desirable step in developing a population diagnostic for sleep disorders. The invention also provides a “health information control facility” (henceforth “control facility”) which provides information to the service facility, enabling the service facility to dispense services in a disciplined and regulated manner. The control facility can be a third party facility, which is independent, in some embodiments. Alternatively, the control facility can be integrated with the service facility in other embodiments. Of course, there can be other ways of carrying out the functionality described herein. Further details of the present invention can be found throughout the present specification and more particularly below. 
       FIG. 1  shows a simplified diagram of a method according to an embodiment of the present invention. This diagram is merely an example, which should not unduly limit the scope of the claims herein. One of ordinary skill in the art would recognize many other variations, modifications, and alternatives. As shown, physiological signals and other data are acquired in patient home  110 . The signals, data, and/or data derived thereof are transmitted from the patient home to one or more service facilities  140  via an electronic communications network  150 . Service facility  140  provides one or more services to one or more end-users located at end-user facility  130 . As part of some services, service facility  140  sends information to the end-user  130  via an electronic communications network  150 , which may or may not be the same communication network by which service facility  140  received data. Actions of service facility  140  may be modified by information received from health information control facility  120 , which is operably coupled to service facility  140  and may optionally communicate to external entities and facilities via electronic communication network  150 . 
     Preferably, patient home  110  represents any facility that is not a sleep laboratory staffed by trained sleep technicians (“trained” as defined by the American Sleep Disorders Association). It is generally intended to represent any facility in which the patient may sleep in the due course of their life, e.g. the patient&#39;s home, a hotel room, the home of another person, the bunk of a tractor-trailer cab, a ship&#39;s cabin, an aerospace vehicle, a hospital bed in a general medical ward, a hospital bed in an intensive care unit, a nursing home, a skilled nursing facility, a research study site, a primary care physician&#39;s office where a nap opportunity may be afforded without the presence of a trained sleep technician, and so on. 
     Typical physiological signals collected in the home for the purpose of diagnosing sleep disorders include, but are not restricted to, electroencephalographic signals; electrocardiographic signals; electromyographic signals; electrooculographic signals; signals derived from movements of the chest, abdomen, or limbs; signals derived from body position, oximetry, penile tumescence, temperature; sound; and video. 
     The physiological signals and/or data derived from the original data are hereinafter collectively referred to as “physiological data,” no matter when, where, how, or how often transformation of signals or data occurs. Likewise, data derived from data are still termed “data.” 
     The communication network  150  may be composed of one or more electronic networks, for example, the Internet, some other wide area network, a local area network, the telephone system, a wireless system, power lines, a cable television network, a satellite network, and so on. Preferably, electronic communications network  150  is not a single fixed network, but may represents many or all types of electronic communications networks over which entities may communicate at any time. Thus, even if two entities are communicating over one network at one instant and another network at another instant, for purposes here, they will be said to be communicating over communications network  150  at both times. 
     Each facility shown in  FIG. 1 , i.e. patient home  110 , end-user facility  130 , control facility  120 , and service facility  140  is a logical entity. That is, each may be composed of zero or more physically distinct facilities and need not be fixed sites, although their functionalities will always be present. The exceptions are: (a) at least one physically distinct service facility  140  is electronically connected to at least one physically distinct end-user facility  130  via electronic communications network  150 , and (b) at least one service facility  140  is operably coupled to at least one control facility  120 . Thus, multiple configurations are possible; one example according to the present invention is shown in  FIG. 2 . 
     Except for the two linkages mentioned above, any facility may communicate with any other facility via communications network  150 , via a different electronic communications means, or (as shown in  FIG. 2 ) may not communicate electronically at all. In particular, it is possible that patient home  110  may not communicate electronically with another facility. In such a case, physical transmission step  160  may move data from patient home  110  to end-user facility  130 , followed by electronic communication of data from end-user facility  130  to service facility  140  via communication network  150 . Merely by way of example, physical communications step  160  may involve a human carrying the data from one facility to another, the data being stored in some device or devices in certain embodiments. 
     Other entities (not shown) may be in electronic communication with entities shown in  FIG. 2 . For example, a bank or an insurance company may communicate with the end-user facility. In addition, there may be multiple end-users, e.g. a primary care physician, a specialist physician, a researcher, a transportation regulatory agency, and so on, each of which may have their own facility(s) or shared facility(s). 
     In an alternate embodiment, the patient is the end-user. Thus, patient home  110  is combined with end-user facility  130  into a unified facility (not shown). Such unified facility electronically communicates with service facility  140  via communications network  150 .  FIG. 2  is also an example, which should not unduly limit the scope of the claims herein. One of ordinary skill in the art would recognize many other variations, modifications, and alternatives. Additional details of the invention are provided throughout the present specification and more particularly below.  FIG. 3  shows further details of patient home  110  according to an embodiment of the present invention. The figure is merely an example, which should not unduly limit the scope of the claims herein. One of ordinary skill in the art would recognize many other variations, modifications, and alternatives. Mammalian patient  200  is monitored by one or more physiological sensors  205  in patient home  110 . Physiological sensor(s)  205  supply data to data marshaling device  210 . A plurality of data and software codes (not shown) may reside on data marshaling device  210 . Optionally, mammalian patient  200  may supply para-physiological data to data marshaling device  210 . As an example of para-physiological data, mammalian patient  200  may activate optional event marker  215  on data marshaling device  210 . As another example of para-physiological data, a microphone may capture patient&#39;s vocalized memo while event marker  215  is activated. 
     At various times, or continuously, data marshaling device  210  transmits accumulated data from patient home  110  to service facility  140 , via electronic connection  220  and communications network  150 . Electronic connection  220  may be nothing more than a cable or cables, a cable jack, an infrared beam, and so on. As described later, data marshaling device  210  may transmit one or more data classes in addition to physiological data and optional para-physiological data. In an alternate embodiment, data marshaling device  210  may connect with communications network  150  via a connection (not shown) with network interface device  230 . 
     In another alternate embodiment, electronic connections  220  and/or  235  to communications network  150  are absent in patient home  110 . In this embodiment, data marshaling device  210  records data, and is later physically transported to another facility where data marshaling device  210  is electronically connected, directly or indirectly, to communications network  150 . For example, data marshaling device  210  may be physically transported  160  to end-user facility  130 , where it is electronically connected to communications network  150 . Once connected to communications network  150 , data recorded on data marshaling device  210  may be transmitted to service facility  140 . Alternatively, data marshaling device  210  may have one or more removable components capable of storing data, e.g. floppy disk, PCMCIA card, Smart Media®, Memory Stick®, SanDisk®, and the like. These removable components may be transported within a facility or between facilities. These removable components may then be coupled to some device that is, in turn, coupled to electronic communications network  150  in some embodiments. 
     Optionally, interested party  225  is a human that is interested in the health or well-being of mammalian patient  200 . Interested party  225  and mammalian patient  200  may or may not be the same person, and they may or may not be located at the same facility. For example, interested party  225  may be parent, bed-partner, caretaker, friend, relative, or physician of mammalian patient  200 .  FIG. 3  depicts the case in which interested party  225  and mammalian patient  200  are separate mammals located at the same facility. Interested party  225  interacts with network interface device  230 , which may be, for example, a personal computer, a telephone, a personal digital assistant, and so on. Network interface device  230  is electronically connected  235  to communications network  150 . 
     In an alternate embodiment, data marshaling device  210  and electronic interface device  230  are the same device (not shown), having all necessary characteristics of each separate device. In an additional alternate embodiment, data marshaling device  210  connects to communication network  150  via an intermediate connection (not shown) with an electronic interface device  230 .  FIG. 4  shows further detail of end-user facility  130  according to an embodiment of the present invention. The figure is merely an example, which should not unduly limit the scope of the claims herein. One of ordinary skill in the art would recognize many other variations, modifications, and alternatives. Data marshaling device  210  can be electronically linked  250  to network interface device  255 , which may be a desktop computer, personal digital assistant, telephone, specialized hardware, etc. Network interface device  255  is electronically connected  260  to communications network  150 . 
     End-user facility  130  optionally also contains one or more report-rendering devices  265  electronically connected  270  to communications network  150 . Report-rendering devices  265  may be identical to network interface device  255 , may be a component of network interface device  255 , or, as shown, may be distinct from it and electronically connected to it through communications network  150  or some other means. Report-rendering device  265  may be a general-purpose desktop computer, a personal digital assistant, a telephone, facsimile machine, printer, video monitor or television, loudspeaker, gaming unit, special purpose hardware, and so on. As noted earlier, patient home  110  and end-user facility  130  may be the same site when the patient is the end-user. In an alternate embodiment, data marshaling device  210  connects directly to communication network  150 , as in  FIG. 3 .  FIG. 5  shows further detail of service center  140  and control facility  120  according to an embodiment of the present invention. The figure is merely an example, which should not unduly limit the scope of the claims herein. One of ordinary skill in the art would recognize many other variations, modifications, and alternatives. Communications network  150  is electronically linked  280  to a network of computers  285  in the service facility  140 . The network of computers  285  may be composed of one or more computing devices, as is widely practiced in the art. A plurality of different network arrangements are possible, not all components necessarily being connected simultaneously. The arrangement shown is for example only and is not meant to restrict the various embodiments possible. It is further understood that the spirit of this embodiment also includes computing devices separated by a short distance, such that electronic media may be physically transported between them by a walking human, pneumatic message tube, or other convenient means. One or more data repositories  290  reside on computing devices that are part of, or are operably coupled to, network of computers  285 . All service facilities  140  need not contain a data repository  290 . Data repositories  290  contain one or more data elements, possibly, but not necessarily, falling into one or more of the data classes shown in table 2a. Descriptors of the patient and/or the diagnostic test are called “patient data.” Patient data is itself composed of a plurality of data classes, shown in table 2b. In a specific embodiment, “Case data” refers to the aggregation of all data classes comprising patient data, excepting physiological data, although other definitions can also exist. 
     
       
         
               
             
               
               
             
               
               
             
               
               
             
           
               
                 TABLE 2a 
               
               
                   
               
               
                 Examples of Sleep-Related Data 
               
               
                   
               
             
             
               
                   
               
             
          
           
               
                   
                 resources, 
               
               
                   
                 patient data, 
               
             
          
           
               
                   
                 physiological data, 
               
               
                   
                 case data, 
               
             
          
           
               
                   
                 queries, 
               
               
                   
                 end-user data, 
               
               
                   
                 end-user supply data, 
               
               
                   
                 end-user preferences, 
               
               
                   
                 service data and test parameters 
               
               
                   
                   
               
             
          
         
       
     
     
       
         
               
             
               
               
             
           
               
                 TABLE 2b 
               
             
             
               
                   
               
               
                 Examples of Patient Data 
               
             
          
           
               
                 Data Class 
                 Example(s) 
               
               
                   
               
               
                 Physiological data 
                 electroencephalographic data; 
               
               
                   
                 electrocardiographic data; 
               
               
                   
                 electromyographic data; 
               
               
                   
                 electrooculographic data; data derived 
               
               
                   
                 from movements of the chest, abdomen, 
               
               
                   
                 limbs, other body parts, 
               
               
                   
                 or the body as a whole; data derived from 
               
               
                   
                 body position, oximetry, penile tumescence, 
               
               
                   
                 temperature, and usage of therapeutic 
               
               
                   
                 devices such as continuous positive airway pressure 
               
               
                   
                 (CPAP); sound, including audible sound, doppler 
               
               
                   
                 flow data, and ultrasound; and video. Derived 
               
               
                   
                 data, such as Bispectral Index ®, too. 
               
               
                 Para-physiological 
                 activation of event marker, recording of 
               
               
                 data 
                 event memos, sleep log 
               
               
                 Physiological meta- 
                 montage data, clock time, time of recording 
               
               
                 data 
                 start(s) and stop(s), parameters used for 
               
               
                   
                 amplification or filtering or digitization, 
               
               
                   
                 error or warning notifications 
               
               
                 Service data 
                 list of services the service center 
               
               
                   
                 should provide; list of analyses 
               
               
                   
                 to be run; values for synchronizing clock on 
               
               
                   
                 data marshalling device; manually 
               
               
                   
                 programmed montage 
               
               
                 Configuration data 
                 serial number of data recording device, 
               
               
                   
                 version number of firmware operating on 
               
               
                   
                 data recording device, checksums of 
               
               
                   
                 firmware instructions 
               
               
                 Clinical data 
                 age, sex, height, weight, blood pressure, 
               
               
                   
                 symptoms, medical history (including co-morbid 
               
               
                   
                 conditions, past medical history, 
               
               
                   
                 medication history, surgical history, family 
               
               
                   
                 history, social history, etc.), physical 
               
               
                   
                 examination findings, laboratory and 
               
               
                   
                 imaging findings, as well as derived or 
               
               
                   
                 calculated values such as 
               
               
                   
                 body mass index or scores on instruments such 
               
               
                   
                 as the Epworth Sleepiness Scale, Stanford 
               
               
                   
                 Sleepiness Scale, SF-36, Minnesota 
               
               
                   
                 Multiphasic Personality Inventory, Beck 
               
               
                   
                 depression inventory, Prime-MD, and so on. 
               
               
                 Administrative data 
                 patient identifiers such as name, social 
               
               
                   
                 security number, driver&#39;s 
               
               
                   
                 license number, medical history number, 
               
               
                   
                 passport number; patient contact information; 
               
               
                   
                 identifier for affiliated third parties 
               
               
                   
                 such as physician medical practice, insurance 
               
               
                   
                 company, or other third-party payor; identifiers 
               
               
                   
                 for third-party programs such as 
               
               
                   
                 insurance policy identifiers; procedure data 
               
               
                   
                 such as CPT codes, LOINC codes, HCPCS, etc.; 
               
               
                   
                 payment account identifiers such as 
               
               
                   
                 credit card number, checking account number, 
               
               
                   
                 PayPal identifier, identifiers referencing 
               
               
                   
                 a line of credit at a service center, etc. 
               
               
                 Authentication data 
                 username, password, physical token 
               
               
                   
                 identifier, or biometric 
               
               
                   
                 identifier (possibly physiological) 
               
               
                   
               
             
          
         
       
     
     Tables 2a and 2b are merely examples, and are not meant to be exhaustive. Note that some data fall into more than one data class. For example, a checksum of firmware instructions may be in both the configuration data class and the authentication data class. A plurality of software codes resides on the network of computers  285 . These codes, possibly in concert with data repositories  290  and possibly in concert with one or more humans, perform one or more services for the end-user(s). Such services may be delivered to end-user via electronic transmission and/or other means. Table 3 lists examples of services provided to end-user(s). Note: although services are performed by network of computer  285  within one or more service facilities, we will, for simplicity, sometimes refer to service center(s)  140  as providing service(s). 
     
       
         
               
             
               
               
             
           
               
                 TABLE 3 
               
             
             
               
                   
               
               
                 Examples of Services Available to End-user(s) 
               
             
          
           
               
                 Name of 
                   
               
               
                 Service 
                 Action 
               
               
                   
               
               
                 Analysis 
                 Identify, characterize, and/or tabulate physiological events by 
               
               
                   
                 processing physiological data, possibly in conjunction with other 
               
               
                   
                 data 
               
               
                 Archive 
                 Data management functions such as long-term storage, making 
               
               
                   
                 backups, and the like 
               
               
                 Authen- 
                 Establish identity and/or role of end-user, patient, interested party, 
               
               
                 tication 
                 or other entity. 
               
               
                 Interview 
                 Collect selected non-physiological data, e.g. clinical data, 
               
               
                   
                 administrative data, etc. 
               
               
                 Resource 
                 Identify resources relevant to a specific set of data 
               
               
                 Summary 
                 Summarize data across multiple patients 
               
               
                 Monitor 
                 Monitor function of hardware, software, and/or patient in real- 
               
               
                   
                 time, before and/or during and/or after a test 
               
               
                 Billing 
                 (1) Submission of electronic claims to third-party payors, and/or 
               
               
                   
                 (2) Prepare documents to assist physician office in securing 
               
               
                   
                 reimbursement (such documents may include HCFA form 1500, 
               
               
                   
                 letter of medical necessity, claim forms, etc.), (3) Electronic funds 
               
               
                   
                 transfer and/or credit card transaction. 
               
               
                 Alert 
                 Deliver urgent communications from service facility to end-user 
               
               
                 Supply 
                 Track usage of consumable items such as disposable sensors; 
               
               
                 management 
                 accept and confirm orders for supplies; coordinate shipping of 
               
               
                   
                 supplies 
               
               
                 Customer 
                 Provide help to end-user 
               
               
                 support 
               
               
                 Community 
                 Facilitate communication between end-users around common 
               
               
                   
                 topic(s) 
               
               
                 Programming 
                 Pro rammin the data marshallin device 
               
               
                 Email 
                 Electronic mail between various entities; in some situations, the 
               
               
                   
                 real-world identity of an entity may be unknown to other entities 
               
               
                 Account 
                 Tabulate and report usage statistics; management of password and 
               
               
                 management 
                 other authentication information; user account creation, deletion, 
               
               
                   
                 and other management functions such as maintaining contact 
               
               
                   
                 information, assigning roles, etc. 
               
               
                 Update 
                 Determine and possibly install updates to software of data 
               
               
                   
                 marshalling device, network interface device, network gateway 
               
               
                   
                 device, or possibly other device(s). May draw on monitoring and 
               
               
                   
                 programming services. 
               
               
                 Tracking 
                 Log hardware that has been stolen, lost, recalled, expired, tainted, 
               
               
                   
                 returned, destroyed, repaired, etc. 
               
               
                   
               
             
          
         
       
     
     Service facility  140  is operably coupled  295  to control facility  120 . In one possible embodiment, control facility  120  includes network of computers  298  electronically coupled to data repository  299 . Note: although services are performed by network of computer  298  within one or more control facilities, we will, for simplicity, sometimes refer to control center(s)  120  as providing service(s). 
     In addition to the data classes shown in tables 2a and 2b, “control information” constitutes a further data class. Control information enables service facility  140  to control access to the services it provides. For example, when service facility  140  provides the analysis service, it may be desirable for the service facility to control the circumstances under which the service is actually provided to end-user. The behavior of such controls may depend on zero or more pieces of information, examples of which are shown in table 4. 
     
       
         
               
             
               
               
             
           
               
                 TABLE 4 
               
             
             
               
                   
               
               
                 Examples of Control Information and Control Decisions 
               
             
          
           
               
                 Control 
                   
               
               
                 Information 
                 Control Decisions 
               
               
                   
               
               
                 Hardware serial 
                 Block service if hardware has been recalled, reported stolen, etc. 
               
               
                 numbers 
                 (Hardware serial numbers may be associated with data marshalling 
               
               
                   
                 device 210, for example.) 
               
               
                 Software version 
                 Block service if software version is obsolete, recalled, etc. 
               
               
                 number 
                 (Software version numbers may be associated with software codes 
               
               
                   
                 that run on network interface device 230, for example. Invention 
               
               
                   
                 may possibly offer option to update software.) 
               
               
                 Medical license 
                 Permit service if end-user is a licensed physician (e.g. federal law 
               
               
                 number 
                 may prohibit performance of certain services, except under the 
               
               
                   
                 prescription of a physician). Permit service if medical license is in 
               
               
                   
                 good standing (licenses may expire, be revoked, etc.). 
               
               
                 Payment account 
                 Permit service if valid and sufficient information is provided to 
               
               
                 number 
                 extract payment. (Control information may include, in this 
               
               
                   
                 example, a credit card number, an identifier for a deposit account 
               
               
                   
                 that end-user maintains with service provider, a checking account 
               
               
                   
                 number, a PayPal account identifier, and so on.) 
               
               
                 Authentication 
                 Permit service if the service request is properly authenticated (e.g. 
               
               
                 data 
                 with a password that is linked to the serial number of the 
               
               
                   
                 hardware). 
               
               
                   
               
             
          
         
       
     
     Notice that control information may be drawn from a variety of data classes listed in tables 2a and 2b, or from other data classes or elements. Control information may be primarily associated with mammalian patient  200 , with interested party  225 , with end-user, or with other entity or entities. Control information may be secondarily related to mammalian patient  200  if it is associated with an entity that is associated with mammalian patient  200 . Note also that control information may include sensitive information that may require a higher degree of confidentiality, e.g. payment codes and authentication data. Thus, optionally separating the control facility from the service facility may offer security advantages. Table 4 is merely an example. 
     It is understood that any electrical connection referred to herein may be a physical connection employing electronic or optical cabling, or a wireless connection employing electromagnetic radiation of any type, e.g. radio frequency radiation, infrared light, visible light, etc. Nothing in the invention prohibits non-electronic communication between entities, e.g. transmission of hard-copy confirmations by postal or courier service, or transmission of electronic items by non-electronic means (e.g. hand-carrying removable electronic storage media such as a floppy disk). 
     According to a specific embodiment, sleep-related data are collected from one or more sources, and are transmitted electronically from patient home  110  or end-user facility  130  to service facility  140  according to embodiments of the present invention. Merely by way of example, we have provided selected methods according to the embodiments of the present invention below. 
       FIG. 6  shows simplified methods according to embodiments of the present invention. The figure is merely an example, which should not unduly limit the scope of the claims herein. One of ordinary skill in the art would recognize many other variations, modifications, and alternatives. In optional step  310  interested party  225  formulates one or more queries about mammalian patient  200 . Such queries may be purely mental, or may be recorded in various ways. Examples of queries include, but are not restricted to, “Is my husband&#39;s snoring dangerous?” or “How should I evaluate hypersomnolence in a 52 year old man having a body mass index of 33 kg/m/m?” or “What is the best sensor montage to use in testing patient John Jones?” 
     As noted earlier, interested party  225  may be the same person as mammalian patient  200 . Also note, however, that interested party may switch from entity to entity during the course of the invention. For example, when mammalian patient is a child, interested party  225  in some steps is most likely to be a parent, and in other steps is most likely to be a physician. The invention provides resources that may aid interested party  225  in satisfying the query(s) formulated in step  310 . The term “resources” applies to sources of information and/or other services. Examples of resources include, but are not restricted to: (a) Articles from scientific or popular sources that are applicable to the diagnostic evaluation or to the management of sleep disorders; (b) Communities of interested parties; (c) Software codes that report the result of calculations or inferences made on the basis of data; (d) Advertisements from companies wishing to influence the buying decisions of interested parties; and (e) Indexes of resources. 
     In step  315 , interested party  225  may optionally consult such resources. It is not expected that all possible queries in step  310  will be addressed by resources available in step  315 . After consulting resources (step  315 ), interested party  225  may return to step  310  by formulating additional query(s). Alternatively, after consulting resources (step  315 ), interested party makes a decision on what to do next (step  320 ). This step  320  occurs whether or not one or more queries were formulated (step  310 ) or whether or not resources were consulted (step  315 ). One or more actions ( 325 ,  325 A,  325 B,  325 C) may result from the decision (or decisions) made in step  320 . For example, interested party may decide to consult a physician, or may decide to get more sleep, or may decide to exercise more, and so forth. Alternatively, interested party  225  may decide not to take any further action at all related to the invention ( 325 D). 
     A possible action  325  resulting from decision  320  is to perform a sleep-related diagnostic test on mammalian patient  200  using aspects of the present invention. The diagnostic test includes two steps, preparing to test (step  330 ) and performing the test (step  335 ). 
     After diagnostic test  325  has been performed, interested party  225  assimilates (step  340 ) the results of the test. In many cases, this will lead to additional queries (e.g. “How should the newly-diagnosed sleep disorder be treated?”), and interested party returns to step  310 . Even if the results of the diagnostic test  325  do not generate queries, steps  310  and  315  are optional, so step  320  is eventually reached, after which interested party may stop. Nothing in the invention precludes the performance of all steps in real time. We now turn to step  315 , consulting resources. In an exemplary embodiment of the invention, resources are indexed or contained in one or more data repositories  290  connected to electronic communications network  285  at service facility  140 . Resources are accessed by interested party  225  using network interface device  230 . Interested party  225  may be located at any facility, so long as there is an electronic connection between network interface device  230  and network of computers  285 . Because interested party  225  may be an end-user for some services, we will henceforth use the more general term “end-user.” 
       FIG. 7  shows details of step  315 , in which end-user consults resources to answer one or more queries formulated in step  310 . The figure is merely an example, which should not unduly limit the scope of the claims herein. One of ordinary skill in the art would recognize many other variations, modifications, and alternatives. Having formulated a query (step  310 ), end-user communicates the query (step  355 ) to network of computers  285 . Software codes on network of computers translate the query (step  360 ) into a “canonical” form that can be readily manipulated by various software codes. As an example of canonization step  360 , a database of canonical queries  363  may be searched by end-user to find the canonical query most closely matching the query formulated in step  310 , e.g. by using Internet “FAQ” web pages as an interface to the database. As a further example, end-user may communicate the query  310  by typing or speaking or writing or signing it; software codes  360  may then select one or more possible canonized queries and possibly ask end-user to pick one or more. Thus, step  360  may involve bi-directional communication between network of computers  285  and end-user. 
     Next, in step  365  a canonical query identified in step  360  is matched against a database of resources  370 , the result being zero or more resources deemed relevant to the canonical query. In cases where the canonical query is being applied to a specific patient population (whether an actual patient, a hypothetical patient, or a class of patients), data may be retrieved from a database containing data describing the patient(s)  375 , such data becoming part of the criteria used to identify relevant resources  365 . In some instances, patient database  375  may contain insufficient data to determine the relevance of a resource. In such instances, end-user may be asked to supply needed data. The relevant resources identified in step  365  are presented  385  to end-user, by various possible means, including electronically via network interface device  230 , electronically by other means, through a mailed paper report, and so on. 
     End-user may ignore relevant resources or may consult them and possibly assimilate their contents (step  390 ). The consultation and assimilation steps may occur immediately or may be delayed. Should end-user have additional queries  395 , the process  315  may repeat. Should end-user lack an additional query, end-user may decide upon some action  320 . Consequences of step  315  may occur immediately or may be delayed. If end-user decides in step  320  to perform test  325 , preparation  330  for test occurs next, as shown in  FIG. 8 . The figure is merely an example, which should not unduly limit the scope of the claims herein. One of ordinary skill in the art would recognize many other variations, modifications, and alternatives. In step  410 , end-user obtains supplies needed to perform the test. Consumption of such supplies may be tracked by a supply database  425 . Supply database may reside on network of computers  285 , or it may reside elsewhere and optionally be in electronic communication with network of computers  285 . In some embodiments, end-user may order supplies (not shown), such orders optionally using supply database  425 . Data marshaling device  210  may be considered a supply item. Mammalian patient  200  may require preparation  415  for the test. For example, the patient may need instructions about the test, may need chest hair shaved, and so on. Some patients may be tested under specific circumstances, e.g. while undergoing a certain therapy, and those circumstances should so be established. The sensor(s)  205  to be used in the test are positioned  420  on or about the patient. In many instances, sensor(s) will be applied to various monitoring regions of the patient&#39;s body. In other instances, sensors may be placed in proximity to the patient (e.g. a video camera or a microphone, or even sensors embedded in a pillow or mattress). If a sensor is positioned on the patient, the act of positioning need not occur in patient home  110 . 
     Data marshaling device (“DMD”)  210 , too, may need preparation for testing (step  430 ), e.g. insertion or checking of batteries. In certain embodiments, data marshaling device  210  stores digital codes, including software codes, operating parameters, patient data, and so on. Thus, in certain embodiments, data marshaling device  210  is configured with these digital codes (step  435 ), possibly in concert with data source  440 . When such configuration is performed in association with information downloaded from service center  140 , it is an example of the “programming service” of table 3. 
     With preparation of patient  200 , sensor(s)  205 , and data marshaling device  210 , testing (step  335 ) of patient may begin.  FIG. 9  shows details of performing test (step  335 ). The figure is merely an example, which should not unduly limit the scope of the claims herein. One of ordinary skill in the art would recognize many other variations, modifications, and alternatives. To begin, data marshaling device  210  begins operation (step  510 ). The device may be commanded or triggered to start by a mammal (e.g. with an on/off switch, a sensor-related action, or other mechanical, electrical, or other input. Alternatively, the device may have been configured to begin operation once a certain set of conditions occur (e.g. at a certain time). 
     Once operating, data marshaling device  210  acquires signals (step  515 ) in patient home  110 , as transduced by sensor(s)  205 . Data marshaling device  210  transforms signals into digitally-formatted data (step  520 ). This step may involve, for example, filtering, analog-to-digital conversion, and a host of other techniques known to persons with ordinary skill in the art. 
     Data marshaling device  210  may acquire non-physiological signals, e.g. para-physiological data corresponding to activation of even button  215  and/or data loaded as part of step  435 . Thus, because data marshaling device  210  may contain information that could assist analysis of data derived from physiological signals, it may be more generally viewed as containing information related to the physiological signals. 
     In certain embodiments, information will be stored (step  525 ) on data marshaling device  210 , for later retrieval. In these embodiments, information would be retrieved after an arbitrary period of time (microseconds, hours, days, etc.) and electronically transmitted to service center  140  in step  530 . In other embodiments, information may be streamed to service center  140  as it arrives in data marshaling device  210  (“DMD”). Note that many embodiments widely regarded to stream data actually store data, for example, the sample-and-hold circuit of an analog-to-digital converter stores data for a period of time. In an exemplary embodiment of step  530 , information stored on DMD  210  are uploaded to a personal computer, then transmitted over the Internet to service center  140  by the personal computer. 
     Information is transmitted to service center (step  530 ). To reach service center (step  535 ), information leaves electronic communications network  150 , traverses electrical connection  280 , and enters network of computers  285 . Network of computers  285  may then process the information (step  555 ). In the event processing cannot be fully performed with the information that has arrived, network of computers  285  may request additional data (step  545 ). Data may be obtained by various means (step  550 ) and reach service center (step  535 ) where processing may again be attempted (step  555 ). Note that data may also be furnished (step  550 ) to service center  140  even when not specifically requested by step  545 ; this will be discussed later. Sensor(s)  205  may be removed from mammalian patient  200  after all physiological data have been stored on data marshaling device (step  525 ) or have been transmitted to service center (step  530 ). 
     Results of processing, whether intermediate or complete, are distributed to end-user(s) by a variety of means (step  560 ). However, at some point before results (often contained in a report) are communicated, the invention asserts control over the availability of processed results and/or archived data. Control is asserted by examination of control information  580  available from control facility  120 . Control information  580  may reach control facility  120  by one or more paths, e.g. from a human interacting with a network interface device connected to electronic communications network  150 , from DMD  210  connected to electronic communications network  150  via a network gateway device, from databases at local or remote sites, etc. The control information can be provided by an independent entity and/or an integrated entity. Service facility  140  determines (step  540 ) the available control information, then decides whether available control information permits communication of results (step  585 ). At a minimum, control information  580  should be present before results are communicated according to certain embodiments. 
     Results may be distributed (step  560 ) to end-user via network interface device (“NID”) (step  565 ) connected to electronic communications network  150 , e.g. a personal computer, a facsimile machine, etc. Results may optionally be archived on or through network interface device (step  570 ). Results may be distributed by other means (step  575 ), including, but not restricted to, paper-based reports sent through the mail. 
       FIG. 10  shows details of electronically transmitting data from data marshaling device  210  to service center  140  (step  530 ). The figure is merely an example, which should not unduly limit the scope of the claims herein. One of ordinary skill in the art would recognize many other variations, modifications, and alternatives. Data marshaling device  210  communicates with electronic communications network  150  via a network gateway device (“NGD”). There are a plurality of embodiments for network gateway device. For example, network gateway device may be network interface device  230  or  235 . As a further example, network gateway device may be a modem built into data marshaling device  210 , in which case step  610  (described below) is also built-in. 
     DMD and NGD are placed in physical proximity to each other (step  610 ) so that electronic communication between them may occur. The necessary degree of proximity will be determined by the nature of the communications link between DMD and NGD. In some embodiments, creating this proximity may involve moving DMD from one facility to another, as exemplified by step  160 . 
     A communications connection between DMD and NGD is established (step  615 ). This may be done by a variety of methods well known in the art. Connection may occur, for example, over a cable, over a data bus, over a wireless link, over an infrared link, over an acoustic link, and so on.  FIG. 4 , for example, shows a connection  250  between DMD and network interface device  255 . As a further example, DMD may connect to a personal computer using a cable plugged into the universal serial bus (USB) port of the personal computer. As an additional example, DMD may connect to a personal digital assistant by any of a variety of methods, as is well known to those of ordinary skill in the art. Establishing communications connection (step  615 ) may include protocols such as “handshaking” between DMD and NGD. 
     Data are transmitted from DMD to NGD (step  620 ) via the communications connection made in step  615 . (Further details are given in  FIG. 11 .) NGD receives data (step  625 ) and transmits data to service center (step  635 ). NGD optionally archives some or all data in a non-volatile storage medium (step  630 ) for later retrieval. As noted earlier, “data” also refers to data derived from data. For example, data transferred from DMD to a personal computer via USB connection may be archived on the personal computer, then digitally filtered and rectified, and followed by transmission of the filtered and rectified data to service center. As a further example, data transmitted to service center in step  635  may be drawn from archive referenced in step  630 . 
     Of note, data arriving at NGD in step  625  may arrive over a long period of time. Steps in  FIG. 10  beyond  625  (i.e. steps  630  and  635 ) may await receipt of all data being transmitted, or may proceed after only a portion of data is received. 
     Also note that there is nothing in the invention to prevent data from being stored on one or more removable components of DMD  210 , e.g. a floppy disk, PCMCIA card, SmartMedia card, etc. A removable component may remain in place in DMD  210 , or it may be removed and transported to another location where it may be enabled to communicate with NGD as described above.  FIG. 11  shows details of electronically transmitting data from network gateway device (NGD) to service center (step  620 ). The figure is merely an example, which should not unduly limit the scope of the claims herein. One of ordinary skill in the art would recognize many other variations, modifications, and alternatives. Before data are moved from DMD to NGD, data are optionally modified (step  655 ). For example, a “header” may be attached to data (or a subset of data) by communications protocols such as TCP/IP or USB. As a further example, checksums may be computed for the data (or a subset of the data). As a further example, data stored on DMD may be permanently removed from storage on DMD as data are prepared to move to NGD. As a further example, a physiological signal may be digitally filtered. A data modification may optionally result in new data being stored on DMD. 
     In one embodiment, the data (possibly of large size) on DMD are divided into smaller-sized blocks. A block of data is transmitted from DMD to NGD (step  660 ) using communications link established in step  615 . Software codes determine if more data are present or are expected to be present (step  665 ). Software codes repeat optional data modification  655  and block transmission  660  until all data have been transmitted, at which time an “end of data” marker is transmitted to NGD (step  670 ). Alternatively, an “end of data” marker may not be needed if, at some point, NGD is informed about the quantity of data to expect and monitors the quantity of data arriving. Steps to check for, and respond to, error conditions are not shown. For example, periodic checks of the communications connection between DMD and NGD are prudent. As an additional example, re-computation of checksums after transmission may disclose an inconsistency and prompt re-transmission of a block of data.  FIG. 12  shows details of electronically transmitting data from network gateway device to service center  140  (step  635 ). The figure is merely an example, which should not unduly limit the scope of the claims herein. Of note, data arriving at NGD in step  625  may arrive over a long period of time. Thus, the steps shown in this figure may await receipt of all data being transmitted, or may proceed after only a portion of data is received. NGD communicates with network of computers  285  at service center  140  via an electronic communication network  150  (“ECN”). Electronic communication between NGD and ECN is established; if necessary, NGD and a connection to ECN are placed in physical proximity to each other (step  710 ) so that electronic communication between NGD and ECN may occur. The necessary degree of proximity will be determined by the nature of the communications link between NGD and ECN. 
     A communications connection between NGD and network of computers  285  is established across ECN (step  715 ). This may be done by a variety of methods known in the art, for example, using protocols such as TCP/IP. Establishing communications connection (step  715 ) may include protocols such as “handshaking” between NGD and network of computers. 
     Data are transmitted from NGD to network of computers in a plurality of steps. Before transmitting, data are optionally modified (step  720 ). For example, a “header” may be attached to data (or a subset of data) by communications protocols such as TCP/IP. As a further example, checksums may be computed for the data (or a subset of the data). As a further example, data archived or buffered on NGD may be permanently removed from storage on NGD as data are prepared to move to network of computers. 
     In one embodiment, the data (possibly of large size) on NGD are divided into smaller-sized blocks. A block of data is transmitted from NGD to network of computers at service center (step  725 ) using communications link established in step  715 . Software codes determine if more blocks of data are present or are expected to be present (step  730 ). Software codes repeat optional data modification  720  and transmission of blocks  725  until all data have been transmitted, at which time an “end of data” marker may optionally be transmitted to NGD. Again, steps to check for, and respond to, error conditions are not shown. After completing data transmission, additional actions may be taken on data residing on NGD (step  735 ), e.g. deleting temporarily-stored data. 
       FIG. 13  shows details of processing the information related to the physiological signals (step  555 ) at service center  140 . The figure is merely an example, which should not unduly limit the scope of the claims herein. One of ordinary skill in the art would recognize many other variations, modifications, and alternatives. After information arrives at network of computers  285  in service center  140 , information is optionally archived (step  810 ), perhaps in data repository  290 , for later retrieval. Before processing can be performed, the parameters of the processing must be determined (step  815 ), e.g. what specific processing is being requested, what options of the processing are to be employed, etc. As an example, for an adult an apneic episode in sleep is generally defined as lasting 10 seconds or longer; for a child the duration threshold is lower. Thus, the “apnea duration threshold” is an example of a parameter associated with the processing. Processing parameters may be stored in one or more databases, for example, a database of user preferences  820 , or a database of parameters  825 ; such databases may be components of data repository  290 . Note that processing parameters may be derived from case data, e.g. age, and that processing of case data may be performed to determine proper parameter(s) to be used in subsequent processing. 
     Additional data may be needed to perform the processing. Thus, the invention determines whether it has sufficient data needed to perform the processing (step  830 ), and, if necessary, retrieves additional data from available sources  835  within the service center network of computers. For example, a database of patient medications may be queried to see if the patient is taking agent(s) that might interfere with one or more analyses. 
     If there is still not sufficient data to perform the processing (this check is performed in step  840 ), additional data may be requested from a source or sources outside of the service center network of computers (step  545 ). Data furnished in response to this request (step  550 ) reaches the service center network of computers by any of a variety of means (step  535 ). The processing request is then re-considered, as described above. 
     Once there is sufficient data to compute some or all of the processing response, the response or partial response is computed (step  845 ). Note that some processing may be architected such that responses may be computed incrementally. That is, responses may be computed on subsets of information. Optionally, the responses to subsets of information would later be unified into a single response (not shown). Also note that third-party data  850  may be needed to perform the processing. The results of the processing are optionally archived in the service center (step  855 ). The results of the processing may be distributed to some number of end-users, as discussed earlier. 
     In step  535 , information that did not enter DMD  210  in patient home  110  may also be used in processing. Merely by way of example, such information may be loaded onto DMD  210  in step  435 , as mentioned earlier. As another example, information may arrive via electronic communications network  150  as the result of a human interaction with a network interface device such as NID  230 , NID  255 , or other NID. As a further example, data may arrive from an external database. In many cases, data may be conveniently transmitted to service center  140  using electronic communications network  150  using steps  625 ,  630 , and  635 . 
     As noted earlier, the present invention is capable of performing numerous services for end-users. It is an advantage of the present invention that the design used to process information related to physiological signals can be applied to the performance of other services. This is apparent by comparing  FIG. 13  and  FIG. 14  and noting their similarities.  FIG. 14  shows details of performing a service (step  556 ). The figure is merely an example, which should not unduly limit the scope of the claims herein. One of ordinary skill in the art would recognize many other variations, modifications, and alternatives. 
     Services are initiated with a service request (not shown—however, a service request may be an action such as  325 A,  325 B, or  325 C). A service request may optionally be archived (step  910 ). Before the service can be performed, the parameters of the service must be determined (step  915 ), e.g. what specific service is being requested, what options of the service are to be employed, etc. As an example, the supply service may have options for automatic disbursement of replacement supplies on a monthly or weekly basis. Service parameters may be stored in one or more databases, for example, a database of user preferences  920 , or a database of services  925 ; such databases may be components of data repository  290 . Note that service parameters may be derived other service parameters. 
     Additional data may be needed to perform the service. For example, the supply service may need to know the current price of specific supply items. Thus, the invention determines whether it has sufficient data needed to perform the service (step  930 ), and, if necessary, retrieves additional data from available sources  935  within the service center network of computers. In the example above, a database of prices may be queried to retrieve the current prices of specific supply items. 
     If there is still not sufficient data to perform the service (this check is performed in step  940 ), additional data may be requested from a source or sources outside of the service center network of computers (step  545 ). Data furnished in response to this request (step  550 ) reaches the service center network of computers by any of a variety of means (step  536 ). The service request is then re-considered, as described above. 
     Once there is sufficient data to compute some or all of the service response, the response or partial response is computed (step  945 ). Note that some services may be architected such that responses may be computed incrementally. That is, responses may be computed on subsets of data. Optionally, the responses to subsets of data would later be unified into a single response (not shown). Also note that third-party data  950  may be needed to perform the service, as in a credit card transaction with a bank. The results of the service are optionally archived in the service center (step  955 ). The results of the service may be distributed to some number of end-users, as discussed earlier. 
     In step  536 , information that did not enter DMD  210  in patient home  110  may also be used in processing. Merely by way of example, such information may be loaded onto DMD  210  in step  435 , as mentioned earlier. As another example, information may arrive via electronic communications network  150  as the result of a human interaction with a network interface device such as NID  230 , NID  255 , or other NID. As a further example, data may arrive from an external database. In many cases, data may be conveniently transmitted to service center  140  using electronic communications network  150  using steps  625 ,  630 , and  635 . In some embodiments, steps  536  and  556  may be integrated with processing of control information (steps  540 ,  585 ,  560 , etc.), akin to the integration of steps  535  and  555 , respectively, in  FIG. 9 . 
     Additional examples illustrate some of these features of the invention. In one example, mammalian patient  200  may visit a physician&#39;s office and complete a symptom questionnaire or other form requesting clinical data. Such data could be stored on DMD  210  in step  435 . Such data could be transmitted to service center  140  in step  530  and step  535 , thereby making it available in step  556  for processing as data related to the service. Of course, other types of data, such as service data, may be stored on DMD  210  in step  435  and be transmitted later. Several different types of data may simultaneously be in storage on DMD  210 . 
     In another example, data may be furnished (step  550 ) to service center  140  even when not specifically requested by step  545 . For example, mammalian patient  200  may drop off DMD  210  at physician&#39;s office after having slept with it the night before. A nurse in the physician&#39;s office may ask mammalian patient  200  questions about the hours and subjective quality of sleep the night before, about medication and alcohol use, and so on. The nurse may enter these data into a desktop computer and transmit the data to service center  140  via electronic network  150 . These data may then be used in a variety of services and processings. 
     Note that results may include the results of a plurality of services, not all of which have been explicitly requested, e.g. relevant resources (possibly advertisements) may be returned with the report. Results may also suggest or offer to perform additional services, e.g. prepare documents to assist the physician (or other health care professional) in securing reimbursement from a third-party payor. Such documents might include a HCFA form 1500 or a letter of medical necessity and might incorporate patient-specific clinical and/or administrative data. 
     Security is often an issue when potentially sensitive medical data are being manipulated. A feature of the invention is that communications across electronic communications network  150  may be performed with a variety of security features. For example, confidential information may be encrypted, which is possible using methods known to persons skilled in the art. However, because encryption has certain disadvantages (e.g. adding overhead to transmission), it may be desirable to minimize encryption without compromising confidential information. One approach to achieve this is to anonymize a portion of the information. Anonymization may be useful in cases where information is not sensitive unless it can be associated with a particular person or other entity. Anonymization blocks the ability of unauthorized parties to make such associations directly. Authorized parties can later reconstruct the association. Merely by way of example, an arbitrary code (e.g. “007-orange-buffalo”) may be assigned to a patient by a nurse in a physician&#39;s office, and this code may be used to identify the patient to service center  140 . Thus, the patient&#39;s true identity is never transmitted over electronic communications network  150 . As another example, the patient&#39;s true identity may be sent, encrypted, to service center  140  which, in turn, assigns an arbitrary unique code to the patient and sends the code back to the end-user site, where it is used to identify the patient. In both cases, authorized parties can make the direct association of data with the patient&#39;s actual identity. 
     An additional feature of the system is the possibility of using DMD  210  as a physical token to enhance security of communications across electronic communications network  150 . For example, each DMD  210  may be configured with a unique identification code. In such a case, merely by way of example, the invention may be configured so that communications are not relayed to service center  140  unless accompanied by a valid identification code obtained from a DMD  210  that is simultaneously connected to electronic communications network  150 . As a further example, the identification code in DMD  210  may be components of a public-key cryptography system. As still a further example, a code in DMD  210  may change over time according to a certain algorithm. 
     Yet another feature of the system is the possibility of freeing the end-user from installing client software on their desktop computer or other network interface device beyond commonly bundled software such as a web browser. Merely by way of example, an applet might run in the desktop computer&#39;s web-browser via a plug-in such as the Java 1.3 plug-in. The applet could read and write data from DMD  210  and could communicate with service center  140  via electronic communications network  150 . The applet would not require end-user to install it on the desktop computer, because it would be downloaded from network of computers  285  at service center  140  as needed. The web-browser might cache the applet on the desktop computer, but this step would be largely invisible to end-user. Furthermore, because many web-browsers contain means to identify when a cached item has been superseded by a new version of the item, it is likely that end-user need not have concerns about executing a manual step in order to have the most recent version of the applet. 
     Limiting the amount of software installed on desktop computers and other devices at the end-user facility is a security advantage because it reduces the risk of mis-configuration, as different software packages may interfere with each other. It also reduces the need to restrict physical access to equipment, since the software configuration of the equipment is less sensitive to disruption. It may also be possible to develop means to verify aspects of web browser operation, e.g. “test pages”, which would add confidence that the desktop computer is properly configured. 
     The occasional existence of a communications link between DMD  210  and service center  140  adds an additional advantage: the software residing on DMD  210  may be examined from time to time to see if it is the most recent version or if it meets other criteria. Should new software or a modification of software be indicated, such changes may be effected without significant intervention by a human. Software in other devices may be similarly updated. It should be understood that several steps have not been shown above. For example, the process may be interrupted at a plurality of steps; recovery from such interruptions has not been shown. As a further example, authentication measures may be inserted at a plurality of steps in the process, and they have not been shown. As an additional example, a record of all steps and activities may be kept; the contributions to such a record have not been shown. As viewed by the end-user, novel features of the present invention (a) simplify the acquisition of physiologic signals, (b) simplify the transmission of information between various facilities, (c) support administrative functions, (d) simplify the analysis of physiological data, (e) simplify the maintenance of diagnostic equipment, including lessening the need for manual updates of software, (f) simplify data management tasks, (g) incur minimal training costs, (h) generate results promptly at the point of care, and (i) can be implemented to comply with certain provisions of the Health Insurance Portability and Accountability Act. 
     It should be noted that the above sequence of steps is merely illustrative. The steps can be performed using computer software or hardware or a combination of hardware and software. Any of the above steps can also be separated or be combined, depending upon the embodiment. In some cases, the steps can also be changed in order without limiting the scope of the invention claimed herein. One of ordinary skill in the art would recognize many other variations, modifications, and alternatives. It is also understood that the examples and embodiments described herein are for illustrative purposes only and that various modifications or changes in light thereof will be suggested to persons skilled in the art and are to be included within the spirit and purview of this application and scope of the appended claims.

Technology Classification (CPC): 6