AU2013201471A1 - An electronic medical history (EMH) data management system for standard medical care, clinical medical research, and analysis of long-term outcomes - Google Patents

Abstract

An information system and method which corroborates first data provided by data owners and second data provided by data controllers includes a computer and first and second databases. The first database stores the first data and the second database stores the second data. The second data is accessible to the data controllers but not to the data owners. The computer receives from a data owner device first data created using input from one of the data owners, stores the received first data in the first database, transmits the first data retrieved from the first database to an administrator device, receives from the administrator device additional regulated data input by one of the data controllers related to the one data owner, and stores the second data which combines the transmitted first data with additional regulated data in the second database. a0

Description

1 TITLE OF THE INVENTION AN ELECTRONIC MEDICAL HISTORY (EMH) DATA MANAGEMENT SYSTEM FOR STANDARD MEDICAL CARE, CLINICAL MEDICAL RESEARCH, AND ANALYSIS OF LONG-TERM OUTCOMES BACKGROUND OF THE INVENTION 1. Field of the Invention [0001] Aspects of the invention relate to a standardized, semi-quantitative electronic medical history (EMH) data management system and method based on self-report using a multidimensional health assessment questionnaire (MDHAQ), available for any clinical medical care, alternative medical care, health maintenance, research or epidemiologic setting. 2. Description of the Related Art [0002] Traditionally and at this time, a patient history is elicited by the physician as the initial component of a patient encounter. In recent years, many physicians have used a self-report questionnaire in order to facilitate acquisition of a medical history. However, the questionnaires used are not in a standard format, although though they are roughly 80% identical in all medical settings. Therefore, although the information may be recorded and/or entered electronically, it generally is not transferable from one setting to another, except as copied files which may not be amended or corrected. Furthermore, quantitative patient self-report scores for physical function, pain, fatigue, exercise status, which often are more prognostic of long-term health than laboratory tests, generally are not included in the patient questionnaire. [0003] A medical record contains a series of notes by a doctor, other health professional, or designated associate to depict each interaction with a patient in an inpatient or outpatient setting, by telephone, Email or other form of encounter. The standard medical record note usually begins with information from a chief complaint, present illness, and other components of a patient history, followed by information from a physical examination of the patient, laboratory tests, ancillary studies and treatment plan. As it is compiled by a health professional in relation to medical treatment, a medical record is a legal document, subject to regulations of the Health Insurance Portability and Accountability Act (HIPAA). See 45 C.F.R. 160 and 164, in particular the definitions of "health information" and "protected health information" at 45 C.F.R. 160.103 2 (as of January 1, 2012). Such information cannot be altered or amended in any way, and disclosure outside certain limited conditions carries penalties. [0004] Information elicited from the patient by the doctor is entered as a patient history into a medical record note, through the physician or an associate writing, dictating, or typing the information. A patient self-report questionnaire provides the information directly from the patient, thereby transferring a major portion of the responsibility of providing the initial information from the doctor to the patient. The doctor or associate must still enter the chief complaint and present illness into a record, in a traditional format which is not provided by the questionnaire. However, other components of the history (more than 80%) in general) including previous illnesses, operations, hospitalizations, family history, allergies, social history, demographic data are provided by the patient and reported in a standard medical record format through the system software. Further, other than requesting a copy from the doctor, there is no mechanism for the patient to retain the information they enter into a medical questionnaire in one medical setting into another medical setting. This situation allows for errors, inconsistencies and conflicts to exist when patients go between multiple medical offices; such problems could be solved if there existed a single electronic format used in different medical settings, which a patient may amend or correct, saving time and directing effort toward a more accurate medical history rather than entering the information redundantly at many medical settings. SUMMARY OF THE INVENTION [0005] An aspect of the invention includes an information system which corroborates first data provided by data owners and second data provided by data controllers, the system including a first database which stores and provides the first data, the first data being accessible to the data owners and the data controllers; a second database which stores and provides the second data, the second data being accessible to the data controllers but not to the data owners; and a computer which controls access of the first data stored in the first database and the second data stored in the second database, receives from a data owner device first data created using input from one of the data owners, stores the received first data in the first database, transmits the first data retrieved from the first database to an administrator device, receives from the administrator device additional regulated data related to the one data owner and which is input by one of the data 3 controllers, and stores the second data which includes the additional regulated data in the second database. [0006] According to an aspect of the invention, the first data includes an electronic medical history provided by a patient as the data owner, and the second data includes an electronic medical record of the patient controlled by a physician as the data controller. [0007] According to an aspect of the invention, the computer history is reported according to standard format for the medical record from the questionnaire which prompts the one data owner to create the first data according to criterion in the questionnaire, and the received first data includes information prompted by the transmitted questionnaire. [0008] According to an aspect of the invention, the computer further detects the data owner device of the one data owner, retrieves one of the first data stored in the first database corresponding to the one data owner, and constructs the questionnaire relative to the retrieved first data. [0009] According to an aspect of the invention, the computer further retrieves one of the second data stored in the second database corresponding to the one data owner, updates the retrieved second data with the received additional regulated data corresponding to the one data owner, and stores the updated second data in the second database. [0010] According to an aspect of the invention, the computer further detects the administrator device, retrieves one of the second data stored in the second database corresponding to the one data owner, and further transmits the retrieved second data to the administrator device. [0011] According to an aspect of the invention, the computer receives from the administrator device updated second data including the additional regulated data input by one of the data controllers related to the one data owner, and stores the updated second data in the second database. [0012] According to an aspect of the invention, the computer further detects the administrator device, receives a query from the administrator device to search for specified information in the 4 first database for a plurality of the data owners, retrieves a search result for the specified information, and transmits the retrieved search result to the administrator device. [0013] According to an aspect of the invention, the computer receives a request for research data from an external device, retrieves first data from the first database responsive to the request, removes from the retrieved first data personal information of the corresponding data owners to create the de-identified research data, and transmits the created research data to the external device. While not required in all aspects, this information is given only if consent is given (which most patients willingly offer to gain better long-term knowledge of their disease and results of treatment). [0014] According to an aspect of the invention, the received request for research data is limited to specific categories of information, the computer searches the first data from the first database responsive to the specific categories in the request to obtain a search response, and removes from the retrieved search response the personal information of the corresponding data owners to create the research data. [0015] According to an aspect of the invention, the computer further sends a reminder message to the one data owner which prompts the one data owner to update the first data according to the criterion in the reminder message, and the received first data includes information prompted by the transmitted reminder message. While not required in all aspects, this reminder message is sent only if consent is given (which most patients willingly offer to gain better long-term knowledge of their disease and results of treatment). [0016] According to an aspect of the invention, the system further includes the administrator device which receives the additional regulated data input by the one of the data controllers and which is related to the one data owner, receives the first data for the one data owner, and transmits the additional regulated data to be stored with the second data in the second database. [0017] According to an aspect of the invention, the system further includes the data owner device which receives the input from the one of the data owners to create the first data, and transmits the created first data.

5 [0018] According to an aspect of the invention, the system further includes a data storage device accessible to the data owner device, where the transmitted first data is further stored in the data storage device and is retrieved according to a request received from the computer for an update to the first data. [0019] According to an aspect of the invention, the first data comprises information from a completed multidimensional health assessment questionnaire (MDHAQ), and the second data comprises a medical record including regulated data regulated under the Health Insurance Portability and Accountability Act (HIPAA). [0020] An aspect of the invention includes a method of corroborating first data provided by data owners and second data provided by data controllers, the method including: sending a questionnaire from a computer to a data owner device of one of the data owners to provide information used to create the first data for the one data owner; receiving the created first data at the computer from the data owner device; storing the received first data in a first database which stores and provides the first data, the first data being accessible to the data owners and the data controllers; retrieving second data related to the one data owner from a second database which stores and provides the second data, the second data being accessible to the data controllers but not to the data owners; transmitting the retrieved second data from the computer to an administrator device of one of the data controllers; receiving regulated data from the administrator device, the regulated data corresponding to the received first data and the transmitted second data of the one data owner; and storing the received regulated data as updated second data in the second database. [0021] According to an aspect of the invention, the method further includes transmitting from the computer to the data owner device a questionnaire which prompts the one data owner to create the first data according to the criterion in the questionnaire, and the received first data includes information prompted by the transmitted questionnaire. [0022] According to an aspect of the invention, the method further includes the computer detecting the data owner device of the one data owner, retrieving one of the first data stored in the first database corresponding to the one data owner, and constructing the questionnaire relative to the retrieved first data.

6 [0023] According to an aspect of the invention, the method further includes the computer combining the retrieved second data with the received regulated data corresponding to the one data owner to create the updated second data. [0024] According to an aspect of the invention, the method further includes the computer receiving from the administrator device the updated second data including the regulated data input by one of the data controllers related to the one data owner. [0025] According to an aspect of the invention, the method further includes the computer receiving a query from the administrator device to search for specified information in the first database for a plurality of the data owners, retrieving a search result for the specified information, and transmitting the retrieved search result to the administrator device. [0026] According to an aspect of the invention, the method further includes the computer receiving a request for research data from an external device, retrieving first data from the first database responsive to the request, removing from the retrieved first data personal information of the corresponding data owners to create the research data, and transmitting the created research data to the external device. [0027] According to an aspect of the invention, the received request for research data is limited to specific categories of information, and the method further comprises the computer searching the first data from the first database responsive to the specific categories in the request to obtain a search response, and removing from the retrieved search response the personal information of the corresponding data owners to create the research data. [0028] According to an aspect of the invention, the method further includes the computer sending a reminder message to the one data owner which prompts the one data owner to update the first data according to the criterion in the reminder message, wherein the received first data includes information prompted by the transmitted reminder message. While not required in all aspects, this reminder message is sent only if consent is given (which most patients willingly offer to gain better long-term knowledge of their disease and results of treatment). [0029] According to an aspect of the invention, a non-transitory computer readable medium encoded with processing instructions readable by the computer to implement the method.

7 [0030] Additional aspects and/or advantages of the invention will be set forth in part in the description which follows and, in part, will be obvious from the description, or may be learned by practice of the invention. BRIEF DESCRIPTION OF THE DRAWINGS [0031] These and/or other aspects and advantages of the invention will become apparent and more readily appreciated from the following description of the embodiments, taken in conjunction with the accompanying drawings of which: FIG 1 is a chart showing the various components of the system, including optional components, and the interactions between them, according to aspects of the invention; FIG 2 is a chart showing the various components of the system, including optional components, and the interactions between them, according to aspects of the invention; FIG 3 is a chart showing the various components of the system, including optional components, and the interactions between them, according to aspects of the invention; and FIG 4 is a flowchart describing the creation process of an EMH, according to aspects of the invention. DETAILED DESCRIPTION OF THE EMBODIMENTS [0032] Reference will now be made in detail to the present embodiments of the present invention, examples of which are illustrated in the accompanying drawings, wherein like reference numerals refer to the like elements throughout. The embodiments are described below in order to explain the present invention by referring to the figures. [0033] Although the exemplary embodiments in FIGs. 1 through 4 describe the invention in terms of physicians, patients, and medical data, such description is only for convenience. The invention is not restricted to clinical encounters or the medical field, and can be used for any system where a piece of information is ideally shared among multiple parties in a standardized format, yet is frequently associated with other information that cannot be so shared due to confidentiality or regulation or cannot be stored in a standardized format. In this manner, there are data owned by and updatable by a private party in one database, and related data which are not updatable by the private party in another database.

8 [0034] By way of example, one option might be to include a personal data file, so that an individual could include a listing of bank accounts, brokerage statements, tax returns, will, insurance policies, which could interact with this system so as to allow third parties to accurately record personal information in internal databases which are not accessible to the person and allow the third party to more accurately advise the individual. Examples where this system would be useful would be in financial systems, such as for loan applications, or where the individual needs to ensure their credit record is accurate. [0035] Another example would be to have the system allow a personal data file to interact with records of Government agencies, thereby facilitating the obtaining of Government documents (such as drivers licenses, passports) or security clearances. A further example would be implementation of the system in a school, thereby allowing students or guardians to control information on a student's academic, personal and/or health records, which could then be used by school officials at a new (or existing) school to create or update official records (possibly limited by consent requirements). As such, the system is usable in a number of situations where one party requires accurate records of another party but cannot allow that other party to directly access or change these records. [0036] However, for purposes of explanation, an implementation relative to a medical system will be described. As background, an electronic medical history (EMH) provides one component of an electronic medical record (EMR), in which all information is completed by the patient, prior to availability, review, and synthesis by a health professional. The medical history usually comprises 50-75% of the medical record note. The proposed EMH system allows the patient to be in complete control of her/his medical history information prior to any encounter, although once entered by a physician into an EMR, the EMR remains in the control of the physician. [0037] Many if not most medical records contain several errors, most of which are innocuous, but some are serious. An example of such an error could include an incorrect date of surgery. These errors are often propagated in an EMR through "cut and paste" of information within a given clinical setting, without further review by a patient. The EMH cannot correct errors which are already entered into a medical record, whether electronic or paper, as this information remains legally outside of change. However, the EMH provides a patient with an opportunity to update, amend, correct, and enter missing data into his/her medical history before or at future encounters.

9 A revised EMH would then be available to any physician or health facility designated by the patient to be available for review and possible entry into a future medical note in an EMR at any time. [0038] According to an aspect of the invention, the standard, quantitative information collected in usual medical care is organized into an electronic format. This electronic format can then serve a number of purposes, including: a. An EMH that can be entered into a standard medical note in a standard "medical" format, saving the doctor 10-20 minutes for a new patient and 5-10 minutes for a return patient. b. Includes MDHAQ quantitative scores for physical function and exercise, as well as for pain, fatigue and global status, to document improvement, worsening, or stability of these common medical symptoms. Poor scores of which have been shown to predict reduced survival in the range of smoking. c. If the patient consents, the EMH can be made available to the patient in electronic media to be updated, amended, or corrected by the patient over a lifetime. Examples of electronic media include a memory stick, disc, internet password protected website or shared storage, or like media. d. If the patient consents, the EMH can be made available for all future encounters with any health professional, to save time for the patient and doctor and improve accuracy of the medical history. e. If the patient consents, the EMH can be made available in a standard format for research studies, with the patient's consent of de-identified data analyzed only in groups for prognosis, predictors of poor and good outcomes, and responses to various therapies, with minimal costs incidental to standard care for collection of the data (although costs of analyzing the data will remain). f. If the patient consents, the system will send periodic notices to provide the patient an opportunity to update, amend, and correct her/his medical history, so that any current medical history is always available. This is far preferable to updating only in medical settings or, worse, emergency circumstances.

10 However, the electronic format need not serve all of these purposes and can serve other purposes. Moreover, it is understood that in a non-medical or non-clinical implementation, the electronic format can serve other purposes which may or may not be consistent with the above-noted purposes. [0039] According to an embodiment of the invention shown in FIG. 1, the system includes a computer 1001 that uses two databases 1002, 1003. As shown, the databases 1002, 1003 are external to the computer 1001. However, it is understood that the databases 1002 and 1003 may be within the computer 1001, may be stored separately in different media and/or accessible to the computer 1001 over a network and/or a cloud. The computer 1001 can be a general or special purpose computer, a server, or any collection of processors capable of implementing programming instructions in relation to the databases 1002, 1003. By way of example, the system can be implemented using a personal computer using a standard commercial database program, such as ACCESS from Microsoft, but the invention also allows for use of custom databases depending on the needs and scale of the practice in question. Lastly, it is understood that additional databases can be used by the computer 1001, such as those related to accounting, communications, or other organized information. [0040] One database 1002 contains the non-confidential, non-regulated information. In the context of a medical system, the database 1002 would contain electronic medical histories (EMHs) for patients which are not regulated by privacy laws such as HIPAA. In this sense, the database 1002 stores user data which is owned or controlled by the user (i.e., a data owner). [0041] The other database 1003 contains the confidential, or regulated information. In the context of a medical system, the database 1003 stores the electronic medical records (EMRs) for the patients which are regulated by privacy laws such as HIPAA. In this sense, the database 1003 contains stored information about the user which is neither owned nor controlled by the user, although the user can request the data controller update its records. In the present example, the data controller can be a physician, a health professional, hospital, or other medical facility. In another example, the data controller can be an insurance carrier. However, it is understood that the data controller is not restricted to such examples, and especially in non-medical implementations not restricted by HIPAA.

11 [0042] A patient uses a device 1005 to interact with the computer 1001. While not limited thereto, the patent's device 1005 can be a smart phone, tablet, a personal computer, or similar electronic device which interacts with the computer 1001 across a wired and/or wireless network. Specifically, the device 1005 and computer 1001 are used by the patient to create and/or update the EMH. [0043] By way of example, the computer 1001 obtains or creates an EMH associated with the patient. In the shown embodiment, the patient device 1005 creates this EMH in response to a series of questions sent 1100 electronically from the computer 1001 which the patient answers using the device 1005. While described in terms of the patient directly entering the information with the patient device 1005, it is understood that in aspects of the invention, the patient completes the series of question on paper, and another person enters this data into the device 1005. In another aspect, the questions could be completed by a surrogate electronically (examples of the surrogate can be a spouse or other relative, nurse or other health professional), and the surrogate would enter the answers into the patient device 1005. In this way, the patient device 1005 can be a device used and owned by the patient, or simply any device through which the patient's answers are entered. [0044] In a further embodiment of the invention, this series of questions is the series listed in an electronic multidimensional health assessment questionnaire (MDHAQ) provided by the computer 1001. Examples of such questions include traditional medical history queries and quantitative scores for physician function, pain, global status, fatigue, and exercise frequency. Using an MDHAQ or similar questionnaire in a standardized format for use in multiple office systems, which allows the information to be stored locally in the device 1005 and reused in multiple different medical office settings. [0045] When the questions are completed, the device 1005 sends 1101 the created EMH to the computer 1001, which then stores the EMH in the database 1002. As an alternative or in addition, in other aspects, the device 1005 can send 1101 stored EMH to the computer 1001, which then stores the EMH in the database 1002 or the computer 1001 can retrieve the EMH previously stored in the database 1002 and provide 1100 the EMH to the device 1005 along with the questions so as to allow the patient to update the EMH on the device 1005 and then send 1101 the updated EMH to the computer 1001. By way of example, the questions sent 1100 with the 12 EMH retrieved from the database 1002 could prompt for specific updates to the EMH. By allowing such updates and continued use of previously-entered data, the patient, who may not otherwise remember information such as the year of an operation or a major medication taken at an encounter, would be able to provide this information to the physician and provides an opportunity to gather this information at a later time, and then have it entered into the "memory" of the computer 1001 indefinitely. [0046] In some embodiments of the invention, the EMH creation is done by enclosing the answers to a series of questions within an email sent 1100 to the patient device 1005. In one such embodiment, the EMH is stored in the form of said email; the computer 1001 serves as an email server and the EMH database 1002 is the email storage on that server. Alternately, the computer 1001 could parse the response to the email to obtain the relevant answers, and save the parsed data in the EMH database 1002. [0047] In another embodiment, the EMH creation is done by an interface on the device 1005 whereby the patient answers questions on the interface, and the answers are saved in the database 1002. [0048] Once the EMH is created, the computer 1001 stores the EMH in the database 1002. Additionally, the computer 1001 or the patient's device 1005 can save the EMH in storage 1006 accessible to the patient, such as to storage 1006. While shown as a detachable storage 1006, the storage 1006 can be internal in the device 1005, a connectable data storage device such as a USB drive or memory card, or network based such as a cloud drive. Where the storage 1006 is detachable or a cloud drive, aspects of the invention allow the computer 1001 or the physician's device 1004 to access the stored EMH. Where the storage 106 is internal memory, aspects of the invention allow the stored EMH to be shared by connecting the computer 1001 and/or the device 1004 with the device 1005 through wired and/or wireless transmission techniques. While not required in all aspects, the computer 1001 may provide the EMH for viewing on the patient's device 1005 or the device 1005 can retrieve the EMH from the storage 1006 for viewing on a display of the device 1005. [0049] In an embodiment of this invention, upon creation of the EMH, the computer 1001 automatically provides the EMH to the patient's device 1005 immediately and without 13 prompting. In this way, the EMH can be synchronized between the device 1005 and the computer 1001. Moreover, where both the database 1002 and the device 1005 have different copies of the EMH, the most recent version can be adopted by the computer 1001 and the device 1005 to ensure that the database 1002 always includes the most current patient EMH information. [0050] In an embodiment of this invention, a given patient may substitute one device 1005 for another with each interaction with computer 1001. For example, the computer 1001 might provide 1104 the EMH to a home computer one day, a tablet another day, and a mobile device another day. In another embodiment, a given patient must always use the same device 1005 to interact with computer 1001. In another example, the patient might purchase or upgrade their device 1005, whereby the EMH is transferred to the upgraded device. In this manner, the EMH is controlled by the patient and is available using any device which the patient may choose independent of the computer 1001. [0051] Once it creates the EMH, the computer 1001 may also provide 1104 it to the device 1004 of an administrator party (in this embodiment, a physician). The computer 1001 may later update the EMH stored in the database 1002, through further information received from either the physician's device 1004 or the patient's device 1005. [0052] In some embodiments of the invention, the computer 1001 may also create in database 1002 a copy of a previously-created EMH. This copy may, in various embodiments, be received from the physician's device 1004, a patient's device 1005, a data storage device directly connected to the computer 1001, or combinations thereof. [0053] Additionally, the computer 1001 may attach confidential information if requested specifically by the patient of a physician, hospital, or other medical facility, received from the physician's device 1004, to an EMH created by the patient's device 1005 to create an EMR or a future note in the EMR. Such a record is not controlled by the patient in the sense that the patient lacks authority to update the EMR, and therefore requires that the physician or a member of the practice create or update the EMR in each instance of such transfer. Such a creation or update is generally based on a face-to-face encounter, but possibly can be accomplished based on telephone, email, or other interaction without direct dialog or a physical examination. In aspects of the invention, the physician can accomplish this on the physician's device 1004 using the 14 EMH received from the computer 1001 and/or patient's device 1005 and sending 1106 this update to the computer 1001, or by authorizing the change by other associated medical personnel using the computer 1001. [0054] However created, the computer 1001 stores this EMR in the EMR database 1003. The computer 1001 may later provide 1107 this EMR to the physician's device 1004, and the computer 1001 can add to the EMR new information transmitted 1108 from physician's device 1004. By way of example, the physician could review the EMH provided 1104 by the computer 1001, select information in the EMH to be included in the EMR as the new information, and transmit 1108 the new information to be included in the EMR by the computer 1001. In another example, the physician's device 1004 could have authority to directly update the EMR, in which case the physician could review the EMH provided1104 by the computer 1001, copy information from the EMH into the EMR, and transmit 1108 the updated EMR back to the computer 1001 to be stored in the database 1003. In this way, the patient's EMH is kept current by the patient, and this format can be copied into/synchronized with an EMR under the direction of the physician to also keep the EMR current. [0055] In an embodiment of the invention, assuming the patient has been given access by the physician under appropriate HIPAA laws, the computer 1001 may provide the EMR of a given patient to the patient's device 1005. This may include important information to be available to other health professionals, such as a lab test report, electrocardiogram, X-ray, MRI, etc. Such an EMR would be created as an EMH by the other health professionals until adopted formally as an EMR under the direction of another physician. Also in an embodiment of the invention, the computer 1001 may add EMR data to a patient's EMH (an action not depicted in FIG. 1) only when interacting with that patient's device 1005. However, it is understood that in other aspects, copies of data included in the database 1003 cannot be provided to the device 1005 by the computer 1001. [0056] While not required in all aspects, the computer 1001 can also provide 1111 to the physician's device 1004 one or more standard computations of information about one or more EMHs stored in the database 1002. Such computations can be in response to a specific search query from the physician, but can also be pre-determined reports established in the computer 1001 relating to standard information requested by physicians in general. These computations 15 may include but are not limited to: how many patients with each diagnosis are seen in the practice, how many patients with each diagnosis take specific medications, and what is the change in patient scores for physical function, pain, and global status associated with treatment with specific medication in specific individual patients over time. In this manner, the physician can use the EMH data to review and analyze a practice as a whole to recognize proportions of patients with a given diagnosis, treatment, response of scores for pain, fatigue, etc. and detect trends in care as well as search the database 1002 to find how specific ailments have been treated in the past and at what success rate. The result of these computations could be displayed as standard reports, the results of search queries, graphs etc. By way of example, the physician could use a search engine installed in the computer 1001 to conduct searches of the EMH data in the database 1002 based upon specific keywords. However, it is understood that such computations need not be performed in any or all aspects, and aspects can be limited to simply providing the EMH for clinical care. [0057] In an embodiment of this invention, the computer 1001 associates databases 1002 and 1003 such that if the computer updates an EMH in database 1002, it will automatically update the corresponding EMR in database 1003 with the same new information or automatically prompt the physician to approve of such changes depending on the requirements for compliance with HIPAA. [0058] While not required in all aspects, the physician may substitute one device 1004 for another with each interaction with computer 1001; for example, the computer 1001 might receive 1108 an EMR update from a laptop one day, and from an office computer another day, or a hospital computer. In another embodiment, the physician must always use the same device 1004 to interact with the computer 1001. [0059] While not required in all aspects, the computer 1001 may also provide 1104 the EMH to a device 1007 of an outside party, such as another physician, with consent of the patient. The other physician could access the computer 1001 using a password provided to that physician. The other physician could be in the same practice, or could be in another practice but needs the EMH of the patient for clinical care decisions. In another embodiment, the patient could give advance consent to allow the EMH to be accessed by a third party physician using the device 1007 in the event of an emergency or where the patient is incapacitated as in the case of a coma. In this way, 16 the EMH can be kept updated between different offices, thereby minimizing the potential for errors in medications, missing data concerning severe side effects, and comorbidities. However, it is understood that such sharing need not apply in all aspects and may be restricted by patient preference and/or laws and regulations governing privacy, and that all entries by the patient must be reviewed and approved by a physician or other health professional before incorporation into a medical record, whether paper or electronic. [0060] If an EMH is saved either to detachable data storage 1006 or to an internal memory of a device 1005, either may directly provide 1103 the EMH file to one or more of devices 1004, 1007, and/or a second patient device (not shown). In various embodiments, this provision 1103 may be automatic upon connection of the devices 1005, 1004, 1007, or at the prompting of the possessor of the storage 1006 or device 1005, among other options. In this manner, the patient can share the EMH with the physician without accessing the computer 1001, which could occur in emergency situations or when or where the computer 1001 is otherwise not available. [0061] In at least some embodiments, the computer 1001 may provide only 1104 an EMH to another party's device 1007 if the content of the EMH allows it. The key content for allowance may, depending on the party owning the device 1007 and the preferences of the owner of the computer 1001, be a simple can/cannot share binary value, selected by the patient's device 1005 or the physician's device 1004 during creation 1101 or updating 1105. It may alternatively, or in combination with the binary value, be related to other contents such as a specific diagnosis (which would make the EMH accessible to specialists in that field), place of residence (which would make it accessible to other physicians in the area), or list of other physicians treating the patient (which would make it accessible to those specific physicians). Such methods of filtering access are by no means limited to the above options. In an embodiment, the binary value is the only factor and may be created 1101 or updated 1105 exclusively by the patient device 1005. [0062] In an embodiment of the invention shown in FIG. 2, the computer 1001 provides 1109 a single or multiple EMHs to a device 1008 of an outside party that seeks patient information but does not need the associated identifiers. Examples of such an outside party include a research group, educational institutions, or groups or organizations of physicians looking for rates of successes of potential treatments. In aspects of the invention, such providing 1109 has the EMHs 17 stripped of information that could identify the associated patient at a public computer, but encrypted for identification in longitudinal studies within the database. [0063] While not required in all aspects, the computer 1001 could provide 1112 computations from the EMHs stored in the databases 1002 in addition to or instead of the EMHs themselves. Examples of such computations include but are not limited to: how many patients with each diagnosis are seen in the practice, how many patients with each diagnosis take specific medications, and what is the change in patient scores for physical function, pain, and global status over time. In this manner, outside groups, such as research institutions, can also benefit from the improved EMH collection system without having to rely on handwritten questionnaire responses from physicians, which also increases the likelihood that such information will be shared due to the ease of doing so. [0064] In a similar manner and using similar filtering methods, in at least some embodiments, the computer 1001 may only provide 1109 an EMH stripped of identifying information by encryption or entirely de-identified for a "locked" database for analysis to specific researcher devices 1008, or none at all. [0065] The possible methods of connecting the various devices are not limited and may be appreciated by those skilled in the art, but can include wired and wireless networks, mobile phone networks, the Internet, or a USB connector, to name but some options. Likewise, the methods used to create an interface between the devices may include but are not limited to firmware, installed software, or web applications. [0066] Also, in at least some embodiments, one, some, or all of devices 1004, 1005, 1007, and 1008 may exist only as interfaces of computer 1001, such as where a Citrix server relays an interface to a remote device whereby the interface is under the control of the computer 1001 and the receiving device acts merely as a display for the computer 1001. In another embodiment, device 1004 and/or multiple devices 1005 may be the same device with separate interfaces for each purpose. [0067] In an embodiment of the invention shown in FIG. 3, the computer 1001 will send 1110 reminder messages to a patient's device 1005 to prompt the patient to update their EMH. These 18 reminder messages can be optional, although the invention is not restricted thereto. These reminders may be periodic, may come after specific events (such as a major treatment), or both. These reminders will suggest that the patient provide 1105 any new information such that computer 1001 may update the EMH. The form of these reminders is not limited and may, to name but a few examples, take the form of emails, text messages, or automated phone calls. Also in an embodiment, the EMH's content includes a can/cannot remind value, selected by the patient's device 1005 or the physician's device 1004 during creation or updating of the EMH, which will determine whether, and in what form, reminders will be sent; a "can remind" value will add the patient's name to the optional EMH registry/outcomes database. In this manner, the patient can easily apprize the physician as to the progress they are making in a treatment, the extent to which they are complying with the physician's instructions, and any side effects they are feeling without relying on later reconstructions when the patient next visits the physician. [0068] In an embodiment, multiple physicians all use the same computer 1001 and database 1002; for example, through a shared cloud computing system. In such cases, the computer 1001 provides 1104 any EMH to any physician using the system, under the limits of the EMH's contents, with each physician using a personal device 1004 for access. [0069] In another embodiment, each physician possesses her own computer 1001 and database 1002, and EMHs can be transferred as each physician requires it. Methods of transferring EMHs between such databases are numerous and quickly apparent to those of ordinary skill in the art. One such method might be that a computer 1001 may provide an EMH to another indirectly, by saving 1102 it first to data storage 1006; the second computer 1001 then creates 1101 a copy of the EMH by retrieving the information from the data storage. Another such method might be that one computer 1001 directly provides 1104 the EMH to another as if the latter were a device 1004 or 1105. [0070] FIG. 4 examines one process of creating the EMH in depth. The patient first completes the multidimensional health assessment questionnaire (MDHAQ), at 201. As can be seen, this questionnaire covers the traditional medical history, the patient's self-reported status, and demographics of the patient. The MDHAQ is derived from the health assessment questionnaire (HAQ) to include physical function in 10 activities, pain, global status, fatigue, self-report joint count, review of systems, recent medical events, morning stiffness, change in status, and 19 demographic data on two sides of one page. MDHAQ includes scoring templates for physical function, pain, global status, fatigue, and self-report joint count, all scored 0-10, as well as templates for composite routine assessment of patient index data (RAPID), which can be scored in 10-20 seconds in a busy clinical setting. [0071] For instance, in the shown MDHAQ, there are three types of information. First, there is the traditional medical history in a standard format e.g., Chief problem and onset, Surgeries, Illnesses, Family History, Hospitalizations, Allergies. Next, there is Patient self-reported status using quantitative scores using a scale such as 1 to 10 with each status having a different weight (e.g., Physical function, Fatigue, Pain, Sleep, Global status, Anxiety, Exercise status, Depression). Lastly, there is Demographic data (e.g., Date of birth, Education level, Race, Occupation, Marital status, Work status). A more detailed description of MDHAQ questionnaires can be found at Pincus T, Swearingen CJ., The HAQ compared with the MDHAQ: "keep it simple, stupid" (KISS), with feasibility and clinical value as primary criteria for patient questionnaires in usual clinical care. Rheum Dis Clin North Am 2009; 35(4):787-98, and Pincus T, Sokka T. Quantitative Clinical Rheumatology: "Keep It Simple, Stupid" (KISS): MDHAQ Function, Pain, Global, and RAPID3 quantitative scores to improve and document the quality of rheumatologic care. J Rheumatol. 2009;36(6):1099-100, the disclosures of which are incorporated by reference. [0072] There are currently different types of MDHAQs: MDHAQ1, MDHAQ2, MDHAQ3, MDHAQ4, and RAPID3. All offer a mechanism for standardization of information taken in which is independent of the specific office. The use of the system reduces the burden on the office and the patient, thereby improving the quality of information received and hence the quality of care received. While described in terms of a MDHAQ, it is understood that other questionnaires can be used or developed to elicit information usable to construct or update an EMH in other aspects of the invention. [0073] When the questionnaire is completed, the resulting data is reported both to the patient, at 202, and to the physician, at 203. The patient may use the opportunity provided by 202 to review the data and revise it; if he does, the revised data is again sent to the physician at 203. The physician, having also reviewed the data, passes it to the EMH database at 204; this also creates a "flowsheet" tracking all changes expressed in the EMH (one of the computations expressed as 1111 in FIG. 1). The physician also adds regulated data to create an EMR at 205. While not 20 required in all aspect, the data is examined by both the patient and the physician before it is added to a database. It is understood that the database can be updated prior to review of the physician in other aspects. [0074] In one embodiment, when the EMR is created, the patient may request it at 206, and create a revised EMH from its data at 202. While not required in all aspects, the patient may create the revised EMH with appropriate consent. This data are then reviewed by the physician at 203, added to the EMH database at 204, and placed in a new EMR at 205. In this manner, there is a uniform mechanism by which a patient can request an update in the EMR and record their request in an EMH. [0075] While reviewing the data at 202, the patient may also volunteer for reminders at 207, which will remind the patient to review the data again at various intervals. The patient may also set options for how to store and update the data at 208. While FIG. 2 shows that the patient's choices at 207 and 208 will be stored in his/her own databases, in other embodiments they may be stored as a part of the EMH itself. [0076] While not limited thereto, an advantage of an aspect of the invention is that the information is completed by the patient in an electronic format which can then be transmitted to an electronic or even paper medical record, without any effort of the physician to acquire the information, thus allowing more time for the physician to review, and interpret, and clarify important clues to diagnosis and management. This process can save at least 10-20 minutes for a new patient and 5-10 minutes for a returning patient, while improving completeness accuracy of the medical history. [0077] While not limited thereto, an advantage of an aspect of the invention is that the EMH presents the medical history information concerning physical function, pain, global estimate, exercise status, fatigue in a standardized quantitative electronic format, which allows a medical history, which is often the most important information in diagnosis of many diseases, to be transformed from a narrative, non-quantitative format, to a quantitative, standardized format, the hallmark of scientific data rather than non-standard descriptions. In this way, the report for the physician is in a standard medical record format so there is no further need for the physician to collect data in a different format to transfer to a medical record format; and the standard format 21 allows entering the information, with the patient's consent, into a database to monitor outcomes over time. [0078] While not limited thereto, an advantage of an aspect of the invention is that the patient is provided an opportunity to save all the information entered electronically in the form of an email directly to the patient, a memory stick to be available at any medical site, or a password-protected website. The EMH would then be available for future visits at the same healthcare setting as well as any other healthcare facility including but not limited to medical physical therapy and exercise programs, for review by the patient and the health professional for updating, but without this feature in an emergency situation. [0079] While not limited thereto, an advantage of an aspect of the invention is that the EMH database also has available voluntary (if selected) automated follow-up mechanisms so that the program can allow for any patient not seen for a given interval to be listed for contact with a telephone call, self-report questionnaire, invitation for a visit, etc. [0080] While not limited thereto, an advantage of an aspect of the invention is that the patient is given an opportunity to consent to several features of the system. While not limited thereto, such features can include one or more of the following: maintenance of the EMH stored as an email, on a memory stick, and/or a password-protected website; monitoring, through periodic automated emails requesting maintenance of the EMH, to track patient status for long-term results for treatment; and program queries for a physician to know standard computations, including but not limited to: how many patients with each diagnosis are seen in the practice, how many patients with each diagnosis take specific medications, and what is the change in patient scores for physical function, pain, and global status over time. [0081] While not limited thereto, an advantage of an aspect of the invention is that the patient may also consent to continued monitoring indefinitely over a lifetime; this monitoring would include data concerning predictors of survival according to different therapies and different baseline markers. This feature can save millions of dollars in outcome studies in the United States without jeopardizing the legal requirements of HIPAA if patients are willing to volunteer for such studies. Patient self-report data are more significant in the general population in predicting long term health than most laboratory tests and high technology imaging studies.

22 [0082] While not limited to a specific questionnaire, one aspect of the inventive system and method involves the patient filling out a standard medical history on a multidimensional health assessment questionnaire (MDHAQ). There are hundreds of available questionnaires for this purpose. While not limited thereto, the MDHAQ provides: an assessment of patient physical function and exercise status, which have been shown to be as likely as smoking history to predict poor 5-year survival in the general population; quantitative assessment of pain; quantitative assessment of global status; quantitative assessment of fatigue; review of systems; review of recent medical history; standard features of medical history, including but not limited to illnesses, operations, hospitalizations, family history, allergies, and medications; demographic variables; consent for further contact to allow follow-up of patient status; consent for sharing information with databases in a de-identified fashion; and consent for maintaining patient history in a database to allow other physicians and health professionals access; and consent for data to be stored and kept by the patient in an electronic format through a password-protected website, with options to allow access by physicians and other health professionals designated by the patient. Of course, additional data fields can be included in addition to or instead of one of these fields, although aspects of the invention do not allow replacement of the these fields. The data are available in the physician report form to be incorporated into a standard patient history. The software and concept are unique to this system. A report is available for patients to electronically modify, amend, or correct the medical history. [0083] It should be emphasized that in an aspect of the proposed system, for recording the patient history and maintaining it to be available over the lifetime of any individual patient, is distinguishable from a patient medical record. The patient medical record is a legal document protected by the Health Insurance Portability and Accountability Act (HIPAA) and not modifiable. The proposed EMH involves only the patient history controlled by the patient. This patient medical history is not controlled by any regulations and should be properly regarded as the property of the patient. It is possible that the system could be expanded to include data from the patient medical record only with entry directed by the patient. No medical data should be available to any database without appropriate patient consent. Therefore, in this embodiment of the system, the patient would be responsible for any possible entries from the medical record, which might include hospitalization records, discharge summaries, laboratory tests, radiographic reports, cardiograms available for comparison to future events, records of devices (such as 23 replacement lenses, total joint replacement, prostheses, and pacemakers), and other vital information which would be desirable to have available in case of emergency, or any other medical visit, at which a computer listing that has been reviewed, often repeatedly, is likely to be more accurate than a patients memory. [0084] A unique feature of an embodiment of the system involves the capacity for the medical history information to be transferred to a medical record in a standard format of the traditional medical record. This step is viewed as saving doctors at least 10 minutes per new patient and at least 3 minutes per return patient, with information that is necessary to collect at each patient visit in order to make optimal clinical decisions, but which is often neglected in the press of time in contemporary medical care. Therefore, the process is viewed as not only saving time for the doctor but likely improving medical care with provision of more information than is usually available to make decisions about diagnosis, prognosis, therapeutic interventions, and outcomes. [0085] While not limited thereto, it is understood that aspects of the system and method can be implemented using computer software and/or firmware encoded on one or more computer readable media or other non-transitory media readable by a processor and/or computer and implemented using one or more processors and/or computers. [0086] Although multiple embodiments of the present invention have been shown and described, it would be appreciated by those skilled in the art that changes may be made in these embodiments without departing from the principles and spirit of the invention, the scope of which is defined in the claims and their equivalents. [0087] Reference to 'an aspect' or 'aspects' of the invention herein should not be interpreted as indicating that such aspect(s) is(are) necessarily essential to the invention. [0088] The term "comprise" and variants of that term such as "comprises" or "comprising" are used herein to denote the inclusion of a stated integer or integers but not to exclude any other integer or any other integers, unless in the context or usage an exclusive interpretation of the term is required. [0089] Reference to prior art disclosures in this specification is not an admission that the disclosures constitute common general knowledge in Australia.

Claims (26)

1. An information system which corroborates first data provided by data owners and second data provided by data controllers, the system comprising: a first database which stores and provides the first data, the first data being accessible to the data owners and the data controllers; a second database which stores and provides the second data, the second data being accessible to the data controllers but not to the data owners; and a computer which controls access of the first data stored in the first database and the second data stored in the second database, receives from a data owner device first data created using input from one of the data owners, stores the received first data in the first database, transmits the first data retrieved from the first database to an administrator device, receives from the administrator device additional regulated data related to the one data owner and which is input by one of the data controllers, and stores the second data which includes the additional regulated data in the second database.

2. The information system of claim 1, where the first data includes an electronic medical history provided by a patient as the data owner, and the second data includes an electronic medical record of the patient controlled by a physician as the data controller.

3. The information system of claim 1, wherein the computer further transmits a questionnaire which prompts the one data owner to create the first data according to criterion in the questionnaire, and the received first data includes information prompted by the transmitted questionnaire.

4. The information system of claim 3, wherein the computer further detects the data owner device of the one data owner, retrieves one of the first data stored in the first database corresponding to the one data owner, and constructs the questionnaire relative to the retrieved first data.

5. The information system of claim 1, wherein the computer further retrieves one of the second data stored in the second database corresponding to the one data owner, updates the 25 retrieved second data with the received additional regulated data corresponding to the one data owner, and stores the updated second data in the second database.

6. The information system of claim 1, wherein the computer further detects the administrator device, retrieves one of the second data stored in the second database corresponding to the one data owner, and further transmits the retrieved second data to the administrator device.

7. The information system of claim 6, wherein the computer receives from the administrator device updated second data including the additional regulated data input by one of the data controllers related to the one data owner, and stores the updated second data in the second database.

8. The information system of claim 1, wherein the computer further detects the administrator device, receives a query from the administrator device to search for specified information in the first database for a plurality of the data owners, retrieves a search result for the specified information, and transmits the retrieved search result to the administrator device.

9. The information system of claim 1, wherein the computer receives a request for research data from an external device, retrieves first data from the first database responsive to the request, removes from the retrieved first data personal information of the corresponding data owners to create the research data, and transmits the created research data to the external device.

10. The information system of claim 9, wherein the received request for research data is limited to specific categories of information, the computer searches the first data from the first database responsive to the specific categories in the request to obtain a search response, and removes from the retrieved search response the personal information of the corresponding data owners to create the research data.

11. The information system of claim 1, wherein the computer further sends a reminder message to the one data owner which prompts the one data owner to update the first data 26 according to the criterion in the reminder message, and the received first data includes information prompted by the transmitted reminder message.

12. The information system of claim 1, further comprising the administrator device which receives the additional regulated data input by the one of the data controllers and which is related to the one data owner, receives the first data for the one data owner, and transmits the additional regulated data to be stored with the second data in the second database.

13. The information system of claim 1, further comprising the data owner device which receives the input from the one of the data owners to create the first data, and transmits the created first data.

14. The information system of claim 13, further comprising the administrator device which receives the additional regulated data input by the one of the data controllers and which is related to the one data owner, receives the first data for the one data owner, and transmits the additional regulated data to be stored with the second data in the second database, wherein the administrator device is capable of receiving the first data from the data owner device and from the computer.

15. The information system of claim 13, further comprising a data storage device accessible to the data owner device, where the transmitted first data is further stored in the data storage device and is retrieved according to a request received from the computer for an update to the first data.

16. The information system of claim 15, wherein the first data comprises information from a completed multidimensional health assessment questionnaire (MDHAQ), and the second data comprises a medical record including regulated data regulated under the Health Insurance Portability and Accountability Act (HIPAA).

17. A method of corroborating first data provided by data owners and second data 27 provided by data controllers, the method comprising: sending a questionnaire from a computer to a data owner device of one of the data owners to provide information used to create the first data for the one data owner; receiving the created first data at the computer from the data owner device; storing the received first data in a first database which stores and provides the first data, the first data being accessible to the data owners and the data controllers; retrieving second data related to the one data owner from a second database which stores and provides the second data, the second data being accessible to the data controllers but not to the data owners; transmitting the retrieved second data from the computer to an administrator device of one of the data controllers; receiving regulated data from the administrator device, the regulated data corresponding to the received first data and the transmitted second data of the one data owner; and storing the received regulated data as updated second data in the second database.

18. The method of claim 17, further comprising transmitting from the computer to the data owner device a questionnaire which prompts the one data owner to create the first data according to the criterion in the questionnaire, and the received first data includes information prompted by the transmitted questionnaire.

19. The method of claim 18, further comprising the computer detecting the data owner device of the one data owner, retrieving one of the first data stored in the first database corresponding to the one data owner, and constructing the questionnaire relative to the retrieved first data.

20. The method of claim 17, further comprising the computer combining the retrieved second data with the received regulated data corresponding to the one data owner to create the updated second data.

21. The method of claim 17, further comprising the computer receiving from the administrator device the updated second data including the regulated data input by one of the data 28 controllers related to the one data owner.

22. The method of claim 17, further comprising the computer receiving a query from the administrator device to search for specified information in the first database for a plurality of the data owners, retrieving a search result for the specified information, and transmitting the retrieved search result to the administrator device.

23. The method of claim 17, further comprising the computer receiving a request for research data from an external device, retrieving first data from the first database responsive to the request, removing from the retrieved first data personal information of the corresponding data owners to create the research data, and transmitting the created research data to the external device.

24. The method of claim 23, wherein the received request for research data is limited to specific categories of information, the method further comprises the computer searching the first data from the first database responsive to the specific categories in the request to obtain a search response, and removing from the retrieved search response the personal information of the corresponding data owners to create the research data.

25. The method of claim 17, further comprising the computer sending a reminder message to the one data owner which prompts the one data owner to update the first data according to the criterion in the reminder message, wherein the received first data includes information prompted by the transmitted reminder message.

26. A non-transitory computer readable medium encoded with processing instructions readable by the computer to implement the method of claim 17.