Method for providing information comprehensive health care linked to clinical trials

Abstract

The clinical trial-linked comprehensive health management information provision method of the present invention provides a comprehensive health management information provision method including information collected from a clinical trial participant. To this end, the method comprises a clinical trial information acquisition step, a clinical trial consent request step, a personal verification information generation step, a medical information use approval request step, a medical information use approval completion step, a health checkup information generation step, a PHR information request step, and a PHR information reception step.

Description

Technology Field

[0001] The present invention relates to a method for providing comprehensive health management information, and more specifically, to a method for providing comprehensive health management information linked to clinical trials, which utilizes the test information of a participant in a clinical trial to provide information in conjunction with public information regarding the participant's health or disease. Background Technology

[0003] A Personal Health Record (PHR) refers to technologies and services that enable individuals to proactively integrate and manage their own medical data, and to provide and utilize it only to those they desire. Here, medical information can encompass all information related to an individual's health, including treatment records, general health information (such as life logs), health insurance information, genomic information, and public information (such as infectious disease and living environment information).

[0004] Conventional smart healthcare services have generally utilized existing PHR data to provide health management services to an unspecified audience. Since services are provided based on data from an unspecified number of people, there is a need to provide more precise data to improve the quality of the service.

[0005] A clinical trial refers to a test or study conducted on humans for the purpose of proving the safety and efficacy of an investigational drug by confirming its pharmacokinetics, pharmacodynamics, pharmacology, and clinical effects, and investigating adverse reactions. To apply such clinical trials to the general public, it is necessary to address issues regarding the cost of subject recruitment and to verify whether the subjects are capable of performing the appropriate clinical trial.

[0006] While it appears that more precise health management services could be provided if data related to health checkup items (blood tests, urine tests, electrocardiograms, and other special tests) generated during the participation of volunteers in Phase 1 clinical trials (including bioequivalence studies) targeting specific patients or healthy adults could be applied to smart healthcare services in conjunction with PHRs, volunteers who participated in clinical trials (including Phase 1 bioequivalence studies) or underwent physical examinations for the purpose of clinical trials underwent tests (blood tests, urine tests, electrocardiograms, and other expensive tests specific to each clinical trial) that are identical to the high-cost health checkup items performed for clinical trial participation and possess the results, these results have not been utilized when establishing their own healthcare services. In other words, regarding the test results of volunteers who participated to support clinical trials and bioequivalence studies, although the subject of the information based on the individual test results is each individual, this information has not been utilized for individual health management services. The problem to be solved

[0008] The method for providing comprehensive health management information linked to clinical trials according to an embodiment of the present invention aims to enable trial participants in a clinical trial (including bioequivalence trials) to receive innovative personalized health management services without the need for other regular health checkups, by integrating the results of expensive health checkup items received during previous trial participation with their personal PHR results.

[0009] The method for providing comprehensive health management information linked to clinical trials according to an embodiment of the present invention aims to efficiently manage information on clinical trial participants by obtaining information on appropriate clinical trial participants through individual health management service data of pharmaceutical companies and clinical trial institutions, and by providing appropriate information to trial participants who meet selection / exclusion criteria, targeting those who have obtained consent from the physician to participate.

[0011] The objectives of the present invention are not limited to those mentioned above, and other objectives not mentioned will be clearly understood by those skilled in the art from the description below. means of solving the problem

[0013] A method for providing comprehensive health management information including information collected about a clinical trial participant according to one aspect of the present invention for solving the above technical problem comprises: a clinical trial information acquisition step in which a data transmission and reception unit of a service server receives clinical trial information transmitted from a first institution server; a clinical trial consent request step in which a clinical trial information management unit of the service server generates first institution participation acceptance request information and clinical trial participation acceptance request information included in the clinical trial information and transmits them to a user device through the data transmission and reception unit; and a personal verification information generation step in which the clinical trial information management unit receives first institution participation acceptance information and clinical trial participation acceptance information corresponding to the first institution participation acceptance request information and clinical trial participation acceptance request information, respectively, from the user device through the data transmission and reception unit, and transmits personal biometric information included in the clinical trial participation acceptance information to a biometric authentication institution server to verify whether the user of the user device is the same person. When the clinical trial information management unit receives confirmation information regarding the personal verification information from the biometric authentication agency server through the data transmission and reception unit, a medical information usage approval request step in which the medical information management unit of the service server transmits, through the data transmission and reception unit, information requesting acceptance of the use of medical information or information requesting acceptance of the use of health information regarding the user of the user device, which is stored in the first agency server or the second agency server equipped to store medical information or health information regarding the public, from the user device; and a medical information usage approval completion step in which the medical information management unit receives information accepting the use of medical information regarding the requesting acceptance of the use of medical information or information accepting the use of health information regarding the requesting acceptance of the use of health information from the user device through the data transmission and reception unit.The above clinical trial information management unit receives, through the data transmission and reception unit, an Electronic Medical Record (EMR) containing medical information or health information about the user of the user device generated as a result of a physical examination and a visit examination for a clinical trial according to the clinical trial information about the user of the user device from the first institution server, and generates health checkup information matching a preset list from the EMR; a PHR information request step in which the medical information management unit transmits the medical information utilization acceptance information or the health information utilization acceptance information to the second institution server through the data transmission and reception unit and transmits PHR transmission request information containing medical information or health information about the user of the user device; and a PHR information reception step in which the medical information management unit receives a PHR corresponding to the PHR transmission request information from the second institution server through the data transmission and reception unit.

[0014] Herein, the comprehensive health information management unit of the service server may further include a health checkup information generation step in which it extracts examination date, measurement test, urine test, blood test, and electrocardiogram test data included in the medical information or health information regarding the user of the user device included in the health checkup information and the PHR, and generates comprehensive health information regarding the user of the user device.

[0015] Here, the personal biometric information may be one or more of retinal information, fingerprint information, facial recognition information, and voice information collected in real time from a biometric information collection unit equipped to enable wired and wireless data transmission and reception provided in advance to the user, or from the user device.

[0016] Here, the comprehensive health information management unit may further include the step of transmitting the comprehensive health information to the user device through the data transmission and reception unit.

[0017] Here, the comprehensive health information management unit may further include the step of transmitting one or more of the time-series disease occurrence information, time-series vaccination information, and time-series health prediction information, extracted from pre-prepared health information big data and having a preset similarity level or higher, to the user device through the data transmission and reception unit.

[0018] Here, the comprehensive health information management unit may further include the step of transmitting the comprehensive health information to the user device through the data transmission and reception unit, wherein the genetic disease information or health status information with a similarity level greater than or equal to a preset level extracted from the pre-prepared health information big data. Effects of the invention

[0020] The method for providing comprehensive health management information linked to clinical trials according to an embodiment of the present invention enables precise health management by allowing trial participants in a clinical trial (including bioequivalence trials) to receive innovative personalized health management services through the integration of the results of expensive health checkup items received during previous trial participation and their personal PHR results, without the need for other regular health checkups.

[0021] The method for providing comprehensive health management information linked to clinical trials according to an embodiment of the present invention secures information on appropriate clinical trial participants through individual health management service data from pharmaceutical companies and clinical trial institutions, and enables the efficient management of information on clinical trial participants by providing appropriate information to those who have consented to participate and meet selection / exclusion criteria, thereby allowing the health status of the participants after the clinical trial to be checked and used as long-term clinical information.

[0023] The effects of the present invention are not limited to those mentioned above, and other unmentioned effects will be clearly understood by those skilled in the art from the description below. Brief explanation of the drawing

[0025] Figure 1 is a system block diagram of a service server. FIG. 2 is a flowchart of a method for providing comprehensive health management information linked to clinical trials according to an embodiment of the present invention. Figure 3 is a system diagram related to the clinical trial-linked comprehensive health management information provision method of the present invention. FIG. 4 is a conceptual diagram of a method for providing comprehensive health management information linked to clinical trials according to an embodiment of the present invention. Specific details for implementing the invention

[0026] The objectives and effects of the present invention, and the technical configurations for achieving them, will become clear by referring to the embodiments described in detail below in conjunction with the accompanying drawings. In describing the present invention, if it is determined that a detailed description of known functions or configurations may unnecessarily obscure the essence of the invention, such detailed description will be omitted. Furthermore, the terms described below are defined with consideration of their function in the present invention, and these may vary depending on the intentions or practices of the user or operator.

[0027] However, the present invention is not limited to the embodiments disclosed below but may be implemented in various different forms. These embodiments are provided merely to ensure that the disclosure of the present invention is complete and to fully inform those skilled in the art of the scope of the invention, and the present invention is defined only by the scope of the claims. Therefore, such definition should be based on the content throughout this specification.

[0028] Throughout the specification, when a part is described as "comprising" or "equipped" with a certain component, this means that, unless specifically stated otherwise, it does not exclude other components but may include additional components. Furthermore, terms such as "...device," "...part," or "...unit" as used in the specification refer to a unit that performs at least one function or operation, and this may be implemented in hardware, software, or a combination of hardware and software.

[0029] Meanwhile, in an embodiment of the present invention, each component, functional block, or means may be composed of one or more sub-components, and the electrical, electronic, and mechanical functions performed by each component may be implemented by various known devices or mechanical elements such as electronic circuits, integrated circuits, and ASICs (Application Specific Integrated Circuits), and each may be implemented separately or two or more may be integrated into one.

[0030] In addition, combinations of each block of the attached block diagram and each step of the flowchart may be executed by computer program instructions. Since these computer program instructions can be loaded into the processors of general-purpose computers, specialized computers, portable laptop computers, network computers, mobile devices such as smartphones, HMDs (Head Mounted Displays), and smart glasses, online game service providers, or other programmable data processing equipment, the instructions executed through the processors of the computer devices or other programmable data processing equipment create means to perform the functions described in each block of the block diagram or each step of the flowchart described below. Since these computer program instructions may also be stored in memory or computer-readable memory available to a computer device capable of orienting the computer device or other programmable data processing equipment to implement functions in a specific manner, it is also possible to produce a manufactured product containing means of instruction that perform the functions described in each block of the block diagram or each step of the flowchart. Since computer program instructions can be loaded onto a computer device or other programmable data processing equipment, it is also possible to create a process for performing a series of operation steps on a computer device or other programmable data processing equipment and to provide steps for executing the functions described in each block of the block diagram and each step of the flowchart.

[0031] Additionally, each block or each step may represent a module, segment, or part of code containing one or more executable instructions for executing one or more specified logical functions. Also, it should be noted that in some alternative embodiments, the functions mentioned in the blocks or steps may occur out of order. For example, two blocks or steps described in succession may actually be performed substantially simultaneously, or the blocks or steps may sometimes be performed in reverse order according to the corresponding functions.

[0032] In an embodiment of the present invention, the term "user device" refers to any computing means capable of collecting, reading, processing, manipulating, storing, and displaying data, such as a desktop computer, a laptop computer, a smartphone, a PDA, a mobile phone, a game console, an HMD, or smart glasses. In particular, the user device in an embodiment of the present invention is a device capable of executing software written in decipherable code and having the function of displaying and transmitting it to a user. Additionally, if necessary, the software may be stored internally or read from an external source along with data.

[0033] In addition, the server or user device in the embodiment of the present invention includes not only the data processing function described above but also functions such as input, output, and storage. To this end, it may include various elements found in general computer devices, such as a CPU, motherboard, graphics card, hard disk, sound card, speaker, keyboard, mouse, monitor, USB, and communication modem, as well as external connection terminals found in wireless smartphone terminals, such as a CPU, motherboard, graphics chip, memory chip, sound engine, speaker, touchpad, USB, communication antenna, and a communication modem capable of implementing communication such as 3G, LTE, LTE-A, 5G, 6G, WiFi, and Bluetooth. These various elements may implement one or more functions individually, in pairs or together, or by combining parts of the various elements. In the embodiment of the present invention, a device or part thereof indicated by one or more blocks in the drawings or detailed description may refer to various elements included in such a user device that represent one or more functions individually, in pairs or together, or by combining parts of the various elements.

[0034] Meanwhile, in an embodiment of the present invention, a user device, a service server, etc. may have wired and wireless data transmission and reception functions, and may be configured to use various network means such as wired internet, wireless internet, infrared communication, Bluetooth, WCDMA, Wibro, WiFi, LTE, LTE-A, 5G, and 6G wired and wireless communication networks to implement data transmission and reception functions.

[0035] Hereinafter, a method for providing comprehensive health management information linked to clinical trials according to an embodiment of the present invention will be described in detail with reference to the attached drawings.

[0036] Figure 1 is a system block diagram of a service server (100).

[0037] Referring to FIG. 1, the service server (100) includes a data transmission and reception unit (110), a clinical trial information management unit (120), a medical information management unit (130), and a comprehensive health information management unit (140).

[0038] The above data transmission and reception unit (110) is configured to transmit or receive data or information related to clinical trials, health information, personal information, etc. to a user device (200), a first institution server (500), a second institution server (700), or a biometric authentication institution server. It is configured to enable wired or wireless communication in relation to data transmission and reception.

[0039] In describing the present invention, "clinical trial / study" refers to a test or study conducted on humans for the purpose of proving the safety and efficacy of a clinical trial drug, confirming the pharmacokinetics, pharmacodynamics, pharmacology, and clinical effects of the drug, and investigating adverse reactions.

[0040] Furthermore, in the case of South Korea, regarding clinical trials, the clinical trial sponsor (First Institution) prepares a clinical trial protocol and applies for approval to the Ministry of Food and Drug Safety (MFDS) and the Institutional Review Board (IRB) within the implementing institution. The MFDS and the IRB then decide whether to grant approval after thoroughly reviewing the protocol. The clinical trial sponsor requests the Principal Investigator (PI) to conduct the clinical trial to verify the safety and efficacy of the new drug candidate. The Principal Investigator obtains informed consent from subjects after fully explaining the trial, and conducts the clinical trial in a scientific and ethical manner in accordance with the protocol. In relation to the clinical trial, the MFDS may conduct on-site inspections of the implementing institution, the clinical trial sponsor, and the Principal Investigator. Through this process, the MFDS evaluates the safety and efficacy of the new drug candidate to determine whether to grant new drug approval, after which the drug can be sold.

[0041] The above clinical trial information management unit (120) may be configured to manage clinical trial information regarding the above content related to the clinical trial and information exchanged with the user for participation therein. The clinical trial information may include information on the first institution's acceptance of participation request, which includes information on whether the user may participate in the clinical trial, or information on the user's expression of intent regarding whether to participate in the clinical trial. The clinical trial information management unit (120) may be configured to transmit personal biometric information included in the clinical trial participation acceptance information to the biometric authentication institution server.

[0042] The clinical trial information management unit (120) receives personal biometric information from the user and transmits it to a biometric authentication agency server to verify whether the user is the same person in order to generate clinical trial participation acceptance information, generates personal verification information requesting verification of whether the user is the same person and transmits it to the biometric authentication agency server, and receives verification information from the biometric authentication agency server, thereby performing verification of whether the user is the same person participating in the clinical trial. In addition, the clinical trial information management unit (120) may be configured to receive an Electronic Medical Record (EMR) containing medical information or health information about the user of the user device (200) generated as a result of a physical examination or on-site examination for a clinical trial according to the clinical trial information about the user of the user device (200) from the first agency server (500) through the data transmission and reception unit (110), and to generate health examination information that matches a pre-set list from the EMR. Here, a physical examination or on-site examination refers to an examination to create a comprehensive physical examination result regarding whether the user has the conditions to participate in the clinical trial.

[0043] The medical information management department (130) may be configured to generate or transmit information regarding the acceptance of use of medical information or health information regarding the user of the user device (200) stored in the first institution server (500) or the second institution server (700) configured to store medical information or health information regarding the public.

[0044] The medical information management unit (130) may be configured to transmit medical information usage acceptance information or health information usage acceptance information to the second institution server (700) through the data transmission and reception unit (110) and to transmit PHR (Personal Health Record) transmission request information including medical information or health information about the user of the user device (200).

[0045] Meanwhile, the second institution server (700) means being equipped to store medical information or health information about the public, and the PHR is, for example, the Korea Health Information Service ( https: / / www.k-his.or.kr / It may be medical information or health information of a user that is held or managed by ). However, it is not limited thereto, and the second institution server (700) may refer to a service server of a specific institution in another country that manages medical information or health information held or managed by the Korea Health Information Service, and PHR may be medical information or health information of a user that is held or managed by the service server of the specific institution in the other country.

[0046] The comprehensive health information management unit (140) may be configured to generate comprehensive health information for the user of the user device (200) by extracting medical information or health information for the user of the user device (200) included in health checkup information and PHR, such as checkup date, measurement test, urine test, blood test, and electrocardiogram test data. The comprehensive health information management unit (140) may be configured to transmit one or more of time-series disease occurrence information, time-series vaccination information, and time-series health prediction information, which are extracted from health information big data and have a preset similarity level or higher, to the user device (200).

[0047] Health information big data may be stored in advance in the Comprehensive Health Information Management Department (140) or received from a third-party institution server, and may include statistical data such as the correlation between diseases and health status, causes of various diseases, frequency of occurrence, and location of occurrence. For reference, health information big data may be transmitted from a data server established by obtaining specimens such as blood and urine based on the consent of the participants subject to information collection to create clinical and genomic data, and linking this with public data and personal health information. Health information big data is not limited to past data and may be updated using continuously collected statistical data.

[0048] FIG. 2 is a flowchart of a method for providing comprehensive health management information linked to clinical trials according to an embodiment of the present invention, FIG. 3 is a system diagram related to the method for providing comprehensive health management information linked to clinical trials according to the present invention, and FIG. 4 is a conceptual diagram of a method for providing comprehensive health management information linked to clinical trials according to an embodiment of the present invention.

[0049] Hereinafter, the present invention will be described in detail with reference to FIGS. 2 to 4.

[0050] A method for providing comprehensive health management information including information collected for a clinical trial participant according to one embodiment of the present invention includes a step of securing clinical trial information in which a data transmission and reception unit (110) of a service server (100) receives clinical trial information transmitted from a first institution server (500) (S110).

[0051] The clinical trial information may include first institution participation acceptance request information containing information regarding the user’s expression of intent regarding whether the first institution conducting the clinical trial may participate in the clinical trial, or clinical trial participation acceptance information containing information regarding the user’s expression of intent regarding whether or not to participate in the clinical trial. Here, the first institution server (500) is a service server operated under the ownership or management responsibility of the first institution conducting the clinical trial, and may be equipped to transmit or edit general information regarding the clinical trial under the control of the first institution.

[0052] Through clinical trial information obtained from the first institution, the clinical trial information and the information of the participants are verified, and identification information capable of identifying an individual, such as contact information of the participants, is extracted.

[0053] Next, the clinical trial information management unit (120) of the service server (100) generates the first institution participation acceptance request information and the clinical trial participation acceptance request information included in the clinical trial information and transmits them to the user device (200) through the data transmission and reception unit (110), thereby including a clinical trial consent request step (S120).

[0054] This is a step of requesting clinical trial consent from the user device (200) of a user whose participation in the clinical trial has been confirmed among the participant information included in the clinical trial information. To this end, the Clinical Trial Information Management Department (120) can obtain confirmation of whether the user consents to the progress of the clinical trial by the first institution by generating a request for acceptance of participation from the first institution to the user device (200) and transmitting it to the user device (200). Additionally, the Clinical Trial Information Management Department (120) generates a request for acceptance of participation in clinical trials to confirm the user's intent to actually participate in the clinical trial and transmits it to the user device (200).

[0055] Next, the clinical trial information management unit (120) receives the first institution participation acceptance information and the clinical trial participation acceptance information corresponding to the first institution participation acceptance request information and the clinical trial participation acceptance request information, respectively, from the user device (200) through the data transmission and reception unit (110), and includes a personal verification information generation step (S130) of transmitting the personal biometric information included in the clinical trial participation acceptance information to a biometric authentication institution server to verify whether the user of the user device (200) is the same person.

[0056] The user of the user device (200) generates first institution participation acceptance information corresponding to the first institution participation acceptance request information transmitted by the clinical trial information management department (120) and transmits it to the clinical trial information management department (120) of the service server (100). Additionally, the user of the user device (200) generates clinical trial participation acceptance information corresponding to the clinical trial participation acceptance request information transmitted by the clinical trial information management department (120) and transmits it to the clinical trial information management department (120) of the service server (100).

[0057] Meanwhile, at this time, personal biometric information may be included and transmitted along with the clinical trial participation acceptance information. The personal biometric information is information collected through the user device (200) or a biometric information verification device to which the user device (200) can connect, and can function as an authentication key to verify whether the user of the user device (200) is a user who is actually participating in the clinical trial. Through this, the clinical trial information management department (120) transmits the personal biometric information included in the clinical trial participation acceptance information to the biometric authentication agency server to proceed with the verification process. Through this step, it can be confirmed whether the user agrees to the clinical trial institution and the progress of the clinical trial.

[0058] At this time, the personal biometric information may be one or more of retinal information, fingerprint information, facial recognition information, and voice information collected in real time from a biometric information collection unit equipped to enable wired and wireless data transmission and reception provided to the user in advance, or from the user device (200). However, it is not limited thereto, and biometric information such as genetic material, such as hair and skin tissue, collected from the user to prove that the user of the user device (200) is a participant in a clinical trial may be utilized.

[0059] Personal biometric information can be collected, for example, through a fingerprint recognition device equipped in a smartphone, and such information can be generated in a form including information such as the user's fingerprint of the user device (200) and transmitted to a service server (100). The user device (200) for this purpose may be a smartphone equipped with a biometric recognition function. However, it is not limited thereto, and any computer, tablet, laptop computer, PDA, etc. equipped with a biometric recognition function may be used as the user device (200).

[0060] Next, when the clinical trial information management unit (120) receives confirmation information regarding the personal verification information from the biometric authentication institution server through the data transmission and reception unit (110), the medical information management unit (130) of the service server (100) includes a medical information usage approval request step (S140) in which the medical information usage acceptance request information or health information usage acceptance request information regarding the user of the user device (200) is stored in the first institution server (500) or the second institution server (700) equipped to store medical information or health information regarding the public from the user device (200) through the data transmission and reception unit (110).

[0061] This step corresponds to the stage where, when the Clinical Trial Management Department receives confirmation information from the biometric authentication agency server that has verified personal verification information from the biometric authentication agency server confirming that the user of the user device (200) matches the personal information of the clinical trial participant, it is confirmed that the user is participating in the clinical trial. Subsequently, the Medical Information Management Department (130) confirms the availability of the user's medical information or health information from the first institution, which is the clinical trial institution, and the second institution, which manages national medical information, in order to use the user's medical information or health information. To this end, the Medical Information Management Department (130) transmits the information requesting acceptance of the use of medical information or the information requesting acceptance of the use of health information to the first institution server (500) or the second institution server (700). The second institution may be a server that stores personal medical information or health information for public purposes and is under the management and control of the Korea Health Information Service. However, it is not limited to this, and any server capable of providing information verifiable as personal medical information or health information may be the second institution server (700) without restriction.

[0062] Next, the medical information management unit (130) receives medical information usage acceptance information regarding the medical information usage acceptance request information or health information usage acceptance information regarding the health information usage acceptance request information from the user device (200) through the data transmission and reception unit (110), and includes a medical information usage approval completion step (S150).

[0063] The medical information management department (130) may be equipped to receive medical information and health information about the user by receiving medical information usage acceptance information that allows the use of medical information or health information usage acceptance information that allows the use of health information stored in advance in relation to the user's health, and to generate information that can be customized for the user based on this.

[0064] The above clinical trial information management unit (120) receives an Electronic Medical Record (EMR) containing medical information or health information about the user of the user device (200) generated as a result of a physical examination and a visit examination for a clinical trial according to the clinical trial information about the user of the user device (200) from the first institution server (500) through the data transmission and reception unit (110), and includes the step of generating health examination information that matches a pre-set list from the EMR (S160).

[0065] Users who have completed all clinical trial consent may undergo various tests prior to participating in the clinical trial, and an EMR containing the collected medical or health information is generated. From the various information included in the EMR, only the information matching a pre-set health-related list can be extracted to generate the user's health checkup information. In this case, the aforementioned list may consist of quantitative information itself, such as an individual's eyesight, blood pressure, and weight, or descriptive text using words that are easy for general users to understand, and can be included in the user's health checkup information.

[0066] Next, the medical information management unit (130) transmits the medical information usage acceptance information or the health information usage acceptance information to the second institution server (700) through the data transmission and reception unit (110), and includes a PHR information request step (S170) in which a PHR (Personal Health Record) transmission request information containing medical information or health information for the user of the user device (200) is transmitted.

[0068] The PHR is personal medical or health information stored in a second institution server (700) separately from clinical trials, and the Medical Information Management Department (130) requests the said information from the second institution server (700). The second institution server (700) may be a server that stores PHR information held by the Korea Health Information Service, but is not limited thereto, and may be a server that the Korea Health Information Service can access and use, or a server owned by another institution or entity under the management and supervision of the Korea Health Information Service.

[0069] Next, the medical information management unit (130) includes a PHR information receiving step (S180) in which it receives a PHR corresponding to the PHR transmission request information from the second institution server (700) through the data transmission and reception unit (110).

[0070] Through this procedure, both the user's medical or health information confirmed in the clinical trial and the medical or health information included in the PHR are secured. Here, the comprehensive health information management unit (140) of the service server (100) may further include a health checkup information generation step in which the comprehensive health information management unit (140) of the service server (100) extracts the examination date, measurement test, urine test, blood test, and electrocardiogram test data included in the health checkup information and the medical or health information regarding the user of the user device (200) included in the PHR, and generates comprehensive health information regarding the user of the user device (200). Although not illustrated, such medical information and health information may be listed and stored sequentially according to the time information of the collection date included in each information.

[0071] Comprehensive health information is transmitted to the user and configured to allow verification of information collected from clinical trials regarding the individual's health, etc. To this end, the comprehensive health information management unit (140) may further include the step of transmitting the comprehensive health information to the user device (200) through the data transmission and reception unit (110).

[0072] The above-mentioned comprehensive health information management unit (140) may further include the step of transmitting one or more of the following to the user device (200) through the data transmission and reception unit (110): the comprehensive health information extracted from the pre-prepared health information big data, time-series disease occurrence information, time-series vaccination information, and time-series health prediction information. Rather than simply transmitting only measured quantitative information to the user, the information is transmitted to the user in the form of past measured quantitative data or quantitative information that can predict expected diseases, provide information on necessary vaccinations, or provide health prediction information regarding areas requiring improvement based on past information, thereby allowing the user to obtain more useful information. Through this, the user can be motivated to participate in clinical trials and maintain a sound national health environment.

[0073] Furthermore, the comprehensive health information management unit (140) may further include a step of transmitting genetic disease information or health status information with a similarity level greater than that of the comprehensive health information extracted from the health information big data prepared in advance through the data transmission and reception unit (110) to the user device (200). Information on various genomes collected from individuals is used for the analysis of genetic disease information, etc., and is transmitted to the user to enable them to acquire information on genetic diseases that may occur in the future in advance, thereby enabling them to verify qualitative information that is difficult to extract from health information or medical information, and to use it to improve their living environment or lifestyle habits in advance.

[0075] Preferred embodiments of the present invention are disclosed in this specification and drawings. Although specific terms have been used, they are used only in a general sense to facilitate the explanation of the technical content of the invention and to aid in understanding the invention, and are not intended to limit the scope of the invention. It is obvious to those skilled in the art that, in addition to the embodiments disclosed herein, other variations based on the technical concept of the present invention are possible.

Claims

Claim 1 A method for providing comprehensive health management information including information collected regarding a clinical trial participant, wherein the method comprises: a clinical trial information acquisition step in which a data transmission / reception unit of a service server receives clinical trial information transmitted from a first institution server; a clinical trial consent request step in which a clinical trial information management unit of the service server generates first institution participation acceptance request information and clinical trial participation acceptance request information included in the clinical trial information and transmits them to a user device through the data transmission / reception unit; a personal verification information generation step in which the clinical trial information management unit receives first institution participation acceptance information and clinical trial participation acceptance information corresponding to the first institution participation acceptance request information and clinical trial participation acceptance request information, respectively, from the user device through the data transmission / reception unit, and transmits personal biometric information included in the clinical trial participation acceptance information to a biometric authentication institution server to verify whether the user of the user device is the same person; and, when the clinical trial information management unit receives confirmation information regarding the personal verification information from the biometric authentication institution server through the data transmission / reception unit, the medical information management unit of the service server through the data transmission / reception unit A medical information usage approval request step in which information regarding the acceptance of medical information usage or information regarding the acceptance of health information usage for a user of the user device is transmitted from the user device to the first institution server or to the second institution server equipped to store medical information regarding a citizen or health information regarding a citizen; and a medical information usage approval completion step in which the medical information management unit receives information regarding the acceptance of medical information usage for the medical information usage request information or information regarding the acceptance of health information usage for the health information usage request information from the user device through the data transmission and reception unit.A step in which the clinical trial information management unit receives an EMR (Electronic Medical Record) containing medical information or health information about the user of the user device generated as a result of a physical examination and a visit examination for a clinical trial according to the clinical trial information about the user of the user device from the first institution server through the data transmission and reception unit, and generates health checkup information matching a preset list from the EMR; a PHR information request step in which the medical information management unit transmits the medical information utilization acceptance information or the health information utilization acceptance information to the second institution server through the data transmission and reception unit, and transmits PHR (Personal Health Record) transmission request information containing medical information or health information about the user of the user device; a PHR information reception step in which the medical information management unit receives a PHR corresponding to the PHR transmission request information from the second institution server through the data transmission and reception unit; and the comprehensive health information management unit of the service server [receives] the examination date, measurement test, urine test, etc. included in the medical information or health information about the user of the user device contained in the health checkup information and the PHR A method for providing comprehensive health management information including collected information for a clinical trial participant, comprising: a health checkup information generation step of generating comprehensive health information for a user of the user device by extracting blood test and electrocardiogram test data; a comprehensive health information transmission step in which the comprehensive health information management unit transmits the comprehensive health information to the user device through the data transmission and reception unit; and a step in which the comprehensive health information management unit transmits to the user device, through the data transmission and reception unit, one or more of time-series disease occurrence information, time-series vaccination information, and time-series health prediction information having a similarity level greater than or equal to a preset similarity level with the comprehensive health information extracted from pre-prepared health information big data. Claim 2 delete Claim 3 A method for providing comprehensive health management information linked to clinical trials, characterized in that, in claim 1, the personal biometric information is one or more of retinal information, fingerprint information, facial recognition information, and voice information collected in real time from a biometric information collection unit equipped to enable wired and wireless data transmission and reception provided in advance to the user or from the user device. Claim 4 delete Claim 5 delete Claim 6 A method for providing clinical trial-linked comprehensive health management information, characterized in that, in claim 1, the comprehensive health information management unit further comprises the step of transmitting to the user device genetic disease information or health status information with a similarity greater than or equal to a preset similarity with the comprehensive health information extracted from pre-prepared health information big data through the data transmission and reception unit.

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