Patient data provision methods, systems, and programs

Abstract

To make it easier than before for data users such as researchers to obtain consent from patients, when patient data such as medical record data is used.SOLUTION: A patient data providing method includes a step of storing part of a patient's data from real-world data in a patient-owned data storage unit 80 as patient-owned data owned by the patient based on consent between the patient and a provider that provides the real-world data. The method includes a step of synchronizing the real-world data with the patient-owned data. The method further includes a step of reading the patient-owned data of the patient from the patient-owned data storage unit 80 and transmitting it to a data user's device 400 based on consent of the patient and the data user.SELECTED DRAWING: Figure 2

Description

Technical Field

[0001] The present invention relates to a patient data providing method and the like, and particularly relates to a patient data providing method and the like for providing a part of real-world data (RWD).

Background Art

[0002] RWD includes electronic medical record data, insurer data, dispensing receipts, and the like. Heretofore, viewing of medical record data has basically been limited to medical staff and the like within a medical institution that manages the medical record data. Even if viewing is exceptionally permitted, it has been limited to cases where a hard copy printed out for only some patients is presented, or cases where it is handled as a sealed document for a second opinion or referral.

[0003] It has not been clearly determined whether the ownership of the medical record lies with the medical institution side or the patient side. Therefore, when conducting clinical research, clinical trials, etc., it has been necessary to obtain written consent from patients for the disclosure of medical record data for each researcher, which has been a cause hindering the effective use of medical record data for research and development.

[0004] Also, in the case of research across medical institutions, a system such as a shared patient registry is constructed in advance. However, even if medical record data registered in the patient registry system is found, if it is data managed by a medical institution other than the researcher's own affiliation, consent from the patient may not be obtained for data use. Also, even for patients belonging to the researcher's own affiliation, the timing of obtaining a consent form from the patient is restricted during outpatient visits. In the case of patients during treatment or before and after surgery, it may be difficult to obtain consent due to the patient's low judgment.

[0005] Thus, there are many restrictions on the work of explaining and obtaining consent for using the medical record data of the patient between the patient and the researcher. Therefore, there is a current situation where the hurdle for using medical record data in research is very high and the research is inefficient. Note that the applicant is unaware of the existence of prior art documents related to the above conventional examples. [Overview of the project] [Problems that the invention aims to solve]

[0006] The present invention aims to improve upon the shortcomings of the above-mentioned conventional examples, and in particular, to make it easier for data users, such as researchers, to obtain patient consent when using patient data such as medical record data. [Means for solving the problem]

[0007] To solve the above problems, the present invention includes the step of storing a portion of the patient's data from the real-world data as patient-owned data in a patient-owned data storage unit, based on the agreement between the patient and the provider of the real-world data. It also includes the step of synchronizing the real-world data and the patient-owned data. Furthermore, it includes the step of reading the patient's patient-owned data from the patient-owned data storage unit and transmitting it to the data user's device, based on the agreement between the patient and the data user. The present invention employs a configuration that executes computer processing including these steps.

[0008] By copying a portion of patient data from each RWDB, which is independently managed by each providing institution, to the system of the present invention as patient-owned data owned by the patient, the copy can be disclosed to data users at the patient's sole discretion with their electronic consent. [Effects of the Invention]

[0009] Therefore, according to the present invention, it becomes easier for data users, such as researchers, to obtain patient consent when using patient data such as medical record data than in the past. [Brief explanation of the drawing]

[0010] [Figure 1] Figure 1 is a block diagram showing one embodiment of the present invention. [Figure 2]Figure 2 is a block diagram illustrating the process of providing patient-owned data to the patient themselves. [Figure 3] Figure 3 is a block diagram illustrating the operation of providing patient-owned data to data users. [Figure 4] Figure 4 is a block diagram illustrating the settlement process for the use of patient-owned data. [Figure 5] Figure 5 is a block diagram illustrating support features that facilitate communication between patients and data users. [Modes for carrying out the invention]

[0011] Hereinafter, embodiments of the present invention will be described with reference to the drawings.

[0012] [Configuration of this system] In Figure 1, a patient data provision system 100 (hereinafter referred to as "the system 100"), which is one embodiment of the present invention, is capable of communicating with a data provisioning organization device 200, a patient device 300, and a data user device 400 via a computer network N. There are multiple data provisioning organization devices 200, patient devices 300, and data user devices 400. The system 100, data provisioning organization device 200, patient device 300, and data user device 400 are each computer devices, equipped with general computer components such as input devices, output devices, storage devices, processors, and network interface cards (NICs), and provide various functions to the user by executing programs. A configuration in which multiple processors and storage devices cooperate is also possible.

[0013] The provider device 200 is a computer device such as a server that controls the input and output of data in the real-world database (RWDB) managed by each provider. The RWDB is stored in a storage device such as a hard disk drive (HDD). A "provider" is an organization that provides data to the RWDB, and includes medical institutions that provide electronic medical record data and companies that have been entrusted with the management of the RWDB.

[0014] The patient device 300 is a personal computer, tablet terminal, smartphone, etc., operated by each patient. In this application, "patient" may be read as their assistant or representative.

[0015] The data user device 400 is a personal computer, tablet, smartphone, etc., operated by a data user who uses patient data. A "data user" is a doctor, researcher, medical institution, company, or other patient.

[0016] The system 100 comprises a user authentication unit 10, a consent processing unit 20, a data management unit 30, a synchronization processing unit 40, a search processing unit 50, a settlement processing unit 60, a support processing unit 70, a patient data storage unit 80, and a consent item storage unit 90. Each unit 10-70 operates by a processor executing a program. Each storage unit 80 and 90 are storage areas of a storage device such as an HDD. Details of each unit 10-70 and each storage unit 80 and 90 will be described later.

[0017] [Using this system] Each device 200-400 connected to this system 100, or their users, shall be authenticated by the user authentication unit 10 before using this system, and each device identifier or each user identifier shall be identified. An "identifier" is a code such as an ID that can uniquely identify a device or user. Authentication of devices or users may be performed using an authentication gateway method.

[0018] [Providing patient-owned data to the patient themselves] In Figure 2, the consent processing unit 20 receives a request from the patient device 300 for disclosure of patient data, including a patient identifier and a provider identifier. Upon receiving this disclosure request, the consent processing unit 20 processes an agreement between the patient and the provider to copy a predetermined portion of the patient's RWD from the RWDB to the system 100 as patient-owned data owned by the patient. The process of concluding the agreement is carried out using e-consent or smart contract procedures.

[0019] The "specified part" refers to the items agreed upon by the patient and the providing institution among the patient data included in the RWD. For example, cases, test results, various measured numerical values, treatment contents such as prescription drugs, etc. are applicable. "e-consent" is known as a procedure for electronically obtaining explanations and consents from subjects participating in clinical trials. Also, "smart contract" is known as a computer protocol intended for smooth verification, execution, enforcement, and negotiation of contracts.

[0020] When this consent is concluded, the consent processing unit 20 associates the patient identifier, the providing institution identifier, and the agreed matters, and stores them in the agreed matters storage unit 90. Also, the consent processing unit 20 associates the patient identifier and the agreed matters, and transmits them to the providing institution device 200 of the corresponding providing institution.

[0021] Based on the association between the patient identifier and the agreed matters received from the system 100, the providing institution device 200 reads out a part of the data of the corresponding patient from the RWDB, associates the patient identifier and the providing institution identifier with the data, and transmits it to the system 100. In the system 100, a part of the patient data received from the providing institution device 200 is stored as patient-owned data with which the patient has ownership in the patient-owned data storage unit 80, associated with the patient identifier and the providing institution identifier. When inputting the data of the RWDB into the system 100, it may be done through an application program interface (API) prepared on the system 100 side.

[0022] After that, when the patient data in the RWDB is updated, the providing institution device 200 associates the patient identifier and the providing institution identifier with the updated data at any time and inputs it into the system 100. The synchronization processing unit 40, when receiving the input of the updated data from the providing institution device 200 at any time, associates the updated data with the patient identifier and the providing institution identifier, and updates the data in the patient-owned data storage unit 80.

[0023] When the patient device 300 requests the system 100 to access the patient's own patient data, the data management unit 30 reads the patient data associated with the patient's patient identifier from the patient data storage unit 80 and sends it to the requesting patient device 300 for viewing. This allows the patient to quickly access their own patient data.

[0024] [Provision of patient data to data users] In Figure 3, the search processing unit 50 receives search conditions for searching for patients from the data user device 400. For example, it receives narrowing conditions such as limiting the number of cases, limiting the test results, limiting the range of various measured values, and limiting the treatment content such as prescribed drugs. The search processing unit 50 then returns a list of patient identifiers of patients that match the search conditions to the data user device 400 as the search result. The patient identifier here may include, for example, a nickname. In addition, the patient identifier may be accompanied by the patient's basic attributes (age, gender, etc.).

[0025] Upon receiving the search results, the data user selects a patient from the list for whom they wish to be permitted to use patient data, and sends a data usage request, along with the patient's patient identifier, from the data user device 400 to the system 100.

[0026] The consent processing unit 20 receives a request from the data user device 400 to use patient-owned data accompanied by a patient identifier. The consent processing unit 20 then processes an agreement between the patient and the data user for the data user to use the patient-owned data of that patient. The process of concluding the agreement is carried out by e-consent or smart contract procedures.

[0027] Once this consent is concluded, the consent processing unit 20 links the patient identifier, data user identifier, and consent items and stores them in the consent item storage unit 90. If the consent items include the return of data usage fees to the data provider, the identifier of the data provider is also linked to the consent items. The consent processing unit 20 also links the patient identifier and consent items and transmits them to the data user's device 400 that made the request.

[0028] Subsequently, the data management unit 30 receives a request from the data user device 400 to view patient-owned data, accompanied by a patient identifier and a data user identifier. The data management unit 30 refers to the consent item storage unit 90 and reads the consent items associated with the same patient identifier and data user identifier. Based on these consent items, the data management unit 30 reads the patient-owned data associated with the same patient identifier from the patient-owned data storage unit 80 and transmits it to the requesting data user device 400 for viewing. This allows the data user to quickly view the desired patient-owned data.

[0029] [Data usage fee payment processing] In Figure 4, the data user pays a predetermined amount of data usage fee according to the consent items stored in the consent item storage unit 90. The data usage fee paid by the data user is pooled in a predetermined usage fee account. The settlement processing unit 60 returns the data usage fee paid by the data user to the patient or / or provider associated with the consent item, according to the consent items stored in the consent item storage unit 90. In order for such a return payment to be made, the settlement processing unit 60 arranges for a transfer to a predetermined institution in the settlement network so that a predetermined amount is transferred from the usage fee account to the relevant patient and / or provider.

[0030] [Support Features] In Figure 5, the support processing unit 70 provides update notification, direct messaging, and file sharing functions between the patient who has given consent and the data user. The support processing unit 70 may also provide only the functions that the patient has authorized to provide to the data user, according to the consent items stored in the consent item storage unit 90.

[0031] The update notification function promptly notifies data users associated with a patient when the patient's data is updated by the synchronization processing unit 40. Notifications are sent to the data user device 400, to the data user's email address, or to the data user's short message service (SMS). This allows data users to quickly learn that the patient's data of a patient who has given consent has been updated and to promptly access the updated patient data.

[0032] Furthermore, the direct messaging function allows patients and data users linked by consent to exchange messages. Additionally, the file sharing function allows patients and data users linked by consent to share files. These functions also enable data users to make appropriate suggestions tailored to each patient.

[0033] [Effects of this embodiment] According to the embodiment described above, first, each providing institution can copy a portion of patient data from its independently managed RWDB to this system as patient-owned data owned by the patient, and then disclose this copy to data users at the patient's discretion with electronic consent. Therefore, it becomes easier for data users such as researchers to obtain patient consent when using patient data such as medical record data. This promotes the effective use of patient data for research and development. Medical institutions using this system do not need to set up a separate patient registry system, even when conducting research that spans multiple medical institutions. Researchers and other data users can obtain patient consent more easily than before, even for data from patients at medical institutions other than their own. Furthermore, researchers can obtain patient consent electronically, not only during outpatient consultations. These changes lower the barrier to using medical record data for research and increase the efficiency of research.

[0034] For research projects that receive sponsorship, it is possible to return a portion of the data usage fees (research funds) to patients or the medical institutions that provide electronic medical records.

[0035] Patients can decide whether or not to consent to each study individually. They can also set consent levels based on the medical institution and the conditions under which their patient data is used. In essence, this system functions as a switching hub controlling the destinations of patient data. Patients can determine how their patient data will be used for services provided by medical institutions and companies other than their own hospital, enabling them to make the optimal data recipient selection.

[0036] By utilizing the support functions, medical institutions and companies can propose and guide patients from other facilities to those services. This system allows for the provision and use of patient data while maintaining the anonymity of both patients and data users. This enables service providers, as data users, to make more sophisticated suggestions than before. Patients can also expect more precise content regarding services outside of their primary healthcare provider. For example, they can expect personalized app recommendations, such as "This person with this condition should use this app." Other suggestions could include prescribing a specific medication for patients with low sodium levels in blood tests, or recommending an exercise program for those with a high BMI. By promoting the use of patient data, data users can make more sophisticated suggestions, and consequently, patients will have more sophisticated content options. Furthermore, search and update notification functions allow doctors to find and track individuals with similar physical characteristics, symptoms, and treatment histories, and similarly, other patients can find and track individuals with similar characteristics.

[0037] Herein, the scope of the present invention is the scope of the invention described in the claims, and the scope of the present invention is not limited to the embodiments described above. [Explanation of Symbols]

[0038] 10. User Authentication Section 20 Consent Processing Section 30 Data Management Department 40 Synchronization Processing Unit 50 Search Processing Unit 60 Payment Processing Unit 70 Support Processing Unit 80 Patient data storage unit 90 Agreement storage section 100 Patient Data Provision System 200 Equipment provided by the organization 300 patient equipment 400 Data User Devices N Computer Network S Payment Network

Claims

1. Based on the agreement between the patient and the provider of real-world data, a step of storing a portion of the patient's data from the real-world data in a patient-owned data storage unit as patient-owned data owned by the patient, A step of synchronizing the real-world data and the patient-owned data, A method for providing patient data, which includes the step of performing computer processing that reads the patient's patient-owned data from the patient-owned data storage unit and transmits it to the data user's device based on the consent of the patient and the data user, A method for providing patient data, including the step of concluding the aforementioned consent via e-consent or smart contract.

2. Based on the agreement between the patient and the provider of real-world data, a step of storing a portion of the patient's data from the real-world data in a patient-owned data storage unit as patient-owned data owned by the patient, A step of synchronizing the real-world data and the patient-owned data, A method for providing patient data, which includes the step of performing computer processing that reads the patient's patient-owned data from the patient-owned data storage unit and transmits it to the data user's device based on the consent of the patient and the data user, A method for providing patient data, which includes the step of reading the patient's patient data from the patient data storage unit and transmitting it to the patient's device that made the request, when the patient requests the provision of the patient's patient data.

3. Based on the agreement between the patient and the provider of real-world data, a step of storing a portion of the patient's data from the real-world data in a patient-owned data storage unit as patient-owned data owned by the patient, A step of synchronizing the real-world data and the patient-owned data, A method for providing patient data, which includes the step of performing computer processing that reads the patient's patient-owned data from the patient-owned data storage unit and transmits it to the data user's device based on the consent of the patient and the data user, A method for providing patient data, comprising the step of arranging a settlement process to return the payment for the use of the patient-owned data by the data user to the providing organization linked to the patient-owned data, the patient, or both.

4. Based on the agreement between the patient and the provider of real-world data, a step of storing a portion of the patient's data from the real-world data in a patient-owned data storage unit as patient-owned data owned by the patient, A step of synchronizing the real-world data and the patient-owned data, A method for providing patient data, which includes the step of performing computer processing that reads the patient's patient-owned data from the patient-owned data storage unit and transmits it to the data user's device based on the consent of the patient and the data user, A step of having the data user search for the patient based on the patient's data prior to obtaining consent from the patient and the data user, A method for providing patient data, comprising the step of receiving a request for consent from the data user for patients who match the search criteria.

5. Based on the agreement between the patient and the provider of real-world data, a step of storing a portion of the patient's data from the real-world data as patient-owned data owned by the patient in a patient-owned data storage unit, A step of synchronizing the real-world data and the patient-owned data, A method for providing patient data, which includes the step of performing computer processing that reads the patient's patient-owned data from the patient-owned data storage unit and transmits it to the data user's device based on the consent of the patient and the data user, A method for providing patient data, comprising the steps of receiving a suggestion for the patient linked to the patient-owned data from the data user who received the patient-owned data, and transmitting the suggestion to the patient's device.

6. Based on the agreement between the patient and the provider of real-world data, a step of storing a portion of the patient's data from the real-world data in a patient-owned data storage unit as patient-owned data owned by the patient, A step of synchronizing the real-world data and the patient-owned data, A method for providing patient data, which includes the step of performing computer processing that reads the patient's patient-owned data from the patient-owned data storage unit and transmits it to the data user's device based on the consent of the patient and the data user, A step of linking the patient and the data user based on the consent of the patient and the data user, A method for providing patient data, which includes the step of notifying the data user associated with a patient that the patient's patient data has been updated when the patient's patient data is updated.

7. Based on the agreement between the patient and the provider of real-world data, a step of storing a portion of the patient's data from the real-world data as patient-owned data owned by the patient in a patient-owned data storage unit, A step of synchronizing the real-world data and the patient-owned data, A method for providing patient data, which includes the step of performing computer processing that reads the patient's patient-owned data from the patient-owned data storage unit and transmits it to the data user's device based on the consent of the patient and the data user, A step of linking the patient and the data user based on the consent of the patient and the data user, A method for providing patient data, comprising the step of processing the exchange of direct messages or the sharing of files between the associated patient and the data user.

8. A patient data provision system comprising a computer that performs the patient data provision method described in any one of claims 1 to 7.

9. A patient data provision program that causes a computer to execute the patient data provision method described in any one of claims 1 to 7.

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