WO2021079925A1 - 情報処理方法、情報処理システムおよび情報処理プログラム - Google Patents

情報処理方法、情報処理システムおよび情報処理プログラム Download PDF

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Publication number
WO2021079925A1
WO2021079925A1 PCT/JP2020/039666 JP2020039666W WO2021079925A1 WO 2021079925 A1 WO2021079925 A1 WO 2021079925A1 JP 2020039666 W JP2020039666 W JP 2020039666W WO 2021079925 A1 WO2021079925 A1 WO 2021079925A1
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Prior art keywords
clinical data
patient
transaction
sharing
information processing
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English (en)
French (fr)
Japanese (ja)
Inventor
賢太郎 新井
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Hara Raian
Ishikawa Mai
Tazawa Tsukasa
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Hara Raian
Ishikawa Mai
Tazawa Tsukasa
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Priority to JP2021553511A priority Critical patent/JP7660787B2/ja
Publication of WO2021079925A1 publication Critical patent/WO2021079925A1/ja
Anticipated expiration legal-status Critical
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    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/60—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records

Definitions

  • the present invention is an invention relating to an information processing method, a system thereof, and a program thereof.
  • Patent Document 1 The invention described in Patent Document 1 is a tool for clinical data mining and analysis, and particularly relates to a method for organizing clinical trial data for efficient search and use.
  • Patent Document 1 The invention described in Patent Document 1 is a single window platform capable of accessing all different information sources required for clinical data mining and analysis, and providing useful information at high speed at the same time. Can be provided.
  • Patent Document 1 relates to clinical data, etc. by supporting consensus building between a patient who is a provider of clinical data, etc. and a researcher, etc., who is a provider of clinical data, etc. There is room for improvement from the perspective of realizing information processing that can realize privacy protection and preferably realize sharing of clinical data and the like.
  • the present invention makes it a problem to be solved to provide a novel technique related to information processing.
  • the present invention is an information processing method, in which a registration step, a storage step, an approval step, and a sharing step are executed by a server processor, and the registration step is performed by a patient.
  • a transaction with a smart contract corresponding to the clinical data is broadcast to the blockchain network
  • the storage step associates the clinical data with a transaction ID unique to the transaction, stores the clinical data, and the approval step.
  • Receives an output request for the clinical data from the user terminal acquires the transaction corresponding to the clinical data subject to the output request from the blockchain, and attaches the transaction to the transaction acquired from the blockchain.
  • the smart contract is executed to make an inquiry regarding the sharing of the clinical data to the patient corresponding to the clinical data subject to the output request, and in the sharing step, the patient who received the inquiry said the inquiry. If sharing is not refused, at least one of the clinical data, the access authority of the clinical data, the download authority of the clinical data, the analysis authority of the clinical data, and the analysis result of the clinical data, which are the targets of the output request. Is given to the user terminal.
  • the storage step encrypts the clinical data based on the patient's encryption key
  • the sharing step decrypts the encrypted clinical data based on the patient's encryption key.
  • the decrypted clinical data is encrypted based on the encryption key of the user terminal and transmitted to the user terminal.
  • the approval step executes the smart contract indicating the amount of compensation to the patient corresponding to the clinical data subject to the output request from the user terminal making the output request.
  • the clinical data which is the subject of the output request when the user terminal is requested to pay the reward amount to the patient and the user terminal makes the payment to the patient.
  • At least one of the access authority of the clinical data, the download authority of the clinical data, the analysis authority of the clinical data, and the analysis result of the clinical data is given to the user terminal.
  • the concealment step is further executed by a processor of the server, and the concealment step is the clinical data in which at least a part of the clinical data is anonymized based on a learning model in which the clinical data is input. Anonymized data is generated, and instead of the clinical data that is the target of the output request, the anonymized data corresponding to the clinical data that is the target of the output request is transmitted to the user terminal. ..
  • the learning model is an Encoder-Decoder model.
  • the learning model is a Sequence-to-Sequence model.
  • the deletion step is further executed by the processor of the server, and the deletion step receives the deletion request of the clinical data from the patient and corresponds to the clinical data which is the target of the output request.
  • the transaction is acquired from the blockchain, the smart contract attached to the transaction acquired from the blockchain is executed, and the verification of the electronic signature generated from the patient's private key and broadcast to the network of the blockchain. If the verification is successful, the clinical data that is the target of the deletion request is deleted.
  • the analysis step is further executed by the processor of the server, and the approval step receives an analysis request for the clinical data from the user terminal and corresponds to the clinical data which is the target of the analysis request.
  • the transaction is acquired from the blockchain, and the analysis step performs an analysis process of the clinical data and acquires the analysis result of the clinical data.
  • the storage step encrypts the analysis result based on the patient's encryption key
  • the sharing step decrypts the encrypted analysis result based on the patient's encryption key.
  • the decrypted analysis result is encrypted based on the encryption key of the user terminal and transmitted to the user terminal.
  • the analysis step performs the analysis process by performing a secret calculation based on the clinical data.
  • the analysis step performs the analysis process based on the secretly distributed clinical data.
  • the present invention is an information processing system, comprising a server having a registration means, a storage means, an approval means, and a sharing means, and the registration means includes clinical data of a patient.
  • a transaction with the corresponding smart contract is broadcast to the blockchain network, the storage means associates the clinical data with a transaction ID unique to the transaction, stores the clinical data, and the approval means is a user.
  • the smart contract that receives the output request of the clinical data from the terminal, acquires the transaction corresponding to the clinical data that is the target of the output request from the blockchain, and is attached to the transaction acquired from the blockchain.
  • an inquiry regarding the sharing of the clinical data is made to the patient corresponding to the clinical data which is the target of the output request, and the sharing means is such that the patient who received the inquiry refuses the sharing. If not, at least one of the clinical data, the access authority of the clinical data, the download authority of the clinical data, the analysis authority of the clinical data, and the analysis result of the clinical data, which is the target of the output request, is given to the user. Give to the terminal.
  • the present invention is an information processing program in which a server functions as a registration means, a storage means, an approval means, and a sharing means, and the registration means is clinical data of a patient.
  • a transaction with the corresponding smart contract is broadcast to the blockchain network, the storage means associates the clinical data with a transaction ID unique to the transaction, stores the clinical data, and the approval means.
  • the smart that receives the output request of the clinical data from the user terminal, acquires the transaction corresponding to the clinical data that is the target of the output request from the blockchain, and is attached to the transaction acquired from the blockchain.
  • the contract is executed to make an inquiry regarding the sharing of the clinical data to the patient corresponding to the clinical data subject to the output request, and the sharing means is such that the patient who receives the inquiry shares the information. If not rejected, at least one of the clinical data, the access authority of the clinical data, the download authority of the clinical data, the analysis authority of the clinical data, and the analysis result of the clinical data, which are the targets of the output request, is given. Give to the user terminal.
  • the present invention can provide a novel technique related to information processing.
  • the configuration according to the present invention may appropriately adopt a part of the configuration of one embodiment of the present invention, and is not limited to the configuration of one embodiment of the present invention, as appropriate as long as the above problems can be solved. It may be transformed.
  • FIG. 1 is a schematic diagram showing a configuration example of a clinical data sharing system.
  • a clinical data sharing system that enables sharing of patient clinical data with external users (for example, researchers, medical personnel, employees of pharmaceutical companies, etc.) using a blockchain will be described.
  • the clinical data sharing system includes a server 1, a patient terminal 2, and a user terminal 3.
  • Each device is connected to a network such as the Internet.
  • Server 1 is a server computer capable of transmitting and receiving various types of information processing and information.
  • the server 1 is, for example, a server computer of a pharmaceutical company that holds clinical data of patients, and is connected to a blockchain network that communicates by P2P (Peer to Peer) as shown in FIG.
  • the pharmaceutical company takes the lead in managing clinical data.
  • a medical institution that conducts clinical trials a medical institution that manages patient chart data in normal medical care, etc. You may become.
  • the server 1 records the access authority to the clinical data of each patient on the blockchain, and provides a platform (API) in which the clinical data can be used by an external user.
  • API platform
  • the blockchain is a so-called distributed ledger, which is a data set of transactions managed by multiple nodes (minors) in a distributed manner.
  • Each node connected to the blockchain network verifies transactions received from other nodes by a process called mining, and if the verification is successful, adds the transaction to the blockchain.
  • This system uses the blockchain as a recording ledger for managing access authority for clinical data.
  • the server 1 storage step
  • the patient terminal 2 is a terminal device possessed by each patient, such as a smartphone, a tablet terminal, or a personal computer.
  • the server 1 makes an inquiry about sharing to the patient terminal 2 when sharing clinical data to the user, and if the sharing is not refused, the patient's clinical data and the like are sent. Share with users.
  • the "state in which sharing has not been refused" in the description of the present specification refers to a state in which the patient terminal 2 has not made a response to the effect of refusal or a request for deletion for a predetermined time.
  • the user terminal 3 is a terminal device used by each user who requests sharing of clinical data, and is, for example, a personal computer, a tablet terminal, or the like.
  • the server 1 receives a clinical data output request from the user terminal 3, inquires of the patient terminal 2, and then performs the clinical data, the access authority of the clinical data, the download authority of the clinical data, and the above.
  • the authority to analyze clinical data and at least one of the analysis results of the clinical data are given to the user terminal 3.
  • FIG. 2 is a block diagram showing a configuration example of the server 1.
  • the server 1 includes a control unit 11, a main storage unit 12, a communication unit 13, and an auxiliary storage unit 14.
  • the server 1 includes a control unit 11, a main storage unit 12, a communication unit 13, and an auxiliary storage unit 14.
  • the control unit 11 has one or more CPUs (Central Processing Units), MPUs (Micro-Processing Units), GPUs (Graphics Processing Units), and other arithmetic processing units, and stores the program P stored in the auxiliary storage unit 14. By reading and executing, various information processing, control processing, etc. are performed.
  • the main storage unit 12 is a temporary storage area for SRAM (Static Random Access Memory), DRAM (Dynamic Random Access Memory), flash memory, etc., and temporarily stores data necessary for the control unit 11 to execute arithmetic processing.
  • the communication unit 13 is a communication module for performing processing related to communication, and transmits / receives information to / from the outside.
  • the auxiliary storage unit 14 is a non-volatile storage area such as a large-capacity memory or a hard disk, and stores a program P and other data necessary for the control unit 11 to execute processing. Further, the auxiliary storage unit 14 stores the patient DB 141, the user DB 142, and the learning model 143.
  • the patient DB 141 is a database that stores information of each patient that provides clinical data. For example, in addition to the clinical data of the patient, a transaction ID that can uniquely identify the transaction that defines the access authority of the clinical data, for each patient. Information such as the corresponding encryption key is stored.
  • the user DB 142 is a database that stores information of each user who acquires clinical data using this system, and in addition to basic information of each user, an encryption key (public key, etc.) corresponding to each user is stored. Information is stored.
  • the learning model 143 is a model constructed by machine learning, and as will be described later, is a model for performing a data conversion process for anonymizing clinical data so that an individual patient cannot be identified from clinical data.
  • the server 1 broadcasts and records data representing the access authority to the patient's clinical data to the blockchain network.
  • the server 1 generates and broadcasts a transaction with a smart contract (program) to the effect that access to clinical data is possible if the patient does not refuse.
  • the server 1 defines other conditions for sharing clinical data and the like in the smart contract, as will be described later.
  • the server 1 stores the transaction ID that can uniquely identify the above transaction in the patient DB 141 in association with the clinical data of the patient. Further, the server 1 (memory step) encrypts the clinical data based on the patient's encryption key and stores it in the patient DB 141. As a result, the clinical data stored in the patient DB 141 is locked so that it cannot be viewed, and the access authority to the clinical data is managed in the blockchain. Each patient (and pharmaceutical company) can check clinical data at any time with their own encryption key.
  • the server 1 receives a clinical data output request from the user terminal 3 for secondary use of clinical data.
  • the server 1 acquires the transaction data corresponding to the patient's clinical data from the blockchain, executes the smart contract (program) attached to the transaction, and is required for access approval. Execute the following processing.
  • the server 1 makes an inquiry to the patient terminal 2 regarding the sharing of clinical data by means such as e-mail.
  • the patient terminal 2 receives the input regarding the inquiry from the patient and responds to the server 1 when the patient refuses.
  • the server 1 (approval step) responds to the user terminal 3 that the sharing is refused and ends the process.
  • a transaction indicating a clinical data output request is used as a trigger, and a smart contract notifies the address of a contact regarding approval or disapproval of sharing clinical data from the blockchain network. It may be.
  • the server 1 (approval step) may generate a transaction indicating the output request and requesting the execution of the smart contract by using the reception of the output request from the user terminal 3 as a trigger and broadcast it to the network of the blockchain.
  • the server 1 (approval step) may be configured to be notified by a smart contract whether or not to share clinical data from the blockchain network, using a transaction indicating a clinical data output request as a trigger.
  • the server 1 extracts the clinical data from the patient DB 141.
  • the server 1 (sharing step) contains encrypted clinical data, information related to the access authority of the clinical data, information related to the download authority of the clinical data, analysis authority of the clinical data, and analysis result of the clinical data. At least one is given to the user terminal 3.
  • the user terminal 3 can decrypt clinical data or the like with a user's encryption key (private key or the like).
  • the server 1 determines whether or not sharing is possible according to the smart contract attached to the clinical data, and performs the processing.
  • smart contracts specify the amount of reward to be paid to patients when sharing clinical data, and the recipient of the reward (for example, the patient's wallet related to virtual currency (cryptographic assets)).
  • the server 1 (approval step) requests the user terminal 3 to pay the reward according to the reward amount and the remittance destination specified in the smart contract.
  • the server 1 (sharing step) transmits the clinical data to the user terminal 3.
  • the wallet may be used to transfer money to the patient's wallet.
  • a smart contract may prescribe a rule for deleting clinical data from the patient DB 141 according to the patient's wishes for each sharing as an example.
  • the server 1 (deletion step) has a smart rule to delete clinical data when the electronic signature generated from the patient's private key is input to the blockchain network and the verification of the electronic signature is successful. Specify in the contract.
  • the patient terminal 2 (or server 1) generates and broadcasts an electronic signature using the patient's private key when the patient wishes to delete clinical data. As a result, clinical data is deleted from the patient DB 141.
  • a transaction indicating a deletion request for clinical data may be used as a trigger to generate a transaction indicating a deletion request and requesting execution of a smart contract, and broadcast (input) to the network of the blockchain. ..
  • the smart contract verifies the electronic signature, and if the verification of the electronic signature is successful, the clinical data may be deleted by the smart contract.
  • server 1 (sharing step) is shared after deleting the user's name and so on.
  • server 1 sharing step
  • the clinical data is anonymized (partial deletion or replacement of the clinical data, etc.) and then transmitted to the user terminal 3. ..
  • the server 1 (confidential step) generates anonymized data using a learning model 143 that inputs clinical data and outputs anonymized clinical data (hereinafter referred to as "anonymized data").
  • the learning model 143 is a model constructed by machine learning, and is an Encoder-Decoder model such as a Sequence-to-Sequence.
  • Server 1 receives input of clinical data before anonymization and anonymized data after anonymization as teacher data, performs learning, and converts clinical data into anonymized data. Generate a training model 143.
  • the server 1 inputs the clinical data acquired from the blockchain into the learning model 143 and generates anonymized data.
  • the server 1 (sharing step) encrypts the anonymized data with the user's encryption key and transmits the anonymized data to the user terminal 3.
  • the learning model 143 was used to uniformly anonymize clinical data, but when recording data related to access authority on the blockchain, the items of clinical data that should be anonymized by smart contracts are defined. You may leave it.
  • anonymization can be performed more preferably, for example, the patient can specify the clinical data that he / she wants to keep secret.
  • clinical data can be shared by multiple pharmaceutical companies, or if a user (employee) of another pharmaceutical company requests to output clinical data, access authority is specified according to the other pharmaceutical company. You may want to reject the output request. This allows, for example, if the user requesting sharing is a competitor, it can be automatically rejected.
  • the server 1 (approval step) receives an analysis request based on the clinical data from the user terminal 3 for the secondary use of the clinical data.
  • the server 1 acquires the transaction data corresponding to the clinical data of the patient from the blockchain.
  • the server 1 extracts the clinical data from the patient DB 141 and calculates (analyzes) the clinical data based on the analysis request. And obtain the calculation result (corresponding to the analysis result) based on the clinical data.
  • the server 1 (sharing step) encrypts the calculation result of clinical data with the encryption key (for example, public key) of the user who is the transmission destination (request source) and transmits it to the user terminal 3.
  • the user terminal 3 can decrypt clinical data with the user's encryption key (private key).
  • the server 1 (sharing step) encrypts the analysis result based on the patient's encryption key, decrypts the encrypted analysis result based on the patient's encryption key, and obtains the decrypted analysis result. It may be encrypted based on the encryption key of the user terminal and transmitted to the user terminal.
  • the server 1 (analysis step) may perform a calculation based on clinical data in the form of a secret calculation.
  • the clinical data may be stored over a plurality of storage units and a plurality of platforms in a secret sharing manner.
  • the clinical data indicates clinical trial data
  • the model may adopt a known or conventional model such as SDTM (Study Data Tabulation Model).
  • a configuration may be adopted in which processing related to medical record data indicating electronic medical record information may be performed, or a configuration in which processing related to genomic data may be performed.
  • the medical record data, the genome data, and the like are associated with an individual such as a patient.
  • processing related to RWD may be performed, and the model adopts a known or conventional model such as CDM (Common Data Model). It's okay. At this time, the RWD is associated with the patient.
  • CDM Common Data Model
  • CRO Constract Research Organization
  • an organization that anonymizes RWD and manages data an organization that anonymizes clinical data and clinical trial data and manages data
  • a research institution possessing genomic data etc. May take the lead in managing clinical data and the like.
  • the patient terminal 2 may take the form of a wearable device, and the form of the computing device is not limited.
  • the blockchain may take the form of a consortium type blockchain such as HLF (Hyperledger Fabric), the form of a public chain, or the form of a private chain. There are no restrictions on the type.
  • HLF Hyperledger Fabric
  • a distributed ledger other than the blockchain may be used to perform processing related to clinical data and the like.
  • Each step and each process according to the embodiment of the present invention is appropriately executed by a processor such as a corresponding server 1, a patient terminal 2, and a user terminal 3.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
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  • Medical Informatics (AREA)
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  • Public Health (AREA)
  • Medical Treatment And Welfare Office Work (AREA)
  • Information Retrieval, Db Structures And Fs Structures Therefor (AREA)
PCT/JP2020/039666 2019-10-23 2020-10-22 情報処理方法、情報処理システムおよび情報処理プログラム Ceased WO2021079925A1 (ja)

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CN116052828A (zh) * 2022-12-29 2023-05-02 北京大学 基于区块链和数字人民币的医疗数据共享体系架构
JP2023114534A (ja) * 2022-02-07 2023-08-18 株式会社島津製作所 機械学習方法
WO2024032658A1 (en) * 2022-08-09 2024-02-15 Wuhan United Imaging Healthcare Co., Ltd. Method for processing medical data processing, system, apparatus, and computer device
US20250139261A1 (en) * 2023-10-27 2025-05-01 Fresenius Medical Care Deutschland Gmbh System and method for data-transfer management
WO2025154156A1 (ja) * 2024-01-16 2025-07-24 日本電気株式会社 ゲノムデータ処理システム、ゲノムデータ処理方法およびゲノムデータ処理プログラム

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JP2019503020A (ja) * 2015-11-24 2019-01-31 ダカドー エージー 自動健康データ取得、処理および通信システムならびに方法
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JP2023114534A (ja) * 2022-02-07 2023-08-18 株式会社島津製作所 機械学習方法
JP7753910B2 (ja) 2022-02-07 2025-10-15 株式会社島津製作所 機械学習方法
WO2024032658A1 (en) * 2022-08-09 2024-02-15 Wuhan United Imaging Healthcare Co., Ltd. Method for processing medical data processing, system, apparatus, and computer device
CN116052828A (zh) * 2022-12-29 2023-05-02 北京大学 基于区块链和数字人民币的医疗数据共享体系架构
US20250139261A1 (en) * 2023-10-27 2025-05-01 Fresenius Medical Care Deutschland Gmbh System and method for data-transfer management
WO2025154156A1 (ja) * 2024-01-16 2025-07-24 日本電気株式会社 ゲノムデータ処理システム、ゲノムデータ処理方法およびゲノムデータ処理プログラム

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