WO2021079925A1 - Information processing method, information processing system, and information processing program - Google Patents

Information processing method, information processing system, and information processing program 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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clinical data
patient
transaction
sharing
information processing
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PCT/JP2020/039666
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French (fr)
Japanese (ja)
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賢太郎 新井
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賢太郎 新井
石井 廣之
石川 麻衣
田澤 司
原 頼安
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Priority to JP2021553511A priority Critical patent/JPWO2021079925A1/ja
Publication of WO2021079925A1 publication Critical patent/WO2021079925A1/en

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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.

Abstract

The present invention addresses the problem of providing novel technology relating to information processing. The present invention is an information processing method in which the following steps are executed in a server: a registration step in which a transaction to which clinical data for a patient and a corresponding smart contract have been attached is broadcast to a blockchain network; a storage step in which the clinical data is stored in association with a transaction ID; an approval step in which a request to output the clinical data is received from a user terminal, the transaction corresponding to the clinical data that is the subject of the output request is acquired from the blockchain, the smart contract attached to the transaction is executed, and an inquiry regarding sharing of the clinical data is made to the patient corresponding to the clinical data that is the subject of the output request; and a sharing step in which, if the patient has not rejected the sharing, the clinical data, and the like, that is the subject of the output request is transmitted to the user terminal.

Description

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Information processing methods, information processing systems and information processing programs
　本発明は、情報処理方法、そのシステムおよびそのプログラムに関する発明である。 The present invention is an invention relating to an information processing method, a system thereof, and a program thereof.
　近年、臨床データ等の活用が、医薬品の臨床開発、安全性評価、有効性評価、およびベネフィットリスク評価等において、注目されている。臨床データを好適に活用するためには、臨床データの流通を好適に支援するようなソリューションやプラットフォームの確立が求められる。 In recent years, the utilization of clinical data, etc. has attracted attention in clinical development of pharmaceutical products, safety evaluation, efficacy evaluation, benefit risk evaluation, etc. In order to make good use of clinical data, it is necessary to establish solutions and platforms that favorably support the distribution of clinical data.
　特許文献１記載の発明は、臨床データマイニング及び分析のためのツールであって、特に、効率的な検索及び使用のための臨床試験データを編成する方法に関する。 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.
　特許文献１記載の発明は、臨床データマイニング及び分析の際に求められる、異なる情報ソースすべてにアクセスし、ときを違えずに且つ高速で有用な情報を提供することが可能である単独のウィンドウプラットフォームを提供することができる。 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.
　しかしながら、特許文献１記載の発明は、臨床データ等の提供元である患者と、臨床データ等の提供先である研究者等と、の間の合意形成を支援することで、臨床データ等にかかるプライバシー保護を実現し、好適に臨床データ等のシェアリングを実現することができるような情報処理を実現する、という視点において、改善の余地がある。 However, the invention described in 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.
特表２０１３－５１８３１８号公報Japanese Patent Application Laid-Open No. 2013-518318
　上記事情を鑑みて、本発明は、情報処理にかかる新規な技術を提供することを、解決すべき課題とする。 In view of the above circumstances, the present invention makes it a problem to be solved to provide a novel technique related to information processing.
　上記課題を解決するために、本発明は、情報処理方法であって、登録ステップと、記憶ステップと、承認ステップと、共有ステップと、をサーバのプロセッサに実行させ、前記登録ステップは、患者の臨床データと対応するスマートコントラクトを付したトランザクションをブロックチェーンのネットワークにブロードキャストし、前記記憶ステップは、前記臨床データを前記トランザクションに一意なトランザクションＩＤと対応付け、前記臨床データを記憶し、前記承認ステップは、ユーザ端末から前記臨床データの出力要求を受け付け、前記出力要求の対象である前記臨床データと対応する前記トランザクションを前記ブロックチェーンから取得し、前記ブロックチェーンから取得された前記トランザクションに付された前記スマートコントラクトを実行し、前記出力要求の対象である前記臨床データと対応する前記患者に対して前記臨床データの共有にかかる問い合わせを行い、前記共有ステップは、前記問い合わせを受けた前記患者が前記共有を拒否しなかった場合、前記出力要求の対象である前記臨床データ、前記臨床データのアクセス権限、前記臨床データのダウンロード権限、前記臨床データの解析権限および前記臨床データの解析結果の少なくとも１つを前記ユーザ端末に付与する。 In order to solve the above problems, 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.
　本発明の好ましい形態では、前記記憶ステップは、前記臨床データを前記患者の暗号鍵に基づき暗号化し、前記共有ステップは、暗号化されている前記臨床データを前記患者の暗号鍵に基づき復号化し、復号化された前記臨床データを前記ユーザ端末の暗号鍵に基づき暗号化し、前記ユーザ端末に送信する。 In a preferred embodiment of the invention, the storage step encrypts the clinical data based on the patient's encryption key, and 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.
　本発明の好ましい形態では、前記承認ステップは、前記出力要求を行う前記ユーザ端末から前記出力要求の対象である前記臨床データと対応する前記患者への報酬額を示す前記スマートコントラクトを実行し、前記患者への前記報酬額の支払いを前記ユーザ端末に対して要求し、前記共有ステップは、前記ユーザ端末が前記患者に対して前記支払いを行った場合、前記出力要求の対象である前記臨床データ、前記臨床データのアクセス権限、前記臨床データのダウンロード権限、前記臨床データの解析権限および前記臨床データの解析結果の少なくとも１つを前記ユーザ端末に付与する。 In a preferred embodiment of the invention, 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.
　本発明の好ましい形態では、秘匿ステップを、さらにサーバのプロセッサに実行させ、前記秘匿ステップは、前記臨床データを入力とする学習モデルに基づき前記臨床データの少なくとも一部が匿名化された前記臨床データである匿名化データを生成し、前記共有ステップ前記出力要求の対象である前記臨床データに代えて、前記出力要求の対象である前記臨床データと対応する前記匿名化データを前記ユーザ端末に送信する。 In a preferred embodiment of the present invention, 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. ..
　本発明の好ましい形態では、前記学習モデルは、Ｅｎｃｏｄｅｒ－Ｄｅｃｏｄｅｒモデルである。 In a preferred embodiment of the present invention, the learning model is an Encoder-Decoder model.
　本発明の好ましい形態では、前記学習モデルは、Ｓｅｑｕｅｎｃｅ－ｔｏ－Ｓｅｑｕｅｎｃｅモデルである。 In a preferred embodiment of the present invention, the learning model is a Sequence-to-Sequence model.
　本発明の好ましい形態では、削除ステップを、さらにサーバのプロセッサに実行させ、前記削除ステップは、前記患者から前記臨床データの削除要求を受け付け、前記出力要求の対象である前記臨床データと対応する前記トランザクションを前記ブロックチェーンから取得し、前記ブロックチェーンから取得された前記トランザクションに付された前記スマートコントラクトを実行し、前記患者の秘密鍵から生成され前記ブロックチェーンのネットワークにブロードキャストされた電子署名の検証を行い、前記検証が成功した場合、前記削除要求の対象である前記臨床データを削除する。 In a preferred embodiment of the present invention, 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.
　本発明の好ましい形態では、解析ステップを、さらに前記サーバのプロセッサに実行させ、前記承認ステップは、前記ユーザ端末から前記臨床データの解析要求を受け付け、前記解析要求の対象である前記臨床データと対応する前記トランザクションを前記ブロックチェーンから取得し、前記解析ステップは、前記臨床データの解析処理を行い、前記臨床データの前記解析結果を取得する。 In a preferred embodiment of the present invention, 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.
　本発明の好ましい形態では、前記記憶ステップは、前記解析結果を前記患者の暗号鍵に基づき暗号化し、前記共有ステップは、暗号化されている前記解析結果を前記患者の暗号鍵に基づき復号化し、復号化された前記解析結果を前記ユーザ端末の暗号鍵に基づき暗号化し、前記ユーザ端末に送信する。 In a preferred embodiment of the invention, the storage step encrypts the analysis result based on the patient's encryption key, and 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.
　本発明の好ましい形態では、前記解析ステップは、前記臨床データに基づき秘密計算を行うことで前記解析処理を行う。 In a preferred embodiment of the present invention, the analysis step performs the analysis process by performing a secret calculation based on the clinical data.
　本発明の好ましい形態では、前記解析ステップは、秘密分散された前記臨床データに基づき前記解析処理を行う。 In a preferred embodiment of the present invention, the analysis step performs the analysis process based on the secretly distributed clinical data.
　上記課題を解決するため、本発明は、情報処理システムであって、登録手段と、記憶手段と、承認手段と、共有手段と、を有するサーバを備え、前記登録手段は、患者の臨床データと対応するスマートコントラクトを付したトランザクションをブロックチェーンのネットワークにブロードキャストし、前記記憶手段は、前記臨床データを前記トランザクションに一意なトランザクションＩＤと対応付け、前記臨床データを記憶し、前記承認手段は、ユーザ端末から前記臨床データの出力要求を受け付け、前記出力要求の対象である前記臨床データと対応する前記トランザクションを前記ブロックチェーンから取得し、前記ブロックチェーンから取得された前記トランザクションに付された前記スマートコントラクトを実行し、前記出力要求の対象である前記臨床データと対応する前記患者に対して前記臨床データの共有にかかる問い合わせを行い、前記共有手段は、前記問い合わせを受けた前記患者が前記共有を拒否しなかった場合、前記出力要求の対象である前記臨床データ、前記臨床データのアクセス権限、前記臨床データのダウンロード権限、前記臨床データの解析権限および前記臨床データの解析結果の少なくとも１つを前記ユーザ端末に付与する。 In order to solve the above problems, 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. Is executed, 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.
　上記課題を解決するため、本発明は、情報処理プログラムであって、サーバを、登録手段と、記憶手段と、承認手段と、共有手段と、として機能させ、前記登録手段は、患者の臨床データと対応するスマートコントラクトを付したトランザクションをブロックチェーンのネットワークにブロードキャストし、前記記憶手段は、前記臨床データを前記トランザクションに一意なトランザクションＩＤと対応付け、前記臨床データを記憶し、前記承認手段は、ユーザ端末から前記臨床データの出力要求を受け付け、前記出力要求の対象である前記臨床データと対応する前記トランザクションを前記ブロックチェーンから取得し、前記ブロックチェーンから取得された前記トランザクションに付された前記スマートコントラクトを実行し、前記出力要求の対象である前記臨床データと対応する前記患者に対して前記臨床データの共有にかかる問い合わせを行い、前記共有手段は、前記問い合わせを受けた前記患者が前記共有を拒否しなかった場合、前記出力要求の対象である前記臨床データ、前記臨床データのアクセス権限、前記臨床データのダウンロード権限、前記臨床データの解析権限および前記臨床データの解析結果の少なくとも１つを前記ユーザ端末に付与する。 In order to solve the above problems, 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.
　本発明は、情報処理にかかる新規な技術を提供することができる。 The present invention can provide a novel technique related to information processing.
臨床データ共有システムの構成例を示す模式図である。It is a schematic diagram which shows the structural example of the clinical data sharing system. サーバ１の構成例を示す模式図である。It is a schematic diagram which shows the configuration example of the server 1.
　〈実施形態１〉
　本明細書は、以下に本発明の一実施形態である実施形態１について、説明する。なお、本発明にかかる構成は、本発明の一実施形態の構成の一部を適宜、採用してよく、本発明の一実施形態の構成に限定されず、上記課題が解決できる範囲で適宜、変形されてよい。 <Embodiment 1>
Hereinafter, the first embodiment, which is an embodiment of the present invention, will be described below. 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.
　図１は、臨床データ共有システムの構成例を示す模式図である。本実施の形態では、ブロックチェーンを用いて、患者の臨床データを外部ユーザ（例えば研究者、医療関係者、製薬会社の社員など）に共有可能とする臨床データ共有システムについて説明する。臨床データ共有システムは、サーバ１、患者端末２、ユーザ端末３を含む。各装置は、インターネット等のネットワークに接続されている。 FIG. 1 is a schematic diagram showing a configuration example of a clinical data sharing system. In this embodiment, 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.
　サーバ１は、種々の情報処理、情報の送受信が可能なサーバコンピュータである。サーバ１は、例えば患者の臨床データを持つ製薬会社のサーバコンピュータであり、図１に示すように、Ｐ２Ｐ（Peer to Peer）で通信を行うブロックチェーンのネットワークに接続されている。なお、本実施の形態では製薬会社が主体となって臨床データの管理を行うものとするが、例えば臨床試験を実施する医療機関、通常診療における患者のカルテデータを管理する医療機関等が主体となってもよい。本実施の形態でサーバ１は、各患者の臨床データへのアクセス権限をブロックチェーンに記録すると共に、臨床データを外部ユーザが利用可能なプラットフォーム（ＡＰＩ）を提供する。 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. In this embodiment, the pharmaceutical company takes the lead in managing clinical data. For example, a medical institution that conducts clinical trials, a medical institution that manages patient chart data in normal medical care, etc. You may become. In the present embodiment, 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.
　ブロックチェーンは所謂分散型台帳であり、複数のノード（マイナー）が分散して管理するトランザクションのデータ集合である。ブロックチェーンのネットワークに接続された各ノードは、マイニングと呼ばれる処理で他のノードから受け取ったトランザクションを検証し、検証に成功した場合はトランザクションをブロックチェーンに追加する。 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.
　本システムでは臨床データのアクセス権限を管理するための記録台帳としてブロックチェーンを利用する。例えばサーバ１（記憶ステップ）は、各患者に対応する暗号鍵（公開鍵など）を管理しており、各患者の臨床データへのアクセス権限を表すデータをトランザクションとしてブロックチェーンのネットワークにブロードキャストして記録させる。 This system uses the blockchain as a recording ledger for managing access authority for clinical data. For example, the server 1 (storage step) manages the encryption key (public key, etc.) corresponding to each patient, and broadcasts the data representing the access authority to the clinical data of each patient to the blockchain network as a transaction. Have them record.
　患者端末２は、各患者が所持する端末装置であり、例えばスマートフォン、タブレット端末、パーソナルコンピュータ等である。本実施の形態でサーバ１（承認ステップ）は、ユーザに臨床データを共有する場合に、患者端末２に対して共有にかかる問い合わせを行い、共有が拒否されなかった場合、患者の臨床データなどをユーザに共有する。なお、本明細書中の説明における「共有が拒否されなかった状態」とは、患者端末２から、拒否の旨の応答または削除のリクエストが所定時間、行われなかったような状態を指す。 The patient terminal 2 is a terminal device possessed by each patient, such as a smartphone, a tablet terminal, or a personal computer. In the present embodiment, the server 1 (approval step) 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.
　ユーザ端末３は、臨床データの共有を要求する各ユーザが使用する端末装置であり、例えばパーソナルコンピュータ、タブレット端末等である。サーバ１（承認ステップ・共有ステップ）は、ユーザ端末３から臨床データの出力要求を受けて、患者端末２に問い合わせた上で臨床データ、前記臨床データのアクセス権限、前記臨床データのダウンロード権限、前記臨床データの解析権限および前記臨床データの解析結果の少なくとも１つをユーザ端末３に付与する。 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 (approval step / sharing step) 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.
　図２は、サーバ１の構成例を示すブロック図である。サーバ１は、制御部１１、主記憶部１２、通信部１３、補助記憶部１４を備える。
　サーバ１は、制御部１１、主記憶部１２、通信部１３、及び補助記憶部１４を備える。
制御部１１は、一又は複数のＣＰＵ（Central Processing Unit）、ＭＰＵ（Micro-Processing Unit）、ＧＰＵ（Graphics Processing Unit）等の演算処理装置を有し、補助記憶部１４に記憶されたプログラムＰを読み出して実行することにより、種々の情報処理、制御処理等を行う。主記憶部１２は、ＳＲＡＭ（Static Random Access Memory）、ＤＲＡＭ（Dynamic Random Access Memory）、フラッシュメモリ等の一時記憶領域であり、制御部１１が演算処理を実行するために必要なデータを一時的に記憶する。通信部１３は、通信に関する処理を行うための通信モジュールであり、外部と情報の送受信を行う。 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. Remember. The communication unit 13 is a communication module for performing processing related to communication, and transmits / receives information to / from the outside.
　補助記憶部１４は、大容量メモリ、ハードディスク等の不揮発性記憶領域であり、制御部１１が処理を実行するために必要なプログラムＰ、その他のデータを記憶している。また、補助記憶部１４は、患者ＤＢ１４１、ユーザＤＢ１４２、学習モデル１４３を記憶している。患者ＤＢ１４１は、臨床データを提供する各患者の情報を格納するデータベースであり、例えば患者の臨床データのほかに、臨床データのアクセス権限を規定するトランザクションを一意に識別可能なトランザクションＩＤ、各患者に対応する暗号鍵などの情報を格納してある。ユーザＤＢ１４２は、本システムを利用して臨床データを取得する各ユーザの情報を格納するデータベースであり、各ユーザの基本的な情報のほかに、各ユーザに対応する暗号鍵（公開鍵など）の情報を格納してある。学習モデル１４３は、機械学習によって構築されたモデルであり、後述するように、臨床データから患者個人を特定できないように、臨床データを匿名化するデータ変換処理を行うためのモデルである。 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.
　以下、本実施の形態の概要を説明する。上述の如く、サーバ１（登録ステップ）は、患者の臨床データへのアクセス権限を表すデータをブロックチェーンのネットワークにブロードキャストして記録させる。例えばサーバ１（登録ステップ）は、臨床データへのアクセスなどが、患者が拒否しなかった場合に可能となる旨のスマートコントラクト（プログラム）を付したトランザクションを生成してブロードキャストする。この際にサーバ１（登録ステップ）は、後述するように、臨床データの共有等についてその他の条件をスマートコントラクトに規定しておく。 The outline of this embodiment will be described below. As described above, the server 1 (registration step) broadcasts and records data representing the access authority to the patient's clinical data to the blockchain network. For example, the server 1 (registration step) 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. At this time, the server 1 (registration step) defines other conditions for sharing clinical data and the like in the smart contract, as will be described later.
　また、サーバ１（記憶ステップ）は、上記のトランザクションを一意に識別可能なトランザクションＩＤを、患者の臨床データと対応付けて患者ＤＢ１４１に記憶する。また、サーバ１（記憶ステップ）は、臨床データを患者の暗号鍵に基づいて暗号化し、患者ＤＢ１４１に格納しておく。これにより、患者ＤＢ１４１に格納された臨床データは閲覧不可能にロックされ、臨床データへのアクセス権限はブロックチェーンにおいて管理される。各患者（及び製薬会社）は、自らの暗号鍵によって臨床データをいつでも確認することができる。 Further, the server 1 (memory step) 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.
　本実施の形態でサーバ１（承認ステップ）は、臨床データの二次利用のため、ユーザ端末３から臨床データの出力要求を受け付ける。出力要求を受け付けた場合、サーバ１（承認ステップ）は、患者の臨床データに対応するトランザクションデータをブロックチェーンから取得し、トランザクションに付されたスマートコントラクト（プログラム）を実行して、アクセス承認に必要な以下の処理を実行する。具体的には、サーバ１（承認ステップ）は、患者端末２に対して、臨床データの共有にかかる問い合わせを電子メール等の手段で行う。問い合わせを受け付けた場合、患者端末２は、患者が拒否する場合、患者から問い合わせに関する入力を受け付け、サーバ１に応答する。臨床データの共有が拒否された場合、サーバ１（承認ステップ）は、共有が拒否された旨をユーザ端末３に応答して処理を終了する。 In the present embodiment, the server 1 (approval step) receives a clinical data output request from the user terminal 3 for secondary use of clinical data. When the output request is received, the server 1 (approval step) 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. Specifically, the server 1 (approval step) makes an inquiry to the patient terminal 2 regarding the sharing of clinical data by means such as e-mail. When the inquiry is accepted, the patient terminal 2 receives the input regarding the inquiry from the patient and responds to the server 1 when the patient refuses. When the sharing of clinical data is refused, the server 1 (approval step) responds to the user terminal 3 that the sharing is refused and ends the process.
　ここで、サーバ１（承認ステップ）では、臨床データの出力要求を示すトランザクションをトリガーとして、スマートコントラクトによりブロックチェーンのネットワークから臨床データの共有にかかる承認の可否に関する問い合わせ先のアドレスを通知される構成であってよい。このとき、サーバ１（承認ステップ）は、ユーザ端末３から出力要求を受け付けることをトリガーとして、出力要求を示しスマートコントラクトの実行を要求するトランザクションを生成しプロックチェーンのネットワークにブロードキャストしてよい。また、サーバ１（承認ステップ）では、臨床データの出力要求を示すトランザクションをトリガーとして、スマートコントラクトによりブロックチェーンのネットワークから臨床データの共有にかかる可否を通知される構成であってよい。 Here, in the server 1 (approval step), 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. At this time, 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. Further, 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.
　臨床データの共有が拒否されなかった場合、サーバ１（共有ステップ）は、患者ＤＢ１４１から臨床データを抽出する。サーバ１（共有ステップ）は、暗号化されている臨床データ、前記臨床データのアクセス権限にかかわる情報、前記臨床データのダウンロード権限にかかわる情報、前記臨床データの解析権限および前記臨床データの解析結果の少なくとも１つをユーザ端末３に付与する。ユーザ端末３は、ユーザの暗号鍵（秘密鍵など）によって臨床データなどを復号することができる。 If the sharing of clinical data is not refused, the server 1 (sharing step) 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).
　上述の処理を行う上で、サーバ１（共有ステップ）は、臨床データに付されたスマートコントラクトに従って共有の可否等を判定し、処理を行う。例えばスマートコントラクトには、臨床データを共有する際に患者に支払うべき報酬額、及び報酬の送金先（例えば仮想通貨（暗号資産）に係る患者のウォレット）が規定されている。サーバ１（承認ステップ）は、スマートコントラクトで規定された報酬額及び送金先に従い、報酬の支払いをユーザ端末３に要求する。指定された送金先に報酬が送金された場合、サーバ１（共有ステップ）は、臨床データをユーザ端末３に送信する。 In performing the above-mentioned processing, the server 1 (sharing step) determines whether or not sharing is possible according to the smart contract attached to the clinical data, and performs the processing. For example, 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. When the reward is remitted to the designated remittance destination, the server 1 (sharing step) transmits the clinical data to the user terminal 3.
　なお、例えば複数のユーザが共同で一定のウォレットに資金（仮想通貨）をプールしておき、臨床データの共有を行った場合、当該ウォレットから患者のウォレットに送金するようにしてもよい。 For example, when a plurality of users jointly pool funds (virtual currency) in a certain wallet and share clinical data, the wallet may be used to transfer money to the patient's wallet.
　また、例えばスマートコントラクトに、例として共有毎に、患者の希望に従って患者ＤＢ１４１から臨床データを削除するためのルールを規定しておいてもよい。例えばサーバ１（削除ステップ）は、患者の秘密鍵から生成された電子署名がブロックチェーンのネットワークに入力され、当該電子署名の検証に成功した場合に、臨床データなどを削除する旨のルールをスマートコントラクトで規定する。患者端末２（又はサーバ１）は、患者が臨床データの削除を希望する場合に、患者の秘密鍵を用いて電子署名を生成してブロードキャストする。これにより、患者ＤＢ１４１から臨床データが削除される。 Further, for example, 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. For 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.
　ここで、サーバ１（削除ステップ）では、臨床データの削除要求を示すトランザクションをトリガーとして、削除要求を示しスマートコントラクトの実行を要求するトランザクションを生成しプロックチェーンのネットワークにブロードキャスト（入力）してよい。このとき、スマートコントラクトにより上記電子署名の検証が行われ、上記電子署名の検証が成功した場合に、スマートコントラクトにより臨床データが削除されてよい。 Here, in the server 1 (deletion step), 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. .. At this time, 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.
　このように、臨床データを管理する上で必要な種々のルールやデータをスマートコントラクトとして付しておくことで、ブロックチェーンを利用した臨床データの共有を好適に行うことができる。 In this way, by attaching various rules and data necessary for managing clinical data as smart contracts, it is possible to preferably share clinical data using the blockchain.
　ところで、臨床データをユーザに共有する場合に、個人情報の保護のため、サーバ１（共有ステップ）はユーザの氏名などは削除した上で共有する。しかしながら、患者が極めて稀な症状を抱えている場合などは、氏名などを削除しても個人を特定できる恐れがある。そこで本実施の形態ではさらに、外部のユーザに臨床データを共有する際に、臨床データを匿名化する処理（臨床データの一部の削除または置換等）を行った上でユーザ端末３に送信する。 By the way, when sharing clinical data to users, in order to protect personal information, server 1 (sharing step) is shared after deleting the user's name and so on. However, if the patient has extremely rare symptoms, there is a risk that the individual can be identified even if the name or the like is deleted. Therefore, in the present embodiment, when the clinical data is shared with an external user, the clinical data is anonymized (partial deletion or replacement of the clinical data, etc.) and then transmitted to the user terminal 3. ..
　例えばサーバ１（秘匿ステップ）は、臨床データを入力として、匿名化を施した臨床データ（以下、「匿名化データ」と呼ぶ）を出力とする学習モデル１４３を用いて匿名化データを生成する。学習モデル１４３は、機械学習によって構築されたモデルであり、例えばＳｅｑｕｅｎｃｅ－ｔｏ－Ｓｅｑｕｅｎｃｅ等のＥｎｃｏｄｅｒ－Ｄｅｃｏｄｅｒモデルである。 For example, 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.
　サーバ１（秘匿ステップ）は教師データとして、匿名化を施す前の臨床データと、匿名化を施した後の匿名化データとの入力を受けて学習を行い、臨床データを匿名化データに変換する学習モデル１４３を生成する。ユーザ端末３から臨床データの出力要求を受け付けた場合、サーバ１（秘匿ステップ）はブロックチェーンから取得した臨床データを学習モデル１４３に入力し、匿名化データを生成する。サーバ１（共有ステップ）は、匿名化データをユーザの暗号鍵で暗号化し、ユーザ端末３に送信する。 Server 1 (confidential step) 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. When the output request of clinical data is received from the user terminal 3, the server 1 (confidential step) 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.
　なお、上記では学習モデル１４３を用いて一律に臨床データの匿名化を行うものとしたが、アクセス権限に係るデータをブロックチェーンに記録する場合に、スマートコントラクトで匿名化すべき臨床データの項目を定義しておいてもよい。これにより、例えば患者が秘密にしておきたい臨床データを自ら指定できるなど、より好適に匿名化を行うことができる。 In the above, 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. As a result, anonymization can be performed more preferably, for example, the patient can specify the clinical data that he / she wants to keep secret.
　また、本実施の形態ではブロックチェーンでアクセス権限を管理する製薬会社（管理者4）が一社であるものとして説明したが、複数の製薬会社が各々アクセス権限に係るデータをブロックチェーンにブロードキャストし、複数の製薬会社の臨床データを共有可能としてもよい。 Further, in the present embodiment, it has been described that there is only one pharmaceutical company (administrator 4) that manages access authority on the blockchain, but a plurality of pharmaceutical companies each broadcast data related to access authority to the blockchain. , Clinical data of multiple pharmaceutical companies may be shared.
　なお、複数の製薬会社で臨床データを共有可能とする場合、他の製薬会社のユーザ（社員）から臨床データの出力要求を受けた場合、当該他の製薬会社に応じてアクセス権限を規定しておき、出力要求を拒否するようにしてもよい。これにより、例えば共有を要求したユーザが競合他社であるような場合に、これを自動的に拒否することができる。 If 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.
　〈実施形態２〉
　本明細書は、以下に本発明の一実施形態である実施形態２について、説明する。なお、実施形態１と同様の構成については、同様の符号を付してその説明を省略する。 <Embodiment 2>
Hereinafter, the second embodiment, which is an embodiment of the present invention, will be described below. The same components as those in the first embodiment are designated by the same reference numerals and the description thereof will be omitted.
　本実施の形態でサーバ１（承認ステップ）は、臨床データの二次利用のため、ユーザ端末３から臨床データに基づく解析要求を受け付ける。解析要求を受け付けた場合、サーバ１（承認ステップ）は、患者の臨床データに対応するトランザクションデータをブロックチェーンから取得する。 In the present embodiment, 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. When the analysis request is received, the server 1 (approval step) acquires the transaction data corresponding to the clinical data of the patient from the blockchain.
　実施形態２では、臨床データの共有にかかる問い合わせについて患者から拒否されなかった場合、サーバ１（解析ステップ）は、患者ＤＢ１４１から臨床データを抽出し、解析要求に基づき臨床データに基づく計算（解析）を行い、臨床データに基づく計算結果（解析結果に相当）を取得する。サーバ１（共有ステップ）は、送信先（要求元）であるユーザの暗号鍵（例えば公開鍵）で臨床データの計算結果を暗号化し、ユーザ端末３に送信する。ユーザ端末３は、ユーザの暗号鍵（秘密鍵）によって臨床データを復号することができる。 In the second embodiment, if the patient does not reject the inquiry regarding the sharing of clinical data, the server 1 (analysis step) 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).
　サーバ１（共有ステップ）は、前記解析結果を前記患者の暗号鍵に基づき暗号化し、暗号化されている前記解析結果を前記患者の暗号鍵に基づき復号化し、復号化された前記解析結果を前記ユーザ端末の暗号鍵に基づき暗号化し、前記ユーザ端末に送信してよい。 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.
　ここで、サーバ１（解析ステップ）は、秘密計算の態様で、臨床データに基づく計算を行ってよい。このとき、臨床データは、秘密分散の態様で複数の記憶部や複数のプラットフォームに亘って記憶されていてよい。 Here, the server 1 (analysis step) may perform a calculation based on clinical data in the form of a secret calculation. At this time, the clinical data may be stored over a plurality of storage units and a plurality of platforms in a secret sharing manner.
　本発明の一実施形態では、臨床データは、臨床試験データを示し、そのモデルは、ＳＤＴＭ（Study Data Tabulation Model）等の既知または慣用のモデルを採用してよい。 In one embodiment of the present invention, the clinical data indicates clinical trial data, and the model may adopt a known or conventional model such as SDTM (Study Data Tabulation Model).
　本発明の一実施形態では、臨床データに代えて、電子カルテの情報を示すカルテデータに関する処理を行う構成をとってよく、ゲノムデータに関する処理を行う構成をとってよい。このとき、カルテデータやゲノムデータ等は、患者等の個人に対応付けられている。 In one embodiment of the present invention, instead of clinical data, 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. At this time, the medical record data, the genome data, and the like are associated with an individual such as a patient.
　本発明の一実施形態では、臨床データに代えて、ＲＷＤ（Real world data）に関する処理を行う構成であってよく、そのモデルは、ＣＤＭ（Common Data Model）等の既知または慣用のモデルを採用してよい。このとき、ＲＷＤは、患者に対応付けられている。 In one embodiment of the present invention, instead of clinical data, processing related to RWD (Real world data) 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.
　本発明の一実施形態では、また、ＣＲＯ（Contract Research Organization）、ＲＷＤを匿名化しデータを管理する組織、臨床データや臨床試験データを匿名化しデータを管理する組織、ゲノムデータを保有する研究機関等が主体となって臨床データ等の管理を行うものであってよい。 In one embodiment of the present invention, CRO (Contract 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.
　本発明の一実施形態では、患者端末２は、ウェアラブルデバイスの態様をとってよく、そのコンピューティングデバイスの態様に制限はない。 In one embodiment of the present invention, the patient terminal 2 may take the form of a wearable device, and the form of the computing device is not limited.
　本発明の一実施形態では、ブロックチェーンは、ＨＬＦ（Hyperledger Fabric）等のコンソーシアム型ブロックチェーンでの態様をとってよく、パブリックチェーンの態様をとってよく、プライベートチェーンの態様をとってよく、その種別に制限はない。 In one embodiment of the present invention, 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.
　本発明の一実施形態では、ブロックチェーンに代えて、ブロックチェーン以外の分散型台帳を用いて、臨床データ等に関する処理を行ってよい。 In one embodiment of the present invention, instead of the blockchain, a distributed ledger other than the blockchain may be used to perform processing related to clinical data and the like.
　本発明の一実施形態では、ブロックチェーン等の分散台帳の合意形成アルゴリズムは、ＰＢＦＴ（Practical Byzantine Fault Tolerance）の態様をとってよく、ＰｏＷ（Proof of Work）の態様をとってよく、ＰｏＳ（Proof of Stake）の態様をとってよく、ＰｏＩ（Proof of Importance）の態様をとってよく、ＰｏＣ（Proof of Consensus）の態様をとってよく、既知または慣用の合意形成アルゴリズムの少なくとも１つに基づく態様をとってよく、その種別に制限はない。 In one embodiment of the present invention, the consensus building algorithm for a distributed ledger such as a blockchain may take the form of PBFT (Practical Byzantine Fault Tolerance), PoW (Proof of Work), or PoS (Proof). Of Stake), PoI (Proof of Importance), PoC (Proof of Consensus), based on at least one of the known or conventional consensus building algorithms. There is no limit to the type.
　本発明の一実施形態にかかる各ステップ・各処理は、対応するサーバ１・患者端末２・ユーザ端末３等のプロセッサにより適宜、実行される。 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.
１　サーバ（情報処理装置）
Ｐ　プログラム
１４１　患者ＤＢ
１４２　ユーザＤＢ
１４３　学習モデル

  1 Server (information processing device)
P program 141 patient DB
142 User DB
143 learning model

Claims (13)

  1. 　情報処理方法であって、
    　登録ステップと、記憶ステップと、承認ステップと、共有ステップと、
    　をサーバのプロセッサに実行させ、
    　前記登録ステップは、患者の臨床データと対応するスマートコントラクトを付したトランザクションをブロックチェーンのネットワークにブロードキャストし、
    　前記記憶ステップは、前記臨床データを前記トランザクションに一意なトランザクションＩＤと対応付け、前記臨床データを記憶し、
    　前記承認ステップは、ユーザ端末から前記臨床データの出力要求を受け付け、前記出力要求の対象である前記臨床データと対応する前記トランザクションを前記ブロックチェーンから取得し、前記ブロックチェーンから取得された前記トランザクションに付された前記スマートコントラクトを実行し、前記出力要求の対象である前記臨床データと対応する前記患者に対して前記臨床データの共有にかかる問い合わせを行い、
    　前記共有ステップは、前記問い合わせを受けた前記患者が前記共有を拒否しなかった場合、前記出力要求の対象である前記臨床データ、前記臨床データのアクセス権限、前記臨床データのダウンロード権限、前記臨床データの解析権限および前記臨床データの解析結果の少なくとも１つを前記ユーザ端末に付与する、
    　情報処理方法。     Information processing method
    Registration step, memory step, approval step, sharing step,
    To the server processor
    The registration step broadcasts a transaction with a smart contract corresponding to the patient's clinical data to the blockchain network.
    The storage step associates the clinical data with a transaction ID unique to the transaction and stores the clinical data.
    In the approval step, an output request for the clinical data is received from the user terminal, the transaction corresponding to the clinical data subject to the output request is acquired from the blockchain, and the transaction acquired from the blockchain is obtained. The attached smart contract is executed, and an inquiry regarding the sharing of the clinical data is made to the patient corresponding to the clinical data that is the target of the output request.
    In the sharing step, if the patient who received the inquiry does not refuse the sharing, the clinical data which is the target of the output request, the access authority of the clinical data, the download authority of the clinical data, and the clinical data. And at least one of the analysis results of the clinical data are given to the user terminal.
    Information processing method.
  2. 　前記記憶ステップは、前記臨床データを前記患者の暗号鍵に基づき暗号化し、
    　前記共有ステップは、暗号化されている前記臨床データを前記患者の暗号鍵に基づき復号化し、復号化された前記臨床データを前記ユーザ端末の暗号鍵に基づき暗号化し、前記ユーザ端末に送信する、請求項１記載の情報処理方法。     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, encrypts the decrypted clinical data based on the encryption key of the user terminal, and transmits the decrypted clinical data to the user terminal. The information processing method according to claim 1.
  3. 　前記承認ステップは、前記出力要求を行う前記ユーザ端末から前記出力要求の対象である前記臨床データと対応する前記患者への報酬額を示す前記スマートコントラクトを実行し、前記患者への前記報酬額の支払いを前記ユーザ端末に対して要求し、
    　前記共有ステップは、前記ユーザ端末が前記患者に対して前記支払いを行った場合、前記出力要求の対象である前記臨床データ、前記臨床データのアクセス権限、前記臨床データのダウンロード権限、前記臨床データの解析権限および前記臨床データの解析結果の少なくとも１つを前記ユーザ端末に付与する、
    　請求項１または２記載の情報処理方法。     In the approval step, the user terminal that makes the output request executes the smart contract indicating the reward amount to the patient corresponding to the clinical data that is the target of the output request, and the reward amount to the patient is calculated. Request payment from the user terminal
    In the sharing step, when the user terminal makes the payment to the patient, the clinical data that is the target of the output request, the access authority of the clinical data, the download authority of the clinical data, and the clinical data. Granting the analysis authority and at least one of the analysis results of the clinical data to the user terminal.
    The information processing method according to claim 1 or 2.
  4. 　秘匿ステップを、さらにサーバのプロセッサに実行させ、
    　前記秘匿ステップは、前記臨床データを入力とする学習モデルに基づき前記臨床データの少なくとも一部が匿名化された前記臨床データである匿名化データを生成し、
    　前記共有ステップ前記出力要求の対象である前記臨床データに代えて、前記出力要求の対象である前記臨床データと対応する前記匿名化データを前記ユーザ端末に送信する、
    　請求項１～３の何れか一項記載の情報処理方法。     Let the server's processor perform more concealment steps,
    The concealment step generates anonymized data, which 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.
    The sharing step 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 information processing method according to any one of claims 1 to 3.
  5. 　前記学習モデルは、Ｅｎｃｏｄｅｒ－Ｄｅｃｏｄｅｒモデルである、
    　請求項４記載の情報処理方法。     The learning model is an Encoder-Decoder model.
    The information processing method according to claim 4.
  6. 　前記学習モデルは、Ｓｅｑｕｅｎｃｅ－ｔｏ－Ｓｅｑｕｅｎｃｅモデルである、
    　請求項５記載の情報処理方法。     The learning model is a Sequence-to-Sequence model.
    The information processing method according to claim 5.
  7. 　削除ステップを、さらにサーバのプロセッサに実行させ、
    　前記削除ステップは、前記患者から前記臨床データの削除要求を受け付け、前記出力要求の対象である前記臨床データと対応する前記トランザクションを前記ブロックチェーンから取得し、前記ブロックチェーンから取得された前記トランザクションに付された前記スマートコントラクトを実行し、前記患者の秘密鍵から生成され前記ブロックチェーンのネットワークにブロードキャストされた電子署名の検証を行い、前記検証が成功した場合、前記削除要求の対象である前記臨床データを削除する、
    　請求項１～６の何れか一項記載の情報処理方法。     Let the server's processor perform the delete step further,
    In the deletion step, the deletion request of the clinical data is received from the patient, the transaction corresponding to the clinical data subject to the output request is acquired from the blockchain, and the transaction acquired from the blockchain is obtained. The attached smart contract is executed to verify the electronic signature generated from the patient's private key and broadcast to the blockchain network, and if the verification is successful, the clinical subject to the deletion request. Delete data,
    The information processing method according to any one of claims 1 to 6.
  8. 　解析ステップを、さらに前記サーバのプロセッサに実行させ、
    　前記承認ステップは、前記ユーザ端末から前記臨床データの解析要求を受け付け、前記解析要求の対象である前記臨床データと対応する前記トランザクションを前記ブロックチェーンから取得し、
    　前記解析ステップは、前記臨床データの解析処理を行い、前記臨床データの前記解析結果を取得する、請求項１～７の何れか一項記載の情報処理方法。     Further, the analysis step is executed by the processor of the server, and the analysis step is executed.
    The approval step receives an analysis request for the clinical data from the user terminal, acquires the transaction corresponding to the clinical data subject to the analysis request from the blockchain, and obtains the transaction.
    The information processing method according to any one of claims 1 to 7, wherein the analysis step performs an analysis process of the clinical data and acquires the analysis result of the clinical data.
  9. 　前記記憶ステップは、前記解析結果を前記患者の暗号鍵に基づき暗号化し、
    　前記共有ステップは、暗号化されている前記解析結果を前記患者の暗号鍵に基づき復号化し、復号化された前記解析結果を前記ユーザ端末の暗号鍵に基づき暗号化し、前記ユーザ端末に送信する、請求項８記載の情報処理方法。     The storage step encrypts the analysis result based on the patient's encryption key.
    In the sharing step, the encrypted analysis result is decrypted based on the encryption key of the patient, and the decrypted analysis result is encrypted based on the encryption key of the user terminal and transmitted to the user terminal. The information processing method according to claim 8.
  10. 　前記解析ステップは、前記臨床データに基づき秘密計算を行うことで前記解析処理を行う、請求項８または請求項９記載の情報処理方法。 The information processing method according to claim 8 or 9, wherein the analysis step performs the analysis process by performing a secret calculation based on the clinical data.
  11. 　前記解析ステップは、秘密分散された前記臨床データに基づき前記解析処理を行う、請求項１０記載の情報処理方法。 The information processing method according to claim 10, wherein the analysis step performs the analysis process based on the secretly distributed clinical data.
  12. 　情報処理システムであって、
    　登録手段と、記憶手段と、承認手段と、共有手段と、を有するサーバを備え、
    　前記登録手段は、患者の臨床データと対応するスマートコントラクトを付したトランザクションをブロックチェーンのネットワークにブロードキャストし、
    　前記記憶手段は、前記臨床データを前記トランザクションに一意なトランザクションＩＤと対応付け、前記臨床データを記憶し、
    　前記承認手段は、ユーザ端末から前記臨床データの出力要求を受け付け、前記出力要求の対象である前記臨床データと対応する前記トランザクションを前記ブロックチェーンから取得し、前記ブロックチェーンから取得された前記トランザクションに付された前記スマートコントラクトを実行し、前記出力要求の対象である前記臨床データと対応する前記患者に対して前記臨床データの共有にかかる問い合わせを行い、
    　前記共有手段は、前記問い合わせを受けた前記患者が前記共有を拒否しなかった場合、前記出力要求の対象である前記臨床データ、前記臨床データのアクセス権限、前記臨床データのダウンロード権限、前記臨床データの解析権限および前記臨床データの解析結果の少なくとも１つを前記ユーザ端末に付与する、
    　情報処理システム。     It is an information processing system
    A server having a registration means, a storage means, an approval means, and a sharing means.
    The registration means broadcasts a transaction with a smart contract corresponding to the patient's clinical data to the blockchain network.
    The storage means associates the clinical data with a transaction ID unique to the transaction, stores the clinical data, and stores the clinical data.
    The approval means receives an output request for the clinical data from a user terminal, acquires the transaction corresponding to the clinical data subject to the output request from the blockchain, and obtains the transaction obtained from the blockchain. The attached smart contract is executed, and an inquiry regarding the sharing of the clinical data is made to the patient corresponding to the clinical data that is the target of the output request.
    When the patient who receives the inquiry does not refuse the sharing, the sharing means includes the clinical data, the access authority of the clinical data, the download authority of the clinical data, and the clinical data which are the targets of the output request. And at least one of the analysis results of the clinical data are given to the user terminal.
    Information processing system.
  13. 　情報処理プログラムであって、
    　サーバを、登録手段と、記憶手段と、承認手段と、共有手段と、として機能させ、
    　前記登録手段は、患者の臨床データと対応するスマートコントラクトを付したトランザクションをブロックチェーンのネットワークにブロードキャストし、
    　前記記憶手段は、前記臨床データを前記トランザクションに一意なトランザクションＩＤと対応付け、前記臨床データを記憶し、
    　前記承認手段は、ユーザ端末から前記臨床データの出力要求を受け付け、前記出力要求の対象である前記臨床データと対応する前記トランザクションを前記ブロックチェーンから取得し、前記ブロックチェーンから取得された前記トランザクションに付された前記スマートコントラクトを実行し、前記出力要求の対象である前記臨床データと対応する前記患者に対して前記臨床データの共有にかかる問い合わせを行い、
    　前記共有手段は、前記問い合わせを受けた前記患者が前記共有を拒否しなかった場合、前記出力要求の対象である前記臨床データ、前記臨床データのアクセス権限、前記臨床データのダウンロード権限、前記臨床データの解析権限および前記臨床データの解析結果の少なくとも１つを前記ユーザ端末に付与する、
    　情報処理プログラム。

          It is an information processing program
    Make the server function as a registration means, a storage means, an approval means, and a sharing means.
    The registration means broadcasts a transaction with a smart contract corresponding to the patient's clinical data to the blockchain network.
    The storage means associates the clinical data with a transaction ID unique to the transaction, stores the clinical data, and stores the clinical data.
    The approval means receives an output request for the clinical data from a user terminal, acquires the transaction corresponding to the clinical data subject to the output request from the blockchain, and obtains the transaction obtained from the blockchain. The attached smart contract is executed, and an inquiry regarding the sharing of the clinical data is made to the patient corresponding to the clinical data that is the target of the output request.
    When the patient who receives the inquiry does not refuse the sharing, the sharing means includes the clinical data, the access authority of the clinical data, the download authority of the clinical data, and the clinical data which are the targets of the output request. And at least one of the analysis results of the clinical data are given to the user terminal.
    Information processing program.
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