A blockchain-based drug development clinical medical data security sharing system

Abstract

The present invention discloses a drug development clinical medical data security sharing system based on blockchain, which relates to the field of data security technology, including a data source end, a data application end, a third-party supervision end and a blockchain network, wherein the data source end, the data application end and the third-party supervision end are all connected to a medical institution server cluster in the blockchain network, and the blockchain network includes a data acquisition unit, a blockchain management unit, a process supervision unit, a request analysis unit and a security warning unit; the present invention encrypts the clinical medical data and uploads it to the blockchain management unit, obtains the access requirements issued by the data application end and the third-party supervision end, judges the allowed access permission coefficient of the access requirements based on the source and content of the access requirements, and judges the abnormal behavior of the data application end and the third-party supervision end when acquiring data, thereby improving the security performance of the data security sharing system and avoiding data leakage caused by malicious behavior.

Description

Technical Field

[0001] The present invention relates to the field of data security technology, and in particular to a drug development and clinical medical data security sharing system based on blockchain. Background Art

[0002] Blockchain is a decentralized distributed ledger that is tamper-proof, secure and reliable. It combines distributed storage, peer-to-peer transmission, consensus mechanism, cryptography and other technologies to record transactions and information through a growing data block chain to ensure data security and transparency.

[0003] Although the existing technology can encrypt data before uploading and storing it, it may still cause information leakage if the illegal behavior cannot be discovered in time for some lawless elements who steal data maliciously.

[0004] In view of the above technical defects, a solution is now proposed. Summary of the invention

[0005] The purpose of the present invention is to improve the security performance of a data security sharing system and avoid data leakage caused by malicious behavior by judging abnormal behavior of a data application end and a third-party supervision end when acquiring data.

[0006] In order to achieve the above-mentioned purpose, the present invention adopts the following technical scheme: a drug development clinical medical data security sharing system based on blockchain, including a data source end, a data application end, a third-party supervision end and a blockchain network, wherein the data source end, the data application end and the third-party supervision end are all connected to a medical institution server cluster in the blockchain network, and the blockchain network includes a data acquisition unit, a blockchain management unit, a process supervision unit, a request analysis unit and a security warning unit;

[0007] The data acquisition unit is used to obtain clinical medical data generated during the drug development process from the data source, and encrypt the clinical medical data before uploading it to the blockchain management unit;

[0008] The blockchain management unit is used to include a project analysis module and a project management module, wherein the project analysis module is used to obtain the project level and project data of the drug research and development project, and calculate the project access permission coefficient according to the project level and project data;

[0009] The project management module is used to obtain the project establishment time of the drug development project from the drug development institution, establish a timeline based on the project establishment time, and deploy blockchain nodes based on the existing servers in the data source end and the data application end. The blockchain nodes use idle computing resources to encrypt and store data, and generate blockchain entry nodes after obtaining new clinical medical data. The blockchain entry nodes are time-stamped on the timeline to obtain the project process timeline;

[0010] The request analysis unit is used to obtain access requests from the data application end and the third-party supervision end, determine the access permission coefficient of the access request based on the source and content of the access request, and give access permission according to the item access permission coefficient corresponding to the access request;

[0011] The process supervision unit is used to obtain the reading frequency, data reading duration and execution operations of the data application end and the third-party supervision end when acquiring data, calculate the access anomaly value, and judge the abnormal behavior of the data application end and the third-party supervision end when acquiring data according to the preset access anomaly threshold to generate an abnormal signal.

[0012] Furthermore, the data source end includes a medical institution source end and a user source end. The medical institution source end is used to upload the clinical medical data generated by the medical institution during the treatment and use of R&D drugs to the blockchain network, and the user source end is used to upload the clinical medical data generated when taking R&D drugs to the blockchain network.

[0013] Furthermore, the data application end includes a medical institution access end, a research and development institution access end and a patient access end. The medical institution access end provides an access port for medical institutions to obtain updated clinical medical data from the blockchain network, the research and development institution access end provides an access port for the responsible institution of the research and development project to obtain updated clinical medical data from the blockchain network, and the patient access end provides an access port for patients in need of drugs to obtain from the blockchain network.

[0014] Furthermore, the third-party supervision end is used to track the clinical medical data provided by the data source end, and the creation, storage and reading process of the clinical medical data, while supervising whether the data application end complies with the access permission requirements to obtain the clinical medical data and whether the clinical medical data is used correctly and legally.

[0015] Furthermore, the specific process of encrypting clinical medical data is as follows:

[0016] S101, initializing the public parameters of the clinical medical data based on the preset security parameters, providing trusted keys for the data source end, the data application end, and the third-party supervision end through the key generation center, the trusted keys including the encryption public key and the encryption mother key, and completing the key distribution through the interaction between the proxy cloud server and the key generation center;

[0017] S102, encrypting the clinical medical data provided by the data source end by using the encryption public key and uploading the data;

[0018] S103. Generate an index directory for the public key information of the clinical medical data and the medical data address index information based on a cryptographic commitment algorithm, generate a project attribute directory based on the index directory and the public key information, and package and upload it to the blockchain management unit.

[0019] Furthermore, the specific process of calculating the project access rights coefficient is as follows:

[0020] S201. Obtaining the project priority levels of drug research and development projects, wherein the project priority levels include major-level drug research and development projects, priority drug research and development projects, common drug research and development projects, and alternative drug research and development projects, and the weight coefficients of the projects corresponding to the project levels are k1, k2, k3, and k4, respectively;

[0021] S202, obtaining project data of a drug development project, wherein the project data includes a project stage, keywords in the project stage, and a project safety level;

[0022] S203. Calculate the project access permission coefficient Wi according to the following formula: , where e1 and e2 are preset proportional coefficients, N is the project stage, M is the keyword level in the project stage, and di is the project security level representation coefficient. The higher the project security level, the larger the value of di. The higher the project access permission coefficient, the lower the level of data application and third-party supervision ends that the drug development project allows to access, that is, the wider the destination of clinical medical data of the drug development project. Conversely, the lower the project access permission coefficient, the higher the level of data application and third-party supervision ends that the drug development project allows to access, that is, the narrower the destination of clinical medical data of the drug development project.

[0023] Furthermore, the specific process of giving access permission is as follows:

[0024] S301, obtaining access requirements issued by the data application end and the third-party supervision end, wherein the access requirements include the identity of the visitor, the data type and the access requirements, identifying the source of the access requirements according to the identity of the visitor and tracing back the access tendency value thereof, wherein the access tendency value corresponding to the access requirements from the data application end is Ut, and the access tendency value corresponding to the access requirements from the third-party supervision end is Ui, wherein Ut is greater than Ui;

[0025] S302, acquiring data types and access requirements according to access requirements, wherein the data types include initial parameters, clinical data, experimental results, and financial data, assigning a permission value of Hi to each data type, and the access requirements include read-only, download, edit, and delete;

[0026] S303, calculating the allowed access permission coefficient Wu of the access request according to the following formula: or , where gi is the weight coefficient corresponding to the access requirement, the weight coefficients corresponding to read-only, download, edit and delete increase step by step, e3 is the preset proportional coefficient, and a and b are both constants;

[0027] S304, obtaining the project access permission coefficient Wi, and if the access permission coefficient is greater than or equal to the project access permission coefficient Wi, granting access permission;

[0028] If the allowed access permission coefficient is less than the item access permission coefficient Wi, an access denial signal is generated.

[0029] Furthermore, the specific process of generating an abnormal signal is as follows:

[0030] S401, obtain the reading frequency F, data reading time T and execution operation when the data application end and the third-party supervision end acquire data, where the execution operation is the access demand, and calculate the access abnormal value qW according to the following formula: , where e5 and e4 are preset proportional coefficients;

[0031] S402: Obtain a preset access abnormality threshold, and if the access abnormality value is greater than the access abnormality threshold, generate an abnormality signal.

[0032] Furthermore, it also includes a security warning unit, which is used to obtain and process abnormal signals, issue warning notifications to the data application end and the third-party supervision end, and perform secondary encryption on the blockchain entry node on the accessed project process timeline to increase the access permission coefficient of the project.

[0033] In summary, due to the adoption of the above technical solution, the beneficial effects of the present invention are:

[0034] This blockchain-based drug development clinical medical data security sharing system encrypts clinical medical data and uploads it to the blockchain management unit. It uses idle computing resources through blockchain nodes to encrypt and store data. It also obtains access requests from data application ends and third-party regulatory ends, determines the access permission coefficient of the access requests based on the source and content of the access requests, and determines abnormal behavior of the data application ends and third-party regulatory ends when acquiring data, thereby improving the security performance of the data security sharing system and avoiding data leakage caused by malicious behavior. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] Figure 1 The overall structural diagram of the present invention is shown. DETAILED DESCRIPTION

[0036] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0037] Example:

[0038] like Figure 1 As shown, a blockchain-based drug development clinical medical data security sharing system includes a data source end, a data application end, a third-party supervision end and a blockchain network. The data source end, the data application end and the third-party supervision end are all connected to a medical institution server cluster in the blockchain network. The blockchain network includes a data acquisition unit, a blockchain management unit, a process supervision unit, a request analysis unit and a security warning unit.

[0039] The data source end includes the medical institution source end and the user source end. The medical institution source end is used to upload the clinical medical data generated by the medical institution when treating and using the R&D drugs to the blockchain network, and the user source end is used to upload the clinical medical data generated when taking the R&D drugs to the blockchain network by itself;

[0040] The data application end includes the medical institution access end, the R&D institution access end and the patient access end. The medical institution access end provides an access port for medical institutions to obtain updated clinical medical data from the blockchain network. The R&D institution access end provides an access port for the responsible institutions of the R&D projects to obtain updated clinical medical data from the blockchain network. The patient access end provides an access port for patients in need of drugs to obtain from the blockchain network.

[0041] The third-party supervisor is used to track the clinical medical data provided by the data source, and to supervise the creation, storage and reading process of the clinical medical data. At the same time, it supervises whether the data application end complies with the access permission requirements to obtain the clinical medical data and whether the clinical medical data is used correctly and legally.

[0042] The data acquisition unit is used to obtain clinical medical data generated during the drug development process from the data source, and encrypt the clinical medical data before uploading it to the blockchain management unit;

[0043] The specific process of encrypting clinical medical data is as follows:

[0044] S101, initializing the public parameters of clinical medical data based on preset security parameters, providing trusted keys for the data source end, data application end, and third-party supervision end through the key generation center, the trusted keys include encryption public keys and encryption mother keys, and completing key distribution through the interaction between the proxy cloud server and the key generation center;

[0045] S102, encrypting the clinical medical data provided by the data source end through the encryption public key and uploading it;

[0046] S103. Generate an index directory based on the public key information of clinical medical data and the medical data address index information based on the cryptographic commitment algorithm, generate a project attribute directory based on the index directory and the public key information, and package and upload it to the blockchain management unit.

[0047] The blockchain management unit is used to include a project analysis module and a project management module. The project analysis module is used to obtain the project level and project data of the drug research and development project, and calculate the project access permission coefficient according to the project level and project data;

[0048] The specific process of calculating the project accessibility coefficient is as follows:

[0049] S201. Obtain the project priority of the drug research and development project. The project priority includes major drug research and development projects, priority drug research and development projects, common drug research and development projects and alternative drug research and development projects. The weight coefficient ki of the project corresponding to the project level is k1, k2, k3 and k4 respectively for major drug research and development projects, priority drug research and development projects, common drug research and development projects and alternative drug research and development projects;

[0050] S202. Obtain project data of the drug development project, where the project data includes project stages, keywords in the project stages, and project safety levels;

[0051] S203. Calculate the project access permission coefficient Wi according to the following formula: , where e1 and e2 are preset proportional coefficients, N is the project stage, M is the keyword level in the project stage, and di is the project security level representation coefficient. The higher the project security level, the larger the value of di. The higher the project access permission coefficient, the lower the level of data application and third-party supervision ends that the drug development project allows to access, that is, the wider the destination of clinical medical data of the drug development project. Conversely, the lower the project access permission coefficient, the higher the level of data application and third-party supervision ends that the drug development project allows to access, that is, the narrower the destination of clinical medical data of the drug development project.

[0052] The project management module is used to obtain the project establishment time of the drug development project from the drug development institution, establish a timeline based on the project establishment time, and deploy blockchain nodes based on the existing servers in the data source end and the data application end. The blockchain nodes use idle computing resources to encrypt and store data, and generate blockchain entry nodes after obtaining new clinical medical data. The blockchain entry nodes are time-stamped on the timeline to obtain the project process timeline;

[0053] The request analysis unit is used to obtain access requests from the data application end and the third-party supervision end, determine the access permission coefficient of the access request based on the source and content of the access request, and give access permission according to the item access permission coefficient corresponding to the access request;

[0054] The specific process of granting access permissions is as follows:

[0055] S301, obtaining access requirements issued by the data application end and the third-party supervision end, the access requirements include the visitor identity, data type and access requirements, identifying the source of the access requirements according to the visitor identity and tracing back their access tendency values, wherein the access tendency value corresponding to the access requirements from the data application end is Ut, and the access tendency value corresponding to the access requirements from the third-party supervision end is Ui, wherein Ut is greater than Ui;

[0056] S302, obtaining data types and access requirements according to access requirements, the data types include initial parameters, clinical data, experimental results and financial data, assigning permissions to each data type as Hi, and the access requirements include read-only, download, edit and delete;

[0057] S303, calculating the allowed access permission coefficient Wu of the access request according to the following formula: or , where gi is the weight coefficient corresponding to the access requirement, the weight coefficients corresponding to read-only, download, edit and delete increase step by step, e3 is the preset proportional coefficient, and a and b are both constants;

[0058] S304, obtaining the project access permission coefficient Wi, and if the access permission coefficient is greater than or equal to the project access permission coefficient Wi, granting access permission;

[0059] If the allowed access permission coefficient is less than the item access permission coefficient Wi, an access denial signal is generated.

[0060] The process supervision unit is used to obtain the reading frequency, data reading duration and execution operation of the data application end and the third-party supervision end when acquiring data, calculate the access abnormality value, and judge the abnormal behavior of the data application end and the third-party supervision end when acquiring data according to the preset access abnormality threshold to generate an abnormal signal;

[0061] The specific process of generating an abnormal signal is as follows:

[0062] S401, obtaining the reading frequency F, data reading duration T and execution operation when the data application end and the third-party supervision end acquire data, wherein the execution operation is the access demand;

[0063] S402, calculate the access abnormal value qW according to the following formula: , where e5 and e4 are preset proportional coefficients;

[0064] S403: Obtain a preset access abnormality threshold, and if the access abnormality value is greater than the access abnormality threshold, generate an abnormality signal.

[0065] It also includes a security warning unit, which is used to obtain and process abnormal signals, send warning notifications to the data application end and the third-party supervision end, and perform secondary encryption on the blockchain entry nodes on the accessed project process timeline to increase the project's accessibility coefficient.

[0066] The present invention encrypts clinical medical data and uploads it to the blockchain management unit, encrypts and stores data using idle computing resources through blockchain nodes, and simultaneously obtains access requests from data application terminals and third-party supervisory terminals, determines the allowed access permission coefficient of the access requests based on the source and content of the access requests, and determines abnormal behavior of the data application terminals and third-party supervisory terminals when acquiring data, thereby improving the security performance of the data security sharing system and avoiding data leakage caused by malicious behavior.

[0067] The threshold is set to facilitate comparison. The size of the threshold depends on the amount of sample data and the number of bases set by technicians in this field for each group of sample data; as long as it does not affect the proportional relationship between the parameter and the quantized value.

[0068] The above formulas are all dimensionless and numerical calculations. The formula is a formula obtained by collecting a large amount of data and performing software simulation to obtain the most recent real situation. The preset parameters in the formula are set by technicians in this field according to actual conditions.

[0069] The above description is only a preferred specific implementation manner of the present invention, but the protection scope of the present invention is not limited thereto. Any technician familiar with the technical field can make equivalent replacements or changes according to the technical scheme and inventive concept of the present invention within the technical scope disclosed by the present invention, which should be covered by the protection scope of the present invention.

Claims

1. A blockchain-based drug development clinical medical data security sharing system, including a data source end, a data application end, a third-party supervision end and a blockchain network, characterized in that: The data source end, the data application end and the third-party supervision end are all connected to the medical institution server cluster in the blockchain network, and the blockchain network includes a data acquisition unit, a blockchain management unit, a process supervision unit, a request analysis unit and a security warning unit; The data acquisition unit is used to obtain clinical medical data generated during the drug development process from the data source, and encrypt the clinical medical data before uploading it to the blockchain management unit; The blockchain management unit is used to include a project analysis module and a project management module, wherein the project analysis module is used to obtain the project level and project data of the drug research and development project, and calculate the project access permission coefficient according to the project level and project data; The project management module is used to obtain the project establishment time of the drug development project from the drug development institution, establish a timeline based on the project establishment time, and deploy blockchain nodes based on the existing servers in the data source end and the data application end. The blockchain nodes use idle computing resources to encrypt and store data, and generate blockchain entry nodes after obtaining new clinical medical data. The blockchain entry nodes are time-stamped on the timeline to obtain the project process timeline; The request analysis unit is used to obtain access requests from the data application end and the third-party supervision end, determine the access permission coefficient of the access request based on the source and content of the access request, and give access permission according to the item access permission coefficient corresponding to the access request; The process supervision unit is used to obtain the reading frequency, data reading duration and execution operations of the data application end and the third-party supervision end when acquiring data, calculate the access anomaly value, and judge the abnormal behavior of the data application end and the third-party supervision end when acquiring data according to the preset access anomaly threshold to generate an abnormal signal.

2. The blockchain-based drug development clinical medical data security sharing system according to claim 1 is characterized in that: The data source end includes a medical institution source end and a user source end. The medical institution source end is used to upload the clinical medical data generated by the medical institution during treatment and use of R&D drugs to the blockchain network, and the user source end is used to upload the clinical medical data generated when taking R&D drugs to the blockchain network.

3. The blockchain-based drug development clinical medical data security sharing system according to claim 1 is characterized in that: The data application end includes a medical institution access end, a research and development institution access end and a patient access end. The medical institution access end provides an access port for medical institutions to obtain updated clinical medical data from the blockchain network. The research and development institution access end provides an access port for the responsible institution of the research and development project to obtain updated clinical medical data from the blockchain network. The patient access end provides an access port for patients in need of drugs to obtain from the blockchain network.

4. The blockchain-based drug development clinical medical data security sharing system according to claim 1 is characterized in that: The third-party supervisory end is used to track the clinical medical data provided by the data source end, and to create, save and read the clinical medical data, while supervising whether the data application end complies with the access permission requirements to obtain the clinical medical data and whether the clinical medical data is used correctly and legally.

5. The blockchain-based drug development clinical medical data security sharing system according to claim 1 is characterized in that: The specific process of encrypting clinical medical data is as follows: S101, initializing the public parameters of the clinical medical data based on the preset security parameters, providing trusted keys for the data source end, the data application end, and the third-party supervision end through the key generation center, the trusted keys including the encryption public key and the encryption mother key, and completing the key distribution through the interaction between the proxy cloud server and the key generation center; S102, encrypting the clinical medical data provided by the data source end by using the encryption public key and uploading the data; S103. Generate an index directory for the public key information of the clinical medical data and the medical data address index information based on a cryptographic commitment algorithm, generate a project attribute directory based on the index directory and the public key information, and package and upload it to the blockchain management unit.

6. The blockchain-based drug development clinical medical data security sharing system according to claim 1 is characterized in that: The specific process of calculating the project accessibility coefficient is as follows: S201. Obtaining the project priority levels of drug research and development projects, wherein the project priority levels include major-level drug research and development projects, priority drug research and development projects, common drug research and development projects, and alternative drug research and development projects, and the weight coefficients of the projects corresponding to the project levels are k1, k2, k3, and k4, respectively; S202, obtaining project data of a drug development project, wherein the project data includes a project stage, keywords in the project stage, and a project safety level; S203. Calculate the project access permission coefficient Wi according to the following formula: , where e1 and e2 are preset proportional coefficients, N is the project stage, M is the keyword level in the project stage, and di is the project safety level representation coefficient. The higher the project safety level, the larger the value of di.

7. The blockchain-based drug development clinical medical data security sharing system according to claim 1 is characterized in that: The specific process of granting access permissions is as follows: S301, obtaining access requirements issued by the data application end and the third-party supervision end, wherein the access requirements include the identity of the visitor, the data type and the access requirements, identifying the source of the access requirements according to the identity of the visitor and tracing back the access tendency value thereof, wherein the access tendency value corresponding to the access requirements from the data application end is Ut, and the access tendency value corresponding to the access requirements from the third-party supervision end is Ui, wherein Ut is greater than Ui; S302, acquiring data types and access requirements according to access requirements, wherein the data types include initial parameters, clinical data, experimental results, and financial data, assigning a permission value of Hi to each data type, and the access requirements include read-only, download, edit, and delete; S303, calculating the allowed access permission coefficient Wu of the access request according to the following formula: or , where gi is the weight coefficient corresponding to the access requirement, the weight coefficients corresponding to read-only, download, edit and delete increase step by step, e3 is the preset proportional coefficient, and a and b are both constants; S304, obtaining the project access permission coefficient Wi, and if the access permission coefficient is greater than or equal to the project access permission coefficient Wi, granting access permission; If the allowed access permission coefficient is less than the item access permission coefficient Wi, an access denial signal is generated.

8. The blockchain-based drug development clinical medical data security sharing system according to claim 1 is characterized in that: The specific process of generating an abnormal signal is as follows: S401, obtain the reading frequency F, data reading time T and execution operation when the data application end and the third-party supervision end acquire data, where the execution operation is the access demand, and calculate the access abnormal value qW according to the following formula: , where e5 and e4 are preset proportional coefficients; S402: Obtain a preset access abnormality threshold, and if the access abnormality value is greater than the access abnormality threshold, generate an abnormality signal.

9. The blockchain-based drug development clinical medical data security sharing system according to claim 1 is characterized in that: It also includes a security warning unit, which is used to obtain and process abnormal signals, issue warning notifications to the data application end and the third-party supervision end, and perform secondary encryption on the blockchain entry node on the accessed project process timeline to increase the accessibility coefficient of the project.

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