CN111539014B - Ethical file archiving method based on block chain - Google Patents
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- G—PHYSICS
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- G06F—ELECTRIC DIGITAL DATA PROCESSING
- G06F21/00—Security arrangements for protecting computers, components thereof, programs or data against unauthorised activity
- G06F21/60—Protecting data
- G06F21/62—Protecting access to data via a platform, e.g. using keys or access control rules
- G06F21/6218—Protecting access to data via a platform, e.g. using keys or access control rules to a system of files or objects, e.g. local or distributed file system or database
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- G—PHYSICS
- G06—COMPUTING; CALCULATING OR COUNTING
- G06F—ELECTRIC DIGITAL DATA PROCESSING
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- G06F—ELECTRIC DIGITAL DATA PROCESSING
- G06F21/00—Security arrangements for protecting computers, components thereof, programs or data against unauthorised activity
- G06F21/60—Protecting data
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Abstract
The invention introduces the blockchain technology into the ethical examination system aiming at the problem that the document is easy to tamper, utilizes the inherent tamper-proof characteristic of the blockchain, combines the blockchain with the ethical examination system, establishes a service layer between the blockchain and the ethical examination system, plays the role of a communication bridge, realizes functions such as key management, identity authority management and the like in the service layer to ensure the safety of data transmission and storage, properly stores the ethical examination file, and effectively prevents technicians or personnel with authority from bypassing the safety control of the system through technical means and tampering the ethical examination file without leaving trace.
Description
Technical Field
The invention relates to the field of electronic document storage, in particular to an ethical document archiving method based on a block chain.
Background
The ethical examination system is basically used in clinical trial ethical examination work at present. By using the system, the workflow can be standardized, the management of personnel and documents is simplified, the working cost is saved, and the ethical examination working efficiency is greatly improved. The security requirements for documents produced in ethical review work are also high. The ethical examination working guidelines of the clinical trial of drugs by the ethical committee prescribe that the examination files are properly kept and the safety and confidentiality of the file files are ensured. The existing ethical examination systems all adopt file systems or database systems to store documents generated in work, and although the systems are subjected to safety protection, technicians or personnel with rights can tamper the documents without leaving marks by bypassing the safety control of the systems through technical means.
Disclosure of Invention
The invention introduces the blockchain technology into the ethical examination system aiming at the problem that the document is easy to tamper, and utilizes the inherent tamper-proof characteristic of the blockchain to properly store the ethical examination document.
An ethical file archiving method based on a blockchain comprises the blockchain, an intelligent contract and an ethical examination system.
The blockchain is a distributed shared ledger and database, and has the characteristics of decentralization, non-tampering, whole trace, traceability, collective maintenance, disclosure and transparency. Further, blockchain is a data synchronization technique that uses data blocks to record transactions, and uses the way the chain organizes the blocks. Limited to the structure of the blockchain, the data on the chain can only be added and cannot be modified or deleted. Once the transaction is completed, the data is synchronized to all nodes, and the aim of tampering the whole data by directly tampering the block data in some nodes by technical means cannot be achieved, because the block chain can automatically correct the wrong block data, and the correctness of the data of all nodes is ensured.
The smart contract is code deployed and running on a blockchain.
The ethical examination system is a medical software information system which provides examination project management, ethical committee management, examination file management, conference management and other functions for clinical trial ethical examination work;
the invention relates to a block chain-based ethical file archiving method, which comprises the following steps:
step S1, a service layer is built between a block chain and an ethical examination system; establishing a bridge connecting the ethical examination system and the blockchain;
step S2, establishing an intelligent contract for archiving the ethical files, and establishing an intelligent contract for archiving the ethical files on a blockchain, wherein the intelligent contract provides functions of archiving the files, archiving and updating the files, inquiring and archiving traceability and inquiring certain archive information;
and S3, modifying the access of the ethical examination system to the service layer, modifying the existing ethical examination system, taking the ethical file archiving event as an access point, and calling the service layer for the related service of ethical file archiving.
Further, the service layer comprises an application management module, a right management module, a key management module, a data encryption module, an electronic signature module, a transaction inquiry module, a relational database service, an object storage service, a data caching service, a blockchain service, an open API and a development SDK;
and an application management module: an ethical auditing system instance for managing access to the service layer, one ethical auditing system instance having a unique application credential that identifies the identity of the access system, which may be exchanged for a temporary access token by logging into the service layer;
and the permission management module is used for: the system is used for controlling the use authority of the access system to each service of the service layer;
a key management module: the system is used for distributing and managing certificates, the certificates comprise RSA key pairs, an access system can apply certificates for users or institutions in the system by itself and used for data encryption and electronic signature, after the application is completed, a service layer can return the generated key pairs to a caller for storage, and the service layer only keeps public keys for data verification;
and a data encryption module: the method comprises the steps of providing an access system for encrypting data by using an applied private key; the data encryption algorithm uses AES256, and the AES key itself uses RSA public key for encryption;
an electronic signature module: the method comprises the steps of providing for an access system to sign data by using an applied private key; the signature algorithm uses SHA256WithRSA;
transaction inquiry module: the method comprises the steps of inquiring detailed information and traceability information of a blockchain transaction;
relational database service: the service layer uses the relational database to store the business data and applies the related data;
object storage service: the service layer uses the object storage service to store specific ethical examination files;
data caching service: the service layer uses a cache database to manage temporary data of the access token;
blockchain service: the service layer uses a blockchain service to store ethical file archiving abstract information, including file information, time and file signature;
open API: the service layer provides an open API for an ethical examination system to be accessed;
development of SDK: for providing the access client with some local operations, access token acquisition and renewal, data encryption signature.
The service layer establishes a bridge between the ethical examination system and the blockchain, and the steps of completing file archiving, file archiving updating, inquiring, archiving and tracing, and inquiring a certain archiving information comprise the following steps:
s11 application certificate
The access system uses the self identity credentials to request a temporary token from the service layer, the service layer checks the identity of the access system through the application management module and the authority management module after receiving the request, the user identity stored in the relational database service is compared and checked, if the identity is valid, a temporary access token is generated, and the access token is used in each step of the following request, so the service layer can place the access token in the data cache service for quick access; after the access system obtains the access token, certificates can be applied for the ethical examination related personnel and the examination institutions of the system, and the work is completed by the key management module;
s12 archiving files
When the ethical files are archived, an access system firstly encrypts and signs each file by using an author private key of the ethical files, and the encryption and signature work is already packaged in a development SDK (software development kit) provided by a service layer and comprising a data encryption module and an electronic signature module, or the same work is completed through an open API (application program interface); and uploading the files to a service layer, and after the service layer uses an electronic signature module to check the files, storing the files by using an object storage service and returning file abstract information. The access system combines the returned file abstract information and signature information of the ethic files into complete filing information, and then signs the filing information by using an ethic examination committee private key initiating filing; all the information is submitted to a service layer after being prepared, and the service layer stores metadata such as archive information and the like into a blockchain service through an intelligent contract;
s13, completing archiving
After the service layer finishes archiving, returning the transaction number of the transaction, and accessing the system for storage; the transaction number is used as a query of the transaction information;
the ethical archive information is stored in the blockchain, and because the blockchain is a decentralised data synchronization technology, data are simultaneously stored in each network node in a distributed mode, and any erroneous or tampered data can be corrected back by other network nodes; the data are stored in blocks which form a chain structure, each block is tightly connected, the validity of the adjacent blocks is determined by the hash value of the block, and any small illegal modification can cause the change of the hash value to cause the block to be invalid; in a system with high fault tolerance and data which can only be added and not be pruned, any means cannot tamper with the data;
s14 traceable query
The access system can inquire the archive tracing information of the ethical examination project, and the service layer returns the data such as abstract information and the like of each archive of the project through the transaction inquiry module;
s15 detailed information query
The access system inquires the detailed information of the archive through a transaction inquiry module of the service layer, and downloads any encrypted file of the archive; after downloading, the file needs to be decrypted locally to see the real file content.
By accessing the blockchain into the ethical review system in the above way, the archived ethical review file is prevented from being tampered.
The beneficial effects are that: the invention introduces the blockchain technology into the ethical examination system aiming at the problem that the document is easy to tamper, utilizes the inherent tamper-proof characteristic of the blockchain, combines the blockchain with the ethical examination system, establishes a service layer between the blockchain and the ethical examination system, plays the role of a communication bridge, realizes functions such as key management, identity authority management and the like in the service layer to ensure the safety of data transmission and storage, properly stores the ethical examination file, and effectively prevents technicians or personnel with authority from bypassing the safety control of the system through technical means and tampering the ethical examination file without leaving trace.
Drawings
FIG. 1 is a schematic diagram of a service layer structure according to the present invention;
FIG. 2 is a flowchart of a block chain based ethical file archiving process in accordance with the present invention;
FIG. 3 is a flow chart of applying for credentials;
FIG. 4 is a flow chart for archiving files and completing archiving;
FIG. 5 is a flow chart of a traceable query;
fig. 6 is a detailed information query flow chart.
Description of the embodiments
An ethical file archiving method based on a blockchain comprises the blockchain, an intelligent contract and an ethical examination system.
The blockchain is a distributed shared ledger and database, and has the characteristics of decentralization, non-tampering, whole trace, traceability, collective maintenance, disclosure and transparency. Further, blockchain is a data synchronization technique that uses data blocks to record transactions, and uses the way the chain organizes the blocks. Limited to the structure of the blockchain, the data on the chain can only be added and cannot be modified or deleted. Once the transaction is completed, the data is synchronized to all nodes, and the aim of tampering the whole data by directly tampering the block data in some nodes by technical means cannot be achieved, because the block chain can automatically correct the wrong block data, and the correctness of the data of all nodes is ensured.
The smart contract is code deployed and running on a blockchain.
The ethical examination system is a medical software information system which provides examination project management, ethical committee management, examination file management, conference management and other functions for clinical trial ethical examination work;
the invention relates to a block chain-based ethical file archiving method, which comprises the following steps:
step S1, a service layer is built between a block chain and an ethical examination system; establishing a bridge connecting the ethical examination system and the blockchain;
step S2, establishing an intelligent contract for archiving the ethical files, and establishing an intelligent contract for archiving the ethical files on a blockchain, wherein the intelligent contract provides functions of archiving the files, archiving and updating the files, inquiring and archiving traceability and inquiring certain archive information;
and S3, modifying the access of the ethical examination system to the service layer, modifying the existing ethical examination system, taking the ethical file archiving event as an access point, and calling the service layer for the related service of ethical file archiving.
Further, as shown in fig. 1, the service layer includes an application management module, a rights management module, a key management module, a data encryption module, an electronic signature module, a transaction inquiry module, a relational database service, an object storage service, a data caching service, a blockchain service, an open API, and a development SDK;
and an application management module: an ethical auditing system instance for managing access to the service layer, one ethical auditing system instance having a unique application credential that identifies the identity of the access system, which may be exchanged for a temporary access token by logging into the service layer;
and the permission management module is used for: the system is used for controlling the use authority of the access system to each service of the service layer;
a key management module: the system is used for distributing and managing certificates, the certificates comprise RSA key pairs, an access system can apply certificates for users or institutions in the system by itself and used for data encryption and electronic signature, after the application is completed, a service layer can return the generated key pairs to a caller for storage, and the service layer only keeps public keys for data verification;
and a data encryption module: the method comprises the steps of providing an access system for encrypting data by using an applied private key; the data encryption algorithm uses AES256, and the AES key itself uses RSA public key for encryption;
an electronic signature module: the method comprises the steps of providing for an access system to sign data by using an applied private key; the signature algorithm uses SHA256WithRSA;
transaction inquiry module: the method comprises the steps of inquiring detailed information and traceability information of a blockchain transaction;
relational database service: the service layer uses the relational database to store the business data and applies the related data;
object storage service: the service layer uses the object storage service to store specific ethical examination files;
data caching service: the service layer uses a cache database to manage temporary data of the access token;
blockchain service: the service layer uses a blockchain service to store ethical file archiving abstract information, including file information, time and file signature;
open API: the service layer provides an open API for an ethical examination system to be accessed;
development of SDK: for providing the access client with some local operations, access token acquisition and renewal, data encryption signature.
Further, as shown in fig. 2, the service layer establishes a bridge between the ethical examination system and the blockchain, and the steps of completing file archiving, file archiving updating, querying, archiving and tracing, and querying a certain archiving information function, namely ethical file archiving, include:
s11, applying for a certificate;
s12, archiving files;
s13, archiving is completed;
s14 traceable query
S15 detailed information query
Wherein, the liquid crystal display device comprises a liquid crystal display device,
s11 application certificate
As shown in fig. 3, the access system uses its own identity credentials to request a temporary token from the service layer, after receiving the request, the service layer checks the identity of the access system through the application management module and the rights management module, and performs comparison and check through the user identities stored in the relational database service, if the identities are valid, a temporary access token is generated, and the access token is used in each step of the following request, so that the service layer will place the access token in the data cache service for quick access; after the access system obtains the access token, certificates can be applied for the ethical examination related personnel and the examination institutions of the system, and the work is completed by the key management module;
the access system is referred to as an ethical review system.
S12 archiving files
When the ethical files are archived, an access system firstly encrypts and signs each file by using an author private key of the ethical files, and the encryption and signature work is already packaged in a development SDK (software development kit) provided by a service layer and comprising a data encryption module and an electronic signature module, or the same work is completed through an open API (application program interface); and uploading the files to a service layer, and after the service layer uses an electronic signature module to check the files, storing the files by using an object storage service and returning file abstract information. The access system combines the returned file abstract information and signature information of the ethic files into complete filing information, and then signs the filing information by using an ethic examination committee private key initiating filing; all the information is submitted to a service layer after being prepared, and the service layer stores metadata such as archive information and the like into a blockchain service through an intelligent contract;
s13, completing archiving
As shown in fig. 4, after the service layer completes archiving, the transaction number of the transaction is returned, and the access system stores the transaction number; the transaction number is used as a query of the transaction information;
the ethical archive information is stored in the blockchain, and because the blockchain is a decentralised data synchronization technology, data are simultaneously stored in each network node in a distributed mode, and any erroneous or tampered data can be corrected back by other network nodes; the data are stored in blocks which form a chain structure, each block is tightly connected, the validity of the adjacent blocks is determined by the hash value of the block, and any small illegal modification can cause the change of the hash value to cause the block to be invalid; in a system with high fault tolerance and data which can only be added and not be pruned, any means cannot tamper with the data;
s14 traceable query
As shown in fig. 5, the access system can query the archived traceability information of the ethical examination item, and the service layer returns the data such as abstract information and the like of each archived item through the transaction query module;
s15 detailed information query
As shown in fig. 6, the access system queries the detailed information of the archive through the transaction query module of the service layer, and downloads any encrypted file of the archive; after downloading, the file needs to be decrypted locally to see the real file content.
By accessing the blockchain into the ethical review system in the above way, the archived ethical review file is prevented from being tampered.
The invention introduces the blockchain technology into the ethical examination system aiming at the problem that the document is easy to tamper, utilizes the inherent tamper-proof characteristic of the blockchain, combines the blockchain with the ethical examination system, establishes a service layer between the blockchain and the ethical examination system, plays the role of a communication bridge, realizes functions such as key management, identity authority management and the like in the service layer to ensure the safety of data transmission and storage, properly stores the ethical examination file, and effectively prevents technicians or personnel with authority from bypassing the safety control of the system through technical means and tampering the ethical examination file without leaving trace.
Claims (1)
1. The method for archiving the ethical file based on the blockchain comprises the blockchain, an intelligent contract and an ethical examination system, wherein the blockchain is a distributed shared account book and a database, and has the characteristics of decentralization, non-falsification, whole trace, traceability, collective maintenance and openness and transparency; the smart contract is code deployed and running on a blockchain; the ethical examination system is a medical software information system which provides examination project management, ethical committee management, examination file management and conference management functions for clinical trial ethical examination work;
the method is characterized by comprising the following steps of:
step S1, a service layer is built between a block chain and an ethical examination system; establishing a bridge connecting the ethical examination system and the blockchain, and performing data interaction with the blockchain by a service layer through an intelligent contract;
step S2, establishing an intelligent contract for archiving the ethical files, and establishing an intelligent contract for archiving the ethical files on a blockchain, wherein the intelligent contract provides functions of archiving the files, archiving and updating the files, inquiring and archiving traceability and inquiring certain archive information;
s3, modifying an ethical examination system to access a service layer, modifying the existing ethical examination system, taking an ethical file archiving event as an access point, and calling an ethical file archiving related service on the service layer;
the service layer comprises an application management module, a right management module, a key management module, a data encryption module, an electronic signature module, a transaction inquiry module, a relational database service, an object storage service, a data caching service, a blockchain service, an open API and a development SDK;
and an application management module: an ethical auditing system instance for managing access to the service layer, one ethical auditing system instance having a unique application credential that identifies the identity of the access system, which may be exchanged for a temporary access token by logging into the service layer;
and the permission management module is used for: the system is used for controlling the use authority of the access system to each service of the service layer;
a key management module: the system is used for distributing and managing certificates, the certificates comprise RSA key pairs, an access system can apply certificates for users or institutions in the system by itself and used for data encryption and electronic signature, after the application is completed, a service layer can return the generated key pairs to a caller for storage, and the service layer only keeps public keys for data verification;
and a data encryption module: the method comprises the steps of providing an access system for encrypting data by using an applied private key; the data encryption algorithm uses AES256, and the AES key itself uses RSA public key for encryption;
an electronic signature module: the method comprises the steps of providing for an access system to sign data by using an applied private key; the signature algorithm uses SHA256WithRSA;
transaction inquiry module: the method comprises the steps of inquiring detailed information and traceability information of a blockchain transaction;
relational database service: the service layer uses the relational database to store the business data and applies the related data;
object storage service: the service layer uses the object storage service to store specific ethical examination files;
data caching service: the service layer uses a cache database to manage temporary data of the access token;
blockchain service: the service layer uses a blockchain service to store ethical file archiving abstract information, including file information, time and file signature;
open API: the service layer provides an open API for an ethical examination system to be accessed;
development of SDK: the access token is used for providing the access client with local operations, obtaining and continuing the access token, and encrypting and signing data;
the service layer establishes a bridge between the ethical examination system and the blockchain, and the steps of completing file archiving, file archiving updating, inquiring, archiving and tracing, and inquiring a certain archiving information comprise the following steps:
s11 application certificate
The access system uses the self identity credentials to request a temporary token from the service layer, the service layer checks the identity of the access system through the application management module and the authority management module after receiving the request, the user identity stored in the relational database service is compared and checked, if the identity is valid, a temporary access token is generated, and the access token is used in each step of the following request, so the service layer can place the access token in the data cache service for quick access; after the access system obtains the access token, certificates can be applied for the ethical examination related personnel and the examination institutions of the system, and the work is completed by the key management module;
s12 archiving files
When the ethical files are archived, an access system firstly encrypts and signs each file by using an author private key of the ethical files, and the encryption and signature work is already packaged in a development SDK (software development kit) provided by a service layer and comprising a data encryption module and an electronic signature module, or the same work is completed through an open API (application program interface); uploading the files to a service layer, and after the service layer uses an electronic signature module to check the files, storing the files by using an object storage service, and returning file abstract information;
the access system combines the returned file abstract information and signature information of the ethic files into complete filing information, and then signs the filing information by using an ethic examination committee private key initiating filing; all the information is submitted to a service layer after being prepared, and the service layer stores metadata such as archive information and the like into a blockchain service through an intelligent contract;
s13, completing archiving
After the service layer finishes archiving, returning the transaction number of the transaction, and accessing the system for storage; the transaction number is used as a query of the transaction information;
the ethical archive information is stored in the blockchain, and because the blockchain is a decentralised data synchronization technology, data are simultaneously stored in each network node in a distributed mode, and any erroneous or tampered data can be corrected back by other network nodes; the data are stored in blocks which form a chain structure, each block is tightly connected, the validity of the adjacent blocks is determined by the hash value of the block, and any small illegal modification can cause the change of the hash value to cause the block to be invalid; in a system with high fault tolerance and data which can only be added and not be pruned, any means cannot tamper with the data;
s14 traceable query
The access system can inquire the archive tracing information of the ethical examination project, and the service layer returns the data such as abstract information and the like of each archive of the project through the transaction inquiry module;
s15 detailed information query
The access system inquires the detailed information of the archive through a transaction inquiry module of the service layer, and downloads any encrypted file of the archive; after downloading, the file needs to be decrypted locally to see the real file content.
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