JP2016136734A - Computer program, information processing apparatus and information processing method - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an information processing method for performing an electronic signature that can verify the orthodoxy of contents at a specific point in time to a record group on a database to be updated at any time.SOLUTION: The method includes the steps for extracting designated data from a database storing clinical trial data (S12), generating data of a different format on the basis of the extracted data (S13), and generating a hash value about the data as storage information to be used to determine the consistency of the data being original data of the different format to be generated (S14).SELECTED DRAWING: Figure 3

Description

  The present invention relates to a computer program, an information processing apparatus, and an information processing method for applying an electronic signature to a group of records on a database.

In recent years, electronic file systems have been adopted in various businesses such as clinical trials. The clinical trial process includes the process of collecting the clinical trial data that is the original data, the process of cleaning the collected clinical trial data and creating the analytical data, and the process of creating the final data to be submitted to the public organization based on the analytical data It is.
Data obtained in each process is registered in the database and updated as needed. Then, when the contents registered in the database are confirmed and it is necessary to submit an electronic file to a public institution, necessary data is extracted from the database, and the extracted data is recorded as a file.

  The mechanism for electronic signatures on electronic files to prevent tampering and spoofing is widespread, and for clinical trials, electronic signatures are applied at the stage of submitting electronic files to public institutions. Measures are taken to prevent the above (see, for example, Patent Documents 1 and 2).

JP 2007-34933 A JP 2006-127365 A

However, the digital signature is not directly applied to the data stored in the database, and it is determined whether or not falsification has been performed before the data is recorded in the final file. There is no method.
This is because a database used in business or the like has a high content update frequency, and the content stored in the database cannot be fixed. In addition, a system used for business or the like has a certain authentication function, and can prevent spoofing. Therefore, it is difficult to take out the database itself, and the risk of falsification by outsiders is low.

  In this way, in the past, it was possible to prevent tampering by an outsider by preventing impersonation by the authentication function, but tampering performed by the insider (the person in charge of the business) itself could be prevented. Had the problem of not.

  In order to solve the above problems, an object of the present application is to provide a computer program, an information processing apparatus, and an information processing method capable of applying an electronic signature to data on a database.

  The computer program disclosed in the present application extracts specified data from a database storing clinical trial data, and generates other types of data based on the extracted data. A computer is caused to execute a process of generating a hash value for the data as storage information used for determining consistency of the data that is the original data.

  According to the present application, the electronic signature data generated by the electronic signature device includes a hash value calculated based on a record group (one or a plurality of information) extracted from the database at a certain point in time. Then, it becomes possible to determine whether the database is falsified using this hash value. Therefore, the electronic signature device of the present application can prove the validity of the contents at a specific time (that data has not been tampered with) in a database that is updated as needed.

It is a schematic diagram which shows the internal structure of the electronic signature apparatus which concerns on this Embodiment. It is a schematic diagram which shows the structure of each database. It is a flowchart which shows the process sequence of an electronic signature. It is a schematic diagram which shows an example of the information received when designating the record group which should be the object of an electronic signature. It is a schematic diagram which shows an example of a search result. It is a schematic diagram which shows an example of an electronic signature management table. It is a flowchart which shows the process sequence of falsification determination.

Hereinafter, as one application example of the present application, an embodiment in which an electronic signature is applied to data on a database used for clinical trial work will be specifically described with reference to the drawings.
FIG. 1 is a schematic diagram showing an internal configuration of an electronic signature device according to the present embodiment. The electronic signature device 10 according to the present embodiment includes a control unit 11, a ROM (Read Only Memory) 12, a RAM (Random Access Memory) 13, a communication unit 14, a storage unit 15, a display unit 16, and an operation unit 17. They are connected to each other via a bus.

The control unit 11 includes a CPU (Central Processing Unit) or an MPU (Micro Processing Unit). When the MPU is provided, the ROM 12 and the RAM 13 may be incorporated in the control unit 11.
The control unit 11 reads out and executes the computer program and data stored in the ROM 12 or the storage unit 15 on the RAM 13 at an appropriate timing, and controls the operation of each hardware unit described above.

  The ROM 12 stores in advance a computer program necessary for realizing the electronic signature method of the present application and a computer program necessary for operating the above-described hardware units.

  In the present embodiment, the ROM 12 stores a computer program necessary for realizing the electronic signature method of the present application and a computer program necessary for operating each hardware unit. However, these computer programs are stored in the storage unit. 15 may be stored.

  The RAM 13 is, for example, a DRAM (Dynamic RAM), an SRAM (Static RAM), a flash memory, or the like, and various data (for example, calculation results, various parameters, a dump to be described later) generated when the control unit 11 executes the computer program. Data) is temporarily stored.

  The communication unit 14 includes a communication interface for communicating with an external communication network by wire or wireless.

  The operation unit 17 is, for example, a keyboard, and includes an input interface for receiving information input. The display unit 16 is a liquid crystal display, for example, and displays information input via the operation unit 17 and information to be notified to the user in accordance with instructions from the control unit 11.

  The display unit 16 and the operation unit 17 provide an interface with the user. The electronic signature device 10 may be configured to perform operation input from other devices and output to other devices via a network, and the display unit 16 and the operation unit 17 are not necessarily provided.

  The storage unit 15 is a nonvolatile storage device such as a hard disk or a flash memory. A part of the storage area of the storage unit 15 is used as a case totalization database 151, a case basic database 152, a case detail database 153, and an electronic signature management table 155.

FIG. 2 is a schematic diagram showing the configuration of each database. FIG. 2A is an example of the case totalization database 151 and shows that “key 1” and “value a” are stored in association with each other. “Key 1” of the case totalization database 151 represents information such as the number of times of medication and the name of a medicinal product administered, and “value a” represents information such as a symptom after medication and a degree of improvement after medication. These pieces of information are information collected by a pharmaceutical company, a hospital, and the like, appropriately input to the electronic signature device 10 through the communication unit 14 or the operation unit 17, and stored in the case totalization database 151. That is, the information stored in the case totalization database 151 is updated as needed.
In the present embodiment, two pieces of information “key 1” and “value a” are associated with each other and stored in the case totalization database 151. However, three or more pieces of information may be associated and stored.

FIG. 2B is an example of the case basic database 152, in which “key 1”, “key 2”, and “value b” are stored in association with each other. “Key 2” represents information such as the name of a medication patient, the name of a company that administered medication, and the name of a hospital that administered medication, and “value b” represents information such as the height, weight, and sex of the medication patient. These pieces of information are, for example, information that is input to the electronic signature device 10 through the communication unit 14 or the operation unit 17 as basic information at the start of medication and stored in the case basic database 152. That is, the information stored in the case basic database 152 is updated as appropriate, although the update frequency is not high.
The information stored in the case basic database 152 and the information stored in the case totalization database 151 are associated with each other via “key 1”.
In the present embodiment, two pieces of information “key 2” and “value b” are stored in the case basic database 152 in association with “key 1”, but three or more pieces of information are stored in “key 1”. It is good also as a structure linked and memorize | stored.

FIG. 2C shows an example of the case detail database 153, in which “key 1”, “key 2”, “key 3”, and “value c” are stored in association with each other. “Key 3” represents information such as medication date and time, dosage, and the like, and “value c” represents information such as blood pressure, body temperature, blood composition and the like after medication. These pieces of information are information collected by a pharmaceutical company, a hospital, and the like, appropriately input to the electronic signature device 10 through the communication unit 14 or the operation unit 17, and stored in the case totalization database 151. That is, the information stored in the case detail database 153 is updated as needed.
The information stored in the case detail database 153 and the information stored in the case totalization database 151 and the case basic database 152 are associated with each other via “key 1” and “key 2”, respectively.
In the present embodiment, two pieces of information “key 3” and “value c” are stored in the case detail database 153 in association with “key 1” and “key 2”, but three or more pieces of information are stored. The configuration may be such that “key 1” and “key 2” are stored in association with each other.

In the present embodiment, three databases are provided in the storage unit 15 of the electronic signature device 10, but the database configuration is not limited to the above.
In this embodiment, three databases are used in association with each other. However, a single database may be used, and a plurality of information may be stored in association with each other in this database.

  Further, the database does not necessarily have to be inside the electronic signature device 10, and may be connected via a communication network such as a LAN (Local Area Network) or the Internet. In this case, the electronic signature device 10 is configured to access a database through the communication unit 14 and acquire information stored in association with the database.

  Further, in the present embodiment, as shown in FIG. 2, a database adopting a relational data model is used. However, any data model database may be adopted. For example, a hierarchical data model, a network data model, or a card data model can be adopted.

  Hereinafter, processing executed by the electronic signature device 10 according to the present embodiment will be described. FIG. 3 is a flowchart showing the processing procedure of the electronic signature. The electronic signature device 10 receives information in the operation unit 17 for designating a record group to be a target of the electronic signature (step S11). Here, the record group to be the target of the electronic signature is a series of information that needs to be proved that it has not been falsified among the information stored in association with each of the databases 151 to 153 at that time. Say. When the electronic signature device 10 is used for clinical trial work, for example, in order to ensure the validity of the clinical trial data for each visit, selection of information to be applied with the electronic signature is accepted in step S11. It is assumed that the signer has a legitimate authority and does not impersonate.

  FIG. 4 is a schematic diagram showing an example of information received when a record group to be subjected to electronic signature is designated. In the present embodiment, information specifying a target database and a key specifying target information are received. The example shown in FIG. 4 indicates that the case summary database 151, the case basic database 152, and the case detail database 153 are specified as the target database, and KeyA (= key 1) is specified as the target search key. ing.

  In the present embodiment, all three databases are specified. However, for example, when it is not necessary to prove the validity of the information of “value b”, the case basic database 152 is excluded from the target of the electronic signature. May be. In this embodiment, the database that is the target of the electronic signature is also specified. However, only the search key is specified, and the database that includes the information specified by the search key is automatically specified. Also good.

  When the operation unit 17 receives information for designating a record group to be subjected to the electronic signature, the electronic signature device 10 searches for the corresponding record from each of the databases 151 to 153 (step S12), and displays the search result. Output in the dump format (step S13). The electronic signature device 10 stores the dump format search result in the RAM 13. FIG. 5 is a schematic diagram showing an example of a search result. For example, when “KeyA” is designated as a search key in step S11, one information “AAAAAA” is searched from the case totalization database 151. Similarly, the case basic database 152 is searched for two pieces of information “AAAA11” associated with “KeyA1” and “AAAAA22” associated with “KeyA2”. The same applies to the case detail database 153, and four pieces of information are searched as shown in FIG.

  In FIG. 5, the search results are expressed as table format data for easy understanding. However, the search results may be expressed by a character string in binary dump format inside the apparatus (on the RAM 13). .

  Next, the electronic signature device 10 calculates a hash value from the search result in the dump format (step S14), and deletes the search result in the dump format. A publicly known method can be used as a hash value calculation method. For example, a hash value can be calculated by using a hash function such as SHA-1 (Secure Hash Algorithm 1) or MD5 (Message Digest Algorithm 5) using the binary representation of the search result as a key.

  In this embodiment, the hash value is calculated. However, the search result can be uniquely calculated using a predetermined algorithm as input data, and the original input data is obtained from the calculated numerical value. It is not necessary to limit to a hash value as long as it has properties that are difficult to calculate. For example, a pseudo random number may be calculated instead of the hash value.

  The electronic signature device 10 stores the calculated hash value in the electronic signature management table 155 (step S15). At this time, the signer is prompted to input his / her name, and the signer information input through the operation unit 17, the electronic signature number assigned by the electronic signature device 10, signature target information (target database, target key), signature date and time, etc. Is stored in the electronic signature management table 155 in association with the calculated hash value.

  FIG. 6 is a schematic diagram showing an example of the electronic signature management table 155. The electronic signature management table 155 shown in FIG. 6 stores an electronic signature number, a target database name, a target key name, a hash value, a signer name, and a signature date and time in association with each other. Since the digital signature management table 155 can identify the signer, the signature date and time, and the data to be signed, the signature range and contents can be confirmed from the digital signature management table 155.

  Next, the falsification determination procedure for information stored in each of the databases 151 to 153 will be described. FIG. 7 is a flowchart showing a processing procedure for falsification determination. The electronic signature device 10 first receives an input of an electronic signature number (step S21). When an electronic signature number is input through the operation unit 17 of the electronic signature device 10, a hash value is calculated in the same manner as when the electronic signature is applied. Specifically, the electronic signature management table 155 is searched using the electronic signature number input in step S21 as a search key, and information on the target database and target key stored in association with the electronic signature number is acquired (step S21). S22).

Next, the electronic signature device 10 searches the target database based on the acquired target database and target key information, and generates dump-format data indicating the search result (step S23).
Then, the electronic signature device 10 calculates a hash value from the generated data using the algorithm used when applying the electronic signature (step S24).

  The electronic signature device 10 compares the calculated hash value with the hash value associated with the input electronic signature number and stored in the electronic signature management table 155 (step S25), and whether or not they match. Is determined (step S26).

  If they match (S26: YES), it is determined that there is no falsification in the information on each database 151-153 (step S27). If they do not match (S26: NO), each database 151- It is determined that any of the information stored in 153 is falsified (step S28). The electronic signature device 10 displays the determination result of step S27 or step S28 on the display unit 16 (step S29).

  The electronic signature data generated by the electronic signature device 10 of the present embodiment includes a hash value calculated based on a record group (one or a plurality of information) extracted from the database at a certain time. Then, it becomes possible to determine whether the database is falsified using this hash value. Therefore, the electronic signature device 10 according to the present embodiment can prove the validity of the contents at a specific time (that data has not been tampered with) in a database that is updated as needed.

  Regarding the above embodiment, the following additional notes are disclosed.

(Appendix 1)
An access unit for accessing a database for storing and associating a plurality of information;
A receiving unit that receives a selection of information to be subjected to an electronic signature from among the information stored in the database;
An information extraction unit that accesses the database and extracts one or more pieces of information stored in association with the selected information from the database when the reception unit accepts the selection;
Based on one or more pieces of information extracted by the information extraction unit, a calculation unit that calculates a unique value uniquely determined from the information;
A signature data generation unit that generates signature data in which the information selected by the reception unit is associated with the eigenvalue calculated by the calculation unit;
And a storage unit for storing the generated signature data.

(Appendix 2)
The electronic signature device according to appendix 1, wherein the unique value is a hash value.

(Appendix 3)
Information extracted from the database is stored as dump format data,
The electronic signature device according to Supplementary Note 1 or Supplementary Note 2, further comprising an erasure unit that erases the data in the dump format when the calculation unit calculates the eigenvalue.

(Appendix 4)
Among the information stored in the database, the reception unit accepts selection of information to be subject to falsification determination, and extracts one or more information stored in association with the selected information from the database And
A comparison unit that compares the eigenvalue calculated by the calculation unit from the extracted information and the eigenvalue stored in the signature data including the information;
The electronic signature device according to any one of appendices 1 to 4, further comprising: a determination unit that determines whether or not falsification is performed based on a comparison result by the comparison unit.

(Appendix 5)
Accepting selection of information to be digitally signed among multiple information stored in association with the database,
Extracting one or more information stored in association with the selected information from the database;
Based on the extracted one or more pieces of information, a unique value uniquely determined from the information is calculated,
An electronic signature method comprising generating signature data associating the selected information with a calculated unique value.

(Appendix 6)
A step of causing a computer to accept selection of information to be a digital signature among a plurality of pieces of information stored in association with a database;
Causing the computer to extract one or more pieces of information stored in association with the selected information from the database;
Causing the computer to calculate a unique value uniquely determined from the extracted information based on the one or more pieces of information;
Causing the computer to generate signature data in which the selected information is associated with the calculated unique value.

10 Electronic Signature Device 11 Control Unit (Information Extraction Unit, Calculation Unit, Signature Data Generation Unit)
12 ROM
13 RAM
14 communication unit 15 storage unit 16 display unit 17 operation unit (accepting unit)
151 Case Summary Database 152 Case Basic Database 153 Case Detail Database 155 Electronic Signature Management Table

Claims (6)

Extract the specified data from the database that stores the clinical trial data,
When data in another format is generated based on the extracted data, the data is hashed as storage information used to determine the consistency of the data that is the original data of the data in the other format to be generated A computer program that causes a computer to execute values. When the information specifying the data to be determined for consistency is received, the data stored in association with the received information is newly extracted from the database,
Generate a hash value for the newly extracted data,
The hash value generated as the storage information is compared with the hash value generated for the newly extracted data,
A computer program for causing a computer to execute a process for outputting a comparison result. An extractor for extracting designated data from a database storing clinical trial data;
When data in another format is generated based on the extracted data, the data is hashed as storage information used to determine the consistency of the data that is the original data of the data in the other format to be generated An information processing apparatus comprising: a generation unit that generates a value. When receiving information specifying data to be determined for consistency, an extraction unit that newly extracts data stored in association with the received information from the database;
A generation unit that generates a hash value for the newly extracted data;
A comparison unit that compares the hash value generated as the storage information with the hash value generated for the newly extracted data;
An information processing apparatus comprising: an output unit that outputs a comparison result. Extract the specified data from the database that stores the clinical trial data,
When data in another format is generated based on the extracted data, the data is hashed as storage information used to determine the consistency of the data that is the original data of the data in the other format to be generated An information processing method that generates values. When the information specifying the data to be determined for consistency is received, the data stored in association with the received information is newly extracted from the database,
Generate a hash value for the newly extracted data,
The hash value generated as the storage information is compared with the hash value generated for the newly extracted data,
An information processing method for outputting a comparison result.

Images