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WO2018105049A1 - Système de sécurité et serveur d'authentification - Google Patents

Système de sécurité et serveur d'authentification Download PDF

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Publication number
WO2018105049A1
WO2018105049A1 PCT/JP2016/086336 JP2016086336W WO2018105049A1 WO 2018105049 A1 WO2018105049 A1 WO 2018105049A1 JP 2016086336 W JP2016086336 W JP 2016086336W WO 2018105049 A1 WO2018105049 A1 WO 2018105049A1
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WO
WIPO (PCT)
Prior art keywords
data
similarity
transmission data
transmission
clinical trial
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Application number
PCT/JP2016/086336
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English (en)
Japanese (ja)
Inventor
太郎 上野
太祐 市川
Original Assignee
サスメド株式会社
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Publication date
Application filed by サスメド株式会社 filed Critical サスメド株式会社
Priority to PCT/JP2016/086336 priority Critical patent/WO2018105049A1/fr
Publication of WO2018105049A1 publication Critical patent/WO2018105049A1/fr

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    • G—PHYSICS
    • G06—COMPUTING OR CALCULATING; COUNTING
    • G06F—ELECTRIC DIGITAL DATA PROCESSING
    • G06F21/00—Security arrangements for protecting computers, components thereof, programs or data against unauthorised activity
    • G06F21/60—Protecting data
    • G06F21/64—Protecting data integrity, e.g. using checksums, certificates or signatures

Definitions

  • the present invention relates to a security system and an authentication server, and is particularly suitable for application to a system configured to sequentially transmit clinical test data from a transmission terminal to a collection server and store the clinical test data in the collection server. Is.
  • clinical trials are conducted to confirm the safety and effectiveness of drugs, medical devices, and treatment methods.
  • data is usually collected in such a way that doctors listen to patient data through measurements or interviews, record them in medical records, and send the data to the clinical trial administration office.
  • CRO Contract Research Research Organization
  • a third party organization is in operation under the current mechanism, and humans visually check the data.
  • the electronic medical record recording system described in Patent Document 2 is made for the purpose of suppressing falsification of the electronic medical record without using a time stamp whose reliability is uncertain.
  • the electronic medical record transmitted from the user terminal and recorded in the electronic medical record reception memory includes the contents of the electronic medical record recorded in the storage electronic medical record database. Only when it is determined that all are included, the electronic medical record in the storage electronic medical record database is overwritten.
  • Patent Document 1 verifies the presence or absence of falsification of the electronic medical record by hand, and cannot satisfy the above-mentioned demand.
  • Patent Document 2 it is possible to prevent falsification of the electronic medical chart without intervention of human hands.
  • the electronic medical record transmitted from the user terminal is considered to be valid data only when it contains all the contents of the electronic medical record recorded in the storage electronic medical record database, the measurement results of clinical trials where the measurement results can change sequentially It cannot be applied to the use of transmitting data.
  • the present invention has been made to solve such a problem, and an object thereof is to prevent falsification of transmission data of clinical trials without human intervention by a third party organization.
  • transmission data that is personal clinical test data transmitted from the transmission terminal to the authentication server and the collection server that collects and accumulates the clinical test data are stored. Calculate the degree of similarity between the individual and the stored data that is clinical trial data of the same person, authenticate the validity of the transmission data based on the calculated degree of similarity, and only the transmission data that has been certified as valid Is provided from the authentication server to the collection server.
  • the clinical trial data transmitted this time and the clinical data transmitted up to the previous time and accumulated in the collection server Based on the similarity to the test data, the validity of the clinical test data transmitted this time is authenticated.
  • a correlation is recognized between the clinical test data that are sequentially transmitted, so that the similarity between the transmitted data and the stored data is relatively large.
  • the transmission data is tampered with, the degree of similarity with the stored data decreases. In this case, it is possible to determine that the transmission data having a low similarity to the stored data is falsified data and not provide the authentication server to the collection server. As a result, it is possible to prevent falsification of transmission data of clinical trials without intervention by a third party organization.
  • FIG. 1 is a diagram illustrating an example of the overall configuration of a security system according to the present embodiment.
  • the security system of the present embodiment includes a transmission terminal 10 that transmits clinical trial data, and collection servers 30 -1 to 30 -3 that collect and store clinical trial data (hereinafter collectively collected). And the authentication server 20 for authenticating the validity of the clinical trial data.
  • the transmission terminal 10 and the authentication server 20 are configured to be connectable via a communication network such as the Internet.
  • the authentication server 20 and the collection server 30 are configured to be connectable via a communication network such as the Internet or a dedicated line.
  • the transmission terminal 10 may be a terminal used by a doctor in a medical institution, or may be a terminal used by a patient who undergoes a clinical test. By transmitting the clinical trial data from the terminal used by the patient, it is possible to prevent the clinical trial data from being falsified by the doctor.
  • the clinical test data transmitted from the transmission terminal 10 includes measurement data measured using a medical device and inquiry data obtained by answering an inquiry.
  • the inquiry data can be transmitted directly from the terminal used by the patient. That is, it is possible to reply to an inquiry at the patient's terminal and transmit the inquiry data obtained as a result from the patient's terminal.
  • measurement data after measurement is performed at a medical institution, the patient inputs the measurement data to the patient's terminal and transmits the measurement data from the patient's terminal.
  • the collection server 30 includes a plurality of servers 30 -1 to 30 -3 connected by a distributed network.
  • a block chain technology is introduced into the plurality of collection servers 30 -1 to 30 -3 . That is, the clinical trial data transmitted from the transmission terminal 10 is shared among the plurality of collection servers 30 -1 to 30 -3 by the block chain technology. For simplicity, only three collection servers 30 -1 to 30 -3 are shown, but more than this may be used.
  • FIG. 2 is a block diagram illustrating a functional configuration example of the authentication server 20.
  • the authentication server 20 of the present embodiment includes a transmission data acquisition unit 21, a stored data acquisition unit 22, a similarity calculation unit 23, an authentication processing unit 24, and a data provision control unit 25 as functional configurations. I have. Further, the authentication server 20 includes a similarity storage unit 26 as a storage medium.
  • the functional blocks 21 to 25 can be configured by any of hardware, DSP (Digital Signal Processor), and software.
  • DSP Digital Signal Processor
  • each of the functional blocks 21 to 25 is actually configured by including a CPU, RAM, ROM, etc. of a computer, and a program stored in a recording medium such as RAM, ROM, hard disk, or semiconductor memory. Is realized by operating.
  • the transmission data acquisition unit 21 acquires personal clinical test data (hereinafter referred to as transmission data) transmitted from the transmission terminal 10.
  • the accumulated data acquisition unit 22 is stored in the collection server 30 (which may be any of a plurality of collection servers 30 -1 to 30 -3 ) when the transmission data acquisition unit 21 acquires transmission data from the transmission terminal 10.
  • Acquire clinical trial data (hereinafter referred to as accumulated data) of the same person as above.
  • the latest clinical trial data accumulated last time is acquired from the clinical trial data accumulated in the collection server 30.
  • the accumulated data acquisition unit 22 acquires the latest clinical test data accumulated last time as accumulated data used as a comparison target with the current transmission data acquired by the transmission data acquisition unit 21.
  • the personal identification information is managed in association with the clinical trial data. That is, when clinical trial data is transmitted from the transmission terminal 10, it is transmitted together with personal identification information. Further, when the clinical trial data is accumulated in the collection server 30, it is stored in the database in association with personal identification information.
  • the personal identification information a uniquely set user ID, a terminal ID of the transmission terminal 10, or the like can be used.
  • the similarity calculation unit 23 relates to the personal clinical test data transmitted this time from the transmission terminal 10 (transmission data acquired by the transmission data acquisition unit 21) and the same person as the individual stored in the collection server 30. The degree of similarity with the previous clinical test data (accumulated data acquired by the accumulated data acquisition unit 22) is calculated.
  • the similarity calculation unit 23 calculates the Mahalanobis distance or the Euclidean distance as the first similarity for multi-value clinical trial data such as measurement data, and the binary type such as inquiry data.
  • the cosine similarity is calculated as the second similarity for the clinical trial data.
  • the Mahalanobis distance When the measurement data includes a plurality of types of data having different units such as blood pressure and weight, it is preferable to calculate the Mahalanobis distance after standardizing them together. On the other hand, when only measurement data having the same unit is included, the Mahalanobis distance or the Euclidean distance may be calculated without standardization. The smaller the calculated distance, the larger the similarity, and the larger the distance, the smaller the similarity.
  • a question item includes a multi-value answer in addition to a yes / no binary answer, the question answered in that multi-value answer
  • the Mahalanobis distance is calculated together with the measurement data.
  • the similarity calculation unit 23 stores the calculated similarity in the similarity storage unit 26. Each time the transmission data acquisition unit 21 acquires clinical trial data from the transmission terminal 10, the similarity calculation unit 23 calculates the similarity with the previous clinical test data acquired by the accumulated data acquisition unit 22, and the calculated similarity Is stored in the similarity storage unit 26. As a result, the similarity storage unit 26 accumulates a plurality of similarities.
  • the authentication processing unit 24 authenticates the validity of the transmission data based on the similarity calculated by the similarity calculation unit 23.
  • the similarity calculation unit 23 calculates the first similarity (Mahalanobis distance or Euclidean distance) calculated for the multivalued clinical trial data and the second similarity calculated for the binary clinical trial data.
  • the validity of the transmission data is authenticated based on the degree (cosine similarity).
  • the authentication processing unit 24 determines that the transmission data is valid when the similarity exceeds a certain level. On the other hand, when the similarity is equal to or lower than a certain level, the authentication processing unit 24 determines that the transmission data is invalid, that is, falsified. Specifically, the authentication processing unit 24 individually performs authentication processing for each of the first similarity and the second similarity, and when at least one of the similarities is below a certain level, the transmission data is invalid. Judge that it is.
  • the authentication processing unit 24 calculates the current similarity calculated for the transmission data by the similarity calculation unit 23 and the similarity calculated by the similarity calculation unit 23 for the accumulated data up to the previous time (that is, the similarity storage).
  • the validity of the transmission data is authenticated depending on whether or not the difference from the average value of the similarity degree stored in the unit 26 exceeds a threshold value.
  • the threshold value used here can be set arbitrarily. For example, the standard deviation ⁇ 2 value of the distribution estimated from a plurality of similarities is used as the threshold value.
  • the authentication processing unit 24 may authenticate the validity of the transmission data based on whether or not the current similarity calculated by the similarity calculation unit 23 exceeds a threshold value.
  • the threshold used in this case can also be set arbitrarily. When comparing the current similarity and the threshold in this way, if the threshold is set to a predetermined fixed value, it is not necessary to store the similarity history in the similarity storage unit 26.
  • the similarity with the previous data is not always constant.
  • the degree of similarity with the previous clinical trial data may be relatively small, such as when symptoms improve rapidly or worsen rapidly.
  • the calculated similarity will vary to some extent. Therefore, of the above two determination methods, the former determination method in which the threshold value is dynamically set in consideration of variations in similarity even in valid clinical test data is more preferable.
  • the authentication processing unit 24 notifies the similarity calculation unit 23 of the authentication result.
  • the similarity calculation unit 23 stores the calculated similarity in the similarity storage unit 26 only when the authentication processing unit 24 determines that the transmission data is valid. That is, when the authentication processing unit 24 determines that the transmission data is invalid, the calculated similarity is not correct and is not stored in the similarity storage unit 26.
  • the data provision control unit 25 performs control so as to provide only the transmission data authenticated by the authentication processing unit 24 to the collection server 30.
  • the data provision control unit 25 provides the transmission data authenticated by the authentication processing unit 24 to the plurality of collection servers 30 -1 to 30 -3 . In this way, by providing only the transmission data authenticated as valid to the collection server 30, for example, a doctor hijacks the patient's transmission terminal 10 and transmits unauthorized clinical test data to the collection server 30. Can be prevented.
  • FIG. 3 is a block diagram illustrating a functional configuration example of the collection server 30.
  • the plurality of collection servers 30 -1 to 30 -3 all have the same functional configuration.
  • FIG. 3 shows a functional configuration example of the collection server 30-1 as a representative.
  • the collection server 30-1 includes a provision data acquisition unit 31, a consensus processing unit 32, a storage control unit 33, and a storage data provision unit 34 as functional configurations.
  • the collection server 30-1 includes a clinical test data storage unit 35 as a storage medium.
  • the functional blocks 31 to 34 can be configured by any of hardware, DSP, and software.
  • each of the functional blocks 31 to 34 is actually configured by including a CPU, RAM, ROM, etc. of a computer, and a program stored in a recording medium such as RAM, ROM, hard disk, or semiconductor memory. Is realized by operating.
  • the provided data acquisition unit 31 acquires clinical test data provided from the authentication server 20 (current transmission data determined to be valid).
  • the consensus processing unit 32 performs consensus forming processing for sharing the transmission data among the plurality of collection servers 30 -1 to 30 -3 as a whole.
  • this consensus building process it is possible to use a consensus algorithm known in the block chain technology.
  • the provided data acquisition unit 31 performs the consensus building process using a PBFT (Practical Byzantine Fault Tolerance) consensus algorithm, thereby validating the clinical trial data acquired by each of the collection servers 30 -1 to 30 -3.
  • PBFT Practical Byzantine Fault Tolerance
  • the accumulation control unit 33 performs control so that only transmission data that is consensus-formed by the consensus processing unit 32 is newly accumulated in the clinical trial data storage unit 35 as accumulated data. In this way, by storing only the transmission data verified as valid by the consensus processing unit 32 in the clinical test data storage unit 35, for example, a clinical program data can be obtained by setting a malicious program on the collection server 30. Can be prevented from being tampered with.
  • the accumulated data providing unit 34 transmits the transmission acquired by the transmission data acquiring unit 21 from the clinical test data stored in the clinical test data storage unit 35 in response to a request from the accumulated data acquiring unit 22 of the authentication server 20.
  • the previous clinical trial data relating to the same individual as the data is read and provided to the accumulated data acquisition unit 22.
  • the clinical test data stored in the clinical test data storage unit 35 is only data verified by the consensus processing unit 32 as valid. Therefore, the validity of the stored data used as a comparison target with the transmission data when the similarity calculation unit 23 of the authentication server 20 calculates the similarity is guaranteed. Thereby, the authentication precision of the transmission data by the authentication process part 24 can be ensured.
  • the validity is determined in a manner that depends on the existing clinical trial data of the same individual.
  • FIG. 4 is a flowchart showing an example of the operation of the security system according to the present embodiment configured as described above.
  • the transmission terminal 10 transmits clinical test data to the authentication server 20 (step S1).
  • the transmission data acquisition unit 21 of the authentication server 20 acquires clinical trial data (transmission data) transmitted from the transmission terminal 10 (step S2).
  • the storage data acquisition unit 22 requests the collection server 30 to acquire storage data related to the same identification information (that is, the same patient) as the identification information of the transmission data. (Step S3).
  • the accumulated data providing unit 34 of the collection server 30 reads the previous accumulated data related to the same patient as the transmission data from the clinical trial data storage unit 35 and provides it to the authentication server 20 (step S4).
  • the accumulated data acquisition unit 22 of the authentication server 20 acquires the accumulated data provided from the accumulated data providing unit 34 (step S5).
  • the similarity calculation unit 23 obtains the current clinical test data (transmission data) acquired by the transmission data acquisition unit 21 in step S2 and the previous clinical test data (accumulation data) acquired by the accumulation data acquisition unit 22 in step S5. ) Is calculated (step S6). And the authentication process part 24 authenticates the legitimacy of transmission data based on the similarity calculated by the similarity calculation part 23 (step S7).
  • the authentication processing unit 24 determines whether or not the current transmission data is valid as a result of the authentication (step S8).
  • the similarity calculation unit 23 stores the calculated similarity in the similarity storage unit 26 (step S9).
  • the data provision control part 25 provides the clinical trial data which the transmission data acquisition part 21 acquired from the transmission terminal 10 by step S2 to the collection server 30 (step S10).
  • the processing of the authentication server 20 is terminated without performing the processing of steps S9 and S10.
  • the provided data acquisition unit 31 of the collection server 30 acquires clinical trial data (current transmission data) provided from the authentication server 20 (step S11). Then, the consensus processing unit 32 performs consensus formation processing for sharing the transmission data among the plurality of collection servers 30 -1 to 30 -3 , and the transmission data acquired by the collection servers 30 -1 to 30 -3. Is verified (step S12).
  • the accumulation control unit 33 determines whether or not consensus processing unit 32 has formed consensus on transmission data (step S13).
  • the accumulation control unit 33 newly stores the transmission data in the clinical trial data storage unit 35 as accumulation data (step S14).
  • the process of step S14 is not performed, and the process of the collection server 30 ends.
  • transmission data that is personal clinical test data transmitted from the transmission terminal 10 to the authentication server 20 and the collection server 30 that collects and accumulates the clinical test data are stored.
  • the degree of similarity between the above-mentioned individual and the stored data that is the clinical trial data of the same person is calculated, the validity of the transmission data is authenticated based on the calculated degree of similarity, and the transmission that has been authenticated is verified Only the data is provided from the authentication server 20 to the collection server 30.
  • the clinical trial data transmitted this time and the previous transmission and accumulation in the collection server 30 are performed.
  • the validity of the clinical trial data transmitted this time is authenticated based on the similarity with the existing clinical trial data.
  • it is possible to determine that the clinical trial data having a small similarity to the stored data is falsified data and not provide the authentication server 20 to the collection server 30.
  • the block chain technology is introduced to the plurality of integrated servers 30 -1 to 30 -3 connected by the distributed network, and the transmission data is transmitted to the whole collection servers 30 -1 to 30 -3. Only when the consensus is formed to share the transmission data, the transmission data provided from the authentication server 20 to the collection server 30 is stored in the clinical trial data storage unit 35 as new accumulated data.
  • the similarity calculation unit 23 of the authentication server 20 can ensure the validity of the accumulated data used as a comparison target with the transmission data when calculating the similarity, the transmission data of the transmission data performed by the authentication processing unit 24 can be secured. The accuracy of the authentication process can be ensured.
  • the authentication processing unit 24 determines that the clinical test data is valid, the similarity is stored in the similarity storage unit 26.
  • the consensus processing unit 32 fails to form a consensus regarding transmission data sharing, the authentication server 20 is notified of this and the latest similarity stored in the similarity storage unit 26 is notified. It is preferable to delete them.
  • the authentication server 20 acquires the previous clinical test data from the collection server 30 has been described.
  • the present invention is not limited to this.
  • the latest clinical test data may be stored in the authentication server 20 and the previous clinical test data may be acquired from the authentication server 20 itself.
  • the authentication server 20 may also be incorporated into the block chain, and a consensus process for sharing the transmission data among the plurality of integrated servers 30 -1 to 30 -3 and the authentication server 20 may be executed. Then, only when the consensus is taken, it may be caused to store the transmission data to a plurality of integrated servers 30-1 to 30 -3 and the authentication server 20.
  • the example in which the block chain technology is introduced by connecting a plurality of servers 30 -1 to 30 -3 via a distributed network has been described, but this is not essential. That is, the authentication server 20 alone can prevent falsification of clinical trial transmission data. However, since the security level increases when combined with the block chain technology, it is more preferable to configure as in the above embodiment.

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  • Engineering & Computer Science (AREA)
  • Computer Security & Cryptography (AREA)
  • Theoretical Computer Science (AREA)
  • Health & Medical Sciences (AREA)
  • Bioethics (AREA)
  • General Health & Medical Sciences (AREA)
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Abstract

Selon la présente invention ce système de sécurité comprend : une unité de calcul de degré de similarité (23) qui calcule un degré de similarité entre des données transmises, qui sont des données de test clinique d'une personne ayant été transmises d'un terminal de transmission (10) à un serveur d'authentification (20), et des données accumulées, qui sont les mêmes données de test clinique de la personne accumulées dans un serveur de collecte (30) pour collecter et accumuler des données de test clinique ; une unité de traitement d'authentification (24) qui tente d'authentifier la validité des données transmises sur la base du degré de similarité calculé ; et une unité de commande de service de données (25) qui effectue une commande de telle sorte que le serveur d'authentification (20) fournit, au serveur de collecte (30), uniquement des données transmises qui ont été authentifiées comme valides. Des données de test cliniques ayant un faible degré de similarité avec les données accumulées correspondantes sont déterminées comme ayant été modifiées, et ne sont pas fournies par le serveur d'authentification (20) au serveur de collecte (30), ce qui permet d'empêcher des données de test clinique non autorisées résultant d'une acquisition du terminal de transmission (10) d'être transmises au serveur de collecte (30).
PCT/JP2016/086336 2016-12-07 2016-12-07 Système de sécurité et serveur d'authentification WO2018105049A1 (fr)

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WO2020079788A1 (fr) * 2018-10-17 2020-04-23 サスメド株式会社 Système de détection de fraude et dispositif de détection de fraude
CN111478957A (zh) * 2020-04-02 2020-07-31 深圳市人工智能与机器人研究院 基于区块链的实验数据处理方法、装置和计算机设备

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CN111478957A (zh) * 2020-04-02 2020-07-31 深圳市人工智能与机器人研究院 基于区块链的实验数据处理方法、装置和计算机设备
CN111478957B (zh) * 2020-04-02 2023-09-08 深圳市人工智能与机器人研究院 基于区块链的实验数据处理方法、装置和计算机设备

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