JP5183242B2 - A medical support information providing method, a medical support information providing system, and a computer program for causing a computer system to execute processing for providing medical support information. - Google Patents

Description

  The present invention relates to a computer system (medical institution system) of a medical institution that provides medical services to a patient, and a highly specialized knowledge about a method for treating a specific disease and a molecular biological analysis of a drug and / or biological sample to be administered. A medical support information providing system that can be connected to each other via a communication network, a medical support information providing method executed by the system, and a medical support information in the computer system The present invention relates to a computer program for executing a providing method.

  With the recent development of medical technology based on molecular biological information, the human personality encoded by DNA, the frequency of RNA transcription, and the disease state reflected in the presence of protein can be used in the selection of medical practice. It is being realized. In medical practice using such medical assistance information, biological characteristics, lifestyle habits, past medical history, including information on the DNA itself, which is the essence of personal information, at each stage of diagnosis, examination, diagnosis, treatment, prescription, etc. It is essential to use various personal information such as history.

  In Japan, electronic medical record systems are rapidly spreading in response to the needs of medical institutions that want to collect a wide range of patient personal information and use it in medical practice.

  On the other hand, in order to prevent the personal information of such patients from being transmitted to others (including other medical institutions) without obtaining the consent of the patient, in the various systems of electronic medical records systems and medical institutions that include / supervise them Strict security system is built to protect the patient's personal information related to medical care.

  Even under such circumstances, measurement and examination of patient biological samples such as hematological tests, biochemical tests, immunological tests, urinalysis, etc., which have been performed in order to know the patient's physical condition Many of the operations to be performed employ a method of accepting an anonymized patient biological sample, performing measurement, and returning a report. In such a system, since there is no fear of the personal information of the patient being leaked, it is possible to commission work at an external organization independent of the medical institution.

  However, in the task of generating information to assist medical practice (medical assistance information) from the patient's DNA and RNA status, the patient's biological characteristics, lifestyle, medical history, and DNA polymorphism are used in the generation of information. You may need to refer to personal information such as information.

  In addition, medical practice using the above-described medical assistance information is an advanced skill field, and human resources having the ability to generate medical assistance information are limited. For this reason, it is difficult to hold and maintain such a mechanism for generating medical assistance information in a medical institution, and there is a demand for the construction of an outsourcing organization having technology and specialist doctors specializing in the work. In other words, there is a growing need for analysis services that apply molecular biology, and in order to realize this, in addition to providing molecular biological data analysis means, personal information on patients managed by medical institutions is also secured. There is a need for a mechanism that enables the provision of information that assists medical practice by maintaining and using information.

  The present invention has been made to solve the above-described problems, and provides specialist doctors with medical support information for specialists regarding the analysis results of biological samples of patients without accompanying personal information that can identify specific patients. An object of the present invention is to provide a method, system, and computer program for providing medical assistance information.

  In order to solve the above-mentioned object, the present invention relates to a computer system (medical institution system) of a medical institution that provides medical services to a patient, a method for treating a specific disease, and a molecular biology of a pharmaceutical and / or biological sample to be administered. A method executed by a medical assistance information providing system that can be connected to a communication terminal (expert terminal) of an expert who has a high degree of specialized knowledge about the statistical analysis, respectively, via the communication network, The application accepting step of acquiring basic medical data of the patient from the medical institution system and accepting the application for providing medical assistance information, and the biological sample containing the nucleic acid of the patient collected at the medical institution Nucleic acid analysis result acquisition process for acquiring information analysis results, and the obtained nucleic acid analysis results and basic medical data Received the medical assistance information creation request process for requesting the creation of medical assistance information for the analysis result by transmitting to the expert terminal, the medical assistance information reception process for receiving the medical assistance information for the nucleic acid analysis result from the expert terminal, and A method comprising: preparing medical assistance information including medical assistance information and nucleic acid analysis results, and transmitting the medical assistance information to a medical institution system via a communication network, and preferably executing the method There is provided a computer program for causing a computer to execute this method.

  Here, “personal information” in the present invention refers to the Ministry of Economy, Trade and Industry, a subcommittee on the handling of human genetic information in the 6th life science research, and a specialized committee on the way of handling personal information in the 5th medical research. , “Review of personal information protection in the Ethics Guidelines for Human Genome / Gene Analysis Research” at the 6th Personal Genetic Information Protection Subcommittee (http://www.meti.go.jp/feedback/downloadfiles/i41022cj. pdf), “linkable anonymized information that does not have a correspondence table and cannot be identified individually”. In order to effectively protect such personal information, the medical assistance information providing system of the present invention is configured not to have a correspondence table between patients and basic medical information or the like and an encryption code.

  In a preferred embodiment of the present invention, the nucleic acid analysis device as the nucleic acid analysis device acquires the nucleic acid analysis result analyzed in relation to the specific disease, drug, or treatment type as the nucleic acid analysis result.

  In another preferred embodiment of the present invention, in the nucleic acid analysis result acquisition step, the nucleic acid analysis device stores nucleic acid analysis data for each type of disease, symptom, drug, or treatment in association with patient medical data. By referring to the nucleic acid analysis database (nucleic acid analysis DB) and using analysis software using analysis parameters obtained by analyzing the data stored in the nucleic acid analysis DB, the nucleic acid state of the patient's biological sample can be determined. The analysis result is acquired. Here, after transmitting the medical assistance information, medical data obtained by the medical institution for the patient who is the target of the medical assistance information from the medical institution system, and stored in the nucleic acid analysis DB It is preferable to provide an acquisition step.

  In a preferred embodiment of the present invention, the medical data acquisition step includes anonymized medical data (anonymized medical data) that does not include personal information that can identify a specific patient among the medical data stored in the medical institution system. And the anonymized medical data is stored in the nucleic acid analysis DB.

  In a preferred embodiment of the present invention, the medical data acquisition step includes, from a medical institution system, physical information of a subject patient, a history, a hematological examination / biochemical examination / immunological examination / urinalysis / X-ray examination. As a result, medical data including the amount, frequency, number of times of medication administered to the patient, patient symptom after administration, and the like are acquired together with the patient ID encrypted by the medical institution system.

  In a preferred embodiment of the present invention, when the medical data acquisition step acquires from the medical institution system consent information indicating patient consent to register the medical data in the nucleic acid analysis DB, the medical data is stored in the nucleic acid analysis DB. Register with.

  In another preferred embodiment of the present invention, the application accepting step includes the contact information such as a telephone number, a FAX number, and an e-mail address of a medical institution and / or doctor in charge who treats the target patient from the medical institution system. The medical assistance information creation requesting step also transmits the medical institution and / or contact information of the doctor in charge obtained from the medical institution system to the expert terminal.

  In a preferred embodiment of the present invention, the application accepting step acquires anonymized data (anonymized basic medical data) that does not include personal information that can identify a specific patient as basic medical data, The medical assistance information creation request process is to send anonymized basic medical data to an expert terminal, and the medical assistance information reception process identifies a specific patient in the medical assistance information input / transmitted from the expert terminal. A personal information discriminating step for discriminating whether personal information that can be included is included at a predetermined timing, and a warning step for issuing a warning to an expert terminal when it is determined that personal information is included.

  In a preferred embodiment of the present invention, the medical assistance information receiving step provides an expert terminal with a user interface (I / F) for inputting anonymized medical assistance information that does not include patient personal information. Anonymized medical assistance information is acquired, and the medical assistance information transmission step creates medical assistance information including anonymized medical assistance information and the nucleic acid analysis result, and transmits the medical assistance information to the medical institution system. Here, the medical assistance information receiving step provides an anonymized medical assistance information input I / F and an I / F for inputting medical information containing personal information including patient personal information independently. The medical assistance information is received separately. In the medical assistance information receiving step, when the medical assistance information input from the medical assistance information I / F with personal information is obtained, the information is obtained. More preferably, it is encrypted with an encryption key acquired in advance from a medical institution and transferred to the medical institution system.

  In a preferred embodiment of the present invention, the medical assistance information receiving step includes a fixed symbol, a numerical value, a term, or a preset preset for each of a plurality of input items as an anonymized medical assistance information input I / F. It provides an I / F in which personal information cannot be input by selecting and inputting from options consisting of sentences.

  Further, in a preferred embodiment of the present invention, the anonymized medical assistance information is further associated with the anonymized medical assistance information input from the anonymized medical assistance information input I / F with the anonymized identification information of the patient. In addition to registering in the database (DB), a medical assistance information storing step of not registering medical assistance information input from the medical assistance information I / F with personal information is provided.

  Further, in a preferred embodiment of the present invention, the medical institution belongs to a group that shares medical data of a patient who has been examined at any of a plurality of medical institutions with other medical institutions via the medical institution system. The application receiving step receives an application from the system of the medical institution that the patient consulted or another medical institution to which the medical institution belongs.

  ADVANTAGE OF THE INVENTION According to this invention, the medical assistance information provision method, system, and computer program which can provide the medical doctor in charge with the medical assistance information of the expert with respect to the analysis result of the biological sample of this patient, without the personal information which can identify a specific patient Can be obtained.

Hereinafter, one embodiment of the present invention will be specifically described with reference to the drawings.
The medical support information providing system according to the present embodiment is anonymized so that a specific individual cannot be specified when acquiring basic medical information and medical information including a patient's personal information, a biological sample, etc. from a medical institution, This makes it possible to obtain the results of molecular biological analysis and specialist medical assistance information without making the patient's personal information known to a third party other than a medical institution or doctor.

(overall structure)
First, with reference to FIG. 1, the outline | summary of the medical treatment information provision scheme implement | achieved by this invention is demonstrated.

  The medical assistance information providing system denoted by reference numeral 1 in FIG. 1 is configured by one or more computer systems installed in the molecular biological analysis center 2. This system 1 is highly specialized in the computer system (medical institution system) 5 of a medical institution 4 that provides medical services to a patient 3, the treatment method of a specific disease, and the molecular biological analysis of a drug or biological sample to be administered. It is electronically connected to a doctor's terminal (expert terminal) 7 which is an expert 6 having technical knowledge through a communication network such as a dedicated line or a public line. It is assumed that a business operator (not shown) that operates the molecular biological analysis center 2 has previously concluded a contract with the medical institution 4 and the specialist 6 to provide a service by the system 1. In the following, a doctor who is an expert 6 is referred to as “specialist doctor 6”.

  The medical assistance information providing system 1 also provides an anonymized information storage logic system 8 for acquiring and registering anonymized patient information from the medical institution system 5 and an input interface for medical assistance information to the expert terminal 7. A medical assistance information generation logic system 9 that obtains medical assistance information and a personal information confirmation device 10 that monitors whether the personal information of the patient 3 is included in the medical assistance information acquired from the expert terminal 7 are provided.

  The medical institution system 5 includes a conventionally well-known electronic medical record system 12 that manages basic medical data, a patient ID anonymization device 13 that anonymizes a patient ID assigned to manage the patient 3 in the medical institution 4, And anonymized patient information input / output device 14 that anonymizes the basic medical data and patient ID and provides them to the outside. Here, the basic medical data includes information such as the age, sex, medical history, hematological examination, biochemical examination, immunological examination, urinalysis, X-ray examination, etc. of the patient 3 and information of the doctor 11 in charge. included.

  The doctor in charge 11 belonging to the medical institution 4 attaches the anonymized patient ID generated by the patient ID anonymization device 13 to the biological sample X1 including the nucleic acid collected from the patient 3 with an RNA blood collection tube for molecular diagnostic testing. Then, the data is sent to an external medical analysis institution 15 to request nucleic acid analysis by the nucleic acid analyzer 16. The medical analysis organization 15 performs nucleic acid analysis such as microarray method, PCR method, body map method, etc. on the biological sample X1 to obtain nucleic acid analysis results X2 such as transcript frequency information, specific transcript presence information, specific transcription structure information, etc. . The nucleic acid analysis result X2 is sent to the molecular biological analysis logic system 17 of the molecular biological analysis center 2 together with the anonymized patient ID.

  In the molecular biological analysis center 2, the acquired diffusion analysis result X2 is processed into information necessary for nucleic acid analysis by a nucleic acid analysis information generation program. Then, the analysis result and the basic medical data are transmitted to the expert terminal 7 to request creation of medical assistance information.

(System configuration)
Next, the configuration of the above-described medical assistance information providing system 1 will be described with reference to the functional block diagram of FIG.
The system 1 includes a CPU 21 built in a computer system of the molecular biological analysis center 2, an external storage device 24 such as a RAM 23, a ROM, an HDD, a semiconductor disk, and an input / output interface (I / F) via a system bus 22. 25 is connected. An input device 26 such as a keyboard and a mouse, an output device 27 such as a display, and a communication device 28 such as a NIC are connected to the input / output I / F 25. The external storage device 24 includes an anonymization analysis information database (DB) 30 and a program storage unit 31. Each is a certain storage area secured in the storage device 24.

  In such a hardware configuration, the operator of the molecular biological analysis center 2 operates the input device 26 to input various commands (commands), or through a communication I / F, a communication device 28, or the like. By receiving various commands from the system 5, the molecular biological analysis logic system 17, the expert terminal 7, etc., the software program installed in the storage device 24 is called and executed on the RAM 23 by the CPU 21. Thus, the functions of the present invention are achieved in cooperation with an OS (operation system).

  The anonymization analysis information DB 30 is a medical institution system 5, a molecular biological analysis logic system 17, an expert terminal via information registered at the time of contract conclusion, a result calculated by software described later, or the communication device 28. Information obtained from 7 etc. is written and updated as needed. Specifically, as shown in FIG. 3, the anonymization analysis information DB 30 stores a medical institution master table 30 a that stores information on affiliated medical institutions 4 and information on doctors 11 that belong to the medical institutions 4. And a specialist doctor master table 30c that stores information on affiliated specialist doctors 6 who request generation of medical assistance information. By managing the information of the medical institution 4, the doctor in charge 11 and the specialist doctor 6 in each master table, when the medical assistance information is newly registered (input), the related medical institution 4, the doctor in charge 11, and the specialist doctor 6 are related. Can be described by the IDs (31a to 31c) defined in each master table.

  The anonymization analysis information DB 30 includes medical institution ID 31a, doctor in charge ID 31b, anonymized patient ID 33, anonymized patient information 34, anonymization analysis information 35, anonymization analysis information 36, and specialist doctors as entry information of medical assistance information. The ID 31c and the anonymized comment 37 are stored in association with the medical assistance information request ID. Here, the anonymized patient ID 33 and the anonymized patient information 34 are information of the patient ID and basic medical data encrypted by the patient ID anonymization device 13 or the anonymized patient information input / output device 14 of the medical institution system 5, respectively. It is. Although the anonymization analysis information 35 is omitted in FIG. 1, the anonymization analysis result X2 received directly from the nucleic acid analyzer 16 is registered, and a molecular biological analysis is performed on the anonymization analysis result X2. The result X3 of the molecular biological analysis (see FIG. 7) executed by the logic system 17 is registered as anonymization analysis information 36. Furthermore, the anonymized comment 37 is medical assistance information entered by the specialist doctor 6 in the medical assistance information input interface (see FIG. 10).

  The computer program stored in the program storage unit 31 configures the computer as the anonymized information storage logic system 8, the medical assistance information generation logic system 9, and the personal information confirmation device 10 described above. Has the following functions.

  That is, the anonymized information storage logic system 8 has an application reception function 40, a nucleic acid analysis result acquisition function 41, and a medical data acquisition function 42, and a medical assistance information generation logic system 9 has a medical assistance information creation request function 43, medical assistance information. The personal information confirmation device 10 has a reception function 44 and a medical care support information transmission function 45, and a personal information monitoring function 46, respectively. Each of these functions is an independent computer program, its module, routine, etc., and is executed by the CPU 21 to configure the computer as each system or device.

  The application receiving function 40 of the anonymized information storage logic system 8 is for acquiring medical care basic data of the patient 3 from the medical institution system 5 via the communication network and receiving an application for providing medical care support information. At this time, contact information such as the telephone number, FAX number, and e-mail address of the medical institution 4 or doctor 11 in charge of the target patient 3 and access information such as accessible time are acquired together with basic medical data. The basic medical data is anonymized data (anonymized basics) so as not to include personal information that can identify the specific patient 3 by the patient ID anonymization device 13 or the anonymized patient information input / output device 14 of the medical institution system 5. Medical data).

  When receiving a request from the medical institution system 5, the application receiving function 40 assigns a medical assistance information request entry to the specialist doctor 6 registered in advance in the specialist doctor master 30c. As a result, the specialist doctor 6 can receive the notification from the anonymized information storage logic system 8 at the expert terminal 7 and can connect to the medical assistance information generation logic system 9 of the medical assistance information provision system 1. The specialist 6 refers to the medical assistance information request entry associated with his / her ID through the medical assistance information generation logic system 9 in an environment where security such as an ID and a password is secured.

  The nucleic acid analysis result acquisition function 41 is a nucleic acid analysis in which the molecular biological analysis logic system 17 analyzes the result of analysis of nucleic acid information by the nucleic acid analyzer 16 in relation to a specific disease, drug, or treatment type. The result is obtained. Specifically, the molecular biological analysis logic system 17 stores a nucleic acid analysis database (nucleic acid analysis DB) in which nucleic acid analysis data for each type of disease, symptom, drug, or treatment is associated with patient medical data. And the analysis result using the analysis parameters obtained by analyzing the data stored in the nucleic acid analysis DB is used to obtain the result of analyzing the nucleic acid state of the biological sample of the patient. The nucleic acid analysis result obtained by the nucleic acid analyzer 16 may be acquired instead of the nucleic acid analysis result.

  The medical data acquisition function 42 transmits the medical support information to the medical institution system 5, and then the medical institution 4 and the doctor 11 in charge of the patient 3 who is the target of the medical support information from the medical institution system 5. Medical treatment information obtained is obtained regularly / irregularly and stored in the anonymized information storage logic system 8. Thereby, the accuracy of the medical assistance information can be improved by verifying the effect of the medical assistance information provided and feeding back to the specialist doctor 6 as necessary.

  This medical information includes the physical information of the subject patient 3, the medical history, the results of hematology, biochemical examination, immunological examination, urinalysis, and X-ray examination, the amount of medicine administered to the patient 3, frequency, The anonymized patient information input / output device 14 stores the specific patient 3 with respect to the medical data stored in the electronic medical record system 12 or the like of the medical institution system 5. This is anonymized data (anonymized medical data) that does not contain personal information that can be identified. The medical data acquisition function 42 acquires the anonymized medical data together with the patient ID encrypted by the patient ID anonymization device 13 of the medical institution system 5. Here, some patients 3 may refuse to disclose medical information to a third party other than the medical institution 4, and therefore provide the molecular biological analysis center 2 when acquiring medical information. It is preferable to include information indicating the consent of the patient 3 to that (registration in the anonymized information storage logic system 8).

  Next, the medical assistance information creation request function 43 of the medical assistance information generation logic system 9 uses the anonymized basic medical data obtained from the medical institution system 5 and the nucleic acid analysis result obtained from the molecular biological analysis logic system 17 as the specialized information. This is transmitted to the home terminal 7 to request creation of medical assistance information for the analysis result. As described above, the basic medical care data includes information such as the contact information of the medical institution 4 in charge and the doctor 11 in charge.

  Here, the basic medical data including the personal information of the patient 3 among the information necessary for creating the medical assistance information is the medical institution system 5 by the anonymized patient information input / output device 14 every time the medical assistance information is requested. The electronic medical record system 12 is extracted and sent to the medical assistance information providing system 1 in an anonymized state. Then, as the medical assistance information request entry, these necessary information is associated with the medical assistance information request ID and the anonymized patient ID and registered in the anonymized information storage logic system 8 (see FIG. 3).

  As shown in FIG. 10, the medical assistance information receiving function 44 has a user interface (I / F) 50 a for inputting anonymized medical assistance information not including personal information of the patient 3 to the expert terminal 7. A user I / F 50b for inputting medical assistance information including personal information including patient personal information is provided independently, and the medical assistance information is obtained separately. This is due to the following reason.

  In other words, when generating medical assistance information, if there is a possibility that the molecular biological analysis result may be recognized as an abnormal value in relation to the patient's age, gender, specific disease, etc., anonymized information storage logic Only the information stored in the system 8 cannot generate sufficient medical assistance information. Therefore, the medical assistance information generation logic system 9 according to the present embodiment refers to the medical institution ID and the doctor in charge included in the medical assistance information request entry (basic medical information acquired at the time of request) and directly communicates with the doctor in charge 11. Provide an exchangeable way. Specifically, as described above, the access method according to the method defined in the medical institution master 30a or the doctor in charge 30b is presented to the expert terminal 7. The access method includes a mail address, a telephone number (extension number), an accessible time, and the like, and is presented according to priority contact means and priority contact address definition information described in the medical institution master 30a.

  On the other hand, if the specialist doctor 6 directly includes the personal information of the patient 3, which is known by directly exchanging information with the medical institution 4 or the doctor 11 in charge, in the medical assistance information as it is, The molecular biological analysis center 2 which is a three party acquires personal information, which is not preferable from the viewpoint of protecting personal information.

  Therefore, in the present embodiment, even when the specialist doctor 6 directly contacts the doctor 11 in charge and knows the personal information of the patient 3, the personal information is stored so that the personal information is not mixed in the medical assistance information. A user I / F 50a for inputting anonymized medical assistance information that is not included and a user I / F 50b for inputting medical assistance information including personal information including patient personal information are independently provided. It is possible to easily determine whether or not the information input by is stored in the anonymized information storage logic system 8. Therefore, as the user interface 50a for anonymized medical assistance information input, options such as radio buttons and pull-down menus, which are preset symbols, numerical values, terms, or sentences set in advance for each of a plurality of input items It is preferable that the setting is selected so that personal information cannot be input.

  Furthermore, the information input in any of the input fields 50a and 50b is the identification information that cannot identify the patient 3 such as a reception number after the personal information confirmation device 10 confirms whether the personal information of the patient 3 is included. They are stored in the anonymized information storage logic system 8 in association with each other. The medical assistance information determined to include personal information is not stored in the anonymized information storage logic system 8 and is not included in the medical assistance information reported to the medical institution system 5 or is previously stored. It is preferable that the data is encrypted with the encryption key acquired from the medical institution 4 and then transferred to the medical institution system 5. In addition to the medical assistance information, the doctor 11 may be notified directly, or the specialist terminal 7 may be notified that “personal information is included”.

  The medical assistance information transmission function 45 synthesizes the medical assistance information including the anonymized medical assistance information received from the expert terminal 7 and the nucleic acid analysis result obtained from the molecular biological analysis logic system 17 into a predetermined format and outputs a report. It is created and transmitted to the medical institution system 5 via the communication network. In the medical institution system 5 that has received this report, the anonymized patient information input / output device 14 and the patient ID anonymization device 13 refer to the electronic medical record system 12 and the like to identify the target patient 3 and the doctor 11 in charge. Store in the chart system 12. In addition, when the medical assistance information input to the medical assistance information I / F 50b with personal information is acquired from the expert terminal 7, the information is encrypted with the encryption key acquired from the medical institution 4 in advance. It may be transferred to the engine system 5.

  The personal information monitoring function 46 of the personal information confirmation device 10 monitors in real time whether or not the medical assistance information input / transmitted from the expert terminal 7 includes personal information that can identify the specific patient 3. Specifically, the personal information monitoring function 46 checks words (person names, etc.) that are considered to contain personal information by dictionary matching, and if text information that may be personal information is input, A function is provided that issues a warning to the terminal 7 to call attention to the specialist doctor 6. It is also possible to reject all reception of medical assistance information including personal information, or to selectively receive in consideration of the type of personal information and the relationship with medical assistance information. Further, before registering medical assistance information in the anonymized information storage logic system 8, the registered contents are stored in the terminal (not shown) of the personal information manager in the analysis center 2 registered in the medical assistance information providing system 1. A process for confirming that there is no problem may be provided. As the personal information manager, it is possible to be a specific specialist 6 who is registered to have a personal information manager in the specialist doctor master 30c.

(flowchart)
Next, specific operations of each system and apparatus will be described with reference to the flowcharts of FIGS.

  First, FIG. 4 is a flowchart illustrating an example of an anonymized patient ID generation operation in the patient ID anonymization device 13 of the medical institution system 5.

  This anonymized patient ID generation operation receives the patient ID used by the medical institution system (S1), the patient ID anonymization program operates (S2), and the value returned by this patient ID anonymization program This is output as an anonymized patient ID (S3). Here, as a method for anonymizing the patient ID in S2, for example, a random number table generation program for generating a random number table in a format that matches the format of the anonymized patient ID to be used is executed (S21), and the generated random number table is used. Anonymized patient ID is numbered (S22). As processing of this random number table generation program, for example, there is a method using Mersenne Twister (Mersenne Twister with improved initialization (2002), http://www.math.sci.hiroshima-u.ac.jp/~m -mat / MT / MT2002 / mt19937ar.html).

  The random number table generation processing by Mersenne Twister is, for example, by first setting an integer to be seed, generating one million random numbers by Mersenne Twister (S210), and converting one million random numbers to SHA (Federal Infromation Processing) Standeards Publication 180-2 2002 August 1 Announcing the SECURE HASH STANDARD http://csrc.nist.gov/ publications / fips / fips180-2 / fips180-2.pdf) (S211) A method of cutting (S212) and collecting the obtained integers to 1 million or less (S213) can be employed. Here, the step of compressing 1 million random numbers into a digest by SHA (S211) generates a 160-bit digest in the case of SHA-1, so that 5 random numbers (total 5 x 5 [byte] x 8 [ bits] = 160 bits) to generate one digest. In the step of extracting integers from the digest (S212), one digest is divided every 20 bits to generate eight integers. Further, in the step of collecting the obtained integers to 1 million or less (S213), since the maximum value of the generated integers is 1,048,576, an integer of 1 to 1 million is shuffled using a value of 1 million or less. Here, 1.6 million 20-bit integers are generated, but only halfway are used.

  FIG. 5 is a flowchart of a process in which the patient ID anonymization device 13 of the medical institution system 5 compares the anonymized patient ID with the patient ID. Before describing this process, first, a method for managing an anonymized patient ID will be described.

  When the specialist doctor 6 creates (inputs) the medical assistance information and directly inquires the doctor 11 in charge of the symptoms of the patient 3, the specialist physician 6 uses the patient ID anonymization device 13 of the medical institution system 5. Since only the anonymized patient ID can be acquired, the medical institution system 5 side needs to specify the patient 3 to be inquired from the anonymized patient ID.

  As a method for that purpose, for example, a first method for storing the anonymized patient ID generated by the patient ID anonymization device 13 in the electronic medical record system 12 or the like as a part of the medical record information and referring to this, or medical record information Separately, the medical institution system 5 stores a correspondence table between anonymized patient IDs and patient IDs and refers to this, or a series of using a connectable anonymization algorithm in the patient ID anonymization device 13 A third method may be considered in which a candidate patient ID is anonymized to generate a plurality of anonymized patient IDs, and a search is made for a match with the anonymized patient ID to be inquired.

  The first method can be said to be preferable from the viewpoint of personal information protection because the anonymized patient ID can be managed with the same security as the patient ID and other personal information stored in association with the patient ID. However, it is necessary to separately construct a mechanism for storing the anonymized patient ID linked to the patient ID in the medical institution system 5 and managing it so that it can be used. There is a problem that the running cost increases.

  Moreover, since the second method can be managed independently of the existing system in the medical institution 4 such as the electronic medical record system 12, the problem at the time of introduction is solved. However, the running cost problem of strict management of personal information remains.

  On the other hand, in the third method, it can be introduced and managed independently from the medical institution system 5, and the patient ID anonymization device 13 itself and the anonymization parameters used in this patient ID anonymization device 13 can be managed individually. Since information security can be easily maintained, running costs can be kept low.

  FIG. 5 shows processing of a management technique using such a connectable anonymization algorithm. In this method, after acquiring the anonymized patient ID (S40), the medical institution system 5 extracts a set of target patient IDs as candidates (S41). For example, in response to an inquiry from a specialist doctor 6, a set of IDs of all patients 3 in charge of the doctor 11 is acquired from the electronic medical record system 12 etc. based on the ID of the doctor 11 in charge included in the basic medical information. To do. The extracted candidate patient IDs are taken out one by one (S42), processed by the anonymization program of the patient ID anonymization device 13 (S43), and the anonymized patient ID is acquired (S44). If the obtained anonymized patient ID does not match the first anonymized patient ID (inquiry target ID), the next patient ID is processed (No in S45), and if it matches (Yes in S45). The patient ID being processed is answered (output) (S46).

FIG. 6 is a flowchart showing the operation of the anonymized patient information input / output device 14 of the medical institution system 5.
When this anonymized patient information input / output device 14 receives the ID of the patient 3 input from a terminal connectable to the medical institution system 5 by the doctor 11 in charge of acquiring medical support information for the patient 3 in charge (S50), A patient ID is passed to the patient ID anonymization device 13 to obtain an anonymized patient ID (S51). Subsequently, the patient's basic medical care information corresponding to this patient ID is acquired from the medical institution system 5 (electronic medical chart system 12) (S52), and anonymized patient ID and medical assistance information request ID are attached to this information. Anonymized patient information is generated (S53) and transmitted to the anonymized information storage logic system 8 of the medical care support information providing system 1 (S54).

  FIG. 7 is a flowchart showing the operation of the molecular biological analysis logic system 17. In the following example, unlike FIG. 1, the anonymized information storage logic system 8 of the medical assistance information providing system 1 first receives and stores the nucleic acid analysis result transmitted from the nucleic acid analyzer 16 of the medical analysis institution 15; The case where the anonymized information storage logic system 8 requests the molecular biological analysis logic system 17 to perform analysis will be described.

  First, when the anonymized information storage logic system 8 receives a medical assistance information request entry, information (see FIG. 3) including a medical assistance information request ID 32 and anonymized analysis information 35 (analysis result X2) as a nucleic acid analysis request record. This is sent to the molecular biological analysis logic system 17. Upon receiving this nucleic acid analysis request record (S60), the molecular biological analysis logic system 17 takes out the nucleic acid analysis result from the nucleic acid analysis request record (S61), and performs analysis using the nucleic acid analysis database 60 by the nucleic acid analyzer. Execute (S62), and return the obtained nucleic acid analysis result to the anonymized information storage logic system 8 (S63).

  Here, as nucleic acid analysis, for example, drug effect prediction based on transcript frequency information, specific transcript existence information, specific transcription structure information, disease possibility survey, health / disease status survey, disease risk survey, recurrence possibility There are investigations.

  For example, in one example of drug effect prediction, statistics are obtained based on transcript frequency information and drug effect information in a biological sample of a patient whose drug effect is collected in advance and stored in the nucleic acid analysis database 60. The discriminator generated by the biological analysis can be configured as this nucleic acid analyzer, and it is valid, invalid, or indistinguishable as a prediction of the effect in drug administration from the transcript frequency in the biological sample of the target patient 3 related to the request for medical assistance information This determination is performed.

FIG. 8 is a flowchart for acquiring information in the nucleic acid analysis database 60.
The transcript frequency information and the drug effect information stored in the nucleic acid analysis database 60 are generated by a process independent of the generation of medical assistance information for the patient 3.

  As a typical example, information stored in the electronic medical record system 12 of the medical institution system 5 can be used as information for the nucleic acid analysis database 60. In addition to unspecified patient information and nucleic acid analysis information, this system 1 also includes information on the results of medical care performed based on the medical support information provided by 1. That is, information on a patient who has been subjected to nucleic acid analysis in the past is used for the current medical care, and the provision of information is premised on the consent of the patient (informed consent). Therefore, in the acquisition of information for the nucleic acid analysis database, a process for confirming the presence or absence of the consent document of the target patient 3 is prepared after the input of the target patient ID (S70) (S71). Also, since it is necessary to anonymize personal information for the patient 3 who has agreed to provide information, after the acquisition of anonymized patient ID (S72), acquisition of patient information (S73), and acquisition of medical treatment result information (S74) The anonymized patient information is generated (S74) and sent to the molecular biological analysis logic system 17 in the same manner as the request for medical assistance information.

  Anonymized patient information sent to the molecular biological analysis logic system 17 is accumulated in the nucleic acid analysis database 60, and statistical analysis such as discriminant analysis is performed by the nucleic acid analysis information generation program 61 periodically or according to a predetermined schedule. It is processed into information necessary for nucleic acid analysis by other methods.

FIG. 9 is a flowchart showing the operation of the medical assistance information generation logic system 9.
The specialist 6 accesses the medical assistance information generation logic system 9 from the expert terminal 7 in a situation where security is ensured, such as login by inputting a user ID or password from a specific IP address or domain.

  Upon receiving access from the expert terminal 7, the medical assistance information generation logic system 9 acquires the medical assistance information request entry assigned to the specialist doctor 6 from the anonymized information storage logic system 8 (S80). Thereby, the specialist doctor 6 can browse the medical assistance information request entry on the expert terminal 7 on the display (S81), and considers from an expert viewpoint with reference to the anonymized patient information and the anonymized analysis information. First, the result of the consideration is input to a standard comment input box or the like provided by the medical assistance information generation logic system 9 shown in FIG. 10 (S82), and further, it is determined whether it can be explained only by the standard comment (S83). ) If it is not possible to explain only by the standard comment (No in S83), it is determined whether or not consultation with the doctor 11 is necessary (S84).

  When consultation with the doctor 11 is necessary (Yes in S84), consultation with the doctor 11 is performed by e-mail or telephone according to the user interface provided by the medical assistance information generation logic system 9 (S85). When consultation with the doctor in charge 11 is not necessary (No in S84), only the judgment of the specialist doctor 6 is performed. When consultation with the doctor in charge 11 is performed, the determination result based on the consultation is generated as shown in FIG. It inputs into the free comment input column which the user interface which the logic system 9 provides provides (S86). When a free comment is input, it is assumed that the personal information of the patient 3 acquired by the specialist doctor 6 in the process of discussion with the doctor 11 is mixed in the comment. Therefore, while such a free comment is transmitted from the medical assistance information generation logic system 9 to the anonymized information storage logic system 8, the personal information confirmation device 10 confirms that the personal information of the patient 3 is not included. (S87). If there is no problem, an anonymized comment is registered in the anonymized information storage logic system 8 in association with the medical assistance information request entry (S88).

(Medical assistance information generation user I / F)
Finally, an example of the medical assistance information generation user I / F will be described with reference to FIG. This medical assistance information generation user I / F 70 mainly includes a standard comment input field 71, anonymization free comment input field 72, a non-anonymization free comment input field 73, a medical assistance information request entry information display field 74, and medical assistance information generation. It comprises a logical system information display field 75, a send button 76, and a cancel button 77.

  The fixed comment input column 71 provides a user interface for inputting a fixed comment provided by the medical assistance information generation logic system 9. Among the standard comments, there are those in which the medical assistance information generation logic system 9 sets values in advance and asks the specialist 6 for confirmation or sets them as default values. In the question item 1 in the figure, the medical assistance information generation logic system 9 sets and displays a prescribed value based on the anonymized analysis information. In addition to setting a value to the radio button in advance, it should be clearly indicated by an asterisk or the like so that the specified value set by the medical assistance information generation logic system 9 can be identified even when the specialist 6 changes the value. Is desirable.

  As for the item for which the specialist 6 is requested to input, the default value is not set as in the example of the question item 2 in the figure, and the transmission cannot be made until any option (value) is selected. desirable.

  In the anonymization free comment input field 72 and the non-anonymization free comment input field 73, an anonymization free comment input field 50a and a non-anonymization free comment input field 50b are prepared, respectively, and the specialist 6 inputs a free comment. Is possible. Thus, by explicitly dividing the free comment input field into anonymization and non-anonymization, it is possible to make the specialist 6 recognize the handling of anonymized information and non-anonymized information. In the non-anonymization free comment input field 73, an information type selection input menu 78 and an information destination selection menu 79 are further provided. The information type selection input menu 78 enables selection of what kind of content the non-anonymized information includes. For example, when non-anonymized information is sent by e-mail to the terminal of the doctor 11 in charge or the medical institution system 5, an e-mail subject is automatically generated based on the type of information selected from the information type selection input menu 78. It is desirable. In the information destination selection menu 79, the destination of non-anonymized information can be selected based on the information defined in the medical institution master 30a and the doctor in charge master 30b of the anonymized information storage logic system 8.

  The medical assistance information request entry information display column 74 displays information related to the medical assistance information request entry currently being processed.

  The medical assistance information generation logical system information display column 75 displays information on the specialized doctor 6 who is logged in and managed by the anonymized information storage logical system 8 and system management information related to the medical assistance information providing system 1.

  Information input by the user I / F 70 can be transmitted by a transmission button 76 or canceled by a cancel button 77.

(Modification)
In addition, this invention is not limited to above-described embodiment, A various deformation | transformation is possible.

  For example, in the above-described embodiment, the specialist doctor 6 for each disease is illustrated as an expert. However, a researcher or a technician other than a doctor such as a university or a research institution specialized in analysis and analysis of molecular information may be used. . In addition, medical assistance information may be requested from a plurality of specialists. In this case, a “second opinion” can be obtained by requesting a plurality of experts in the same field, or comments can be obtained from a plurality of experts in different fields. Furthermore, if the expert 6 belongs to a university or research institution and is in an environment where analysis can be performed with a molecular biological analysis system, the basic medical information and the nucleic acid analysis result are transmitted to the expert terminal 7, It is also possible for the expert 6 to acquire analysis results as necessary and generate medical assistance information based on the analysis results.

  In addition, the medical institution 4 may belong to a group that shares medical data of patients who have received medical examinations at any of a plurality of medical institutions with other medical institutions via the medical institution system. In this case, the application acceptance function 40 of the present system 1 accepts an application from the system of the medical institution 4 where the patient 3 consulted or another medical institution to which the medical institution 4 belongs.

Furthermore, the processes performed in the molecular biological analysis center 2, the medical institution system 5, and the medical analysis institution 15 according to the equipment in each facility, cost burden, responsibility sharing, business form, business development, etc. are as follows. It can also be changed.
1) The nucleic acid analyzer 16 is installed in the medical institution system 5, and both the nucleic acid analysis result and the basic medical care data of the patient are transmitted from the medical institution system 5 to the medical care support information providing system 1.
2) The nucleic acid analyzer 16 is installed in the molecular biological analysis center 2, and the biological sample X1 of the patient 3 collected in the medical institution 4 is obtained offline, and the nucleic acid analysis is performed in the molecular biological analysis center 2. Run.
3) Anonymized information storage logic system 8, medical assistance information generation logic system 9, and personal information confirmation device 10 of this system 1 are installed in medical institution 4. Only the scientific analysis logic system 17 is installed. Also in this case, only the anonymized patient ID and patient information are transmitted from the medical institution system 5 to the system 1.
4) As in the above-described embodiment, the external medical analysis institution 15 executes the nucleic acid analysis. However, the analysis result is once returned to the medical institution system 5, and both the nucleic acid analysis result and the basic medical care data of the patient are The information is transmitted from the institution system 5 to the medical assistance information providing system 1.

FIG. 1 is a diagram showing a network configuration according to an embodiment of the present invention. FIG. 2 is a block diagram showing a schematic configuration of the medical assistance information providing system. FIG. 3 is a diagram schematically illustrating the configuration of data stored in the anonymization analysis information DB. FIG. 4 is a diagram showing an operation flow of the patient ID anonymization apparatus. FIG. 5 is a diagram showing a process of matching processing between an anonymized patient ID and a patient ID. FIG. 6 is a diagram showing an operation flow of the anonymized patient information input / output device. FIG. 7 is a diagram showing an operation flow of the molecular biology analysis logic system. FIG. 8 is a diagram showing a flow of constructing a nucleic acid analysis database. FIG. 9 is a diagram showing an operation flow of the medical assistance information generation logic system. FIG. 10 is a diagram showing an example of a user interface of the medical assistance information generation logic system.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 ... Medical assistance information provision system 2 ... Molecular biological analysis center 3 ... Patient 4 ... Medical institution 5 ... Medical institution system 6 ... Expert (specialist)
7 ... Expert terminal 8 ... Anonymized information storage logic system 9 ... Medical assistance information generation logic system 10 ... Personal information confirmation device 11 ... Doctor in charge 12 ... Electronic medical record system 13 ... ID anonymization device 14 ... Anonymized patient information input / output Device 15 ... Medical analyzer 16 ... Nucleic acid analyzer 17 ... Molecular biological analysis logic system 21 ... CPU
22 ... System bus 23 ... RAM
24 ... External storage device 25 ... Input / output interface 26 ... Input device 27 ... Output device 28 ... Communication device 30 ... Anonymized analysis information database (DB)
30a ... Medical institution master table 30b ... Doctor in charge master table 30c ... Specialized doctor master table 31 ... Program storage unit 31a ... Medical institution ID
31b ... Doctor ID
31c ... Specialist doctor ID
32 ... Medical assistance information request ID
33 ... Anonymized patient ID
34 ... Anonymized patient information 35 ... Anonymized analysis information 36 ... Anonymized analysis information 37 ... Anonymized comment 40 ... Application acceptance function 41 ... Nucleic acid analysis result acquisition function 42 ... Medical data acquisition function 43 ... Medical assistance information creation request function 44 ... Medical assistance information reception function 45 ... Medical assistance information transmission function 46 ... Personal information monitoring function 50a ... Anonymization free comment input field 50b ... Non-anonymization free comment input field 60 ... Nucleic acid analysis database 61 ... Nucleic acid analysis information generation program 71 ... Standard comment input field 72 ... Anonymization free comment input field 73 ... Non-anonymization free comment input field 74 ... Medical assistance information request entry information display field 75 ... Medical assistance information generation logic system information display field 76 ... Send button 77 ... Cancel button 78 ... Information type selection input menu 79 ... Information destination selection menu

Claims (16)

A computer system of a medical institution that provides medical services to a patient, the means for storing anonymized data (anonymized basic medical data) that does not include personal information that can identify a specific patient, and a biological sample of the patient A medical institution system having means for attaching an anonymized patient ID ;
A communication terminal (expert terminal) of an expert who has a high degree of expertise in the treatment method of a specific disease and the molecular biological analysis of a drug and / or biological sample to be administered;
A method performed by each connectable diagnosis support information providing system through the communication network,
A computer of the medical assistance information providing system,
An application receiving step for receiving the application for provision of medical assistance information by acquiring the anonymized basic medical data from the medical institution system via a communication network;
A nucleic acid analysis result acquisition step for acquiring a result obtained by analyzing a nucleic acid information together with the anonymized patient ID for a biological sample including a patient's nucleic acid collected at a medical institution;
A medical assistance information creation requesting step for requesting creation of medical assistance information for the analysis result by transmitting the obtained nucleic acid analysis result and the anonymized basic medical data to the expert terminal;
Medical assistance information that provides a user interface (I / F) for inputting anonymized medical assistance information that does not include patient personal information to an expert terminal and receives anonymized medical assistance information for a nucleic acid analysis result Receiving process;
A medical assistance information transmission step of creating medical assistance information including the received anonymized medical assistance information , the nucleic acid analysis result, and the anonymized patient ID , and transmitting the medical assistance information to a medical institution system via a communication network. And how to. The method of claim 1, comprising:
The nucleic acid analysis result acquisition step is characterized in that a nucleic acid analysis device as a nucleic acid analysis device acquires a nucleic acid analysis result analyzed in relation to a specific disease, drug, or treatment type as a nucleic acid analysis result. how to. The method of claim 2, comprising:
In the nucleic acid analysis result acquisition step, the nucleic acid analysis device refers to a nucleic acid analysis database (nucleic acid analysis DB) in which nucleic acid analysis data for each type of disease, symptom, drug, or treatment is stored in association with patient medical data. At the same time, using analysis software using analysis parameters obtained by analyzing the data stored in the nucleic acid analysis DB, the result of analyzing the nucleic acid state of the patient's biological sample is acquired. A method characterized by. The method of claim 3, comprising:
Further, after transmitting the medical assistance information, obtaining medical data obtained by the medical institution for the patient who is the target of the medical assistance information from the medical institution system and storing it in the nucleic acid analysis DB A method characterized by comprising a process. The method of claim 4, comprising:
The medical data acquisition step acquires anonymized medical data (anonymized medical data) that does not include personal information that can identify a specific patient among the medical data stored in the medical institution system. A method characterized by storing data in the nucleic acid analysis DB. The method of claim 4, comprising:
The medical data acquisition process includes the physical information of the subject patient, the past history, the results of hematological examination / biochemical examination / immunological examination / urinalysis / X-ray examination, and the drug administered to the patient from the medical institution system. Obtaining clinical data including the amount, frequency, number of times, patient symptoms after administration, etc. together with the patient ID encrypted by the medical institution system. The method of claim 4, comprising:
The medical data acquisition step is characterized by registering the medical data in the nucleic acid analysis DB when acquiring consent information indicating patient consent to register the medical data in the nucleic acid analysis DB from a medical institution system. Method. The method of claim 1, comprising:
The application receiving step acquires from the medical institution system the contact information such as the telephone number, FAX number, and e-mail address of the medical institution and / or doctor in charge who treats the target patient together with the anonymized basic medical data. And
In the medical assistance information creation requesting step, the contact information of the medical institution and / or the doctor in charge acquired from the medical institution system is also transmitted to the expert terminal. The method of claim 1, comprising:
Before Symbol medical auxiliary information receiving process,
A personal information determination step for determining at a predetermined timing whether or not the medical assistance information input / transmitted from the expert terminal includes personal information that can identify a specific patient;
A warning step of issuing a warning to an expert terminal when it is determined that personal information is included. The method of claim 1 , comprising:
The medical assistance information receiving step independently provides an I / F for anonymized medical assistance information input and an I / F for inputting medical assistance information including personal information including patient personal information. Ru der configured to acquire medical auxiliary information separated,
A method characterized by that. The method of claim 10, comprising:
In the medical assistance information receiving step, when medical assistance information inputted from the medical assistance information I / F containing personal information is acquired, the information is encrypted with an encryption key acquired in advance from the medical institution. Transferring to a system . The method according to claim 11,
In the medical assistance information receiving step, an anonymized medical assistance information input I / F is selected and input from a choice of a fixed symbol, numerical value, term, or sentence set in advance for each of a plurality of input items. A method of providing an I / F in which personal information cannot be input. The method of claim 10,
Further, the anonymized medical assistance information input from the anonymized medical assistance information input I / F is associated with the anonymized identification information of the patient and is registered in the anonymized medical assistance information database (DB). A method comprising a medical assistance information storing step of not registering medical assistance information input from medical assistance information I / F with information. The method according to claim 1,
The medical institution belongs to a group that shares medical data of patients who have been examined at any of a plurality of medical institutions with other medical institutions via the medical institution system,
The application accepting step accepts an application from a system of a medical institution where the patient consulted or another medical institution to which the medical institution belongs. A computer system of a medical institution that provides medical services to a patient, the means for storing anonymized data (anonymized basic medical data) that does not include personal information that can identify a specific patient, and a biological sample of the patient A medical institution system having means for attaching an anonymized patient ID ;
A communication terminal (expert terminal) of an expert who has a high degree of expertise in the treatment method of a specific disease and the molecular biological analysis of a drug and / or biological sample to be administered;
A medical assistance information providing system that can be connected to each other via a communication network,
Application accepting means for obtaining the anonymized basic medical data from the medical institution system and accepting the application for providing medical assistance information via the communication network;
Nucleic acid analysis result acquisition means for acquiring a result obtained by analyzing a nucleic acid information together with the anonymized patient ID for a biological sample containing a patient's nucleic acid collected at a medical institution;
Medical assistance information creation requesting means for requesting creation of medical assistance information for the analysis result by transmitting the obtained nucleic acid analysis result and the anonymized basic medical data to the expert terminal;
Medical assistance information that provides a user interface (I / F) for inputting anonymized medical assistance information that does not include patient personal information to an expert terminal and receives anonymized medical assistance information for a nucleic acid analysis result Receiving means;
Medical assistance information transmitting means for creating medical assistance information including the received anonymized medical assistance information , the nucleic acid analysis result, and the anonymized patient ID , and transmitting the medical assistance information to a medical institution system via a communication network. System. A computer system of a medical institution that provides medical services to a patient, the means for storing anonymized data (anonymized basic medical data) that does not include personal information that can identify a specific patient, and a biological sample of the patient A medical institution system having means for attaching an anonymized patient ID ;
A communication terminal (expert terminal) of an expert who has a high degree of expertise in the treatment method of a specific disease and the molecular biological analysis of a drug and / or biological sample to be administered;
A computer program stored in a storage device of a computer system connectable via a communication network to cause the computer system to execute processing for providing medical assistance information,
An application receiving step for receiving the application for provision of medical assistance information by acquiring the anonymized basic medical data from the medical institution system via a communication network;
A nucleic acid analysis result acquisition step for acquiring a result obtained by analyzing a nucleic acid information together with the anonymized patient ID for a biological sample including a patient's nucleic acid collected at a medical institution;
A medical assistance information creation requesting step for requesting creation of medical assistance information for the analysis result by transmitting the obtained nucleic acid analysis result and the anonymized basic medical data to the expert terminal;
Medical assistance information that provides a user interface (I / F) for inputting anonymized medical assistance information that does not include patient personal information to an expert terminal and receives anonymized medical assistance information for a nucleic acid analysis result Receiving process;
Creating a medical assistance information including the received anonymized medical assistance information , the nucleic acid analysis result, and the anonymized patient ID , and transmitting the medical assistance information to the medical institution system via a communication network. A computer program characterized by the above.

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