Opinion How to make the Next Generation Medical Infrastructure Act a better system

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The Office of Pharmaceutical Industry Research Norihiro Okada, Senior Researcher

Introduction

The Act on Anonymously Processed Medical Information for the Purpose of Contributing to Research and Development in the Medical Field (Next Generation Medical Infrastructure Act), which went into effect in May 2018, was promulgated in May 2023 as a revised law after discussions in the Next Generation Medical Infrastructure Act Study Working Group based on the provision in the supplementary provisions of the Act for review five years after its enforcement. The three points of amendment, "1. establishment of a mechanism for the utilization of pseudonymized medical information," "2. linkage with public databases such as NDB," and "3. cooperation with measures to promote the utilization of medical information," all promote research and development using medical information and are expected to expand its utilization in the ^future1). On the other hand, the issues resolved by this revision are only a limited part of the diverse matters discussed within the working group, and we believe that continued discussion by each stakeholder will be necessary after the revision in order to establish a system that facilitates the use of medical information in Japan. This paper summarizes the issues that are expected to be discussed in the future, corresponding to the flow of information based on this revision.

Figure 1 shows the information flow in the Next Generation Medical Infrastructure Act and the five classifications based on the information flow used to organize the issues in this paper. In the figure, "(1) Information generation" refers to the flow of information when medical institutions and local governments obtain medical information of citizens, and "(2) Information aggregation" refers to the flow of information when medical institutions and local governments obtain information held by them from certified anonymized processed medical information creators or certified pseudonymized processed medical information creators (hereinafter referred to as "certified creators" in this paper) under the Next Generation Medical Infrastructure Act. (iii) "Provision of processed medical information" refers to the flow of information when the authorized processor provides anonymized processed medical information or pseudonymized processed medical information to academic institutions or private companies, (iv) "Creation of results" is categorized as the return of research results obtained from medical information to society, and other matters concerning the optimization of the overall system and appropriate use of information are categorized as "v) Overall system" and "vi) Information flow". Other matters related to the optimization of the overall system and appropriate use of information shall be organized as "5) Overall system".

Prior to each issue, Table 1 shows the results of tabulating the issues discussed in the 7th working group where this amendment proposal was presented, the Council on Infrastructure for Utilization of Health and Medical Data, the conference body that established the working group, and in the process of deliberations in the Diet, by tying them to the above classifications. The matters mentioned in these meetings were mainly opinions regarding the correction of issues that had arisen prior to the revision and opinions regarding the measures to be taken after the revision, indicating that opinions were expressed in full throughout the entire flow of information. In particular, many committee members and councilors pointed out issues that were not included in the current revision, such as requests for the expansion of data that can be provided to certified providers, requests for ensuring the reliability of information, and requests for public relations activities to improve understanding of the system among the public, medical institutions, and local governments, and continued consideration is desired.

From the following section, the current situation and issues based on the current amendments are presented for reference in the ongoing discussion for more active use of medical information under the Next Generation Medical Infrastructure Act, and the author, as a person who wishes to promote decision-making using medical information in drug development and medical policy, will present the following points based on the records of past meetings and other bodies. The direction that the author considers desirable is shown along the flow of information in the system (Table 2). For each item, in addition to the issues that need to continue to be considered based on the discussions that took place in the process of this legal revision, including the statements introduced in Table 1, the author selected items that are thought to be relevant in the future to the government's promotion of DX in the medical field.

(1) Information generation

①-1 Protection of the rights of information providers

Current Status and Issues

The issue of protecting the rights of information providers is one of the most important issues when medical information is used for research, and is being discussed not only in the Next Generation Medical Infrastructure Act but also in various other situations where medical information is used. Under the Next Generation Medical Infrastructure Act, it is possible for medical institutions, etc. to provide medical information, which is personal information requiring special consideration, to certified preparation business operators through careful opt-out (i.e., the person who received the notice in advance or his/her surviving family members do not request the suspension) that meets certain requirements (such as notification using documents). This means that medical information can be used for research without the need for opt-in (prior consent by the person in question). The necessity of the provider's involvement when medical information is used for research is judged from the perspective of whether or not the individual provider can be identified from the information used, and opt-in is required for the use of genetic information such as whole exome sequencing, which falls under personal identification code.

In the current revision, the use of pseudonymized processed medical information is newly permitted under the Next Generation Medical Infrastructure Act on an opt-out basis. Pseudonymous processed medical information is defined as information that has been processed in such a way that individuals cannot be identified unless it is cross-checked with other information, and detailed medical information such as information on specific clinical laboratory values and the names of rare diseases, which were previously not available with anonymized processed medical information, can now be used, thus increasing the risk of individual identification. During the Diet session in which the amendment was discussed, there were also discussions from the perspective of whether the rights of providers would be adequately protected by opting ^{out2) 3)}. With regard to the identifiability of individuals in medical information used for research, it depends on the characteristics of the information handled and the progress of information technology for information protection. It is necessary to continuously examine the appropriate balance between the usefulness of information and the protection of personal information when conducting research.

Desired direction of consideration

The fact that more detailed medical information can now be used for research and development, with personal information protected, as a result of the availability of pseudonymized processed medical information is a desirable direction. In the future, when the expansion of information including the use of genetic information, which was requested in the discussion of the revision, and the consideration of the bias that the suspension of use by opt-out may have on research results, it will be necessary to prepare appropriate responses in each case, taking into consideration the characteristics of the information to be handled and the protection of personal information. Figure 2 provides a simplified summary of options for protecting the rights of informants and their impact on research. This consideration is not limited to Japan, but also arises in the European Health Data Space (EHDS), a proposed regulation on health data in Europe. There are two major opinions: those of patient groups and others who want to adopt opt-in or opt-out to create an environment in which they can manage their own information, ⁴⁾ and those of medical and healthcare-related organizations who express concern about the adoption of opt-out in consideration of its impact on research results ^.5) Thus, the protection of the rights of information providers is an issue that is always under consideration when medical information is used for research, as it is very difficult to reach a conclusion that is acceptable to a wide variety of positions. In order to collect the detailed medical information sought by users, it is essential to continuously examine measures to gain the trust of the public, who will be the providers of the information.

Transparency of information use

Current Status and Issues

It is important to make the public, the providers of information, understand the purpose of the system and to try to dispel their concerns about providing information in order to encourage their active cooperation with the system. In research using medical information, there has been an increase in activities to inform information providers of what purposes their own medical information is used for and by whom, and how their personal information is protected through what kind of processing. Such efforts are expected to improve the public's understanding of the system, increase transparency in the use of information, and reduce opt-out It is believed that this will also lead to a reduction in the number of stops using the system.

At present, the utilization results of the Next Generation Medical Infrastructure Act are posted on the websites of the respective accredited preparers, and although the scope of public information differs depending on the accredited preparer, the names of issues, information utilized, and companies applying for use are publicly available. In the case of domestic biobanks that handle similar information, 8 out of 12 institutions disclose the name of the research proposal that used the information and 7 out of 12 institutions disclose the name of the organization to which the information was provided on their ^websites6) (as of February 2021).

Desired direction of consideration

In order to improve the public's understanding of the system and increase transparency in the use of information, it is desirable to continue disclosing information in easily accessible locations. In the European Opinion on Opt-in or Opt-out for EHDS, it is required that the status of one's own medical information use be made available, and disclosure of the status of use is considered to ensure public ^confidence4). The information to be disclosed may include information related to competitive areas in which companies using the information wish to keep the research content private, and careful consideration is required regarding the scope and method of disclosure.

In addition, by allowing the use of pseudonymized medical information, authorized pseudonymized medical information creators will be able to track whose information was provided, for what purpose, and to which research institutions. Although the current revision does not permit the identification of individuals except when responding to investigations by review organizations for pharmaceutical affairs examinations, in the future, as an activity to increase the transparency of information use, it may be possible to provide information to individuals or to research organizations in cooperation with medical information sharing via MyNa Portal, ⁷⁾ which is promoted by the Ministry of Health, Labor and Welfare, as an activity to increase the transparency of information use. The introduction of bi-directional communication, such as that being considered for biobanks, could also be ^considered8). If such functions are realized in the future, feedback to individuals of research results conducted at the UK Biobank and requests for participation by the public in obtaining additional information, such as quality of life surveys required by users in their individual research, will also be possible through the authorized creation business entity, in a form that does not identify users as individuals. This may expand the options for the use of medical information.

(1)-3 Management of information provision status

Current Status and Issues

The Next Generation Medical Infrastructure Act also cites as a major advantage the fact that when an individual uses multiple medical institutions, etc., the information can be consolidated as the information of the same person by an accreditation creation business entity. Assuming such a situation, the public will receive explanations about opting out at each medical institution, municipality, etc. Medical institutions would also need to manage patients notified of the system and those not yet notified of the system, as well as complicated management procedures such as opt-out suspension procedures for both anonymized and pseudonymized processed medical information. The working group also called for reducing the burden by simplifying opt-out notification at medical institutions, but no change in policy was made during the consideration of this revision.

Desired direction of consideration

Currently, there is a need to improve the public's understanding of the system, and careful explanation is required. In the future, however, there may be a shift to an environment where notification and opt-out suspension can be managed on a national basis, rather than on a per medical information handling business entity basis (Figure 3). In the primary use of medical information, plans have already been made to make it possible to manage consent for sharing information with other medical institutions through Mynaportal, and it is hoped that following this method of management in the secondary use of medical information will help reduce the burden on information providers and medical ^{institutions9)}. At the current stage, when the number of medical information handlers participating in the system is limited, the information that can be consolidated is limited. In order to maximize the benefits of the Next Generation Medical Infrastructure Act, priority should be given to expanding the number of participating medical information handlers as described in (2)-2 below. However, for the future expansion of this system, we believe that this is an important issue for reducing the burden on both the citizens, who are information providers, and medical institutions, who are responsible for managing medical information. In linking diverse medical information, the collective management of individual information will be effective in identifying the names of citizens. The MHLW's conference body has presented the use of an online eligibility verification infrastructure for name identification in the Next Generation Healthcare Infrastructure Act as a possible ^example10). The fact that information providers have a common ID is also considered to be highly beneficial in using information derived from a wide range of sources (see ②-1 below).

(ii) Aggregation of information

(2) 1-1 The ideal state of authorized preparers

Current Status and Issues

Under the current operation of the Next Generation Medical Infrastructure Act, in general, information held by one medical information handling business operator is provided to users via only one authorized creation business operator. As of May 2023, the electronic medical record data and receipt data, which are mainly used at present, are provided by multiple accredited data providers, making it difficult for users to determine which accredited data provider has a high affinity with the information they wish to conduct research on. The working group has also expressed the opinion that the number of accredited preparers should be increased in order to increase the volume and types of information to be handled. On the other hand, if the current operation is continued, medical information will become more unevenly distributed as the number of accredited preparers increases, so it is necessary to consider how to manage information when the number of accredited preparers increases.

Desired direction of consideration

The working group also called for the publication of a data catalog to make it easier for users to search for the type and amount of information available. From the viewpoint of improving accessibility to information, it would be desirable to construct such a system to enable users to search for information held by each certified biobank, not by each certified biobank, but as a cross-search system among information managers (certified biobanks), as was created in the AMED's Biobank Utilization Program for Realizing Genomic Medicine11) . ¹¹⁾.

Furthermore, from a long-term perspective, in order to create more accurate research results using exclusively available information, it is necessary to centralize the collection of basic information such as electronic medical record data and receipt data into a national medical information platform, as planned in the promotion of medical DX, and to examine the possibility of information linkage among certified preparation providers. We believe it is necessary to consider the possibility of information linkage. The aggregation method to date has been to have accredited creation providers collect information based on a specific type of information. However, in the case where clinical information outcomes are required for research using imaging information, or where a variety of information needs to be combined for analysis, such as in research to confirm prognosis after drug administration, it is necessary to use the information as information that can be tracked on an individual basis, rather than as a specific type of information. It is desirable that the information be aggregated as information that can be traced over the life course of an individual, rather than a specific type of information (Figure 4). In order to achieve the ideal situation where such diverse information becomes available, it is expected that the system will be designed so that medical information provided by multiple authorized creation providers can be consolidated and used for research purposes according to the purpose of use. The transfer of medical information to and from other accredited preparation providers is envisaged in the current law, and is made possible by concluding a contract. The centralized management of information provision status indicated in (1)-3 is also expected to contribute to the realization of these, and it would be desirable to proceed with the study in conjunction with the management of information based on the individual.

2-2 Promotion of medical information provision

Current Status and Issues

As of May 2023, there were only 110 businesses handling medical information cooperating with the Next Generation Medical Infrastructure Act, and during discussions in the working group and the Diet, it was pointed out that the number of medical institutions providing information was low. In light of this situation, the current revision stipulates that business operators handling medical information shall endeavor to cooperate with national policies by providing medical information, etc. In research using medical information, a certain number of research subjects is required in order to draw more generalizable conclusions. Even in research with a limited number of subjects, such as research to detect rare diseases or the risk of side effects of certain drugs, the cooperation of a larger number of medical institutions will be necessary to make the information provided by this system available.

Desired direction of consideration

The newly added article in the amendment makes the provision of medical information an obligation of effort. Considering the increased workload on medical institutions and local governments that will accompany participation in the system, it will be necessary to consider whether it is possible to expand the number of participating medical institutions and local governments in an operation that leaves the decision of whether to participate in the system to the autonomy of medical information handlers, based on future trends in the number of participating medical institutions. In the promotion of medical DX, discussed below, standardization of electronic medical record data is being promoted, and it is expected that standardization of standards in primary use will progress. It is hoped that the simplification of information aggregation will lower the threshold for participation in the system, expand the number of participating medical institutions and municipalities, and increase public awareness of the system.

Standardization of information

Current Status and Issues

In order to use information provided by multiple medical institutions in a single study, it must be appropriate to treat information from each institution in the same manner. In terms of information standardization, both structural standardization, such as unifying the format of information and terminology used, and qualitative standardization, which derives from differences in specimen management methods and equipment used during testing, are important. The importance of structural standardization has already begun to be recognized, and the Ministry of Health, Labour and Welfare (MHLW) has taken the initiative in promoting electronic medical records and developing MHLW standards to address this issue. The PMDA has issued a notice on the concept of validation of outcome definitions in post-marketing surveillance, which is also a notice on qualitative standardization. The need to consider such standardization is one of the factors that delay the start of research using medical ^{information12)}.

Desired direction of consideration

Consideration of information standardization, both structural and qualitative standardization, is greatly related to the government's promotion of medical DX. In terms of structural standardization, standardization of electronic medical record data has begun to move forward, and it is assumed that in the future it will be possible to integrate information from all over Japan. In terms of qualitative standardization, the concept of an electronic medical record information sharing service has been announced, and while the sharing of medical information for primary use is being promoted, the issues that make secondary use of medical information such as receipt disease names difficult are also expected to be resolved at the same ^time13). The standardization of units of clinical laboratory test values and other details is also being considered by Rinchu Net, a project of the AMED, and collaboration between these projects is also necessary. The study of qualitative standardization of information obtained from specimens is currently underway in biobanks that handle more detailed medical information than the Next Generation Medical Infrastructure Act. In particular, as a policy on how to handle biological specimens, the material version of the Handbook for Utilization of Biobanks, although a provisional version, is available on the AMED ^website14). Based on these external trends, it is hoped that further consideration will be given to making it easier to handle information provided by multiple medical institutions in conducting research.

②-4 Expansion of information types

Current Status and Issues

The track record of medical information provided under the Next Generation Medical Infrastructure Act was limited to only three types as of May 2023: electronic medical record data, DPC survey data, and receipt data, and the working group requested that the types be expanded. The revision of the new system allows linkage with public databases such as the NDB, which will enable future use of information on specific health checkups and deaths, thereby expanding the range of available information. However, since NDB is used as anonymized information based on the Law Concerning the Assurance of Medical Care for the Elderly, linkage with NDB is limited to use in anonymized processed medical information. Since it cannot be used as pseudonymized processed medical information, which was newly established in this revision, the Diet raised the question of whether this revision would promote its use. The working group also made other requests regarding linkage with biobanks and registries held by academic societies, and future consideration is expected to be given to the possibility of linkage with information managed by academic institutions and private companies.

Desired direction of consideration

When medical information is used in research, there are many situations in which information that is rarely available in ordinary medical practice, such as information on genetic mutations and the results of endpoint evaluation indices, is required. From the user's standpoint, it is desirable to have a large selection of available information when planning research. However, since the collection and management of medical information requires a certain level of cost, a certain priority must be placed on the type of information needed when considering the profitability of certified preparation providers. As mentioned above, as a precondition for combining information, the method of obtaining consent from the information provider at the time the information is obtained is problematic, and it is expected that consideration will be given to combining information with information from biobanks and other sources collected using methods other than careful opt-out in the Next Generation Medical Infrastructure Act. Furthermore, a major obstacle in combining with external information is that there is often no personal identifier used for the combination. Even when the My Number system was introduced, problems occurred in matching and linking with other credential information, etc., and it is assumed that combining with existing databases will be highly difficult, so the use of online credential verification, etc., will also be an important issue for expanding the types of information.

(iii) Provision of processed medical information

(3) 1-1 Methods of information use

Current Status and Issues

Although users of anonymized processed medical information were not required to be accredited by the government, when using the pseudonymized processed medical information newly established by the amendment, the user business operators will also be required to be accredited by the government. Depending on the accreditation requirements contained in the guidelines to be revised by the time the revised law comes into effect, users will also be required to take appropriate safety management measures. At the working group meeting held after the revision of the law, it was indicated that the use of cloud computing as a new method of security control measures when providing information will be considered. The medical and nursing care data analysis infrastructure that handles information such as NDB, etc., which is being studied in advance, also proposes an information management method that does not place the information provided for analysis under the control of the user, and is expected to move in the direction of similar safety control ^measures15).

Desired direction of consideration

The method of using the cloud to strengthen information security control measures is beginning to be adopted worldwide by biobanks and other organizations, and is expected to be a method of limiting more information leaks and inappropriate use. Information management methods that use the cloud to allow analysis to be performed without moving sensitive information to an analysis environment controlled by the user can be broadly classified into two methods: one that isolates both the information and the user, and one that isolates only the information (Figure 5) ¹⁶⁾. Since the introduction of these analysis infrastructures requires a large initial cost, it is necessary to consider the appropriate method by balancing the required strength of security and investment in equipment. From the aspect of analysis, in backward-looking studies that use information accumulated prior to the development of the research plan, it is desirable to consider analysis methods without access to information on the endpoints to prevent arbitrary results, especially when using an external control group, and methods that isolate only the information are ^{17) that} can also contribute to reducing intervening bias in research.

Simplification of usage procedures

Current Status and Issues

In order to conduct research efficiently, it is desirable to provide access to information in a short period of time through a consistent and convenient procedure from the application for use. The process for users to obtain information under the Next Generation Medical Infrastructure Act is operated by each accreditation creation business, but under the current system, which requires users to select an accreditation creation business for each feature of their research project, users may use information from different accreditation creation businesses depending on the characteristics of their research, and it is Diversification of different processes is not considered a desirable direction.

Desired direction of consideration

In order to make the system easier for users to understand, it would be desirable to have a unified system for the process from how to apply for use, to screening for use or non-use, to how to obtain information. In particular, for the method of information use mentioned in (3)-1, a situation where an analysis environment is built by each certified creation business and users have to learn how to use different analysis environments and information management rules each time would lead to an inefficient situation for users. Furthermore, assuming the use of cloud computing, which is being considered by the working group, it is assumed that the environment to be prepared will be restricted from exchanging information with the outside world to ensure security. It is desirable to have a unified system for bringing in code groups called libraries and packages, which are necessary for analysis, and the results of separately conducted clinical trials that serve as comparison groups, into the analysis environment, as well as a system that prevents the mixing of information used for research projects with different purposes. It is desirable for these operational methods to be coordinated among certified preparers and to be standardized regulations.

In terms of standardization of information mentioned in ②-3, unifying not only information from medical information handling business operators to certified preparers but also the structural format of information provided from certified preparers to users among certified preparers is expected to contribute to the efficiency of research, such as users' understanding of data structure and reuse of analysis codes. This is expected to contribute to the efficiency of research by allowing users to understand the data structure and reuse of analysis codes.

(3) 3-3 Management of users

Current Status and Issues

With the revision of the law allowing the use of pseudonymized processed medical information, the accreditation of users of pseudonymized processed medical information is to be conducted by the government based on the standards for safety management, etc. Accredited providers are to provide users with processed pseudonymized medical information based on the accreditation by the government. Until now, the exchange of information between accreditation creation business operators and users alone has facilitated user management, but the use of processed medical information under a pseudonym will require the exchange of information such as credentials with the government and cloud service providers in addition, and information management is expected to become more complicated.

Desired direction of consideration

A mechanism to accurately and efficiently manage credential information and medical information made available to each user is highly compatible with the Trusted Web promoted by the Digital ^Agency18). The use of decentralized identifiers (DID: Decentralized Identifier) and verifiable credentials (VC: Verifiable Credential) to manage the transfer of user credentials and pseudonymous processed medical information will enable the transfer of information with even stronger security protection The current system allows for the transfer of information with even stronger security protection. Under the current system, penalties are provided for unauthorized use, but if access to information from overseas is considered in the future, these technical security control measures will become even more important.

(iv) Creation of outcomes

(4)-1 Use in pharmaceutical applications

Current Status and Issues

The anonymized processed medical information used before the amendment could not be used in applications for pharmaceutical approval because it was impossible to trace back to the information before anonymized processing. One of the major changes in this revision is that now that pseudonymized processed medical information is available, it is possible to trace back to the pre-processing information and use it in applications for approval. However, the expression "made available" here means that the information can now be queried during the reliability survey conducted by the review authority, indicating that the pseudonymous processed medical information under the Next Generation Medical Infrastructure Act has reached the same standing as other registry data that is built on an opt-in basis. The data is not only the data of the registry, but also the data of the other registries. Therefore, various problems in using previously existing external data for approval applications still remain. Although the MHLW has issued a "Notice of Basic Approach to the Use of Registries in Applications for Approval, etc., " ¹⁹⁾ only a small number of cases have been used in Japan, and the use of such data in applications for approval is not expected to increase immediately.

Desired direction of consideration

The major issues in using information obtained outside of clinical trials in regulatory applications are comparability and sample size, according to an ^analysis17). In terms of comparability, validation of the target population and endpoints and information on background factors are important, and the qualitative standardization mentioned in ②-3 and the expansion of the types of information mentioned in ②-4 are largely relevant. In terms of sample size, the expansion of participating medical institutions mentioned in ②-2 is relevant, and information on a scale that ensures a certain number of cases in the patient population to which the drug concerned is applicable is necessary. In addition, a notice has been issued to ensure the reliability of such information when it is used in an application for approval, and accredited manufacturers will be required to take measures such as quality control of the information as described in ②-3, so appropriate preparations will be ^necessary20).

4-2 Return of results to the public

Current Status and Issues

In order to make the public aware of the need for the system, it is necessary to return research results to the informants. Possible methods of return include the application for approval of new drugs and the detection of safety risks of existing drugs. Activities to publicize these results will be important to ensure that the public understands the usefulness of the system and to encourage active cooperation in research. Even now, five years after the Next Generation Medical Infrastructure Act came into effect, the results of the research have not been made public on the website. The three major biobanks in Japan that handle similar information all disclose the results of their research on their websites, and the same disclosure is required under this system.

Desired direction of consideration

As of May 2023, only 22 projects have used medical information based on the Next Generation Medical Infrastructure Act, and regarding the breakdown of this figure, it was indicated during the parliamentary questioning that many cases were used for feasibility studies prior to the implementation of research projects. Feasibility studies are generally difficult to produce tangible results, such as submission for publication, and the small number of cases in which they were used for research with significant social impact is thought to be behind the lack of public disclosure of examples of results. The low overall number of use has been pointed out many times by the working group and the National Diet, and as an immediate issue, measures to increase the number of users are needed to link this to results. In the Diet, the reasons for the low number of use were cited as the low complete coverage of information and the difficulty in handling anonymously processed medical information. However, considering that information is being collected in the midst of the need to maintain income for the continuation of the business of certified preparers, measures to increase the number of trial use, even with limited information, will be necessary. Without such measures, future development will be difficult. As for the release of information, similar to the status of utilization shown in (1-2), careful consideration is needed regarding the scope and method of release, as information regarding results may include information on competitive areas in which the companies using the information wish to keep the research content private.

4-3 Increase in the number of users

Current Status and Issues

A close examination of the issue of the low number of use of the Next Generation Medical Infrastructure Act is an important matter for the development of this system. In addition to the fact that the information provided in the Next Generation Medical Infrastructure Act does not meet the needs of users, as stated in the Diet's answer, we believe that this issue is partly due to the decline in research capacity in Japan. Research using medical information requires specialized knowledge, as there are many matters to be considered that are unique to retrospective studies. A survey by the Ministry of Education, Culture, Sports, Science and Technology (MEXT) has shown a relative decline in the number of papers from Japan compared to other ^countries21). If research using medical information is advanced in other countries, there is concern that the creation of information for the Japanese population will be delayed. During the deliberations in the Diet, it was pointed out that the profit structure of authorized creation providers, and the absence of users may lead to a decline in investment in the development of Japan's medical information infrastructure and a decrease in the public's willingness to provide information.

Desired direction of consideration

As for the need to expand the types and quantity and quality of medical information provided to address a wide range of research issues in order to increase the number of users, this has been discussed in the previous section. A review of the results of the use of the Next Generation Medical Infrastructure Act shows that 17 of the 22 proposals were used by private companies and 6 by academic institutions (1 was an industry-academia joint proposal). In addition to the need for measures to increase the number of private companies and the government, from the perspective of raising the level of research capacity and education, the fact that academic institutions are the main users of the information provided by Tohoku Medical Megabank and UK Biobank indicates that the number of cases selected as the subject of research conducted by academic institutions is It can be seen that the number of cases selected as the subject of research conducted by academic institutions is low. We believe it is necessary to clarify the cause of the difference in the number of information accessed by academic institutions compared to other similar medical information. From the perspective of increasing the number of users and increasing investment in the development of Japan's medical information infrastructure, opening the doors of access to researchers in China and other countries with growing research capabilities and to overseas pharmaceutical companies that are strengthening their use of data would be effective in terms of accumulating research results using Japanese information and securing funding. This is also considered to be effective in terms of accumulating research results using Japanese information and securing funds.

(v) System as a whole

⑤-1 Optimization of the system

Current Status and Issues

Since the Next Generation Medical Infrastructure Act is a law that allows authorized creation business operators to handle medical information through careful opt-out, it does not aim to optimize the overall R&D use of medical information in Japan, as mentioned in the corresponding sections of individual items in (1) through (4). The fact that certified preparers are required to manage information proactively is related to the multiple issues mentioned above, such as uneven distribution of information. In the working group, the need for a quasi-public organization to standardize information and to provide overall coordination was also raised by some certified preparers. Certified preparation providers provide information in the midst of the need to maintain income for business continuity, and the implementation of differentiation strategies among certified preparation providers is expected to lead to uneven distribution of information and diversification of the process of using the analysis environment.

Desired direction of consideration

Looking at trends in biobanks, the GA4GH (an international cooperative organization for the development of medicine and medical science using genome information) is playing a central role in studying a mechanism to standardize projects that were initially started sporadically in various regions and to implement search and integrated analysis on a global basis, and domestic biobanks are also working on the development of an AMED project to The domestic biobanks are also moving in the direction of making dispersed information available in a centralized manner, as evidenced by the construction of a cross-biobank search system as part of an AMED project. The uneven distribution of information and know-how may hinder the development of domestic data use, and should be avoided. With regard to the joint use of information, the NDB, which became available under the current revision, plays a certain role, and the information can be used in common by any authorized processing business. ⁽ A study is also planned for the information managed by the National Medical Information Platform, which is currently under consideration in the promotion of medical DX, to be used for research purposes in the ^future13). From a long-term perspective, basic information such as electronic medical record data and receipt data will be used for information collected on a public platform similar to the NDB that has become available as a result of this revision, and each certified provider will collect medical image information and collaborate with biobanks according to their special characteristics, and if necessary, make such information By making this information available for joint use, it is expected that they will be responsible for the consolidation and processing of information with their own special characteristics. The linkage with NDB made available by this revision is limited only to anonymized processed medical information. In the future, information collected by public infrastructures and information collected by authorized preparers, including whether information managed by NDB and the National Medical Information Platform will be made available for pseudonymized processed medical information, should be organized. It will be important to organize the information to be collected in public infrastructures and the information to be collected by accredited providers, and to consider what information should be collected in public infrastructures and accredited providers, respectively, in order to determine the direction of Japan's medical information infrastructures.

⑤-2 Measures to deal with inappropriate use

Current Status and Issues

The pseudonymized processed medical information that will be made available under the revised law has a higher possibility of personal identification than anonymized processed medical information, so a supplementary resolution to establish strict standards for safety control measures was attached. While it is necessary to relax the accreditation standards required of organizations in order to broaden the base of users, a case of inappropriate acquisition of medical information under the Next Generation Medical Infrastructure Act occurred last year, and in the examination of the guidelines to be revised by the time the revised law comes into effect, a balanced operational method between promotion of use and safety control measures must be considered22). ^22). Safety management under the Next Generation Medical Infrastructure Act before the revision includes organizational safety management measures, human safety management measures, physical safety management measures, and technical safety management measures, and strict standards are required for certified preparers.

Desired direction of consideration

The consideration of safety control measures through the use of cloud-based information, as presented by the working group after the revision of the law, are technical measures that do not depend on the safety control status of the user's information use environment, and the use of these evolving IT technologies for information protection is required for the expansion of users. An information management system in which the strength of safety control measures does not depend on the user's organization is also expected to provide peace of mind to the public to whom the information is provided. On the other hand, since the introduction of these technologies will require a large amount of cost and human resources, it is necessary to continue to consider whether or not to require individual authorized preparers to take action.

(5)-3 Securing human and financial resources

Current Status and Issues

In order to manage medical information in a manner conducive to research and to conduct research that leads to the return of results to society, it is important to secure human and financial resources capable of appropriately managing and using medical information. In (iv)-3, we mentioned the decline in research capacity, and in addition, it is also important to have human resources who can properly manage medical information. The "Medical Data Human Resource Development Center Formation Project" led by the Ministry of Education, Culture, Sports, Science and Technology is an extremely important initiative from the perspective of setting up an educational curriculum at academic institutions and fostering human resources interested in research using medical information, and is expected to lead to an increase in the number of academic institutions using information under this ^system23).

From a financial perspective, the Diet discussion at the time of the revision also discussed the fact that the revenue and expenditures of certified medical information handling trustees are in the red. It was mentioned in the Diet that the income and expenditures are expected to improve as the use of this information expands in the future. As for public funds related to the development of medical information utilization infrastructure in Japan, an estimated request of 16.6 billion yen, which is significantly more than the FY2023 budget, has been submitted for the promotion of medical DX in FY20242424 ⁾. These are expected to lead to research and development use of medical information in the future. However, the promotion of medical DX is mainly intended for primary use at this point, and the environment for secondary use is scheduled to be developed around 2030.

Desired direction of consideration

Medical information processed under the Next Generation Medical Infrastructure Act can provide a valuable opportunity to come into contact with actual large-scale medical information in Japan. In order to increase the number of students interested in research using medical information, consideration should also be given to making the system more widely used by academic institutions. For example, if academic institutions are given preferential treatment in terms of research funding and usage fees, and in return they are required to disclose analysis codes and know-how used in their research to the user community after completion of the research or submission of a paper, this will lead to more efficient use of information. This would also help alleviate the uneven distribution of specialized research knowledge. OpenSAFELY, an analysis platform for medical records in the U.K., functions as an open academic platform, with all analysis codes and execution logs made ^public25). Better cooperation between non-profit and for-profit research in various aspects, such as research knowledge and operational funding, is desirable.

With regard to funding for the development of a medical information utilization infrastructure, the EHDS is expected to receive €810 million from the European Commission. Based on the status of utilization of this system after the amendment of the law, we would like to consider the necessity of using public funds in Japan as an investment in medical information infrastructure designed not only for primary use but also for secondary ^use26).

Summary

The following is a list of major issues that can be envisioned in the future based on the current status of the Next Generation Medical Infrastructure Act. In this paper, we attempted to identify issues from the standpoint that we hope to promote decision-making using medical information in drug development and medical policy in Japan, but there are some issues that are difficult to realize in light of the cost burden, etc., and there may be arguments that differ from the policy described in this paper from a different standpoint. In other words, there may be arguments that differ from the policy described in this paper from different perspectives. We hope that this document will serve as a supplemental material for further consideration, including as an opportunity for opposing views to be expressed.

Since each item in the descriptions presented in this paper describes content related to the flow of information, a possible overall diagram based on these items is shown in Figure 6. One assumes the use of pseudonymized processed medical information where only information obtained by opt-in or polite opt-out will be available, and the other assumes that the National Medical Information Platform will also be able to be treated as a public database, and the use of anonymized processed medical information when it can be linked with anonymized processed medical information. The desired direction presented in this paper is added in light blue to the flow of information after the revision of the law, assuming two states. In the future, it would be ideal to enable personal information protection measures so that public databases such as NDB can be used as pseudonymized processed medical information, and the flow of anonymized processed medical information in Figure 6 can be used for pseudonymized processed medical information as well. This paper considered the ideal future image based on the Next Generation Medical Infrastructure Act, but if we are to keep up with other countries in building a medical information infrastructure for secondary use that is more comprehensive, we should accelerate the movement to make the information in the national medical information platform, which is planned in the promotion of medical DX, available for secondary use as well. The division of roles between information collected by public institutions and authorized providers needs to be clarified. In order for the country to become a nation capable of making decisions based on information, we hope that the opinions of each stakeholder will be respected and that developmental studies will be conducted on an ongoing basis.

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