“JPMA Media Forum” Held Current Status and Challenges Toward Realizing the “Japanese Version of EHDS” – Toward the Realization of Next-Generation Healthcare –

March 18, 2026

2026年3月18日、室町三井ホール＆カンファレンス（東京都中央区）にて「製薬協メディアフォーラム」を開催しました。今回は「“日本版EHDS”実現に向けた現状と課題－次世代医療の実現に向けて－」をテーマに、製薬協産業政策委員会の安中良輔委員、The Office of Pharmaceutical Industry Researchの渡邉奈都子主任研究員、東京大学名誉教授／一般社団法人次世代基盤政策研究所代表理事の森田朗氏による講演を実施しました。当日は会場およびウェブ配信にて、メディアや会員会社含め70名以上が参加しました。

Background of the Forum

The effective use of health and medical data is essential for promoting digital transformation in healthcare—which is indispensable for creating an environment where every citizen can receive optimal medical care, ensuring the sustainability of the social security system, and fostering the development of innovative new drugs.Following the enactment of the amendments to the Medical Care Act and related laws in December 2025, while progress is expected in initiatives to promote the secondary use of medical information, challenges remain to be addressed, and the path to resolution is by no means smooth. In this forum, we will discuss the Japanese version of the EHDS (European Health Data Space)^* To discuss the current status and challenges in achieving this goal, we held presentations by Mr. Yasunaka, a member of the Cabinet Office’s “Study Group on Promoting the Utilization of Medical and Related Information,” and Mr. Morita, along with a presentation summarizing the results of the “Public Awareness Survey on the Utilization of Health and Medical Information” conducted by the Policy Research Institute. The following is a transcript of the presentations.

Presentation 1

Discussions and Future Challenges at the Study Group on Promoting the Utilization of Medical and Related Information

Pharmaceutical companies aim to deliver innovative medicines to patients as quickly as possible through efficient drug discovery using health and medical data. However, given the burden on already overworked healthcare settings, it is not realistic to expect them to build comprehensive databases solely for the benefit of pharmaceutical companies.The ideal approach is an integrated master plan in which data generated through “primary use”—for promoting patient health and treatment—is also utilized for “secondary use,” such as improving the cost-effectiveness of healthcare by government agencies and supporting research and development by pharmaceutical companies and academic institutions like ours.

By utilizing healthcare data, pharmaceutical companies can provide the public with three main benefits. First is the reduction of the risk of side effects. We recognize that analyzing drug safety information in real time based on large-scale healthcare data to ensure proper use is of the utmost importance.Second, using this data in research and development shortens the time it takes to bring new drugs to market. Third, by utilizing genomic data and improving the quality of research plans, we can reduce failures in clinical development and increase the probability of successfully bringing new drugs to market.

 

Specifically, there is a need to streamline data collection by storing medical data for some or all of the control groups in clinical trials.Furthermore, there is a need to track side effects—such as carcinogenicity—that do not manifest until many years later, as well as a need for data linkage between parents and children in research on hereditary diseases. To achieve this, it is necessary to build a foundation for “life-course data” that connects information from before birth through death—including Japan’s world-renowned Maternal and Child Health Handbooks and school health checkups.

 

The Ministry of Health, Labor and Welfare is currently working to establish a National Healthcare Information Platform, aiming to link data from healthcare, long-term care, and local governments to provide better medical care to patients.Most recently, amendments to the Medical Care Act and related laws enacted last December will allow for the secondary use of public databases held by the Ministry of Health, Labor and Welfare in a secure, pseudonymized, and anonymized state, with a target date of three years from now.The legislation also includes a goal of achieving 100% adoption of cloud-based electronic health records by the end of 2030, which I find very encouraging.

Under this new framework, various databases—centered on the National Database (NDB)—will be able to interoperate.Of particular note is the fact that various types of medical data will be able to be linked and analyzed together with “mortality data.” Whether for evaluating efficacy or analyzing the most severe adverse events, this mortality data was precisely what pharmaceutical companies needed most—and until now, it has not been readily available even from private databases.

Furthermore, the system is designed with very robust safeguards to prevent unauthorized use. While users can analyze data in the cloud, they cannot download the data being analyzed, which constitutes personal information. Since the system is designed so that only the results of the analysis (non-personal information) can be extracted, it is structurally impossible for personal information to be leaked or circulated.

The significance of being able to analyze these databases not in isolation but through “linkage” is immeasurable. For example, by linking the NDB—which contains prescription and mortality data—with the National Cancer Registry, which holds detailed information, it becomes possible to conduct the most critical assessments, such as overall survival (OS) following anticancer drug administration.Furthermore, we expect that as the vaccination database is expanded, it will become possible to evaluate vaccine side effects and efficacy.

As Japan moves forward with database integration, Europe’s “EHDS” serves as a truly excellent model.In a 2025 Cabinet decision, the Japanese government also demonstrated its unwavering resolve to conduct studies based on the EHDS model and aims to submit a bill during next year’s regular session of the Diet. In response, a new study group chaired by Mr. Morita has been established, and the JPMA will participate in this group with the utmost sincerity.

In designing this system, there are two points we particularly emphasize. The first is the use of “generative AI (large language models, or LLMs)” for data structuring.Given the current situation where data structuring is progressing slowly, we should consider the use of AI from multiple perspectives. In fact, there have been cases where “results evaluated by humans” and “results evaluated by AI” were nearly identical regarding changes in tumor size following the administration of anticancer drugs, suggesting that AI can be fully utilized.

The second point is “international collaboration.” Research and development in the medical field can no longer be conducted without international collaboration.While economic security is currently a major concern, a look at the number of research papers using real-world data (RWD) reveals that strong collaboration exists even between the United States and China. I believe Japan should strike a balance between national security and international collaboration and move forward with establishing rules based on international standards that facilitate cooperation with other countries.

 

Presentation 2

Summary of Results from the Public Awareness Survey on the Utilization of Health and Medical Information

 

Based on these five perspectives, we conducted a web-based survey of 2,900 men and women aged 20 and older from all 47 prefectures nationwide, ensuring the sample was representative of Japan’s population demographics to avoid bias.

First, regarding the most important findings: 57.2% of respondents expressed support for “primary use”—the use of their own medical data to “improve their own treatment and medical services”—while 54.8% expressed support for “secondary use,” which aims to achieve objectives such as “research and development of new pharmaceuticals and improvements in public health.”Both figures represent a majority, and no significant difference in acceptance levels was observed between primary and secondary use.Furthermore, approximately 90% of those who expressed support for primary use also expressed support for secondary use, indicating a strong overlap in acceptance. On the other hand, about 30% responded that they were undecided, revealing that there is a significant number of people who are not explicitly opposed but are reserving judgment.

 

When viewed in an international comparison, Japan ranks in the middle group alongside France and the United Kingdom, but remains below the Organization for Economic Cooperation and Development (OECD) average of 64%.

So, what factors are driving the increase in support for secondary use? The analysis revealed that the strongest influencing factor was “the large number of expected benefits.”This was followed by “not feeling anxiety or resistance,” “existing trust in the entities utilizing the data,” and other prerequisites such as “knowledge of anonymization” and “high levels of health literacy and digital literacy.”

In other words, willingness to provide data is not determined solely by fixed values; it is an aspect that can be significantly increased even later through an understanding of the benefits, the alleviation of concerns, and the accumulation of knowledge.

When we delved deeper into the specific benefits, we found that the largest group placed equal importance on both personal benefits—such as “being able to receive medical care suited to myself and my family”—and societal benefits—such as “contributing to the development of new drugs and treatments.”Furthermore, while the approval rate among those who do not perceive any benefits at all remains at about 18%, more than 80% of those who expect four or more benefits are in favor. A clear trend was observed: the more benefits people recognize, the higher their level of support becomes.

 

We also analyzed the factors contributing to concerns about data utilization. Less than 30% of respondents expressed strong concerns, while the largest group—42.7%—said they were “undecided.”Furthermore, it is noteworthy that among those who feel anxious, only just under 20% reported having “specific concerns,” while approximately 80% expressed “vague anxiety.”This suggests that the nature of the public’s anxiety stems not so much from specific risks as from a vague sense of concern arising from a lack of information and a lack of trust in the system as a whole.

 

Finally, regarding the level of trust in entities that utilize data: Medical institutions, universities, and research organizations were found to enjoy the highest level of trust, while government and administrative agencies, as well as IT companies, remained at a relatively low level; pharmaceutical companies like ours fell somewhere in between.

 

When asked why they were willing to provide data, respondents cited “public interest” when dealing with government agencies and “expertise” when dealing with medical institutions and pharmaceutical companies. Conversely, the main reasons for refusing to provide data were “concerns about profit motives” regarding pharmaceutical and IT companies, and “a lack of transparency and accountability” regarding government agencies.Furthermore, a common concern shared by all parties was “anxiety regarding privacy protection.” These results demonstrate that it is essential for data recipients to establish a transparent governance framework that clearly outlines “the purpose for which the data will be used, how it will be handled, and how privacy will be protected.”

Through this survey, we found that a certain percentage of the public remains in a “neither agree nor disagree” state, without expressing a clear stance. This group does not necessarily harbor strong opposition; rather, it is believed that they lack the information necessary to make a judgment or that their level of interest is not yet high.To increase acceptance, it is important to stimulate interest among this group that has reserved judgment and to promote a concrete understanding of the significance and value of utilizing the system.

Presentation 3

Current Status and Challenges Toward Realizing a “Japanese Version of EHDS”

“Secondary use”—the topic of today’s discussion—involves collecting and analyzing the health and medical data of the entire population to statistically identify patterns such as “this medication is effective for this type of person” or “this person is at risk,” thereby contributing to drug discovery, medical research, and the development of optimal healthcare policies.

To achieve this, it is crucial to maintain “lifelogs” that record health status from birth to death. By documenting this health status, it becomes possible to identify conditions before they reach the “threshold” at which a disease manifests, thereby enabling preventive medicine that delays the onset of disease.

However, linking data requires uniform formats (standardization) and a common “identifier (ID)” that enables reliable verification of a person’s identity.Japan possesses world-class data resources, such as maternal and child health handbooks and school health checkups; however, because various government departments have developed systems optimized for their own specific purposes, the data is not standardized and cannot be linked.Furthermore, personal information protection—which has placed too much emphasis on “consent” and “anonymization” as methods for safeguarding individual rights—has hindered the effective use of data. In short, Japan has lacked an overarching “grand design” for how to use and link medical information.

Driven by a sense of urgency regarding these delays, policies to promote data utilization were strongly emphasized in the 2025 “Basic Policy” and the Regulatory Reform Implementation Plan, among others. To put this into practice, the “Study Group on Promoting the Utilization of Medical and Related Information,” which I chair, has been launched. We aim to reach a conclusion by this summer and submit a bill.

In this discussion, the model cited in the government’s Cabinet decision is the “EHDS Regulation,” which took effect in the EU in March 2025.It is rare for a Japanese Cabinet decision document to state so explicitly, “Let us refer to a foreign system.” While it is certainly important to develop a system unique to Japan, this reflects the expectation that we should thoroughly incorporate good practices and use them as a reference to create an even better system—and the EHDS is precisely such a system worthy of reference.

The EHDS was created in response to the COVID-19 pandemic that began in 2020. Within the EU, where people can move freely without passports, both infected individuals and the virus itself cross borders; yet, the systems for managing healthcare data varied widely among the 27 EU member states.Although a system was hastily created to respond to the emergency, this bitter experience led to the stark realization that “we must accurately grasp the infection situation across the entire EU and make the data usable.” At the same time, the system was created with the aim that “if this much data is being collected, there is no reason not to link it not only to public health but also to industrial promotion, such as drug discovery and medical device development.”Looking ahead to an era where data drives society, the EU is currently striving to create a grand, matrix-style legal framework that combines cross-sectoral laws—such as the General Data Protection Regulation (GDPR) and the AI Act—with sector-specific legislation covering areas like health, agriculture, and the environment.

The EHDS is a system designed to accumulate life logs for each individual from birth to death and utilize them for daily health management and treatment (primary use), as well as for medical research and drug discovery (secondary use). At its core is a highly standardized and secure electronic health record (EHR).As platforms connecting databases in various countries that meet these EHR standards, “MyHealth@EU” has been established for primary use, and “HealthData@EU” for secondary use.

The most highly valued aspect of primary use (MyHealth@EU) is “the patient’s right to receive better medical care.” For example, if a Swedish citizen suddenly falls ill while traveling in France, they can have a French doctor review their Swedish electronic health record and request the best possible treatment.While patients have the right to opt out and prevent their medical history from being shared with doctors in other countries, the system operates on the principle that if they do not receive optimal treatment due to missing information, “that is their own responsibility.” In this way, the system is designed with the patient’s best interests as the top priority.

With regard to “secondary use,” a highly rigorous and carefully designed system has been implemented. The key element is the “Health Data Access Bodies”—contact points or regulatory agencies that each country is required to establish. The process for secondary use is as follows.

It is precisely because the process is so rigorous that the European Commission initially proposed that “no individual consent is required for secondary use.”However, during the discussions, countries such as Denmark and Finland—which do not require an opt-out at all—opposed the proposal on the grounds that “some countries guarantee the right to opt out under their constitutions.” Ultimately, the right to opt out was recognized. However, as an exception, the right to opt out is not recognized for research or policy-making for public purposes.Furthermore, a technical approach is being pursued that minimizes the risk of personal data leaks even without an opt-out by utilizing “PETs (Privacy-Enhancing Technologies),” which make it virtually impossible to identify individuals through advanced mathematical processing.

 

While data can be used for medical research, drug discovery, public health, and policy formulation, using it for “discrimination” or for “product sales and advertising” purposes—such as targeted marketing—is strictly prohibited, and the agencies granting access will strictly monitor compliance.

Looking at the current situation in Japan, there are several challenges in establishing such a framework. First, while the EU proceeds with top-down decision-making regardless of whether something is “possible or not,” Japan tends to start only after reaching a consensus that something is “definitely feasible,” which inevitably slows progress.Furthermore, regarding system architecture, while the EU adopts a model where “various applications run on a common information infrastructure,” Japan’s systems are built in a “siloed” manner, organized by specific administrative objectives. Attempting to connect these systems to a common infrastructure retroactively makes for an extremely arduous task.
Above all, “public trust” is crucial.There are still people who harbor a vague sense of unease, wondering, “Is it really okay to let for-profit pharmaceutical companies use this data?” It is essential to properly explain to these individuals the benefits of data utilization and the strict mechanisms in place to ensure safety, thereby earning their trust.

Q&A Session

（Public Affairs Committee）

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