Healthcare and life science regulation in Japan

AWhile the utilisation of medical information is key to innovation in the healthcare industry, such uses had been widely restricted in Japan because this health data often contains sensitive personal information. However, the Japanese government has been shifting towards promoting the utilisation of medical information under the Act on the Protection of Personal Information (APPI) and other new legislation, while balancing it with necessary protections for the privacy and personal information of patients.

This article provides a general overview of these recent developments in privacy and personal information regulation related to medical information, and also offers an overview of laws and regulations applicable to new technologies within the healthcare industry, including AI-related technologies.

Utilisation of medical information

Overview of utilisation under the APPI. Medical information often contains medical history, which constitutes “sensitive personal information” defined by the APPI. The utilisation of such sensitive personal information is heavily restricted under the act. For example, such sensitive personal information cannot be shared with third parties through the opt-out procedure, requiring explicit prior consent from the individual instead.

Although the APPI provides a few limited exceptions for the use of medical information, including: (1) a special need to improve public hygiene or promote healthy child development; and (2) the purposes of academic research, such exceptions are not broadly applicable.

Specifically, exceptions also require obtaining consent from the individual, which is difficult, and they do not apply if the medical information is used for product development.

Anonymised and pseudonymised medical information. The complicated and heavy restrictions under the APPI have been an obstacle for the utilisation of medical information, which can be a valuable resource for improving the quality of medical care and promoting medical research. To address this issue, Japan has enacted the Act on Anonymised Medical Data that Contributes to Research and Development in the Medical Field, officially called the Next Generation Medical Infrastructure Law (NGMIL), as a special law under the APPI.

The NGMIL introduced the concept of “anonymised medical information”, which must be anonymised by certain entities certified by the authority as having reliable anonymisation technology (certified anonymised medical information preparers). Medical institutions may provide medical information to these preparers through an opt-out procedure without obtaining explicit consent from patients. The preparer then anonymises the medical information and provides it to research institutions or pharmaceutical companies. However, the anonymised medical information is not always useful, as the anonymisation process requires the deletion of certain medical data.

To deal with this problem, the NGMIL was further amended in May 2023 to introduce “pseudonymised medical information”, which can be utilised without any deletion of medical data, and therefore meets the following needs in the research field:

1. Data provision of rare diseases;
2. Continuous and developmental data provision regarding the same target group; and
3. Proving reliability by returning to the original data for authenticity verification, which is a requisite for pharmaceutical applications.

The amended NGMIL allows an interlinked analysis between pseudo-nymised medical information and the National Database of Health Insurance Claims and Specific Health Checkups of Japan. The pseudonymised medical information must also be processed by certain entities certified by the authority, and business operators utilising the pseudonymised medical information must also be certified by the authority.

Further discussion on the APPI. Further amendments to the APPI are being discussed at the Personal Information Protection Commission as part of a periodic review of the APPI to have relaxed requirements for the utilisation of personal data under certain circumstances (e.g. the provision of personal data used merely for the preparation of statistical information).

Regulation for new technologies

Software as a medical device (SaMD). Many healthcare apps are now widely available through our smartphones, smartwatches and other digital devices. Some of these healthcare apps may be considered medical devices regulated under the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act).

If any software serves a medical purpose (e.g. diagnosis, medical treatment or prevention of diseases), and if any defect in such software may affect the life or health of the patient or user, such software will be regarded as a medical device under the PMD Act.

In such cases, the marketing approval or certification of such software will be required, and the company marketing such software must obtain a relevant marketing business licence under the PMD Act. Such a purpose will be determined by taking into account product performance, the labelling of target users and usage rules, and advertising.

The Ministry of Health, Labour and Welfare (MHLW) has issued the guideline for medical device applicability of programs, which describes how to determine the medical device applicability of the software.

The MHLW has further issued case examples of the medical device applicability of software and a relevant database of SaMD. It is possible to consult with the relevant department within the ministry for the medical device applicability, and the Pharmaceuticals and Medical Devices Agency also provides one-stop consultation services related to SaMD.

Usage of AI-based technologies. Artificial intelligence is already widely used for diagnosis and medical treatment assistance. Since article 17 of the Medical Practitioner’s Act prohibits anyone other than a medical practitioner from engaging in medical practice, it would be a violation of this act if an AI-based diagnosis system were to proactively conduct a medical diagnosis definitively.

In this regard, the MHLW issued guidance on the relationship between AI-aided programs assisting diagnosis, medical treatment, etc., and article 17 of the Medical Practitioner’s Act (dated 19 December 2018), stating that as long as medical practitioners proactively provide a diagnosis and the AI-based program merely supports such diagnosis, such AI-based program would not be a violation of article 17 of the Medical Practitioner’s Act. This is one of the local regulations to consider when providing AI-based medical services in Japan.

As a guideline applicable to AI-related business in Japan, the Ministry of Economy, Trade and Industry (METI) and the Ministry of Internal Affairs and Communications jointly issued the AI Guideline for Business Version 1.01 on 25 December 2024, which integrates the previous R&D, utilisation and governance guidelines for the implementation of AI principles. This guideline explains basic principles of AI ethics such as transparency, justice and fairness, and non-maleficence separately for AI developers, providers and business users.

The METI also recently issued the Checklist for Contracts Related to Utilisation and Development of AI, which can be used by business operators when entering into AI-related contracts.

Regarding AI governance in healthcare-related companies, the Japan Digital Health Alliance – an alliance of information and communication technology companies, venture companies and pharmaceutical/medical device manufacturers engaged in the digital health industry – issued the Guide to Generative AI Application for Healthcare Business Operators Version 2.0, which provides a practical guide on the development of products and services related to generative AI and the use of such products and services within medical institutions.

The government submitted a bill on the Promotion of Research and Devel-opment and Application of Artificial Intel-ligence-Related Technologies (AI bill) in February 2025, which provides a national framework for AI development, defines AI-related technologies, and further imposes an obligation on business operators utilising AI-related technologies to co-operate with measures implemented by the government. The AI bill is expected to be passed by the National Diet in the final quarter of 2025.

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