Digital healthcare in Japan

Navigating Japan's Healthcare: Public and Private Synergy for Universal Health

Japan’s healthcare system is centrally regulated by the Ministry of Health, Labor and Welfare (MHLW), but delivered by a mix of public and private providers.

It is structured around universal health coverage, with services reimbursed through public social insurance schemes :

Employees’ Health Insurance (健康保険, Kenkō Hoken) :
- Employees
- Dependents of people who also fall under National Health Insurance (e.g. children or spouses not eligible through employment)
National Health Insurance (国民健康保険, Kokumin Kenkō Hoken) :
- Self-employed individuals (e.g. freelancers, independent contractors, small business owners)
- Part-time and temporary workers who work too few hours to qualify for employer-based health insurance
- Students, including international students who reside in Japan for more than 3 months
- Retired individuals under 75 and not covered by a company pension plan that includes insurance
- Unemployed persons who are not receiving insurance via a previous employer or unemployment benefit plan
- Foreign residents staying in Japan for more than 3 months and not covered by other public schemes
The official English-language resource of the Japanese Pension Service (日本年金機構, Nihon Nenkin Kikō) is available here. To find more about the social insurance system and Employees' Pension Insurance (EPI) & Employees' Health Insurance (EHI)

Japan’s healthcare system is organized into hospital and specialist care delivered by public and private providers, alongside outpatient services and prescriptions covered through insurance with patient co-payments :

Hospital and specialist care: Provided by public and private hospitals; reimbursed by insurers; patients pay ~30% out-of-pocket.
Outpatient care and prescriptions: Covered by insurance; includes use of My Number Card and growing adoption of e-prescriptions.

Presentation of the Nationwide Healthcare Information Platform by clicking here.

Transforming Healthcare: Japan's Strategic Roadmap to Digital Health

Japan is rapidly advancing digital health implementation through a series of coordinated national policies.

In 2023, the Ministry of Health, Labour and Welfare (MHLW) introduced the "Healthcare DX Promotion Roadmap",aimed at standardizing and accelerating healthcare digitization :
- Acceleration of integration of the My Number Card with the health insurance card
- Establishment of the Nation-wide Healthcare Information Platform
- Electronic medical chart information standardization, etc.
- Digitalisation of NHI (National Health Insurance) reimbursement rate table revision
To support this healthcare digital transformation, Japan is lowering regulatory hurdles, such as requiring standardized Fast Healthcare Interoperability Resources (FHIR)‑based interoperability and streamlined certification and providing substantial subsidies (covering 40–70 % of costs) for adopting and integrating certified electronic medical record systems.

More information on Japan’s national roadmap is available here.

How do you access the Japanese market?

SaMD (Software as a Medical Device) :

Engage a Japanese Marketing Authorization Holder (MAH), either a local partner or your own subsidiary. ICST is one licensed MAH example. Multiple pathways exist for MAH designation.

Resource : Consultations | Pharmaceuticals and Medical Devices Agency

Non-SaMD (Wellness apps, Remote Monitoring, EHRs, Admin Tools) :

MAH is not mandatory for non-SaMD digital health solutions but recommended for smoother market entry as it is helpful for market access, distribution, localization, and navigating business practices in Japan.

Otherwise, JETRO lists business opportunities for foreign companies as well as a "Laws & Regulations" pamphlet for starting a business in Japan which can help establish an initial local presence.

Resource : Setting Up Business | Investing in Japan - Japan External Trade Organization - JETRO

SaMD (Software as a Medical Device):

Early engagement with PMDA to confirm your software qualifies as SaMD. PMDA consultations require a MAH and often interpreters

Resource : Consultations | Pharmaceuticals and Medical Devices Agency

Non-SaMD (Wellness apps, Remote Monitoring, EHRs, Admin Tools) :

Confirm product is not classified as a medical device under Japanese law. Wellness and admin apps generally exempt, but remote monitoring with diagnostics may qualify as SaMD.

Resource : Regulations and Approval/Certification of Medical Devices | Pharmaceuticals and Medical Devices Agency

SaMD (Software as a Medical Device):

Submit form for PMDA approval via your MAH with required clinical data and quality inspections.

Fees for Class II/III digital therapeutics approx. ¥13M (~$80K-$110K).

Non-SaMD (Wellness apps, Remote Monitoring, EHRs, Admin Tools) :

Not required if not a medical device.

SaMD (Software as a Medical Device):

Apply to include product in public health insurance fee schedule post-PMDA approval. The first step is to, together with you MAH, submit a reimbursement request to Japan’s Ministry of Health, Labour and Welfare (MHLW). Once accepted by the Device Insurance Committee, pricing negotiations begin. If both parties agree, the reimbursement listing is published quarterly (January, April, July, October). A provisional price can also be requested before the official listing, this is typically easier for C1 devices, which already have existing codes. Please find all reimbursement categories here.

Resource : Reimbursement Guide (PDF)

Non-SaMD (Wellness apps, Remote Monitoring, EHRs, Admin Tools) :

Public insurance reimbursement unavailable.

Comply with APPI privacy laws. Use domestic or approved cloud servers.

Resource : Personal Information Protection Commission

SaMD (Software as a Medical Device):

Conduct clinical trials or participate in government pilot programs (e.g., AMED) to collect Japanese data supporting PMDA approval and reimbursement. Also useful to pilot with universities listed below.

Resource : Calls for Proposals | Japan Agency for Medical Research and Development

Non-SaMD (Wellness apps, Remote Monitoring, EHRs, Admin Tools) :

Pilot with hospitals, universities, or innovation hubs to build local evidence and reputation. (see below)

Resource : Calls for Proposals | Japan Agency for Medical Research and Development