Bring healthcareAI to Japan
Tokyo and New York
Nearly three in ten people in Japan are 65 or older, and the health system is short of hands. We help healthcare AI companies reach the hospitals, partners and approvals that adoption depends on.
Outside medical knowledge has always reached Japan through people who could translate it, in every sense.
We translate products, evidence and workflows for Japanese hospitals, and work with specialists on everything regulated.
Who it’s for. Companies building clinical decision support, imaging AI, workflow automation, remote monitoring, digital therapeutics and patient engagement.
What we lead. Market strategy, positioning, product and EMR localization, hospital partnerships, pilot design and your first hires in Japan.
What specialists lead. PMDA consultations and filings, reimbursement dossiers, clinical studies and legal opinions, through partners we bring in and coordinate.
How to start. A 30-minute intro call. Bring what you know about your regulatory status, and we’ll tell you what we’d check first.
A health system that needs help
Japan has a national strategy for software medical devices (DASH for SaMD), a two-step approval route and a way to agree a plan for AI model updates in advance (IDATEN). Software can be reimbursed too. CureApp’s apps for quitting smoking and for hypertension have been covered by national insurance since 2020 and 2022.
- 29.6%of Japan’s population is 65 or older, a record, and the share is projected to reach about 35% by 2040.
- 570,000more care workers Japan will need in 2040 than it had in 2022, by the health ministry’s estimate.
- 2024the year overtime caps for hospital doctors took effect.
Sources: Statistics Bureau of Japan, September 2026, MHLW, care workforce estimate, MHLW, doctors’ work-style reform, MHLW, DASH for SaMD 2, PMDA, IDATEN, MHLW, Chuikyo materials on CureApp
Approval gets the attention
Adoption is usually decided by the things around it.
- 01
Is it a medical device at all?
PMD Act 薬機法
Software with a medical purpose that could affect a patient’s health is generally regulated as a medical device under the PMD Act (only very low-risk software is exempt), and overseas makers must appoint a marketing authorization holder in Japan. Classification decides everything after it, so we settle it first with specialist regulatory advisers.
- 02
Approval starts with a conversation
PMDA consultation PMDA相談
The PMDA offers early consultations, and Japan’s software device strategy added a two-step approval route and IDATEN, which confirms a plan for future AI updates in advance. We help you prepare for those conversations and bring in the specialists who lead them.
- 03
Approval isn’t payment
reimbursement 診療報酬
Listing on the national fee schedule is a separate decision from approval, made through Chuikyo and revised every two years. Without it, the cost often falls on the hospital’s own budget. We plan for both from the start, with reimbursement specialists.
- 04
Workflow decides adoption
EMR 電子カルテ
In 2023 about two thirds of hospitals and 55% of clinics used electronic records, across many vendors, and the government aims for nearly every provider to have records that can share patient information by 2030. A tool that adds clicks rarely lasts. We map the workflow and the integrations that matter before a pilot starts.
- 05
Health data has its own rules
health data 医療情報
Medical history is sensitive personal information under the APPI (amended in July 2026, with most changes not yet in force), and hospital systems follow the health ministry’s own security guidelines. We help you prepare the answers hospital IT teams ask for, with counsel where needed.
- 06
Clinicians follow clinicians
medical societies 学会
Adoption spreads through medical societies and respected physicians. We help you find clinical champions early and understand the evidence they’ll want to see.
The route for healthcare
The same four stations, with specialists joining where the work is regulated.
- 01
Discover
Three to five weeks
Market and clinical fit, with an early regulatory view from specialist advisers.
You leave with A classification view and a go or not-yet decision
- 02
Plan
Six to ten weeks
Pathway, evidence and reimbursement planning with partners, plus pilot sites and clinical champions.
You leave with An entry plan with regulatory and evidence steps
- 03
Land
Six to twelve months
Hospital pilots, EMR integration, Japanese clinical content and support for consultations and filings.
You leave with Pilots in hospitals and a filing plan under way
- 04
Scale
Ongoing
Reimbursement strategy, medical society engagement, distribution and channel partners.
You leave with A healthcare business in Japan that can grow
Who does what
We lead
The commercial and product side of entry, start to finish.
- Market and segment strategy
- Positioning and Japanese clinical messaging
- Product, content and EMR localization
- Hospital partnerships and pilot design
- Distribution and channel partners
- Hiring your first team in Japan
Specialist partners lead
The regulated work, with us coordinating so it fits the plan.
- PMDA consultations and applications
- Reimbursement and health economics dossiers
- Clinical studies in Japan
- Legal and data protection opinions
Tell us what you’re building and why Japan.
We’ll tell you honestly whether it’s time.
Jet VillegasTokyo, local time
Aditya PandyaNew York, local time
Prefer email or a call?
We reply within one business day, from Tokyo or New York.