Clinic software for Japan, built to help you achieve an on-site inspection with nothing to correct.
In Japan a physician's clinic is notified to the 保健所 within 10 days of opening, a 医療法人's clinic needs a 開設許可 first, and the same authority may walk in to inspect the 診療録, the staff and the safety systems. wai runs booking, signed clinical notes, patient messaging in Japanese, English or any language, payments and an audit trail on one record, so what an inspector reads is kept as the work is done.
Updated . Every MHLW fact is checked against mhlw.go.jp and the other official pages cited below.
For
Physician-owned clinics, 医療法人 groups, day surgery and diagnostic centres, hospitals and health systems
Regulators
Ministry of Health, Labour and Welfare, with each prefecture, city health centre and Tokyo special ward, and the Personal Information Protection Commission
Framework
医療法 and 医療法施行規則, 医師法, 個人情報保護法, and MHLW's security guideline 第7.0版
Records
Kept in each clinic's own country, under its rules
Five areas the 医療法, the 医師法 and the APPI regulate, from opening to the patient's data.
Five areas Japanese law regulates for a clinic, from opening to the patient's data. Open one for the rules behind it.1
01Opening a clinic, 開設届 or 開設許可A clinic opened by a physician who has completed clinical training is notified within 10 days of opening. Anyone else, a 医療法人 included, needs permission before opening.5 requirements
医療法 第8条, 開設届 within 10 days of opening, for a clinic opened by a 臨床研修等修了医師
医療法 第7条, 開設許可 before opening, for a clinic opened by anyone else, a 医療法人 included
医療法施行規則 第4条, what the 開設届 states, the clinical training certificate shown
医療法 第9条, 廃止届 within 10 days of closing
医療法 第30条の18の6, notice 6 months before opening in a designated 外来医師過多区域
02The 管理者 and the peopleEvery clinic is managed by a physician who has completed clinical training, who supervises the staff and posts who practises when.5 requirements
医療法 第10条, a 臨床研修等修了医師 as 管理者
医療法 第12条, the 管理者 manages one clinic only, unless the governor permits
医療法 第15条, the 管理者 supervises every doctor and member of staff
医療法 第14条の2, 院内掲示 of the 管理者, the doctors and their hours
03Medical safety and cybersecurityThe 管理者 must keep a written safety guideline, train staff, run incident reporting and infection control, and take the cybersecurity measures MHLW sets.5 requirements
医療法 第6条の12 and 施行規則 第1条の11, 医療に係る安全管理のための指針, staff training and incident reporting
施行規則 第1条の11 第2項, 院内感染対策, a 医薬品安全管理責任者 and medical device safety
医療法 第6条の10, 医療事故 reported to the 医療事故調査・支援センター without delay
04The 診療録A doctor writes the 診療録 without delay after every consultation, and the clinic's 管理者 keeps it 5 years. An electronic record must stay authentic, readable and preserved.5 rules
医師法 第24条 第1項, the 診療録 written 遅滞なく after each consultation
医師法 第24条 第2項, the 診療録 kept 5 years by the clinic's 管理者
医療情報システムの安全管理に関するガイドライン 第7.0版, 真正性, 見読性 and 保存性 of electronic records
医療法 第25条 第1項, the 診療録 and 帳簿書類 open to the 立入検査
医師法 第20条, no treatment or prescription without examining the patient
05Patient data under the APPIA patient's medical history is 要配慮個人情報. The clinic posts its purposes of use, protects the data, reports serious leaks to the PPC and discloses the record on request.6 rules
個人情報保護法 第20条 第2項, consent before acquiring 要配慮個人情報
個人情報保護法 第23条 to 第25条, 安全管理措置 and the supervision of staff and contractors
個人情報保護法 第26条, 漏えい等 reported to the 個人情報保護委員会 and the patient told
個人情報保護法 第27条 and 第28条, consent before provision to a third party, or to one abroad
個人情報保護法 第33条, the patient's right to disclosure
医療・介護関係事業者における個人情報の適切な取扱いのためのガイダンス, 利用目的 posted in the clinic
The 管理者 and every doctor and nurse against what was notified, with licences on file.
02
Premises and hygiene
The rooms against the plans filed, cleanliness, and X-ray equipment where it is installed.
03
The 診療録 and books
The 診療録, 帳簿書類 and other records the clinic keeps, which article 25 lets the inspector see.
04
Medical safety
The written safety guideline, staff training, incident reporting, infection control, medicines and devices.
05
Cybersecurity
The FY2026 checklist filled in, and the incident contact chart shown on request.
06
Who runs the clinic
That the 開設者 really runs it on a non-profit basis, checked closely at self-pay clinics.
How does a 立入検査 end?
There is no public grade. The inspector checks each item as met or not met, and the authority tells the clinic what to correct.3
Nothing to correctEvery item checked is met
Items to correctThe clinic is told, and may be asked for an improvement plan
OrdersReports or documents ordered, and changes required
Closure or finesPermission revoked, closure ordered, or a fine
10 days
is how long a physician has after opening a clinic to file the 開設届 under article 8 of the 医療法.1
5 years
is how long the clinic's 管理者 must keep each 診療録 under article 24 of the 医師法.4
91.1%
of hospitals inspected in FY2023 met the cybersecurity item, the lowest rate of any item checked.3
Where an item is not met, the authority notifies the 開設者 or 管理者 and gives the guidance needed to correct it, which may include an improvement plan.
Refusing or obstructing a 立入検査, or failing to file the 開設届, carries a fine of up to ¥200,000 under article 89 of the 医療法.
Opening without a required 開設許可 carries up to 6 months' imprisonment or a fine of up to ¥300,000 under article 87.
The governor may revoke a permission or order a clinic closed for a set period, for example where the 開設者 commits a crime or a medical irregularity.
What has changed for clinics in Japan?
Four things a clinic should know in October 2026, each marked as in force or not yet in effect.
In force. MHLW revised its security guideline for medical information systems to 第7.0版 in June 2026.
In force. The FY2026 cybersecurity checklist asks clinics to answer yes to every item during the year, and the 保健所 checks it at the 立入検査.5
In force, area by area. Since 1 April 2026 a clinic without beds opening in a designated 外来医師過多区域 gives 6 months' notice, and Tokyo had designated no area as of April 2026.
Not yet in effect. The amended APPI was promulgated on 17 July 2026 and takes effect on a date set by cabinet order within two years.
Who does what
MHLW writes the law, the local authority applies it, and the PPC supervises patient data.1
Body
What it does for a clinic
Ministry of Health, Labour and Welfare
Administers the 医療法 and the 医師法, publishes the security guideline, and issues the 立入検査 notice each year
Prefecture, health centre city or Tokyo special ward
Takes the 開設届, grants the 開設許可, and runs the 立入検査 through its 保健所
Personal Information Protection Commission
Supervises the APPI, receives leak reports, and issues the guidance for medical and care providers with MHLW
医療事故調査・支援センター
Receives the report of an unexpected death linked to care, under article 6-10
The Japanese names
The official names behind this page, in the words clinics search for.
医療法, the Medical Care Act, which governs opening and running a clinic.6
医師法, the Medical Practitioners' Act, which sets the 診療録 rule.
開設届, the notification filed within 10 days of opening.
開設許可, the permission needed before opening when the 開設者 is not a physician.
立入検査, the on-site inspection under article 25.
保健所, the public health centre that inspects most clinics.
管理者, the physician who manages the clinic.
要配慮個人情報, the sensitive personal information a medical history is.
What should clinic software in Japan run?
Each module runs part of the clinic and records the evidence for the requirements listed beside it.
01
Appointments and booking
Online booking from your own website, every clinician's diary read from their calendar, reminders, rebooking after a missed visit and waitlist offers when a slot opens.
Online booking at any hour, with a reminder before the visit.
For the business
Fewer missed appointments, and cancelled slots offered to the waitlist.
On the record
Every booking, reminder and change, with a time and a name.
02
Billing and payments
Card payments into your own Stripe account, the cancellation policy shown at booking, invoices, statements and reconciliation, with an export for your accountant.
A clear price and policy before they commit, and an invoice in their app.
For the business
Payments reconciled against visits, with an export for your accountant.
On the record
What was charged, when, against which visit, and the policy the patient saw.
03
AI scribe and clinical notes
The note, letters and referrals written from the consultation, cited to published clinical guidelines, with the transcript beside the note, for the clinician to read, edit and sign.
The clinician's attention stays on them during the consultation.
For the business
Less time spent writing notes after clinic.
On the record
A contemporaneous note, signed, with the time, the signature and the source it cites.
04
Follow-ups and patient messaging
WhatsApp, email and calls in one thread per patient, replies drafted in the patient's own language for your team to approve, a response clock on every new enquiry, and recalls a clinician approves.
A reply in the language they wrote in, approved by your team.
For the business
More enquiries answered within the hour, when they are most likely to book.
On the record
The whole conversation on one record, with response times.
05
Referrals, consent and audit trails
Recording consent taken at booking, referrals written from the visit, patient flags for controlled drugs and safeguarding notes, and every read of a record logged against a named account.
What is the best clinic software for a clinic in Japan?
The best software for a Japanese clinic is the system the clinic already runs on, so the evidence is kept as the work is done. Look for a 診療録 that shows the author and time of every entry, notes signed by the doctor, messaging in Japanese and English, named accounts with role-based access and a full audit trail. wai is built that way, to help you achieve an on-site inspection with nothing to correct.
Is there MHLW approved clinic software?
MHLW administers the law, and the prefecture or public health centre registers and inspects clinics. It does not approve, certify or endorse software, wai included, and software cannot earn an inspection result on a provider's behalf. wai keeps the records your team uses to show the 保健所 how care is delivered, and the 保健所 decides the inspection result.
Does a doctor need permission to open a clinic in Japan?
No. A doctor who has completed clinical training opens the clinic and files a 開設届 within 10 days. A 医療法人 or anyone else needs a 開設許可 before opening.
How often does the 保健所 inspect a clinic?
MHLW's 要綱 sets an inspection of every hospital in principle once a year, and asks authorities to inspect clinics as the need arises. MHLW also asks them to check each newly notified clinic on site against its 開設届, promptly.
How long must a Japanese clinic keep the 診療録?
5 years under article 24 of the 医師法, kept by the clinic's 管理者. Other records the clinic keeps carry their own periods.
Can AI write the 診療録 in a Japanese clinic?
The 医師法 requires the doctor to write the 診療録 without delay, and only a doctor may practise medicine. A note drafted by AI fits that when the doctor reviews it, edits it and signs it under their own name, and every change stays in the audit trail.
Where does wai keep our records?
In each clinic's own country, under that country's rules, encrypted, with a full audit log. We set this up with you before go-live.
Fifteen minutes on video, in Japanese or English, on your own clinic's records. Built to help you achieve an on-site inspection with nothing to correct. wai hosts each clinic's records in its own country, under that country's rules. We set this up with you before go-live.
