Healthcare Regulation - Japan Compliance

Japan Compliance

Healthcare Regulation

A collection of 13 posts

Slide mapping Japan’s pandemic legal framework: new crisis-management agency, law revisions, fiscal measures, digital-system gaps, and business action items.

Regulatory Updates

Japan’s Public-Health Playbook: Legal Lessons from the Pandemic for the Next Crisis

TL;DR * COVID-19 exposed coordination gaps between Japan’s national command and local implementation, prompting a new Cabinet Agency for Infectious-Disease Crisis Management (2023). * Key legal pivots—Infectious Diseases Control Law revisions, fiscal mega-stimulus, “requests” versus enforceable orders—reshape how firms must plan for the next emergency. * Businesses should track

Slide summarising the 2011 Supreme Court LTCI decision: valid designation prevents clawback of care benefits despite initial flaws.

Administrative Law

Supreme Court Clarifies LTCI Clawback: Valid Provider Designations Survive Initial Flaws (2011)

Japan Supreme Court (2011): Care benefits can’t be clawed back if the provider’s designation stays valid, despite flaws in its initial approval.

Diagram summarising Japan’s 2011 Supreme Court decision on mixed medical care, contrasting insured and uninsured treatments with Article 86 exceptions.

Japan’s Supreme Court Affirms Ban on Mixed Medical Care – Key Takeaways from the 2011 Judgment

TL;DR * In 2011 Japan’s Supreme Court confirmed that combining insured and uninsured treatments (“mixed medical care”) generally voids health‑insurance benefits unless strict Article 86 exceptions apply. * The Court grounded its reasoning in legislative history, system coherence and patient‑safety considerations, rejecting constitutional challenges. * The decision reinforces regulated

Summary slide illustrating the 1986 Supreme Court ruling tying High‑Cost Medical Expense Benefits to treatment compliance under the National Health Insurance Act.

When Treatment Standards Matter: Japan’s Supreme Court on High‑Cost Medical Expense Benefits (1986)

TL;DR In its 17 October 1986 ruling (Case No. 1986 (Gyo‑Tsu) 68), the Supreme Court of Japan confirmed that insurers may conduct substantive reviews of claimed treatments under the National Health Insurance Act and may deny High‑Cost Medical Expense Benefits when underlying care violates official standards. Non‑

Summary slide illustrating the 1978 Supreme Court ruling that medical‑fee reductions (‘genten’) are not administrative dispositions and must be contested in civil court.

Japan Supreme Court on Medical‑Fee Reductions (1978): Why ‘Genten’ Isn’t an Administrative Disposition

TL;DR The 1978 Supreme Court clarified that fee “reductions” (genten) imposed by the Social Insurance Medical Fee Payment Fund are not administrative dispositions. Providers therefore must sue in ordinary civil court—rather than file an administrative revocation suit—to recover any amounts they believe were wrongly withheld. Table of

Diagram summarizing the 1973 Supreme Court decision

Supreme Court Clarifies Third‑Party Debtors in Japan’s Health Insurance (1973)

TL;DR (3‑sentence summary) The 1973 Supreme Court of Japan held that the Social Insurance Medical Fee Payment Fund and National Health Insurance Federations become direct debtors—“in their own name”—once they are delegated to review and pay claims. Because they owe a public‑law duty to pay

Single‑slide summary illustrating how a non‑binding hospital‑opening recommendation became judicially reviewable after Japan’s Supreme Court’s 2005 ruling.

Challenging "Guidance": Japan's Supreme Court on the Reviewability of Hospital Opening Recommendations (2005)

TL;DR Japan’s Supreme Court held in 2005 that a seemingly non‑binding recommendation under the Medical Care Act becomes a reviewable “administrative disposition” when it predictably leads to denial of national health‑insurance designation, effectively blocking a new hospital from operating. Table of Contents * Background: Health Planning, Recommendations,

Key points of the 2022 Supreme Court decision on revoking dependent status under Japan’s Health Insurance Act, including appeal routes and 60‑day filing deadline — one‑slide summary.

Dependent Status Disputes in Japan's Health Insurance: Supreme Court Clarifies Appeal Routes (2022)

TL;DR Japan’s Supreme Court (Dec 13 2022) held that a notice revoking a spouse’s dependent status under the Health Insurance Act is an appealable administrative disposition. Such disputes must first go through the special two‑tier social‑insurance appeal system, but strict 60‑day filing limits apply—

Slide summarizing the 2004 Japan Supreme Court ruling on National Health Insurance eligibility for undocumented residents and the negligence standard for state liability.

Japan Supreme Court on Undocumented Residents’ NHI Eligibility & State Liability (2004)

TL;DRThe 2004 ruling held that an undocumented long‑term resident who had registered locally and applied for Special Permission for Residence could, in rare cases, meet the “address” requirement of Japan’s National Health Insurance Act.The denial of NHI coverage in the case was therefore illegal, yet no

Summary slide illustrating Japan’s 2021 Supreme Court decision requiring face‑to‑face pharmacist counselling for “Drugs Requiring Guidance” and its impact on online OTC sales.

Japan Supreme Court Confirms Face‑to‑Face Pharmacist Guidance for “Drugs Requiring Guidance” (2021 Online‑Pharmacy Ruling)

TL;DR Japan’s 2021 Supreme Court ruling upheld the Pharmaceutical and Medical Device Act provision that “Drugs Requiring Guidance” must be sold only after face‑to‑face counselling by a pharmacist. The Court held that (i) protecting public health is a legitimate aim; (ii) in‑person interaction is a

One‑slide summary of Japan’s 2005 Supreme Court decision on denying insurance designation to a new hospital in a bed‑surplus region.

Can Japan Deny Insurance Status to New Hospitals? Supreme Court Balances Planning & Provider Rights (2005)

TL;DR Japan’s Supreme Court (2005) upheld a prefectural decision to deny a new hospital “Insurance Medical Institution” status because it ignored a non‑binding recommendation under the regional Medical Plan. The Court ruled that (i) the denial fit the Health Insurance Act’s clause for “extremely inappropriate” institutions,

One-slide summary illustration of the 1958 Supreme Court decision upholding compulsory National Health Insurance in Japan

Japan’s Supreme Court Upholds Compulsory National Health Insurance (1958)

TL;DR In 1958 the Japanese Supreme Court’s Grand Bench ruled that municipalities can mandate National Health Insurance enrollment and premiums without violating constitutional rights. Citing public welfare and mutual aid, the Court rejected claims under Articles 19 and 29 and confirmed the procedural validity of Ogi Town’s

Summary slide illustrating the 2006 Supreme Court ruling on National Health Insurance premium setting and hardship exemptions in Japan

Japan Supreme Court 2006: National Health Insurance Premiums & Hardship Exemptions Explained

TL;DR Japan’s Supreme Court Grand Bench (March 1, 2006) upheld Asahikawa City’s method of setting compulsory National Health Insurance (NHI) premiums and its narrow hardship‑exemption rule. The Court held that NHI premiums, although mandatory, are not “taxes” under Article 84 of the Constitution. Therefore, ordinances may