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Imported item 10
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Term of the Day

Natural history study

A natural history study is a preplanned observational study intended to track the course of a disease over time, identifying demographic, genetic, environmental and other variables that correlate with its development and outcomes in the absence of intervention, or under standard of care. Designs may be retrospective (chart review of existing records) or prospective (longitudinal follow-up of a cohort or registry).

Natural history data is particularly important in rare and paediatric diseases, where randomised placebo-controlled trials may be infeasible or unethical. The FDA (guidance on rare disease natural history studies, 2019) and the EMA accept well-designed natural history studies to define endpoints and biomarkers, identify patient subgroups, estimate sample sizes and, in some cases, serve as external or historical control arms for single-arm trials supporting orphan products.

Because they are non-interventional, natural history studies fall outside the CTR and are governed by national law (for example France's MR-003 or MR-004 reference methodologies) and by the GDPR. They typically involve secondary use of medical records, long-term follow-up, genetic data and small populations in which anonymisation is rarely achievable, so pseudonymisation, a DPIA and a robust research legal basis under Art. 9(2)(j) are essential. Registries maintained by patient organisations or academic consortia raise additional questions of joint controllership and data access governance.

A

Imported item 28

APPI is Japan’s Act on the Protection of Personal Information, which governs the handling of personal information. For life sciences organisations, it matters when research involves identifiable people in Japan, sensitive medical information or cross-border data sharing. It is a separate legal framework from the EU GDPR.

Key takeaways

  • Medical history falls within APPI’s sensitive personal information category.
  • EU-Japan adequacy operates within a defined scope.
  • Onward transfers require their own assessment.

How APPI Applies to Research

The Personal Information Protection Commission publishes the Act and implementing materials. Japanese legal texts prevail over translations. Rather than treating APPI as a Japanese copy of GDPR, identify the organisation, information and processing activity concerned. The PPC supplementary rules add protections for personal data received under EU or UK adequacy arrangements.

IssuePractical distinction
Medical informationMedical history is sensitive personal information.
Purpose of useSpecified purposes constrain subsequent use.
Foreign recipientDestination and recipient safeguards matter.

Why It Matters for Data Protection

The European Commission lists Japan under its adequacy decisions, but this is not permission for unrestricted research use. As an operational recommendation, document the receiving entity, applicable adequacy scope, original purpose and every onward recipient. A Japanese recipient receiving EU data under adequacy must also consider the supplementary rules, including their purpose and onward-transfer provisions.

Hypothetical example: An EU sponsor proposes sending coded study records to a Japanese laboratory, which uses an overseas analysis provider. A useful review separates the initial EU-to-Japan transfer from the laboratory’s onward disclosure, rather than approving the entire chain with one country-level tick box.

Frequently Asked Questions

Is APPI the same as GDPR?

No. Similar protective aims do not make their definitions, scope or exceptions interchangeable.

Does adequacy cover every Japanese recipient?

No. Check the decision’s scope and the recipient’s status before relying on it.

Can the recipient reuse study data freely?

No. Purpose restrictions and the relevant research permissions still need assessment.

Related reading: third country, adequacy decision.

For practical implementation, explore global data governance support.

Updated: 27 October 2026