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Imported item 10
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Imported item 12
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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.

S

Imported item 30

Schrems II is the Court of Justice of the European Union’s judgment of 16 July 2020 in case C-311/18 on international personal data transfers. It invalidated the EU-US Privacy Shield decision while keeping standard contractual clauses valid, subject to assessment of whether transferred data receive essentially equivalent protection.

Key takeaways

  • The judgment invalidated Privacy Shield, not every EU-US transfer.
  • Signing contractual clauses alone may be insufficient.
  • The transfer route and destination safeguards determine the assessment.

What Changed for International Transfers

The Court’s judgment summary distinguishes the validity of a transfer mechanism from whether it works for a particular transfer. Where destination-country law prevents the promised protection, organisations cannot simply rely on the contract. The EDPB supplementary-measures recommendations explain assessment and additional safeguards; transfers may need suspension if adequate protection cannot be achieved.

Transfer routeKey distinction
Privacy ShieldInvalidated in 2020.
Standard contractual clausesRemain usable subject to applicable safeguards.
EU-US Data Privacy FrameworkSeparate adequacy route for covered recipients.

Why It Matters for Data Protection

The Commission’s current adequacy list includes participating US commercial organisations under the EU-US Data Privacy Framework. Do not assume every US vendor is covered or that an SCC-based assessment is required for a transfer validly relying on adequacy. As an operational recommendation, check the exact legal entity, certification scope, onward disclosures and actual access arrangements before choosing the route.

Hypothetical example: A European sponsor uses a US analysis provider. The team first checks whether that recipient and service are covered by the Framework. If relying instead on SCCs, it assesses relevant destination-law risks and whether proposed safeguards actually protect the study data.

Frequently Asked Questions

Did Schrems II ban US cloud services?

No. It requires an appropriate transfer route and effective protection, not a blanket country ban.

Is encryption always sufficient?

No. Its effectiveness depends on the transfer, access needs and who can obtain the keys.

Does the Framework replace every transfer assessment?

No. Its adequacy route applies only within its scope; other routes remain relevant.

Related reading: standard contractual clauses, transfer impact assessment, EU-US Data Privacy Framework.

For practical implementation, explore contractual review support.

Updated: 27 October 2026