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Randomisation and trial supply management (RTSM)
R
Randomised clinical trial (RCT)
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Real-world data (RWD)
R
Real-world evidence (RWE)
R
Recipient
R
Record of processing activities (RoPA)
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Restriction of processing
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Right not to be subject to solely automated decision-making
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Right of access
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Right of information
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Right of rectification
R
Rights of the data subject
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Right to data portability
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Right to erasure ("right to be forgotten")
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Right to object
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Right to restriction of processing
S
Scientific research purposes (Art. 89 GDPR)
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Secondary use of health data
S
Security breach (security incident)
S
Security of processing
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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.

E

EU-US Data Privacy Framework (DPF)

The EU-US Data Privacy Framework (DPF) is the mechanism under which the European Commission, by adequacy decision of 10 July 2023 adopted under Art. 45 GDPR, recognised that US organisations self-certified under the Framework provide an adequate level of protection for personal data transferred from the EU. It succeeds the Safe Harbour and Privacy Shield arrangements invalidated by the Court of Justice in Schrems I (2015) and Schrems II (2020), and rests on Executive Order 14086 of October 2022, which introduced necessity and proportionality limits on US signals intelligence and a two-tier redress mechanism including the Data Protection Review Court. The General Court upheld the decision in Latombe v Commission (T-553/23) in September 2025; an appeal is pending before the Court of Justice.

US organisations subject to FTC or Department of Transportation jurisdiction self-certify annually with the US Department of Commerce, publicly commit to the DPF Principles (notice, choice, accountability for onward transfer, security, data integrity and purpose limitation, access, recourse and enforcement) and are listed on the DPF website. Certification can cover HR data specifically. Transfers to a certified organisation for the purposes covered by its certification require no SCCs and no transfer impact assessment. Transfers to non-certified US recipients, including federal agencies such as the FDA, still need another Chapter V mechanism. The UK Extension to the DPF (the "data bridge", in force since 12 October 2023) and the Swiss-US Data Privacy Framework (since 15 September 2024) provide parallel routes for UK and Swiss data.

For life sciences, the DPF simplifies transfers of trial, patient and employee data to certified US sponsors, CROs and technology vendors, but exporters should verify the certification scope (including whether sensitive data and HR data are covered), monitor the recipient's status, and keep SCCs as a fallback given continuing litigation risk. The Framework does not relieve the importer of US obligations such as HIPAA where applicable. See the regulations centre entries on the EU-US DPF, the UK extension and the Swiss-US DPF.