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21 CFR Part 11
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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

Special categories of personal data

Special categories of personal data are the categories listed in Art. 9(1) GDPR whose processing is in principle prohibited: personal data revealing racial or ethnic origin, political opinions, religious or philosophical beliefs or trade union membership, and the processing of genetic data, biometric data for the purpose of uniquely identifying a natural person, data concerning health, or data concerning a natural person's sex life or sexual orientation. They are commonly called sensitive data. The Court of Justice reads the category broadly: data from which a special category can be inferred (Meta Platforms, C-252/21; Lindenapotheke, C-21/23) is itself special category data.

The prohibition is lifted only where one of the exceptions in Art. 9(2) applies, in addition to an Art. 6 legal basis. Those most used in life sciences are: explicit consent (a); vital interests where the person is incapable of consenting (c); health or social care and management of health systems, by or under the responsibility of a professional bound by secrecy (h); public interest in the area of public health, such as pharmacovigilance and ensuring standards of quality and safety of medicinal products and devices (i); and scientific research based on Union or Member State law with Art. 89 safeguards (j). Under Art. 9(4) Member States may add conditions for genetic, biometric and health data, and many have: French rules on health research (reference methodologies and CNIL authorisations), German state hospital laws, Italian Garante authorisations, and Nordic biobank acts.

Practical consequences include a mandatory DPIA for large-scale processing, appointment of a DPO where such processing is a core activity, stricter conditions for automated decisions (Art. 22(4)), heightened security expectations and the top fine tier. The UK GDPR adds the Data Protection Act 2018 Schedule 1 conditions and requires an appropriate policy document; the Swiss FADP uses the parallel term "sensitive personal data".