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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.

L

Lawfulness

Lawfulness is the requirement in Art. 5(1)(a) GDPR that personal data be processed lawfully, which means on the basis of one of the six legal bases listed in Art. 6(1): consent, performance of a contract, compliance with a legal obligation, protection of vital interests, performance of a task in the public interest or exercise of official authority, and legitimate interests of the controller or a third party. Processing without a legal basis is unlawful even if it is transparent and secure.

For special categories of personal data such as health and genetic data, lawfulness has a second layer: in addition to an Art. 6 basis, one of the exceptions in Art. 9(2) must apply, for example explicit consent, health care provision, public health, or scientific research with appropriate safeguards. Member State law may add conditions (Art. 9(4)), and processing must also comply with any other applicable law, since "lawful" is read broadly by the Court of Justice.

In clinical research, the lawfulness analysis is usually the first and most consequential step of the DPIA: the EDPB considers that a sponsor typically relies on Art. 6(1)(c) and 9(2)(i) for safety and regulatory obligations, and on Art. 6(1)(e) or (f) with 9(2)(j) for the research itself, rather than on consent. The choice of basis determines which data subject rights apply, what happens on withdrawal, and what must be said in the informed consent form. It should be documented per purpose and per country, since national research laws differ.

Can strong security make health-data processing lawful?

No. Security protects processing but does not supply its legal justification. Under the EU GDPR, identify an Article 6 basis and, for health data, an applicable Article 9 condition. Then address security and the other principles. A secure research database can still be used unlawfully if those foundations are missing.