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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.

B

Biometric data

Biometric data means personal data resulting from specific technical processing relating to the physical, physiological or behavioural characteristics of a natural person, which allow or confirm the unique identification of that person, such as facial images or fingerprint data (Art. 4(14) GDPR).

Two conditions must be met: the data must derive from a technical process (a raw photograph is not biometric data; a facial template extracted from it is), and it must be capable of uniquely identifying the individual. When biometric data is processed for the purpose of uniquely identifying a person, it becomes a special category of personal data under Art. 9 and requires an exemption such as explicit consent or a substantial public interest basis.

In life sciences, biometric processing is increasingly common: voice biomarkers, gait analysis from wearables, retinal and facial imaging, and biometric authentication for eConsent or site access. Where the purpose is clinical measurement rather than identification, the data may not fall under Art. 9 as biometric data, but it will usually qualify as data concerning health. Biometric identification systems are also regulated as high-risk or prohibited practices under the EU AI Act.

Is every photograph used in a clinical trial biometric data?

No. A photograph is not automatically biometric data under the GDPR. That classification depends on specific technical processing capable of identifying a person uniquely. An image used for clinical assessment may nevertheless be personal health data. Record the purpose of image processing and distinguish clinical measurement from identity verification.