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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.

V

Vital interests (Art. 6(1)(d) GDPR)

Vital interests is the legal basis in Art. 6(1)(d) GDPR under which processing is lawful where it is necessary to protect the vital interests of the data subject or of another natural person. Recital 46 explains that vital interests means interests essential for the life of the person, and that this basis should in principle be relied on only where the processing cannot manifestly be based on another legal basis; it gives as examples humanitarian purposes such as monitoring epidemics and their spread, and humanitarian emergencies including natural and man-made disasters. For special category data, the parallel exception in Art. 9(2)(c) applies only where the data subject is physically or legally incapable of giving consent.

The basis is therefore narrow and exceptional. It covers, for instance, accessing an unconscious patient's medical history in an emergency department, disclosing a trial participant's treatment allocation to an emergency physician through unblinding, sharing location or health data during a rescue operation, or processing by humanitarian organisations in conflict or disaster zones. It does not justify routine healthcare (which relies on Art. 9(2)(h)), pharmacovigilance (Art. 6(1)(c) and 9(2)(i)), or research (Art. 9(2)(j)), and the EDPB has cautioned against stretching it to public health measures that are better founded on Union or Member State law under Art. 9(2)(i).

In clinical research, vital interests is relevant to emergency trials under Art. 35 CTR 536/2014, where a participant is enrolled before informed consent can be obtained: the initial processing of the patient's data to include them and treat them may rest on vital interests and Art. 9(2)(c), with the research legal basis taking over once consent or representative consent is obtained. It also underpins emergency unblinding procedures in IRT systems and the disclosure of urgent safety information to treating physicians. Because it is exceptional, each reliance on vital interests should be documented in the RoPA and the DPIA with the circumstances that made other bases unavailable.