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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.

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Scientific research purposes (Art. 89 GDPR)

Scientific research purposes is a category of processing that the GDPR treats favourably in several respects, subject to the safeguards of Art. 89. Recital 159 says it should be interpreted broadly, covering technological development and demonstration, fundamental and applied research, privately funded research, and studies conducted in the public interest in the area of public health; the EDPB has cautioned that the research must follow the sector's methodological and ethical standards, and the UK Data (Use and Access) Act 2025 now defines it as research that can reasonably be described as scientific, whether publicly or privately funded and whether commercial or not.

The favourable regime has four elements. First, further processing for research is presumed compatible with the original purpose under Art. 5(1)(b), easing secondary use. Second, Art. 9(2)(j) allows processing of special category data for research on the basis of Union or Member State law, proportionate to the aim and with suitable safeguards. Third, storage beyond the original need is permitted under Art. 5(1)(e). Fourth, Art. 89(2) allows Union or Member State law to derogate from the rights of access, rectification, restriction and objection where they would render impossible or seriously impair the research, and Art. 14(5)(b) and 17(3)(d) relax information and erasure duties. In exchange, Art. 89(1) requires appropriate safeguards, in particular data minimisation, pseudonymisation wherever the purposes can be fulfilled that way, and anonymisation where possible.

Because most of these provisions depend on national law, the research regime differs across Member States: France channels it through the CNIL reference methodologies, Germany through federal and state research clauses, Ireland through the Health Research Regulations 2018 (which require explicit consent unless a committee grants a declaration), and Italy through Garante rules. A sponsor relying on Art. 9(2)(j) must identify the specific national provision in each country in its DPIA and informed consent form; the European Health Data Space will provide a Union-law basis for secondary use of electronic health data from 2029. See iliomad's clinical research services.