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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.

C

Codes of conduct

Codes of conduct are voluntary sets of rules drawn up by associations or other bodies representing categories of controllers or processors to specify the application of the GDPR in their sector, approved by the competent supervisory authority and, for codes covering several Member States, by the EDPB and the European Commission (Art. 40). Art. 40(2) lists topics a code may address, including fair and transparent processing, legitimate interests, collection and pseudonymisation, information to the public and data subjects, rights, protection of children, security, breach notification, international transfers and dispute resolution. Compliance is monitored by an accredited monitoring body (Art. 41).

Adherence to an approved code has legal effects: it may be used to demonstrate compliance with controller obligations (Art. 24(3)), processor guarantees (Art. 28(5)) and security (Art. 32(3)); it is taken into account in DPIAs (Art. 35(8)) and when setting fines (Art. 83(2)(j)); and a code approved with binding and enforceable commitments by third-country recipients can serve as an appropriate safeguard for transfers under Art. 46(2)(e), as clarified by EDPB Guidelines 04/2021. The EDPB has approved transnational codes for cloud infrastructure and cloud service providers (the EU Cloud CoC and CISPE), which many life sciences vendors adhere to.

For health and research, several national codes exist or are under development, for example on health research in the Netherlands and on hospital data processing in France, and the European Health Data Space and the Commission's Code of Conduct on secondary use of health data initiative aim to give sponsors and data holders sector-specific reference rules. Codes complement rather than replace legal obligations; a sponsor can use a vendor's adherence to the EU Cloud CoC as evidence in its vendor assessment, but still needs a DPA, a TIA where relevant and its own DPIA.