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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.

D

Data Protection Officer (DPO)

A Data Protection Officer (DPO) is the person designated by a controller or processor to inform and advise the organisation on its data protection obligations, monitor compliance, advise on DPIAs, cooperate with the supervisory authority and act as its contact point (Art. 39 GDPR). The DPO must be designated on the basis of professional qualities and expert knowledge of data protection law and practice (Art. 37(5)).

Appointment is mandatory under Art. 37(1) for public authorities, for organisations whose core activities consist of regular and systematic monitoring of individuals on a large scale, and for organisations whose core activities consist of large-scale processing of special category data. Pharmaceutical sponsors, CROs, HealthTech platforms and MedTech companies processing health data at scale therefore generally fall within the obligation, and some national laws (Germany, for example) add headcount thresholds.

The DPO must be independent, may not be dismissed or penalised for performing their tasks, must report to the highest management level and must not hold a position that determines purposes and means of processing (Art. 38). The role may be filled internally or by an external service provider on a contract, which is why many life sciences companies use an outsourced or "global" DPO combining EU, UK and Swiss expertise. iliomad's DPOs are CDPO-certified; see outsourced Data Protection Officer services and how the mandate works for founders and executives. The DPO's contact details must be published and communicated to the supervisory authority.