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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

Cookies

Cookies are small text files placed on a user's device by a website or application to store information such as session identifiers, preferences or tracking identifiers. The term is used more broadly to cover similar technologies such as pixels, local storage, SDK identifiers in mobile apps and device fingerprinting.

Under Art. 5(3) of the ePrivacy Directive (2002/58/EC, as amended), storing or accessing information on a user's device requires prior informed consent, unless the operation is strictly necessary to provide a service explicitly requested by the user (for example, a shopping basket or authentication cookie) or is used solely for transmitting a communication. Where cookies process personal data, the GDPR applies in parallel, and consent must meet the Art. 7 standard: freely given, specific, informed, unambiguous and as easy to withdraw as to give. Cookie walls and pre-ticked boxes are not valid, and national authorities such as the CNIL have issued substantial fines for non-compliant banners.

For life sciences companies the stakes are higher than for most websites: patient-facing apps, disease awareness sites and trial recruitment pages can reveal a user's health condition through analytics or advertising identifiers, turning ordinary tracking into processing of health data. Cookie audits, consent management platforms configured for opt-in, and careful review of third-party tags are therefore part of any HealthTech or pharma compliance programme.