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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.

R

Right of information

The right of information, more precisely the controller's obligation to inform, requires that data subjects receive, in a concise, transparent, intelligible and easily accessible form, using clear and plain language, the information listed in Art. 13 GDPR where data is collected from them, and in Art. 14 where it is obtained from another source. It is the operational expression of the transparency principle and the prerequisite for exercising every other right.

The required content includes the identity and contact details of the controller and its EU representative, the contact details of the DPO, the purposes and legal basis of processing (including the legitimate interests pursued), the recipients or categories of recipients, any international transfers and the safeguards used, the retention period or criteria, the existence of data subject rights and of the right to withdraw consent and to lodge a complaint, whether provision of data is mandatory, and the existence and logic of any automated decision-making. Under Art. 14 the categories and source of the data must also be stated, and information is due within a reasonable period, at the latest within one month or at first communication. Art. 14(5) exempts cases where the individual already has the information, where provision is impossible or would involve disproportionate effort (notably for research, subject to Art. 89 safeguards and public information), or where secrecy is required by law.

In life sciences the information duty is fulfilled through the data protection section of the informed consent form, separate privacy notices for site staff, app users, healthcare professionals and website visitors, and, for secondary use of existing data, through layered notices, hospital websites and transparency portals when individual information is disproportionate. Layered and standardised formats are recommended by the EDPB transparency guidelines (WP260). The information must be consistent with the RoPA and DPIA; discrepancies between them are a common inspection finding.