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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

Recipient

A recipient means a natural or legal person, public authority, agency or another body, to which personal data are disclosed, whether a third party or not. Public authorities which may receive personal data in the framework of a particular inquiry in accordance with Union or Member State law are not regarded as recipients, and their processing of those data must comply with the applicable data protection rules according to the purposes of the processing (Art. 4(9) GDPR).

The definition is functional: a processor is a recipient even though it acts on behalf of the controller; a joint controller receiving data is a recipient; an affiliate within the same group is a recipient. The exclusion for authorities is narrow and covers, for example, a tax authority or court requesting specific information in an investigation, not routine or systematic reporting to regulators such as adverse reaction reporting to the EMA or data submissions to the FDA, which remain disclosures to recipients.

Recipients matter because data subjects must be informed of "the recipients or categories of recipients" under Art. 13(1)(e) and 14(1)(e), and the right of access includes the right to know to whom data has been disclosed; the Court of Justice (Österreichische Post, C-154/21) held that individuals are entitled to the identity of specific recipients where they ask for it. In a clinical trial the recipients typically include the sponsor and its affiliates, the CRO, laboratories, imaging and technology vendors, ethics committees, regulators, data monitoring committees, auditors and insurers. The informed consent form, the record of processing activities and the DPIA should list them consistently, and the list should be updated when vendors change.

Can an organisation be a data recipient without being a third party?

Yes. A processor receiving trial data on a controller’s behalf can be a recipient without being a third party under the GDPR definitions. For transparency, map who receives which data and for what purpose. Keep the recipient information in participant notices consistent with the study’s actual data flows.