Click here to open the filter panel
Click a letter to view all its definitions
Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.

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 not to be subject to solely automated decision-making

The right not to be subject to a decision based solely on automated processing is set out in Art. 22 GDPR: the data subject shall have the right not to be subject to a decision based solely on automated processing, including profiling, which produces legal effects concerning him or her or similarly significantly affects him or her. The EDPB (Guidelines WP251) and the Court of Justice (SCHUFA, C-634/21) read the provision as a general prohibition rather than a right to be invoked, so controllers must comply proactively.

The prohibition does not apply where the decision is necessary for entering into or performing a contract, is authorised by Union or Member State law with suitable safeguards, or is based on the data subject's explicit consent (Art. 22(2)). In the first and third cases the controller must at least provide the right to obtain human intervention, to express one's point of view and to contest the decision (Art. 22(3)). Decisions based on special category data such as health data are permitted only with explicit consent or for substantial public interest, with suitable safeguards (Art. 22(4)). Meaningful information about the logic involved and the envisaged consequences must be given under Art. 13(2)(f), 14(2)(g) and 15(1)(h).

Health applications include automated triage or eligibility decisions, insurance underwriting on health data, algorithmic prioritisation of care and fully automated screening of trial candidates. Where a clinician reviews and can overturn the output, the decision is generally not "solely" automated, provided the review is meaningful rather than a rubber stamp. Many of these systems are also high-risk AI systems under the EU AI Act, whose Art. 14 human oversight and Art. 86 right to explanation of individual decisions complement Art. 22 GDPR.