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21 CFR Part 11
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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.

E

Electronic health record (EHR)

An electronic health record (EHR) is a digital, longitudinal record of a patient's health information created and maintained by healthcare providers, including demographics, medical history, diagnoses, medications, allergies, immunisations, laboratory and imaging results, clinical notes and treatment plans. Unlike a departmental electronic medical record, an EHR is designed to be shared across providers and settings, and increasingly to be accessible to the patient through portals and national infrastructures such as France's Mon espace santé.

EHR data is the primary source for real-world data, for pragmatic and observational studies, for feasibility and recruitment in clinical trials, and for building health data warehouses. Its research value depends on interoperability standards such as HL7 FHIR, SNOMED CT and ICD-10/11, and on data quality that varies widely between providers.

EHR content is data concerning health and often includes genetic and other special category data. Providers are controllers; any secondary use by a sponsor or HealthTech company requires a legal basis under Art. 6 and 9 GDPR, national research rules (for example France's MR-004 or a CNIL authorisation), pseudonymisation and a governance framework. The European Health Data Space regulation creates an EU-wide access regime for EHR data through health data access bodies, with the first secondary-use provisions applying from 2029. In the US, EHRs are protected health information under HIPAA.

Is an electronic health record automatically a research-ready dataset?

No. An EHR is primarily a record supporting care, not a dataset designed around a particular research question. Before reuse, examine whether its content, completeness and timing support the intended analysis. Separately assess permission to access and reuse personal data; technical availability is not itself a lawful basis.