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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.

S

Sensitive data

Sensitive data is the everyday term for what the GDPR calls special categories of personal data: personal data revealing racial or ethnic origin, political opinions, religious or philosophical beliefs or trade union membership, genetic data, biometric data processed for the purpose of uniquely identifying a natural person, data concerning health, and data concerning a natural person's sex life or sexual orientation (Art. 9(1)). Data relating to criminal convictions and offences is governed separately by Art. 10, and some national laws and the Swiss FADP add further categories such as social security measures.

The processing of sensitive data is prohibited unless one of the ten exceptions of Art. 9(2) applies, including explicit consent, employment and social security law, vital interests, processing by non-profit bodies, data manifestly made public, legal claims, substantial public interest, health and social care, public health, and scientific research with Art. 89 safeguards. Member States may add conditions for genetic, biometric and health data (Art. 9(4)). Sensitive data also triggers other obligations: a mandatory DPIA for large-scale processing (Art. 35(3)(b)), the appointment of a DPO where such processing is a core activity (Art. 37(1)(c)), loss of the small-organisation exemption from record-keeping (Art. 30(5)), and the highest fine tier.

The term "sensitive" is also used loosely to describe data that is commercially confidential (trade secrets, unpublished trial results) or that carries elevated risk without falling under Art. 9 (financial data, location data, children's data). These deserve strong protection but are not special category data in the legal sense, and conflating them leads to both over- and under-compliance. For life sciences companies, virtually all patient-facing processing involves health data and therefore sits at the most demanding end of the GDPR.

Is commercially confidential trial information always special-category personal data?

No. Commercial confidentiality and GDPR special-category status are different classifications. A manufacturing method can be confidential without relating to an identifiable person, while participant health data is a special category. Assess both dimensions so that technical secrets receive appropriate security and personal data receives the additional safeguards its processing requires.