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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

EU AI Office

The European AI Office is a body established within the European Commission to support implementation of the EU AI Act and the development of trustworthy AI. It has a central role in supervising general-purpose AI models and coordinating the wider governance framework, alongside national authorities and other European bodies.

Key takeaways

  • The AI Office is part of the European Commission, rather than an independent national regulator for every organisation using AI.
  • General-purpose AI model supervision is a central AI Office function, including investigation, evaluation and support for implementing the AI Act.
  • A life sciences company should identify its AI role and product context before deciding which authority or regulatory pathway is relevant.

Who Does What?

BodyMain distinction
European AI OfficeEU-level AI governance and GPAI supervision
National competent authoritiesEnforcement for other AI systems within their remit
European Data Protection SupervisorAI Act oversight for EU institutions

The European Commission describes the Office’s work on guidance, codes of practice, evaluations and investigation of possible infringements. Its enforcement overview explains how responsibilities are shared. Do not assume that an enquiry about a healthcare AI application automatically belongs to the AI Office.

For example, consider a hypothetical biotech using a third-party general-purpose model to draft internal research summaries. Its operational questions differ from those of an organisation placing its own general-purpose model on the market. The inventory should identify the model provider, downstream application and intended users.

Why It Matters for Data Protection

AI governance does not replace data-protection governance. Operationally, review which patient, staff or research data enter the system, what the provider can do with those inputs and whether outputs could disclose sensitive information.

We recommend maintaining one evidence map connecting AI roles, contracts, privacy assessments and incident escalation. This helps the team route questions without confusing model supervision, medical-device requirements and personal-data oversight.

Frequently Asked Questions

Is the AI Office an EU-wide DPO?

No. AI Act governance and data-protection officer responsibilities are different functions.

Does the Office regulate only medical AI?

No. Its mandate extends beyond life sciences.

Should every AI user contact the Office?

Not automatically. Identify the role, issue and competent authority first.

Related: AI Act; general-purpose AI models; AI compliance support.

Updated: 27 October 2026