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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.

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Authorised representative (EU AI Act)

An authorised representative under the EU AI Act is a natural or legal person located or established in the Union that has received and accepted a written mandate from a provider of an AI system or a general-purpose AI model established in a third country, to perform and carry out on the provider's behalf the obligations and procedures established by the Regulation (Art. 3(5)). Appointment is mandatory before a high-risk AI system is made available on the Union market (Art. 22) and, for third-country providers of general-purpose AI models, before the model is placed on the market (Art. 54). The concept mirrors the authorised representative under the MDR and other product legislation.

The mandate must empower the representative at least to: verify that the EU declaration of conformity and technical documentation have been drawn up and that the conformity assessment procedure has been carried out; keep at the disposal of authorities, for ten years, the provider's contact details, the declaration of conformity, the technical documentation and, where applicable, the notified body certificate; provide authorities with all information and documentation necessary to demonstrate conformity, including access to logs; cooperate with authorities on any action they take to reduce risks; and, where applicable, comply with the registration obligations. The representative must terminate the mandate if it considers that the provider is acting contrary to its obligations and inform the market surveillance authority. Authorities may address the representative directly, and the representative's identity must appear on the system or its documentation.

For non-EU developers of AI-enabled medical device software, diagnostic algorithms or health AI platforms, the AI Act representative is a second mandatory EU footprint alongside the MDR authorised representative and the GDPR Art. 27 Data Protection Representative. The three roles have different legal bases, mandates and liabilities (the GDPR representative deals with data subjects and supervisory authorities on all processing issues, the AI Act representative with market surveillance authorities on conformity), but they can be held by the same organisation to ensure a consistent interface with EU regulators. iliomad acts as EU AI Act authorised representative for life sciences providers alongside its GDPR representative service.