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Imported item 10
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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.

H

Imported item 38

HDS certification is the French certification framework for hosting personal health data within the scope of the Public Health Code. HDS stands for Hébergeur de Données de Santé. It evaluates specified hosting activities against a security framework; it is not a blanket certification of a research project’s GDPR compliance.

Key takeaways

  • Applicability depends on the data, context and hosting arrangement.
  • A certificate covers defined activities, not every supplier service.
  • The revised 2024 framework has completed its transition period.

Which Hosting Activities Are Covered?

The Agence du Numérique en Santé explains the certification scheme and its activity-based scope. The statutory trigger concerns hosting specified personal health data on behalf of the producer, collector or patient. As an operational recommendation, assess clinical research arrangements individually rather than assuming every research dataset is automatically covered or automatically exempt.

Activity groupExamples to check
InfrastructurePhysical sites and hardware supporting hosting.
PlatformsApplication platforms and virtual infrastructure.
OperationsAdministration, operation and backups.

Why It Matters for Data Protection

The 2024 framework update strengthened hosting and sovereignty requirements, including physical hosting in the European Economic Area and transparency about certain overseas access risks. The transition deadline was 16 May 2026. ANS also announces version 2.1 changes; confirm the published text and effective dates before relying on a version number. As an operational recommendation, verify the current certificate, covered legal entity, activities and subcontracting chain. An HDS certificate does not itself settle lawful processing, controller responsibilities or every international-access issue.

Hypothetical example: A sponsor selects a platform for a French health data warehouse. Its procurement team recommends comparing the supplier’s certificate scope with the actual application administration, infrastructure and backup responsibilities. A certified infrastructure provider alone should not be assumed to cover every activity performed by a separate application supplier.

Frequently Asked Questions

Must every sponsor obtain HDS certification?

Not merely because it sponsors research. Assess whether it performs hosting activities within the statutory scope.

Is ISO 27001 alone the same as HDS?

No. HDS builds on security management requirements with additional health-hosting requirements.

Does HDS mean data stay only in France?

No. The revised framework refers to physical hosting in the EEA, not exclusively France.

Related reading: health data warehouse, secondary use of health data.

For practical implementation, explore clinical data hosting support.

Updated: 27 October 2026