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Imported item 10
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Imported item 11
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Imported item 12
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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

Imported item 17

The Système National des Données de Santé (SNDS) is France’s national health data system. It brings together major administrative health datasets for authorised uses, including research. Its main database includes healthcare reimbursement, hospital and mortality information; it is not an unrestricted public database of individual medical records.

Key Takeaways

  • SNDS research requires the correct access route and safeguards for the project, not simply a useful scientific question.
  • Hospital activity and reimbursement data describe different parts of a care pathway and need careful interpretation.
  • MR-008 is a conditional research framework, not blanket permission for every pharmaceutical or commercial use.

What Information Does the SNDS Contain?

ElementMeaning
DCIR reimbursement dataHealthcare consumption and reimbursed services
PMSIHospital activity information
Mortality dataInformation about deaths and their causes

The official SNDS documentation describes linked information from several health and administrative sources. This can support studies of care pathways or medicine use, but researchers should establish the meaning, coverage and limits of each variable. CNIL’s MR-008 covers certain research, studies and evaluations using the main SNDS database by organisations pursuing legitimate interests. The processing must serve a public-interest purpose, comply with the framework’s conditions and receive a favourable CESREES opinion; insurers are excluded from its scope.

Primary guidance: Official SNDS documentation; CNIL MR-008.

Why It Matters for Data Protection

For a hypothetical pharmaceutical outcomes study, we recommend defining the population, observation period and variables before choosing the access procedure. Check whether the requested work fits MR-008 or needs another route, including a CNIL authorisation where applicable. Do not equate a pseudonymised research extract with an open dataset. Assign responsibility for authorised users, secure analysis, output controls and transparency. Keep the access decision aligned with the actual analysis rather than extending the project informally after data become available.

Frequently Asked Questions

Is SNDS the same as a hospital record?

No. It combines administrative health datasets with their own coding and coverage.

Does MR-008 cover every SNDS project?

No. Eligibility, purpose and all framework conditions must be checked.

Can pharmaceutical researchers use SNDS?

Potentially, through an appropriate authorised or compliant access pathway.

Related reading: health data warehouse; MR-008 access guidance.

Explore iliomad’s european local regulations support for your organisation.

Updated: 27 October 2026