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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 29

A health data access body (HDAB) is an authority designated under the European Health Data Space framework to oversee access to electronic health data for permitted secondary uses. Its role includes assessing applications and authorising access under defined conditions, rather than making patient-level datasets freely available to researchers.

Key takeaways

  • An HDAB assesses access for permitted secondary uses.
  • A data permit is not unrestricted access to patient records.
  • EHDS secondary-use obligations apply in phases, not all at once.

How the Access Process Works

The EHDS framework links data discovery, applications and controlled analysis. Under the Commission’s implementation guidance, most secondary-use rules apply from March 2029; additional categories, including clinical-trial and genomic data, follow in March 2031. These dates matter when planning a study in 2026: an anticipated EHDS pathway should not be mistaken for an operational permission already obtained.

StageHDAB-related function
ApplicationAssess purpose and requested data.
PermitSet authorised use and access conditions.
AnalysisProvide controlled access through secure processing environments.

Why It Matters for Data Protection

As an operational recommendation, prepare a precise research question, minimum dataset, proposed users and output plan before requesting access. Secure access does not make confidentiality, permitted purposes or disclosure risks irrelevant. Belgium’s Health Data Agency illustrates the intermediary role: it facilitates lawful, secure reuse without itself collecting the underlying data. That description alone does not prove a particular EHDS permit is currently available.

Hypothetical example: A research team wants linked hospital data for a medicines-safety study. It can prepare its purpose, variable list and analysis plan now, while confirming which national access route is actually available and which future HDAB procedures will apply.

Frequently Asked Questions

Does an HDAB replace the data holder?

No. Data holders and access bodies have distinct functions.

Can researchers download any dataset?

No. Access is purpose-bound and controlled, not an open-data entitlement.

Are all EHDS permits available in 2026?

No. Check national arrangements and the phased implementation timetable.

Related reading: EHDS, Belgian Health Data Agency.

For practical implementation, explore health data warehouse support.

Updated: 27 October 2026