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Imported item 10
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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.

F

Imported item 13

The Federal Data Protection and Information Commissioner (FDPIC) is Switzerland’s independent federal authority for data protection and freedom of information. Under the Federal Act on Data Protection, it supervises processing by federal bodies and private persons, including companies, and can investigate suspected violations and impose administrative measures.

Key takeaways

  • The FDPIC supervises federal data-protection compliance, while its role should not be confused with Swissmedic’s therapeutic-product responsibilities.
  • Controllers must assess whether a data-security breach is likely to create a high risk before applying the Swiss notification threshold.
  • The FDPIC’s administrative powers are distinct from criminal fines and civil compensation, so avoid describing every enforcement outcome as a fine.

When the FDPIC May Be Relevant

SituationPractical response
Suspected non-compliant processingPreserve facts and respond to the investigation
Qualifying data-security breachAssess risk and prepare the required notification
Individuals exercising rightsHandle the request and document the response

The FDPIC investigation factsheet explains supervision under Articles 49 to 53 FADP. Its breach guidance identifies a likely high risk to personality or fundamental rights as the notification threshold. Do not transplant the GDPR’s notification test into a Swiss incident assessment without checking the differences.

Operationally, record the data involved, affected people, likely consequences, safeguards and containment actions. Explain the reasoning behind the reporting decision rather than relying on the number of records alone.

Why It Matters for Data Protection

For example, consider a hypothetical research vendor exposing a coded participant dataset. Coding should be part of the risk analysis, not a reason to dismiss the incident automatically. Assess what other information could link the records to individuals and which recipients obtained access.

We recommend assigning a Swiss escalation owner before an incident occurs and aligning vendor reporting arrangements with the controller’s assessment process. Parallel obligations in other jurisdictions need their own review.

Frequently Asked Questions

Does the FDPIC regulate medicines?

No. Its remit is distinct from therapeutic-product oversight.

Must every incident be notified?

No. Apply the relevant legal threshold and document the assessment.

Can the FDPIC award damages?

No. Its published FAQ distinguishes its supervisory role from compensation claims.

Related: Swiss FADP; personal data breaches; Swiss data-protection support.

Updated: 27 October 2026