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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.

P

Predetermined change control plan (PCCP)

A predetermined change control plan (PCCP) is documentation describing specified future changes to a medical device and how those changes will be developed, tested and assessed. FDA may authorise a PCCP within a marketing submission, allowing covered modifications without a new submission when the authorised plan is followed.

Key takeaways

  • A PCCP covers defined future modifications, not an unrestricted right to change an authorised medical device or its intended use.
  • FDA describes three core PCCP components: a description of modifications, a modification protocol and an assessment of their impact.
  • A US PCCP does not by itself resolve European device requirements or establish a lawful basis for reusing patient data.

What a PCCP Contains

ComponentPractical question
Description of modificationsWhat may change?
Modification protocolHow will changes be tested and implemented?
Impact assessmentWhat are the individual and combined risks?

The FDA PCCP overview explains the boundary: changes must be included in and implemented under the authorised plan. A modification outside that scope needs a separate regulatory assessment; do not treat a PCCP as blanket permission for continuous learning.

For example, consider a hypothetical imaging model retrained using additional hospital data. The manufacturer should define the permitted modification, evaluation dataset, acceptance criteria and implementation process before relying on the PCCP route.

Why It Matters for Data Protection

Operationally, assess the retraining data as a separate workstream: provenance, permitted uses, identifiability, access, international transfers and retention. Regulatory permission to modify software does not automatically authorise access to the underlying health records.

For a product supplied in Europe, we recommend recording a separate EU change assessment. US authorisation should not be presented as equivalent to acceptance under the MDR, IVDR or AI Act.

Frequently Asked Questions

Does every software update need a PCCP?

No. FDA distinguishes PCCPs from ordinary device-change assessments; the route depends on the proposed change.

Can a PCCP cover any future change?

No. Its value comes from a specified and authorised scope.

Is a PCCP a privacy assessment?

No. Device-change documentation and personal-data governance answer different questions.

Related: software as a medical device; US AI medical-device requirements; AI compliance support.

Updated: 27 October 2026