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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.

L

Imported item 41

The LGPD is Brazil's General Data Protection Law, Law No. 13,709/2018. It regulates the processing of personal data and gives sensitive information, including health data, specific protection. For life sciences organisations, it provides a framework for assessing research data use, responsibilities and safeguards alongside other applicable requirements.

Key takeaways

  • Health data require a sensitive-data analysis.
  • Do not import a GDPR assessment unchanged.
  • ANPD is Brazil’s data protection authority.

LGPD and GDPR in Context

The ANPD’s official guidance distinguishes the general lawful bases in Article 7 from the sensitive-data rules in Article 11. The European Commission’s explanation of sensitive data provides the GDPR side of the comparison below.

QuestionLGPDGDPR comparison
Regulatory frameworkBrazilian federal lawEU data protection regulation
Health informationSensitive personal dataSpecial-category personal data
Assessment approachCheck Article 11 conditionsCheck the relevant GDPR conditions separately

Why It Matters for Data Protection

For a Brazilian study, our recommended starting point is a data map covering sites, sponsor teams, laboratories and technology suppliers. Identify the purpose of each use before choosing a legal basis. Health protection and research provisions have conditions: a commercial sponsor should not assume that every activity qualifies simply because it supports medical research. Record the reasoning and obtain local advice where the role or purpose is uncertain.

Hypothetical example: A sponsor adds Brazilian sites to a multinational study. Before reusing its European privacy notice, the team checks local data uses, participant-facing explanations and the relevant Article 11 condition. It documents differences rather than treating translated GDPR wording as a completed LGPD assessment.

Frequently Asked Questions

Does the LGPD cover only electronic records?

No. Its framework is not limited to digital processing.

Can legitimate interests justify all health-data processing?

No. Article 11 has a separate set of conditions for sensitive data.

Does GDPR compliance prove LGPD compliance?

No. Assess the Brazilian requirements and the actual processing separately.

Related reading: GDPR, third country. For practical support, see gap analysis.

Updated: 27 October 2026