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Transfer impact assessment (TIA)
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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.

T

Transfer impact assessment (TIA)

A transfer impact assessment (TIA), also called a transfer risk assessment, is the documented analysis a data exporter must perform, together with the importer, before relying on appropriate safeguards under Art. 46 GDPR such as standard contractual clauses or binding corporate rules to transfer personal data to a third country. The requirement flows from the Court of Justice's Schrems II judgment (C-311/18, 16 July 2020), which held that contractual safeguards work only if the law and practice of the destination country do not prevent the importer from complying with them, and is codified in Clause 14 of the 2021 SCCs and in the EDPB Recommendations 01/2020.

The EDPB's six-step roadmap structures the exercise: map the transfers (including onward transfers and sub-processors); identify the transfer tool relied on; assess whether the tool is effective in light of the destination's legislation and practices, particularly public authority access for surveillance or law enforcement, and the availability of redress, taking into account the specific circumstances of the transfer (nature of data, sector, recipients, format); adopt supplementary measures where needed (encryption with keys in the EEA, pseudonymisation, split processing, contractual and organisational measures); take procedural steps such as amending contracts; and re-evaluate at appropriate intervals. Sources include the destination country's legislation, official reports, case law, importer transparency reports and, since the 2021 SCCs, the importer's documented experience of government access requests.

For a sponsor or CRO, TIAs are required for every non-adequate destination in the trial data flow, most commonly the United States (for importers not certified under the Data Privacy Framework), India, China, and other countries hosting sites, laboratories or technology vendors. Because health data is involved, the assessment should be specific rather than templated, but it can be streamlined by grouping transfers by importer and destination. The UK equivalent is the transfer risk assessment under ICO guidance, and Switzerland requires a similar analysis. TIAs form part of the DPIA file and are requested in inspections and due diligence.