Act on Secondary Use of Health Data will not be applied to clinical trials
Finnish Medicines Agency Fimea and Health and Social Data Permit Authority Findata have received questions on the interpretation of the Act on the Secondary Use of Health and Social Data and the legislation on clinical trials.
The Act on the Secondary Use of Health and Social Data (552/2019) does not apply to clinical trials reported to Fimea.
The definitions of interventional and non-interventional clinical trials can be found on e.g. Fimea's Administrative Regulation 8/2019. If necessary, Fimea can give advice on whether a study should be considered a clinical trial.
The Act on the Secondary Use of Health and Social Data applies to register research. Register research means research which utilises health and social data for other purposes than for which the data was originally saved in the customer register, or utilises national registries.
If necessary, Findata can advice on the applicability of the Act in connection with register research or other unclear situations.
- Pirjo Inki, Head of Section Clinical Trials, Senior Medical Officer, tel. +358 29 522 3362
- Juliana Raitis, Legal Officer, tel. +358 29 522 3656
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