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 (opens in a new window). If necessary, Fimea can give advice on whether a study should be considered a clinical trial.
What does the Act on Secondary Use apply to?
The Act on the Secondary Use of Health and Social Data applies to register based research. Register based research is 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 advise on the applicability of the Act on the Secondary Use in connection with register based research or other unclear situations.
Who is responsible for processing applications?
Findata’s jurisdiction with regard to data permits and requests is based on section 44 of the Act on Secondary Use. On our Services page, you will find a summary of when Findata or an individual controller of data is competent to process your application and grant a permit or make a decision for a data request. See the summary here.
In addition, we have illustrated this with a table of imaginary examples detailing the competencies of Findata and other controllers of data on a case-by-case basis. Please find the table from this link.
See also:
- Act on the Secondary Use of Health and Social Data (552/2019) (opens in a new window)
- Fimea.fi: Act on Secondary Use of Health Data will not be applied to clinical trials (opens in a new window)
- Fimea’s Administrative Regulation 8/2019 (opens in a new window)
