Data access authorisations
The use of confidential data for purposes such as scientific research or for planning and reports by authorities will require a data permit. Confidential data include trade secrets and personal health data. As a rule, a data permit for the use of Fimea’s datasets shall be applied for from the Finnish Social and Health Data Permit Authority, Findata. If the requested dataset does not contain social or health data, Fimea may grant a data permit for the use of the dataset.
Data permits for social and health data
A data permit for social and health data is applied for from Findata. Findata processes data permit applications concerning Fimea’s registers where data from several controllers specified in the Act on the Secondary Use of Health and Social Data are requested to be combined, as well as applications concerning only Fimea’s registers.
Findata’s guidance is available here: Permits
Data permits from Fimea
Fimea may grant a data permit for the use of a dataset if the requested dataset does not contain social or health data.
Use this form to apply for data permit: Data Permit Application (pdf)
Complete the form carefully and ensure that the necessary attachments are included. Mandatory attachments are specified on the form with an asterisk*.
Non-disclosure commitments are to be submitted by form: Confidentiality argeement (pdf)
You can use this template when drafting a privacy statement: Privacy Notice for Scientific Research (pdf)
You can use this template when drafting a data utilisation plan: Data Utilisation Plan (pdf)
When preparing the data protection impact assessment, either the applicant organisation's own form template or the template available on the website of the Office of the Data Protection Ombudsman can be used. An impact assessment must always be completed if personal data is processed. A data access authorisation application must include information on the basis of which the decision for access can be made.
The applicant must include the intended use of the data and give grounds for why the data should be provided in the requested scope in their data access authorisation application. In addition, they must provide information on how the information security of confidential data will be ensured appropriately.
Supplying all the necessary information will speed up the processing of the data permit application. Please pay particular attention to the providing the information requested by Fimea in as much detail as possible.
Data permits in research collaboration projects
In Fimea’s research projects, such as the Medicines Barometer, it is possible to carry out collaborative research. More information on research collaborations conducted with Fimea is available here: Medicines Barometer
Descriptions of data contents
Data descriptions of the registers can be found in the Data Catalogue. Further information on the data contents of the registers can be obtained from the contact persons responsible for the registers. Please note the remarks presented in the dataset descriptions, as well as the document Haittavaikutusrekisterin tietojen käytössä huomioitavaa (pdf, in Finnish).
Submission of the application
Submit the application to Findata if you are applying for a data permit for social and health data.
If the requested dataset does not contain social or health data, a signed data permit application form with its appendices shall be submitted to the Fimea registry office [email protected]. The application can be submitted to Fimea via Fimea’s secure mail service: Secure mail. Use secure mail if your application contains confidential information.
Alternatively, the application documents may also be submitted by post. If the application is submitted by post, the documents should not be stapled together. Postal address: Fimea, P.O. Box 55, FI-00034 Fimea.
Decision on the data permit
If the data permit application concerns confidential data, a fee will be charged for the data permit decision. The applicant is obliged to comply with the conditions of the decision. Decisions issued by Findata are invoiced in accordance with Findata’s pricing.
The fee for data permits granted by Fimea is laid down in the Ministry of Social Affairs and Health Decree on the chargeable services of Fimea: Fimea Decree on Fees (pdf).
Delivery of data
Fimea charges the applicant for data extraction and delivery on an hourly basis in accordance with the Fimea's price list for services priced according to commercial criteria (pdf). The applicant may request a cost estimate for the data extraction in advance.
Where data are disclosed under the Act on the Secondary Use of Health and Social Data, the dataset is delivered only to a secure processing environment. The applicant is responsible for arranging access to a secure processing environment and for the related costs. The data may be processed, for example, in Findata’s remote access environment; further information and pricing are available on Findata’s website.
When Fimea has granted a data permit, Fimea and the data permit holder will together agree on how data will be provided.
Advisory service under the Act on the Secondary Use of Health and Social Data
Information on the secondary use of data stored in Fimea’s registers is provided via email at: [email protected].