PLEASE NOTE!

A permit service is being developed to allow users to submit one application for use permits to data in several data sources. This will mean that each authority will not have to be contacted separately. Read more about the service »

A central authorising body is also being considered for Finland that would grant health and welfare data use permits and process data requests. Read more about the changes »

Individual-level health and welfare data always requires an official permit to use. The permit and the data collection are usually subject to a charge.

In addition to the use permit, a research permit from the organisation acting as the research site may be required, as well as certain reports to the authorities.

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Use permits granted by the authorities

The permit for health and welfare data is typically granted by the authority acting as the data controller. If permits are required from several authorities under the same ministry, the permit will be granted by the ministry in charge.

In addition to the data it manages, THL grants use permits for patient documents and social welfare customer documents if the research uses documents from a private service provider, independent practitioner or one or more municipalities or joint municipal authorities. THL also grants permits for using data in the Prescription Centre and the Prescription Archive, even though Kela is their data controller.

What are the purposes use permits can be granted for?

By default, it is forbidden to handle sensitive or confidential health and welfare data, or disclose it to third parties. The current legislation does permit an exception to this if sensitive or confidential personal data is to be used for scientific research, statistics, or the planning or investigation activities of a public authority. In addition, new legislation is being prepared to allow the use of health and welfare data for activities such as development and innovation. Read more about the changes »

What are the things I should take into account in the use permit application?

At minimum, the following information is required for the permit application:

1
The name, duration and location of the research
2
The party or person responsible for the research
3
Research plan
4
As detailed a description as possible about the data or samples required, as well as their purpose of use

Additionally, you also need:

5
A file description and non-disclosure agreements from persons who will handle the data, if personal data is used in the research
6
Consent from the research subjects, if the research combines data collected from sources containing health and welfare data with data collected from the subjects

The permit decision is subject to a charge that varies by data source and applicant. The expected duration of the permit process also varies. The expediency of the process will benefit from a carefully prepared application.

Tips for the permit application have been listed in the table below, categorised by data source. The table also includes links to the websites of permit-granting authorities that provide information about the permit applications for the data maintained by the authority in question. The permit websites also include details about the charges and fees of the permit decision.

Things to note about the permit application and permit authorities by data source

Data source Notes Permit granting authorities
Registers
Particular attention must be paid in the application to the ability to combine the data and how the data is to be combined, if data is to be collected from several registers for the research.
Statistics Finland More info »
National Institute for Health and Welfare (THL) More info »
Social Insurance Institution of Finland (Kela) More info »
Finnish Institute of Occupational Health More info (in Finnish) »
National Supervisory Authority for Health and Welfare More info (in Finnish) »
Population Register Centre Read more (in Finnish) »
Legal Register Centre More info (in Finnish) »
Finnish Centre for Pensions More info (in Finnish) »
Patient documents and social welfare customer documents
The applicant should be in touch with the units in question already when preparing the application. The application form submitted must indicate that appropriate agreements on the collection, contents and protection of data to be used in the research have been reached with the data controllers.
National Institute for Health and Welfare (THL) More info »
Biobank samples and data
The samples and data suitable for the research must be negotiated with the biobank for each case before submitting the application.

The application must also provide information for the ethical review of the research, if there was no preliminary ethical review by a competent ethical review committee.

Finnish Biobanks More info »
Data collected in population studies
Surveys that use data collected from the research subjects may not be combined with such data that the research participant did not give their consent to.
Statistics Finland More info »
National Institute for Health and Welfare (THL) More info »
The use permit dictates how data can be used

The terms of use will be defined in the use permit for health and welfare data. Special terms of use may apply to the use of some data. In general, the terms of use will determine at least the following:

1
The data may only be used for the purpose that was applied for, i.e. the specific research purpose.
2
The data is often confidential and sensitive. No deliberate effort may be made to identify a person, and no confidential data may be disclosed or used for the purpose of personal or other gain, or to cause harm.
3
The data may not be disclosed, transferred or sold to a third party, or combined with data other than that is obtained by consent or official authorisation for the purpose of the research.
4
All research data must be stored as separate datasets during research and protected against unauthorised access at all stages of research.

Fees on use permits and data collection

The permit and the data collection are usually subject to a charge. The use permit fee is a one-time charge. The data collection fees are hourly charges and hence depend on the extent of the data to be collected. Changes to a granted use permit are also subject to a fee that is less than the fee charged for the original use permit. Use permits for theses may be eligible for a discount.

Fees on use permits and data collection by authority

Authority Permit fee (excluding VAT, 24%) Data collection fee and other charges (excluding VAT, 24%)
Statistics Finland More info » No separate charge for the permit. Price of the permit is included in the price of the data assignment. A data assignment includes free of charge 10 hours of preparatory work. Any work exceeding this is subject to a charge of €105/hour.

Extension or expansion of permit: 150 €.
Research service, €105/hour.

Pre-compiled data is subject to a charge between €300 and €600.

The remote use of research data is subject to a monthly or annual charge that depends on the number of researchers. The prices start at €1,500/year, €200/month.
National Institute for Health and Welfare (THL) More info » Use permit for international disclosure: €700.

Decision on the extension or verification of an existing use permit, or for adding research team members: €50.
The charge for research data collection is based on the working hours used.
Social Insurance Institution of Finland (Kela) More info » New use permit or a decision to expand the data: €300.

Use permit for a thesis: €150.

Decision to extend an existing use permit: €100.
€78/hour
Finnish Institute of Occupational Health (TTL) More info (in Finnish) » No separate charge. The collection and combining of data is subject to a charge according to the working hours used. The permit applicant will be informed of the potential charges before the work is undertaken.
National Supervisory Authority for Health and Welfare More info (in Finnish) » New use permit: €250.

Use permit for a thesis: €80.
Specialist work: €225/hour.

Assisting work: €90/hour.
Population Register Centre More info (in Finnish) » Delivery fee for collection: €660.

Control collection fee: €550.
The Population Register Centre charges for data collected from the Population Information System according to the data units. The data unit charge is based on the total number of units. Charges start from €0.022/data unit.
Legal Register Centre More info (in Finnish) » No separate charge. €50.93/hour.
Finnish Centre for Pensions More info (in Finnish) » The price of the office work required by the permit application (minimum one working day) is added to the data disclosure fee. All direct person-hour and IT costs resulting from the disclosure of data will be charged. Collection from the pension and earnings register are evaluated separately. An estimate of the costs will be provided in advance.
Finnish Biobanks The costs will be determined in the Material Transfer Agreement (MTA) signed with the researcher’s organisation. The THL Biobank has the most detailed pricing information of the biobanks, and the information is available on their website.

Reports to the authorities

According to current legislation, you must notify the Data Protection Ombudsman if you use sensitive personal data in your research without the subjects’ consent. Once the decree on personal data enters into force, the general duty of notification will be rescinded. The future data protection authority will only be consulted in cases where the processing of personal data carries a high risk, according to the preliminary impact analysis.

The data protection authority must be notified of any data security breaches without undue delay. The data subjects must also be notified of the breaches if they pose a high risk to the subjects’ rights and liberties.

The Medical Research Act lists special requirements for the notices sent to ethical review committees and the Finnish Medicines Agency (Fimea) regarding clinical pharmaceutical research. These notices concern the starting, progress, ending and premature discontinuation of research.