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Finland’s Globally Unique Legislation Simplifies Your RWE Research

Oct 15, 2023

Regulatory compliance is a critical element of successful RWE research. In Finland, up-to-date national legislation ensures that healthcare data in Finnish registers can be used for new scientific innovation. The current regulations allow for easier and more efficient use of social welfare and health data in research and development.

Finland’s policies for secondary use of health data are among the best in European countries. In the Open Data Institute’s report on the secondary use of health data in Europe from 20211, Finland was among the top two in country policy ranking. It was acknowledged for recognizing the value of this data for innovation as well as incorporating the use of real-world data and real-world evidence into health systems.

Discover the unique benefits that Finland can offer for biomedical researchers and companies

The well-earned ranking is directly related to the Finnish Act on the Secondary Use of Health and Social Data that came into effect in 2019. It allows for Finnish register data created during health care and social welfare activities to be used for research and innovation purposes while respecting the privacy of individuals.

This act is unique on a global scale, as similar legislation at a national level is not available in other countries. Instead, different regions of one country can have distinct policies that govern the use of data.

For anyone planning to conduct RWE research, Finland’s unambiguous legislation and straightforward permit processing are clear advantages. Combined with the Finnish Biobank Act, which authorizes the collection of samples and biodata to be saved in biobanks and to be used for future research purposes, the Finnish Act on the Secondary Use of Health and Social Data provides a solid background for data and sample use to advance research and innovation.

Up-to-date legislation to accelerate RWE research

The main goals of the Finnish Act on the Secondary Use of Health and Social Data are to provide timely access to data, to provide a single point of contact for data permits, and to ensure secure processes for data handling.

Researchers wishing to use data from only one register can directly contact the register keeper. However, the act is particularly valuable when researchers want to combine data from different registers, which is possible because of the long history of nationwide use of individual ID numbers.

Find out how the Finnish ID code system helps you to easily combine data for your RWE research.

The current process is smooth and predictable since requests for numerous register controllers are handled through a single actor, the social and health data permit authority Findata. Findata ensures that the data subject to a permit is pseudonymized or aggregated and disclosed in a secure manner.2 Similarly, the requests for samples and data from multiple Finnish biobanks are handled centrally through FINBB, the Finnish Biobank Cooperative.

With a clear legal framework for using health and social welfare data for innovation and development activities, RWE research can be conducted in Finland efficiently and in compliance with national and international regulations.

Discover the research possibilities that Finland's unique gene variants and population-wide registers can offer

Find a Finnish partner with local legislation experience

In Finland, significant public funds have been invested in health research, and advancing local biomedical research is a government-level commitment. For example, The Finnish Health Sector Growth Strategy aims to open new possibilities for public-private cooperation and competence development.

In addition, the Finnish Ministry of Social Affairs and Health supports research in Finland. Together with the Finnish Biobank Cooperative – FINBB and the Finnish Institute for Health and Welfare (THL), they coordinate the Fingenious® Ecosystem.

The ecosystem partners provide services related to biomedical research, including data and sample sources, data analytics, IT solutions, and consultation. They have extensive experience with local legislation and the Finnish permit-granting processes and know what valuable data is available within different registers. Local partners will help you tailor a high-quality application to ensure a smoother process with a smaller chance of rejection or delays.

Finnish legislation is designed to remove the barriers between biomedical researchers and valuable data. Find a partner for your RWE research and secure access to health and social welfare data from 5.5 million Finnish citizens.

1. Open Data Institute: Secondary use of health data in Europe. Mark Boyd, Dr Milly Zimeta, Dr Jeni Tennison, and Mahad Alassow. Published in 2021.

2. www.findata.fi

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