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New provision on research use of health data – individuals can be contacted based on significant research findings

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It is now also possible to develop the individual care of patients through findings made in register studies.

At the start of 2024, section 55 of the Act on Secondary Use of Health and Social Data came into force, bringing changes to health care and research.

The act, also referred to simply as the Secondary Use Act, has already been in force since 2019, but the entry into force of section 55 makes it possible to contact persons on the basis of clinically significant findings in cases where a health-related risk could be prevented or the quality of their treatment improved.

In practice, this means that you could get a health-related call connected with a study in which you did not even know you were involved.

“In the past, this has not been possible, so the change is significant. The matter also involves sensitive ethical considerations,” says Johanna Seppänen, Director of the Health and Social Data Permit Authority Findata.

Specialists assess the significance of the findings

In Finland, research use of health and social register data requires an official permit, and the data can only be processed in audited processing environments that meet the set requirements. In addition, the data is pseudonymised, meaning that direct identifiers such as personal identity number and names have been removed.

If a researcher makes a clinically significant finding while using the data, they can now contact Findata. Findata establishes who the finding concerns and then submits the information to a specialist at the Finnish Institute for Health and Welfare (THL).

After this, THL’s appointed specialists assess the significance of the data and the expected benefits of taking action. If the benefit is assessed to be so clear that it would be important for the patient to receive treatment, the information is then disclosed to the wellbeing services county responsible for the patient’s treatment.

Ultimately, an employee of the wellbeing services county contacts the patient to find out whether they want to know about the finding, any medical examinations and treatment that would need to be carried out, and the expected benefit of these.

“We will monitor the impact of the new provision on the research field. HUS, for example, is already working on a project aimed at applying this provision to help identify rare diseases,” Seppänen says.

Everyone has the right to decide whether they wish to be contacted

The EU’s General Data Protection Regulation safeguards citizens’ right to influence how their health data is used and shared. Everyone has the right to access and rectify their data and to limit or object to the processing of their data.

Everyone also has the right to prohibit attempts to contact them based on section 55 of the Secondary Use Act. This prohibition can be set up in any operating unit that provides public health care and also online via My Kanta’s system for issuing declarations of intent. Contact prohibitions cannot be set up via Findata, Kela or THL.

What is this all about?

  1. In register studies, researchers use pseudonymised social and health data that cannot be used to identify individuals.
  2. If a researcher makes a clinically significant finding while using the data, this can now also be used to prevent individual health risks or improve treatment.
  3. In such cases, the researcher contacts Findata, the Health and Social Data Permit Authority.
  4. Findata removes the pseudonymisation in order to establish who the finding concerns, then it submits the information to a specialist at the Finnish Institute for Health and Welfare (THL).
  5. THL’s appointed specialists then assess the significance of the finding and the expected benefits of taking action. If the finding is found to be important, the information is passed on to the wellbeing services county in question.
  6. The wellbeing services county staff then contact the patient to offer additional information and any treatment options.
  7. Everyone has the right to prohibit such attempts to contact them. This can be done at public health service locations and also, as of later this spring, through the online My Kanta service.

Contact

Sampo Viiri
Senior Planning Officer, THL
029 524 7936
firstname.lastname@thl.fi

Hanna Tervonen
Chief Data Manager, Findata
029 524 7491
hanna.tervonen@findata.fi

Henrika Merenlehto
Customer Relations Coordinator, Kela
henrika.merenlehto@kela.fi

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