Is the EU’s new AI regulation a concern for Finnish healthcare? Ministry of Social Affairs and Health says it provides a competitive edge

New EU AI Regulation Brings Clearer Guidelines for Healthcare Sectors and Promotes Competitive Advantage for Member States

The EU has finalized its new artificial intelligence regulation, which allows member states to create their own national legislation. This regulation takes into account concerns related to health and safety sectors, advocated for by Finland during negotiations. The European Parliament approved the regulation on March 13, with the aim of ensuring safe and respectful use of artificial intelligence, including restrictions like prohibiting real-time biometric monitoring and profiling based on sensitive characteristics.

The regulation classifies social care and healthcare as high-risk sectors for AI use. During negotiations, concerns about pre-written analytics systems falling under the regulation’s scope were addressed, ensuring that regulations are limited to systems that can learn on their own. Healthcare stakeholders also worried about added administrative burdens for medical devices, but the regulation harmonizes requirements to prevent duplication of work.

The new artificial intelligence regulation is viewed as a competitive advantage for Europe, expected to pave the way for member states to develop their national legislation. This legislation is necessary not only for public but also private sectors, especially for applications like generative language models in healthcare. Once national implementation begins, clarity will improve in Finland and other EU countries.

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