New AI Regulation in the EU: Balancing Health and Safety Concerns while Fostering Competition

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

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

The regulation classifies social care and health care 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 AI regulation is seen as a welcome framework that creates a competitive advantage for Europe. It is 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 the national implementation begins, it is believed that clarity will improve in Finland and other EU countries.

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