European Union Approves New AI Regulation: Balancing Safety with Competition in High-Risk Sectors

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, which allows member states to create their own national legislation. This regulation takes into account the views of Finland, which advocated for health and safety sectors during negotiations. The European Parliament approved the regulation on March 13, with the aim of ensuring the safe and respectful use of AI, while imposing restrictions such as 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. Concerns about pre-written analytics systems falling under the regulation’s scope were addressed during negotiations, ensuring that regulations apply only 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 viewed 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 national implementation begins, clarity will improve in Finland and other EU countries.

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