EU Regulating AI ‘Like A Microwave’ When Focus Should Be Its Ability To Cook
Concerns are mounting over how the EU’s AI Act will impact the medtech sector. Now, a computer science expert has argued that the proposed regulation is fundamentally flawed in its approach, because it puts the focus on the AI product instead of its output.
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The second half of 2022 has seen much debate and concern from EU medtech stakeholders around numerous proposed horizontal rules that will affect digital products. Changes in policies around AI, cybersecurity and data-sharing are likely to be an even bigger theme in 2023.
The UK’s medtech regulator is “going big on guidance” when it comes to artificial intelligence and software as a medical device, an expert from the agency has said, while legislation will be light in comparison to the EU’s planned AI Act.
Is regulating artificial intelligence a good idea? A lawyer questions whether the European Commission’s proposed AI Act is appropriate for medtech, where a growing “regulatory lasagna” could compound notified body capacity issues and SME workload.