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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EU guidance on clinical evidence requirements for medical device software does not yet include AI-specific information. An expert group explains how regulators can determine how much evidence is needed for AI-based devices and why common standards should be utilized.
The UK government has proposed a “pro-innovation” AI regulation strategy, which will utilize the expertise of existing regulators and avoid new legislation. But what does this mean for the medtech sector, and how does the UK approach differ from the EU’s AI Act?
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.