Europe’s ‘Regulatory Lasagna’: Commission Facing Yet More AI Act Criticism
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.
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A two-day workshop saw EU policymakers and regulators meet with dozens of representatives from the pharmaceutical, health and medtech industries to discuss the future of regulating AI in medicine and its uses in the medicinal product lifecycle.
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 European Commission’s proposed Data Act is among a growing pile of horizontal regulations set to impact the medtech industry. But changes should be made to protect trade secrets and other sector-specific nuances, MedTech Europe warns.