UK seeks overhaul of AI, software as a medical device regs


With the withdrawal of the U.K. from the European Union, MHRA as part of its new Brexit freedoms is moving to update the country's regulations for software and AI as a medical device without the burden of accommodating the regulatory approaches of EU members. "These measures demonstrate the U.K.'s commitment, following our exit from the European Union, to drive innovation in healthcare and improve patient outcomes," states MHRA's announcement. "Regulatory measures will be updated to further protect patient safety and take account of these technological advances." AI and SaMD technologies have the potential for better diagnosing and treating a wide variety of diseases, but FDA has yet to finalize a regulatory framework for machine learning-based software as a medical device. The agency is considering a total product lifecycle-based regulatory framework for adaptive or continuously learning algorithms.

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