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DISCERNING DATA

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Update: AI Regulation in the U.K. — New Government Approach

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In October 2022, the U.K. Medicines and Health products Regulatory Agency (MHRA) published its Guidance, Software and AI as a Medical Device Change Programme – Roadmap, setting out how it will regulate software and AI medical devices in the U.K. by balancing patient protection and providing certainty to industry.

Background to the Reforms

The MHRA initially announced the Software as a Medical Device (SaMD) and Artificial Intelligence as a Medical Device (AIaMD) Change Programme in September 2021, designed to ensure that regulatory requirements for software and AI are clear and patients are kept safe. This builds on the broader reform of the medical device regulatory framework detailed in the Government response to consultation on the future regulation of medical devices in the United Kingdom, which recently saw its timetable for implementation extended by 12 months to July 2024.

Read the full article on the Faegre Drinker website.

The material contained in this communication is informational, general in nature and does not constitute legal advice. The material contained in this communication should not be relied upon or used without consulting a lawyer to consider your specific circumstances. This communication was published on the date specified and may not include any changes in the topics, laws, rules or regulations covered. Receipt of this communication does not establish an attorney-client relationship. In some jurisdictions, this communication may be considered attorney advertising.

About the Author: Huw Beverley-Smith

Huw Beverley-Smith advises customers and suppliers on a wide range of international transactions and regulatory issues, including technology, telecommunications and business process outsourcing, complex services agreements, intellectual property ownership and licensing. He counsels clients on privacy and cybersecurity issues and helps navigate regulatory hurdles and operational and commercial risks. View Beverly's full bio on the Faegre Drinker website.

About the Author: Charlotte Perowne

Charlotte Perowne advises clients on a wide range of international transactions and regulatory issues, including technology transactions, outsourcing, intellectual property ownership and licensing, data privacy, and cybersecurity. View Charlotte's full bio on the Faegre Drinker website.

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December 6, 2022
Written by: Huw Beverley-Smith and Charlotte Perowne
Category: Data Strategy
Tags: AI, EU, International, Regulatory

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