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On October 24, 2023, the U.S. Food and Drug Administration (“FDA”), Health Canada, and the U.K.’s Medicines and Healthcare products Regulatory Agency (“MHRA”) jointly released a publication identifying five guiding principles for predetermined change control plans (“PCCP”) for machine learning-enabled medical devices (“MLMD Guiding Principles”).

On October 30, President Joe Biden signed an Executive Order (“EO”) 14110 entitled, “Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence,” which establishes a policy framework to manage the risks of artificial intelligence (“AI”), to direct agency action to regulate the use of health AI systems and tools, and to guide AI innovation

On October 24, 2023, the European Data Protection Supervisor (EDPS), which is the supervisory authority for the EU institutions, bodies, offices and agencies (EUIs), published a new opinion on the widely discussed proposal for an EU Regulation laying down harmonized rules on artificial intelligence (commonly known as the AI Act Proposal). Although the EDPS