Docs of the Month: Regulating AI and AI Regulating You

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Artificial intelligence continues to capture the attention of lawmakers and regulators not only as an important focus of oversight, but also as a tool to be harnessed to help perform such oversight. We look at some key AI items captured by Pathways Document Depot over the past two months.

Docs of the Month is a regular column highlighting key findings from Pathways’ Document Depot, a database of global medtech regulatory and policy official documents, including rules, guidance documents, memos, white papers, and more from national authorities, non-governmental groups, and global organizations.

One of the most significant medtech-relevant policy documents from the past two months is the European Parliament-endorsed AI Act (approved March 13), which sets out a comprehensive, cross-industry legal framework governing development and deployment of AI technology.

But the legislation also may be the recent document that raised, rather than answered, the most questions for device companies. As Market Pathways has covered, medtech advocates are hoping for the EU government to deliver a lot more clarity, in the form of guidance documents and other tools, about how the new law (still waiting for final administrative sign-offs and publication before it is officially enacted) will work alongside other laws like the Medical Device and IVD Regulations.

The Parliament-approved AI Act is one of our Docs of the Month selections (this time around, we are including two months’ worth of items to align with our spring double issue). The others on the list (see box below) come from regions that are further ahead than the EU in providing some closer-to-the-ground medtech-specific regulatory information on rapidly evolving AI medical device tools. US FDA has been ahead of the pack with some targeted guidance documents and work on AI medtech policy principles with global partners, in particular in Canada and the UK.


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