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Artificial Intelligence Life Sciences Medicines and Healthcare Products Regulatory Agency (MHRA)

Hogan Lovells

MHRA confirms five technologies selected for AI Airlock Pilot

Hogan Lovells on

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced the five technologies selected to participate in the ‘AI Airlock Pilot’ for AI-powered medical devices. The pilot is a regulatory “sandbox” for...more

Hogan Lovells

JPM2025: AI integration into UK’s MHRA’s processes presents opportunities, and challenges for regulating medicinal product...

Hogan Lovells on

Access to first-in-class medicinal products that can save and transform lives is crucial for patients in the UK – and the earlier the access, the more significant the impact. Equally vital, however, is that such products are...more

Smart & Biggar

Health Canada paving the way for more AI/ML medical devices

Smart & Biggar on

Since 2018, Health Canada has undertaken an initiative to adapt its regulatory approach to better support digital health technologies, specifically medical devices. Key focus areas include artificial intelligence, software as...more

Goodwin

FDA Issues Guiding Principles for Good Machine Learning Practice for Medical Device Development

Goodwin on

On October 27, 2021, the U.S. Food and Drug Administration (FDA), Health Canada and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a set of ten guiding principles meant to aid the...more

McDermott Will & Emery

FDA Issues Good Machine Learning Practice Guiding Principles

McDermott Will & Emery on

On October 27, 2021, pursuant to the Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device Action Plan (Action Plan), the US Food and Drug Administration (FDA) released its Good Machine Learning...more

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