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Machine Learning Medical Devices – FDA, UK MHRA and Health Canada Join Forces (Again) in Promoting Transparency

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In 2021, the U.S. Food and Drug Administration (FDA), Health Canada, and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) collaboratively identified ten guiding principles for good machine learning practice (GMLP). These principles aim to ensure the safe, effective, and high-quality development of AI/ML technologies in medical devices. Building on GMLP, these agencies are now developing a proposed regulatory framework for modifications to Artificial Intelligence / Machine Learning (AI/ML) – Based Software as a…

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In Digital Health

MHRA launches AI Airlock to address challenges for regulating medical devices that use Artificial Intelligence

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The UK Medicines and Healthcare products Regulatory Agency (MHRA) on 30 April 2024 set out its strategic approach to artificial intelligence (AI). In particular, the MHRA welcomed the publication of the UK Government’s white paper ‘A pro-innovation approach to AI regulation’, published in 2023, and has taken significant steps in the past 12 months to adopt its recommendations in the work they do based on five key strategic principles. These principles encompass safety, security and robustness; appropriate…

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In Digital Health

The EU AI Act and medicines R&D: EFPIA brings clarity, but open questions for devices

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How does the EU AI Act impact upon medicines R&D? The answer is not much at all. This position stems from an exemption for scientific R&D in the AI Act, as explained by a recent statement from the European Federation of Pharmaceutical Industries and Associations (EFPIA). This will be welcome news for the pharmaceutical industry, but questions remain for the medical device industry, where the position is far murkier at the research and development stages.…

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In Digital Health

Clinical Trials Agreements – How Much Flexibility is there for Sponsors Across the Globe?

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Baker McKenzie has recently conducted a survey across over 100 jurisdictions, asking our Healthcare & Life Sciences global network of specialists to compare the degree of flexibility clinical trial sponsors have to negotiate with sites in clinical trial agreements. We have received input from our healthcare regulatory experts in 105 jurisdictions and are therefore able to build a global picture of how the flexibility afforded to sponsors varies from market to market. The results are…

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In Digital Health

EU AI Act Approved by the EP – Update and Insight Into Other AI Industry Specific Developments

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EU AI Act On 13 March, the European Parliament approved the EU AI Act. The link to the adopted text is available here. The next step is Council’s adoption, expected next month. Following the Council’s sign off, the final text will be prepared for publication in the Official Journal and will enter into force 20 days afterwards. Once adopted, the Act will become applicable in a gradual manner. For products that are already required to…

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In Digital Health

Healthcare and AI: WHO Releases AI Guidance for Large Multi-Modal Models

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The World Health Organisation (WHO) has issued new guidance on the ethics and governance of large multi-modal models (LMMs). The guidance details over 40 recommendations for governments and companies involved in healthcare and technology, and covers both the design and deployment of LMMs. So what are LMMs? LMMs, also known as “general-purpose foundation models”, are a type of generative AI. LMMs can accept one or more type of data input and generate diverse outputs that…

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In Digital Health

Key Legal Trends in The United States For Healthcare And Life Sciences In 2024

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In brief As we look back at 2023, we reflect on a year marked by significant developments in the legal framework governing the life sciences and healthcare industries in the US. These developments include the implementation of the Medicare Drug Price Negotiation Program under the Inflation Reduction Act; the rise of artificial intelligence in drug development and manufacturing; the evolving landscape of US Food and Drug Administration regulation and enforcement of laboratory-developed tests; and the…

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In Digital Health

EU Reaches Agreement on AI Regulation: Impact on Pharma and Medtech

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On Friday 8 December, after intense negotiations, EU lawmakers reached a major political agreement on the EU Artificial Intelligence (AI) Regulation. This is the bloc’s landmark legislation regulating the development and use of AI in Europe and one of the world’s first comprehensive attempts to regulate the use of AI. More details on this agreement and on the Regulation are available here. In this blog, we have been following the Regulation’s legislative process closely and…

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In Digital Health

AI as a Medical Device: MHRA’s Five Principles for Predetermined Change Control Plans

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Manufacturers of Machine Learning-Enabled Medical Devices (MLMDs) face a key challenge: existing requirements and processes on the notification and management of ‘substantial’ and ‘significant’ changes to medical devices need adapting for MLMDs. The MHRA, together with the U.S. Food and Drug Administration (FDA) and Health Canada, has published five guiding principles on predetermined change control plans (PCCPs) to help resolve this tension. What is the tension between AI and change management for medical devices? Some…

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In Digital Health

EU Standard Clauses for AI Procurement: 5 Takeaways for Pharma and Medtech

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The EU has published its draft Standard Contractual Clauses for the procurement of AI (AI SCCs). These are drafted for public organisations (such as public hospitals) wishing to procure AI systems developed by an external supplier, and are based on the requirements for high-risk AI systems in the EU AI Act. The AI SCCs might be a good starting point, but dig a little deeper, and you’ll find that the clauses are based on some…

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