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FDA Convenes Medical Device Workshop Focused on Artificial Intelligence and Machine Learning Transparency

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On October 14, 2021, the U.S. Food and Drug Administration ("FDA" or the "Agency") held a virtual workshop entitled, Transparency of Artificial Intelligence ("AI")/Machine Learning ("ML")-enabled Medical Devices. The workshop builds upon previous Agency efforts in the AI/ML space. Back in 2019, FDA issued a discussion paper and request for feedback called, Proposed Regulatory Framework for Modifications to AI/ML-Based Software as a Medical Device ("SaMD"). To support continued framework development and to increase collaboration and innovation between key stakeholders and specialists, FDA created the Digital Health Center of Excellence in 2020. And, in January 2021, FDA published an AI/ML Action Plan, based, in part, on stakeholder feedback to the 2019 discussion paper.


Nicolas Babin disruptive week about Artificial Intelligence - November 29th 2021 - Babin Business Consulting

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I am regularly asked to summarize my many posts. I thought it would be a good idea to publish on this blog, every Monday, some of the most relevant articles that I have already shared with you on my social networks. Today I will share some of the most relevant articles about Artificial Intelligence and in what form you can find it in today's life. I will also comment on the articles. AI is everywhere, but how does it make decisions, balance society, and remain free from bias? These days, technology is making leaps in an unprecedented manner.


Frontier technologies need better governance to tackle COVID-19

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Today: Accelerating Medical and Drug Discovery To be sure, the quality of these tools and their promise varies, but given there is already reliance on AI to accelerate disease insights and drug development, we should be accelerating work on guardrails too. Among the bigger governance challenges is assessing the reliability, safety, and fairness of such tools. In many instances, a well-designed audit framework would enable leaders to evaluate whether the system is trustworthy but this can be challenging in practice. Tomorrow: Enabling Population Management and Limiting Disease Spread Tracking COVID-19 patients and their contacts is widely understood to be central to the effort to contain spread and eventually, loosen the restrictions on our mobility and economic activity. The AI/ML-enabled contact tracing tools that were so effective in Singapore and South Korea are now, in some form, likely coming to the EU and US.


UK seeks overhaul of AI, software as a medical device regs

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With the withdrawal of the U.K. from the European Union, MHRA as part of its new Brexit freedoms is moving to update the country's regulations for software and AI as a medical device without the burden of accommodating the regulatory approaches of EU members. "These measures demonstrate the U.K.'s commitment, following our exit from the European Union, to drive innovation in healthcare and improve patient outcomes," states MHRA's announcement. "Regulatory measures will be updated to further protect patient safety and take account of these technological advances." AI and SaMD technologies have the potential for better diagnosing and treating a wide variety of diseases, but FDA has yet to finalize a regulatory framework for machine learning-based software as a medical device. The agency is considering a total product lifecycle-based regulatory framework for adaptive or continuously learning algorithms.


Great Powers Must Talk to Each Other About AI

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Imagine an underwater drone armed with nuclear warheads and capable of operating autonomously. Now imagine that drone has lost its way and wandered into another state's territorial waters. Russia aims to field just such a drone by 2027, CNBC reported last year, citing those familiar with a U.S. intelligence assessment. Known as Poseidon, the drone will be nuclear-armed and nuclear-powered. While the dynamics of artificial intelligence and machine learning, or ML, research remain open and often collaborative, the military potential of AI has intensified competition among great powers.