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FDA Outlines Proposed Framework for Regulating Artificial Intelligence Software

On April 2, 2019, FDA released a discussion paper entitled “Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD)” (the “AI Framework”). The AI Framework is the Agency’s first policy document describing a potential regulatory approach for medical devices that use artificial intelligence (“AI”) and machine learning (“ML”). The … Continue Reading

ICO opens beta phase of privacy “regulatory sandbox”

On 29 March 2019, the ICO opened the beta phase of the “regulatory sandbox” scheme (the “Sandbox”), which is a new service designed to support organizations that are developing innovative and beneficial projects that use personal data.  The application process for participating in the Sandbox is now open, and applications must be submitted to the … Continue Reading

Are Wearables Medical Devices Requiring a CE-Mark in the EU?

Wearable watches that help consumers obtain a better understanding of their eating patterns; wearable clothes that send signals to treating physicians; smart watches: they are but a few examples of the increasingly available and increasingly sophisticated “wearables” on the EU market. These technologies are an integrated part of many people’s lives, and in some cases … Continue Reading

Key Takeaways from FDA’s Framework for Real-World Evidence for Pharmaceuticals

On December 7, FDA published the much-anticipated “Framework for FDA’s Real-World Evidence Program” for drugs and biological products (the “Framework”).  In a statement announcing the Framework, Commissioner Gottlieb recognized the opportunities and challenges of using real-world data (“RWD”) and real-world evidence (“RWE”) to enhance regulatory decision-making and noted that leveraging this information is “a top … Continue Reading

IoT Update: The UK Government’s Response to Centre for Data Ethics and Innovation Consultation

On 20 November 2018, the UK government published its response (the “Response”) to the June 2018 consultation (the “Consultation”) regarding the proposed new Centre for Data Ethics and Innovation (“DEI”). First announced in the UK Chancellor’s Autumn 2017 Budget, the DEI will identify measures needed to strengthen the way data and AI are used and … Continue Reading
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