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How To Operate In The AI Compliance Vacuum

How To Operate In The AI Compliance Vacuum
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US Artificial Intelligence Regulations: Watch List for 2023 | Goodwin

Companies are developing, deploying, and interacting with artificial intelligence (AI) technologies more than ever. At Goodwin, we are keeping a close eye on any regulations that may. ....

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Digital Health: Significant FDA Policy Developments In 2022 - Healthcare

In 2022, FDA retreated from a flexible approach to its regulation of digital health in two key areas: (1) its PreCertification Program for software as a medical device (SaMD) and (2) its guidance. ....

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Virtual And Digital Health Digest - Healthcare

Welcome to the first installment of Arnold & Porter's Virtual and Digital Health Digest. This inaugural edition covers September and October highlights across the virtual and digital health space. ....

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Global Healthtech CEO Connect: Software As A Medical Device In The U.S. And EU Recap | MoFo Life Sciences

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On Friday, March 26, 2021, over 180 attendees worldwide attended McKinsey & Company’s first Global HealthTech CEO Connect of 2021. The discussion focused on regulatory and legal considerations for software as a medical device (SaMD) in both the United States and Europe and specific use cases for digital therapeutics and other digital health products. Speakers included Morrison & Foerster partners Bethany Hills and Wolfgang Schönig as well as special guest Corey McCann, president and CEO of Pear Therapeutics, in a fireside chat at the end of the program.
Globally, the convergence of software technology and life sciences creates a massive opportunity for growth, and the market for these products is growing exponentially. Both the U.S. Food and Drug Administration (FDA) and European regulators have focused on establishing a regulatory framework for oversight of SaMD. ....

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