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Scott Danzis

Scott Danzis practice focuses primarily on the regulation of medical devices, but also includes regulation of drugs, biologics, and tobacco products. Mr. Danzis regularly works with companies in developing strategies for interacting with the U.S. Food and Drug Administration (FDA), including strategies for clinical development and premarket review (including appeals and dispute resolution, when needed). He also advises on compliance with postmarket requirements, including advertising and promotion restrictions, quality system and manufacturing requirements, postmarket reporting, recalls, and enforcement actions.

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The COVID-19 pandemic is accelerating the digital transition and the adoption of artificial intelligence (“AI”) tools and Internet of Things (“IoT”) devices in many areas of society. While there has been significant focus on leveraging this technology to fight the pandemic, the technology also will have broader and longer-term benefits. As the New York Times has explained, “social-distancing directives, which are likely to continue in some form after the crisis subsides, could prompt more industries to accelerate their use of automation.”

For businesses proceeding with reopenings over the coming weeks and months, and for sectors that have continued to operate, AI and IoT technologies can greatly improve the way they manage their operations, safely engage with customers, and protect employees during the COVID-19 crisis and beyond. But businesses also should take steps to ensure that their use of AI and IoT technologies complies with the evolving legal requirements that can vary based on several factors, including the industry sector where the technology is deployed and the jurisdiction where it is used. Businesses also will want to have mechanisms in place to help ensure that the technology is used appropriately, including appropriate oversight and workforce training and other measures.…

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