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Olivia Dworkin

Olivia Dworkin minimizes regulatory and litigation risks for clients in the medical device, pharmaceutical, biotechnology, eCommerce, and digital health industries through strategic advice on complex FDA issues, helping to bring innovative products to market while ensuring regulatory compliance. With a focus on cutting-edge medical technologies and digital health products and services, Olivia regularly helps new and established companies navigate a variety of state and federal regulatory, legislative, and compliance matters throughout the total product lifecycle. She has experience counseling clients on the development, FDA regulatory classification, and commercialization of digital health tools, including clinical decision support software, mobile medical applications, general wellness products, medical device data systems, administrative support software, and products that incorporate artificial intelligence, machine learning, and other emerging technologies.

Olivia also assists clients in advocating for legislative and regulatory policies that will support innovation and the safe deployment of digital health tools, including by drafting comments on proposed legislation, frameworks, whitepapers, and guidance documents. Olivia keeps close to the evolving regulatory landscape and is a frequent contributor to Covington’s Digital Health blog. Her work also has been featured in the Journal of Robotics, Artificial Intelligence & Law, Law360, and the Michigan Journal of Law and Mobility.

This quarterly update highlights key legislative, regulatory, and litigation developments in the first quarter of 2024 related to artificial intelligence (“AI”), connected and automated vehicles (“CAVs”), and data privacy and cybersecurity.  As noted below, some of these developments provide industry with the opportunity for participation and comment.Continue Reading U.S. Tech Legislative, Regulatory & Litigation Update – First Quarter 2024

This quarterly update highlights key legislative, regulatory, and litigation developments in the fourth quarter of 2023 and early January 2024 related to technology issues.  These included developments related to artificial intelligence (“AI”), connected and automated vehicles (“CAVs”), data privacy, and cybersecurity.  As noted below, some of these developments provide companies with the opportunity for participation and comment.Continue Reading U.S. Tech Legislative, Regulatory & Litigation Update – Fourth Quarter 2023

This quarterly update summarizes key legislative and regulatory developments in the third quarter of 2023 related to key technologies and related topics, including Artificial Intelligence (“AI”), connected and automated vehicles (“CAVs”), and data privacy and cybersecurity.Continue Reading U.S. Tech Legislative & Regulatory Update – Third Quarter 2023

This quarterly update summarizes key legislative and regulatory developments in the first quarter of 2023 related to Artificial Intelligence (“AI”), the Internet of Things (“IoT”), connected and autonomous vehicles (“CAVs”), and data privacy and cybersecurity.Continue Reading U.S. AI, IoT, CAV, and Privacy & Cybersecurity Legislative & Regulatory Update – First Quarter 2023

On March 23, 2023, FDA released a Framework for the use of digital health technologies in drug and biological product development (the “DHT Framework”).  This DHT Framework is on the heels of a Discussion Paper the Agency released earlier this month on the use of artificial intelligence (AI) in drug manufacturing to seek public input on issues of critical focus (the “AI Discussion Paper”).  While both actions are significant, the AI Discussion Paper is one of CDER’s few policy statements related to the deployment of AI around regulated activities (though the Center did establish an AI steering committee in 2020).  CDRH, on the other hand, has issued several policy documents around AI-based software potentially regulated as “software as a medical device” (SaMD), including through an April 2019 discussion paper that proposed a regulatory framework for modifications to AI-based SaMD, an AI “Action Plan” for SaMD in January 2021, and guiding principles to inform the development of Good Machine Learning Practice for AI-based medical devices in October 2021.  CDER has requested public comment on the recent DHT Discussion Paper and AI Framework by May 1 and 23, respectively.Continue Reading FDA Seeks Comments on Agency Actions to Advance Use of AI and Digital Health Technologies in Drug Development

This quarterly update summarizes key legislative and regulatory developments in the fourth quarter of 2022 related to Artificial Intelligence (“AI”), the Internet of Things (“IoT”), connected and autonomous vehicles (“CAVs”), and data privacy and cybersecurity.Continue Reading U.S. AI, IoT, CAV, and Privacy Legislative Update – Fourth Quarter 2022

This quarterly update summarizes key legislative and regulatory developments in the third quarter of 2022 related to Artificial Intelligence (“AI”), the Internet of Things (“IoT”), connected and autonomous vehicles (“CAVs”), and data privacy and cybersecurity. 

This quarter, Congress has continued to focus on the American Data Privacy Protection Act (“ADPPA”) (H.R. 8152), which

This quarterly update summarizes key federal legislative and regulatory developments in the second quarter of 2022 related to artificial intelligence (“AI”), the Internet of Things, connected and automated vehicles (“CAVs”), and data privacy, and highlights a few particularly notable developments in U.S. state legislatures.  To summarize, in the second quarter of 2022, Congress and the Administration focused on addressing algorithmic bias and other AI-related risks and introduced a bipartisan federal privacy bill.Continue Reading U.S. AI, IoT, CAV, and Data Privacy Legislative and Regulatory Update – Second Quarter 2022

A recent AAA study revealed that, although the pandemic has resulted in fewer cars on the road, traffic deaths have surged.  Speeding, alcohol-impairment, and reckless driving has caused the highest levels of crashes seen in decades, and the National Safety Council estimates a 9% increase in roadway fatalities from 2020.  Autonomous vehicles (AVs) have the potential to increase traffic safety, and the California Public Utilities Commission (CPUC) just took a step to advance their commercialization and deployment.
Continue Reading CPUC Issues First Autonomous Vehicle Drivered Deployment Permits

NHTSA recently issued a First Amended Standing General Order requiring electronic portal submission of crash incident data for automated and semi-autonomous vehicles. As of August 12, 2021, automated motor vehicle manufacturers, motor vehicle equipment manufacturers, and operators will be required to report and upload crash incident data within 24 hours to the NHTSA Incident Report