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.
FDA Seeks Comments on Agency Actions to Advance Use of AI and Digital Health Technologies in Drug Development
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.
U.S. AI, IoT, CAV, and Privacy Legislative Update – Fourth Quarter 2022
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.
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U.S. AI, IoT, CAV, and Privacy Legislative Update – Third 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
U.S. AI, IoT, CAV, and Data Privacy Legislative and Regulatory Update – Second Quarter 2022
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.
CPUC Issues First Autonomous Vehicle Drivered Deployment Permits
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.
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NHTSA Amends Standing General Order on Automated Vehicle Crash Reporting
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