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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.

Prior to joining Covington, Olivia was a fellow at the University of Michigan Veterans Legal Clinic, where she gained valuable experience as the lead attorney successfully representing clients at case evaluations, mediations, and motion hearings. At Michigan Law, Olivia served as Online Editor of the Michigan Journal of Gender and Law, president of the Trial Advocacy Society, and president of the Michigan Law Mock Trial Team. She excelled in national mock trial competitions, earning two Medals for Excellence in Advocacy from the American College of Trial Lawyers and being selected as one of the top sixteen advocates in the country for an elite, invitation-only mock trial tournament.

Contact:Read more about Olivia DworkinEmail

This quarterly update highlights key legislative, regulatory, and litigation developments in the second quarter of 2024 related to artificial intelligence (“AI”), connected and automated vehicles (“CAVs”), and data privacy and cybersecurity. 

I. Artificial Intelligence

Federal Legislative Developments

  • Impact Assessments: The American Privacy Rights Act of 2024 (H.R. 8818, hereinafter “APRA”) was formally introduced in the House by Representative Cathy McMorris Rodgers (R-WA) on June 25, 2024.  Notably, while previous drafts of the APRA, including the May 21 revised draft, would have required algorithm impact assessments, the introduced version no longer has the “Civil Rights and Algorithms” section that contained these requirements.
  • Disclosures: In April, Representative Adam Schiff (D-CA) introduced the Generative AI Copyright Disclosure Act of 2024 (H.R. 7913).  The Act would require persons that create a training dataset that is used to build a generative AI system to provide notice to the Register of Copyrights containing a “sufficiently detailed summary” of any copyrighted works used in the training dataset and the URL for such training dataset, if the dataset is publicly available.  The Act would require the Register to issue regulations to implement the notice requirements and to maintain a publicly available online database that contains each notice filed.
  • Public Awareness and Toolkits: Certain legislative proposals focused on increasing public awareness of AI and its benefits and risks.  For example, Senator Todd Young (R-IN) introduced the Artificial Intelligence Public Awareness and Education Campaign Act (S. 4596), which would require the Secretary of Commerce, in coordination with other agencies, to carry out a public awareness campaign that provides information regarding the benefits and risks of AI in the daily lives of individuals.  Senator Edward Markey (D-MA) introduced the Social Media and AI Resiliency Toolkits in Schools Act (S. 4614), which would require the Department of Education and the federal Department of Health and Human Services to develop toolkits to inform students, educators, parents, and others on how AI and social media may impact student mental health.
  • Senate AI Working Group Releases AI Roadmap: On May 15, the Bipartisan Senate AI Working Group published a roadmap for AI policy in the United States (the “AI Roadmap”).  The AI Roadmap encourages committees to conduct further research on specific issues relating to AI, such as “AI and the Workforce” and “High Impact Uses for AI.”  It states that existing laws (concerning, e.g., consumer protection, civil rights) “need to consistently and effectively apply to AI systems and their developers, deployers, and users” and raises concerns about AI “black boxes.”  The AI Roadmap also addresses the need for best practices and the importance of having a human in the loop for certain high impact automated tasks.

Continue Reading U.S. Tech Legislative, Regulatory & Litigation Update – Second 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.

I. Artificial Intelligence

Federal Executive Developments on AI

The Executive Branch and U.S. federal agencies had an active quarter, which included the White House’s October 2023 release of the Executive Order (“EO”) on Safe, Secure, and Trustworthy Artificial Intelligence.  The EO declares a host of new actions for federal agencies designed to set standards for AI safety and security; protect Americans’ privacy; advance equity and civil rights; protect vulnerable groups such as consumers, patients, and students; support workers; promote innovation and competition; advance American leadership abroad; and effectively regulate the use of AI in government.  The EO builds on the White House’s prior work surrounding the development of responsible AI.  Concerning privacy, the EO sets forth a number of requirements for the use of personal data for AI systems, including the prioritization of federal support for privacy-preserving techniques and strengthening privacy-preserving research and technologies (e.g., cryptographic tools).  Regarding equity and civil rights, the EO calls for clear guidance to landlords, Federal benefits programs, and Federal contractors to keep AI systems from being used to exacerbate discrimination.  The EO also sets out requirements for developers of AI systems, including requiring companies developing any foundation model “that poses a serious risk to national security, national economic security, or national public health and safety” to notify the federal government when training the model and provide results of all red-team safety tests to the government.

Federal Legislative Activity on AI

Congress continued to evaluate AI legislation and proposed a number of AI bills, though none of these bills are expected to progress in the immediate future.  For example, members of Congress continued to hold meetings on AI and introduced bills related to deepfakes, AI research, and transparency for foundational models.

  • Deepfakes and Inauthentic Content:  In October 2023, a group of bipartisan senators released a discussion draft of the NO FAKES Act, which would prohibit persons or companies from producing an unauthorized digital replica of an individual in a performance or hosting unauthorized digital replicas if the platform has knowledge that the replica was not authorized by the individual depicted. 
  • Research:  In November 2023, Senator Thune (R-SD), along with five bipartisan co-sponsors, introduced the Artificial Intelligence Research, Innovation, and Accountability Act (S. 3312), which would require covered internet platforms that operate generative AI systems to provide their users with clear and conspicuous notice that the covered internet platform uses generative AI. 
  • Transparency for Foundational Models:  In December 2023, Representative Beyer (D-VA-8) introduced the AI Foundation Model Act (H.R. 6881), which would direct the Federal Trade Commission (“FTC”) to establish transparency standards for foundation model deployers in consultation with other agencies.  The standards would require companies to provide consumers and the FTC with information on a model’s training data and mechanisms, as well as information regarding whether user data is collected in inference.
  • Bipartisan Senate Forums:  Senator Schumer’s (D-NY) AI Insight Forums, which are a part of his SAFE Innovation Framework, continued to take place this quarter.  As part of these forums, bipartisan groups of senators met multiple times to learn more about key issues in AI policy, including privacy and liability, long-term risks of AI, and national security.

Continue Reading U.S. Tech Legislative, Regulatory & Litigation Update – Fourth Quarter 2023

On September 6, Senator Bill Cassidy (R-LA), the Ranking Member of the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee, issued a white paper about the oversight and legislative role of Congress related to the deployment of artificial intelligence (AI) in areas under the HELP Committee’s jurisdiction, including health and life sciences.  In the white paper, Senator Cassidy disfavors a one-size-fits-all approach to the regulation of AI and instead calls for a flexible approach that leverages existing frameworks depending on the particular context of use of AI.  “[O]nly if our current frameworks are unable to accommodate . . . AI, should Congress look to create new ones or modernize existing ones.”  The Senator seeks public feedback on the white paper by September 22, 2023.  Health care and life sciences stakeholders should consider providing comments. 

This blog outlines five key takeaways from the white paper from a health care and life sciences perspective. Note that beyond health and life sciences issues, the white paper also addresses considerations for other areas, such as use of AI in educational settings and labor/employment implications created by use of AI.

5 Key Takeaways for AI in Health Care and Life Sciences

The white paper – entitled “Exploring Congress’ Framework for the Future of AI: The Oversight and Legislative Role of Congress Over the Integration of Artificial Intelligence in Health, Education, and Labor” – describes the “enormous good” that AI in health care presents, such as “the potential to help create new cures, improve care, and reduce administrative burdens and overall health care spending.”  At the same time, Senator Cassidy notes that AI presents risks that legal frameworks should seek to minimize.  Five key takeaways from the white paper include:Continue Reading Framework for the Future of AI: Senator Cassidy Issues White Paper, Seeks Public Feedback

This quarterly update summarizes key legislative and regulatory developments in the second quarter of 2023 related to key technologies and related topics, including Artificial Intelligence (“AI”), the Internet of Things (“IoT”), connected and automated vehicles (“CAVs”), data privacy and cybersecurity, and online teen safety.

Artificial Intelligence

AI continued to be an area of significant interest of both lawmakers and regulators throughout the second quarter of 2023.  Members of Congress continue to grapple with ways to address risks posed by AI and have held hearings, made public statements, and introduced legislation to regulate AI.  Notably, Senator Chuck Schumer (D-NY) revealed his “SAFE Innovation framework” for AI legislation.  The framework reflects five principles for AI – security, accountability, foundations, explainability, and innovation – and is summarized here.  There were also a number of AI legislative proposals introduced this quarter.  Some proposals, like the National AI Commission Act (H.R. 4223) and Digital Platform Commission Act (S. 1671), propose the creation of an agency or commission to review and regulate AI tools and systems.  Other proposals focus on mandating disclosures of AI systems.  For example, the AI Disclosure Act of 2023 (H.R. 3831) would require generative AI systems to include a specific disclaimer on any outputs generated, and the REAL Political Advertisements Act (S. 1596) would require political advertisements to include a statement within the contents of the advertisement if generative AI was used to generate any image or video footage.  Additionally, Congress convened hearings to explore AI regulation this quarter, including a Senate Judiciary Committee Hearing in May titled “Oversight of A.I.: Rules for Artificial Intelligence.”

There also were several federal Executive Branch and regulatory developments focused on AI in the second quarter of 2023, including, for example:

  • White House:  The White House issued a number of updates on AI this quarter, including the Office of Science and Technology Policy’s strategic plan focused on federal AI research and development, discussed in greater detail here.  The White House also requested comments on the use of automated tools in the workplace, including a request for feedback on tools to surveil, monitor, evaluate, and manage workers, described here.
  • CFPB:  The Consumer Financial Protection Bureau (“CFPB”) issued a spotlight on the adoption and use of chatbots by financial institutions.
  • FTC:  The Federal Trade Commission (“FTC”) continued to issue guidance on AI, such as guidance expressing the FTC’s view that dark patterns extend to AI, that generative AI poses competition concerns, and that tools claiming to spot AI-generated content must make accurate disclosures of their abilities and limitations.
  • HHS Office of National Coordinator for Health IT:  This quarter, the Department of Health and Human Services (“HHS”) released a proposed rule related to certified health IT that enables or interfaces with “predictive decision support interventions” (“DSIs”) that incorporate AI and machine learning technologies.  The proposed rule would require the disclosure of certain information about predictive DSIs to enable users to evaluate DSI quality and whether and how to rely on the DSI recommendations, including a description of the development and validation of the DSI.  Developers of certified health IT would also be required to implement risk management practices for predictive DSIs and make summary information about these practices publicly available.

Continue Reading U.S. Tech Legislative & Regulatory Update – Second Quarter 2023

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.

Artificial Intelligence

In the last quarter of 2022, the annual National Defense Authorization Act (“NDAA”), which contained AI-related provisions, was enacted into law.  The NDAA creates a pilot program to demonstrate use cases for AI in government. Specifically, the Director of the Office of Management and Budget (“Director of OMB”) must identify four new use cases for the application of AI-enabled systems to support modernization initiatives that require “linking multiple siloed internal and external data sources.” The pilot program is also meant to enable agencies to demonstrate the circumstances under which AI can be used to modernize agency operations and “leverage commercially available artificial intelligence technologies that (i) operate in secure cloud environments that can deploy rapidly without the need to replace operating systems; and (ii) do not require extensive staff or training to build.” Finally, the pilot program prioritizes use cases where AI can drive “agency productivity in predictive supply chain and logistics,” such as predictive food demand and optimized supply, predictive medical supplies and equipment demand, predictive logistics for disaster recovery, preparedness and response.

At the state level, in late 2022, there were also efforts to advance requirements for AI used to make certain types of decisions under comprehensive privacy frameworks.  The Colorado Privacy Act draft rules were updated to clarify the circumstances that require controllers to provide an opt-out right for the use of automated decision-making and requirements for assessments of profiling decisions.  In California, although the California Consumer Privacy Act draft regulations do not yet cover automated decision-making, the California Privacy Protection Agency rules subcommittee provided a sample list of related questions concerning this during its December 16, 2022 board meeting.Continue Reading U.S. AI, IoT, CAV, and Privacy Legislative Update – Fourth 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.

Artificial Intelligence

Federal lawmakers introduced legislation in the second quarter of 2022 aimed at addressing risks in the development and use of AI systems, in particular risks related to algorithmic bias and discrimination.  Senator Michael Bennet (D-CO) introduced the Digital Platform Commission Act of 2022 (S. 4201), which would empower a new federal agency, the Federal Digital Platform Commission, to develop regulations for online platforms that facilitate interactions between consumers, as well as between consumers and entities offering goods and services.  Regulations contemplated by the bill include requirements that algorithms used by online platforms “are fair, transparent, and without harmful, abusive, anticompetitive, or deceptive bias.”  Although this bill does not appear to have the support to be passed in this Congress, it is emblematic of the concerns in Congress that might later lead to legislation.

Additionally, the bipartisan American Data Privacy and Protection Act (H.R. 8152), introduced by a group of lawmakers led by Representative Frank Pallone (D-NJ-6), would require “large data holders” (defined as covered entities and service providers with over $250 million in gross annual revenue that collect, process, or transfer the covered data of over five million individuals or the sensitive covered data of over 200,000 individuals) to conduct “algorithm impact assessments” on algorithms that “may cause potential harm to an individual.”  These assessments would be required to provide, among other information, details about the design of the algorithm and the steps the entity is taking to mitigate harms to individuals.  Separately, developers of algorithms would be required to conduct “algorithm design evaluations” that evaluate the design, structure, and inputs of the algorithm.  The American Data Privacy and Protection Act is discussed in further detail in the Data Privacy section below.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. …
Continue Reading CPUC Issues Its First Autonomous Vehicle Drivered Deployment Permits

On 27 October 2021, the U.S. Food and Drug Administration (“FDA”), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (“MHRA”) (together the “Regulators”) jointly published 10 guiding principles to inform the development of Good Machine Learning Practice (“GMLP”) for medical devices that use artificial intelligence and…
Continue Reading U.S., UK and Canada Regulators Collaborate to Develop “10 Guiding Principles” for Good Machine Learning Practices (“GMLP”) for Medical Devices