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Olivia Dworkin

Associate

Los Angeles +1 424 332 4817

  • About
  • Representative Matters
  • Credentials
  • About

    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.

    Areas of Expertise

  • Practices and Industries
  • Representative Matters
    • Advise medical device and technology companies on FDA’s digital health policies, including the regulation of software as a medical device (SaMD), mobile medical applications, clinical decision support tools, and AI/ML-enabled devices.
    • Counsel clients on the FDA regulatory framework that applies to potential uses of RWD/E and AI by biopharma companies, including throughout drug discovery, non-clinical research, clinical trials, FDA review and approval, commercial manufacturing, and postmarket safety monitoring.
    • Perform FDA regulatory diligence for medical device and digital health companies and negotiate key regulatory deal terms.
    • Outside counsel for a cloud-based communication, collaboration, and data exchange platform for the regulatory ecosystem.
    • Prepare public comments on proposed regulations and draft guidance documents for trade organizations and device manufacturers.
    • Counsel clients on strategic engagement with FDA.
    • Advise Fortune 500 Company in multi-jurisdictional review of regulatory and enforcement risks posed by its online advertising policies.
    • Draft internal and external policies for eCommerce and social media platforms to minimize FDA regulatory risk.
    • Coordinate international surveys to support global marketing and distribution plans for medical device companies.

    • Prepare and conduct trainings for in-house attorneys on several topics, including:
      • Regulation of medical devices and digital health tools;
      • Human factors studies for combination products; and
      • FDA enforcement trends.
    • Support the day-to-day legal operations of device and technology clients through in-house secondments during periods of transition.
    • Prepare company witnesses for Congressional hearings on behalf of a major pharmaceutical company.
    • Represent dietary supplement and consumer product companies in bringing and responding to marketing claim challenges before the National Advertising Division (NAD).
    • Counsel food and beverage companies receiving consumer demand letters alleging claims under state consumer protection statutes.
    • Representation of a major pharmaceutical company in complex multi-district litigation involving chemical exposure claims.

    Areas of Expertise

  • Credentials
    Education
    • University of Michigan Law School, J.D., 2020
        • cum laude
        • Michigan Journal of Gender and Law, Online Editor
    • University of Michigan, B.A., 2017
        • With High Distinction
    Bar Admissions
    • California
    Pro Bono
    • Assisting client to self-petition for immigration relief under the Violence Against Women Act.
    • Preparation of 50-state survey of laws and policies related to sterilization of adults and children with disabilities.
    • Deposed and defended the depositions of expert witnesses in a class action litigation.
    Memberships and Affiliations
    • National Association of Women Lawyers
    • Food and Drug Law Institute (FDLI)

    Areas of Expertise

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