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AI Transparency in Healthcare: Navigating a Changing Regulatory Landscape

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Transparency of artificial intelligence (AI) systems in healthcare is quickly becoming a central concern for regulators due to...

We are Morrison Foerster — a global firm of exceptional credentials. Our clients include some of the largest financial institutions, investment banks, and Fortune 100, technology, and life sciences companies. Our lawyers are committed to achieving innovative and business-minded results for our clients, while preserving the differences that make us stronger.Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations. Prior results do not guarantee a similar outcome.

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Transparency of artificial intelligence (AI) systems in healthcare is quickly becoming a central concern for regulators due to potential impacts on patient safety, healthcare quality, bias mitigation, and public trust.Read the full <a href="https://lifesciences.mofo.com/topics/ai-transparency-in-healthcare-navigating-a-changing-regulatory-landscape" target="_blank">blog post</a>.

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Marijn Storm specializes on the intersection of law and technology, with a focus on cutting-edge technologies, such as (generative) artificial intelligence (AI) and large language models, ethical tech, and biometrics. Based in Morrison Foerster’s Amsterdam office, he advises global companies and organizations on a wide range of their most complex and pressing privacy and data security challenges.Marijn’s deep experience in both law and technology enables him to navigate the rapidly evolving landscape of privacy, data security, and technological innovation. Bridging the gap between legal requirements and technological advancements, Marijn advises and educates in-house legal teams on how to effectively manage and oversee technical applications such as AI and, specifically, generative AI. In addition, Marijn trains technical teams on implementing technical solutions in a privacy-by-design fashion, enabling compliance with AI and data protection laws around the world.Marijn also represents clients in class action and other litigation. For example, he has defended both digital advertising and public health clients against claims of alleged GDPR violations. In addition, he counsels clients on investigating and responding to major cybersecurity and ransomware incidents, including notification and related obligations. Marijn has also assisted a number of companies in obtaining regulatory approval for their Binding Corporate Rules, in both the EU and the UK.A recognized thought leader, Marijn regularly speaks at international data protection conferences (including IAPP) on topics such as the future of behavioral biometrics, the ethical application of AI, and developments in EU class actions. Marijn frequently publishes articles and client alerts on a variety of evolving topics, such as the EU AI Act and the NIST AI Risk Management Framework. Since 2019, he has been a guest lecturer at the Tilburg Institute for Law, Technology, and Society, where he teaches Algorithmic Accountability within the biannual course on AI & Law.Marijn is a Dutch-qualified lawyer and is fluent in Dutch and English.

Marijn Storm

Partner

Brigid is a food, drug, and medical device lawyer who counsels life sciences companies on a wide range of U.S. Food & Drug Administration pre- and post-market regulatory issues.As the lead of our FDA + Healthcare Regulatory and Compliance Group, Brigid practices across the spectrum of FDA-regulated products, including medical devices, drugs, biologics, cell and gene therapies, food, cosmetics, dietary supplements, tobacco, laboratory-developed tests, in vitro diagnostics, radiation-emitting electronic products, combination products, and products that may not fit neatly into any of these categories. Accordingly, she counsels established and start-up companies in life sciences, healthcare, and consumer products on a wide range of FDA pre- and post-market regulatory issues. Brigid also frequently advises innovative product developers on threshold FDA jurisdictional questions and develops strategies for approval and marketing, while identifying and mitigating regulatory risks.In her day-to-day practice, Brigid advises on:<ul><li>product development and FDA’s pre-authorization requirements;</li><li>advertising and promotion of FDA-regulated products;</li><li>clinical trials regulation, including strategic advice for sponsors in receipt of a clinical hold;</li><li>responses to warning letters, Form 483s, import alerts, and FDA enforcement actions;</li><li>informal and formal dispute resolution for high-stakes issues;</li><li>compliance with FDA regulatory requirements such as current good manufacturing practice (GMP), quality system regulation (QSR), food safety preventive controls, adverse event reports, product recalls, radiological health issues, risk evaluation and mitigation strategies (REMS), pharmacy compounding and the new track-and-trace regulations for prescription drugs; and</li><li>technical legal questions involving the Food, Drug and Cosmetic Act (FDCA), the Public Health Service Act (PHSA), Federal Advisory Committee Act (FACA), Freedom of Information Act (FOIA), and the Administrative Procedure Act (APA).</li></ul>Brigid also has experience in the development, regulation, and procurement of medical countermeasures (MCMs) against chemical, biological, radiological, and nuclear (CBRN) threats and pandemic infectious diseases, including animal rule approvals and special incentives for the development of MCMs.Complementing her focus on FDA regulatory law, Brigid has a strong litigation background and has served as FDA counsel in product liability cases, civil litigation, international arbitration, and FDA enforcement proceedings. She particularly enjoys providing clients with advice that integrates technical, legal, and political considerations.Brigid maintains an active pro bono practice focused primarily on reproductive health and especially enjoys working with inventors who aim to improve health outcomes for mothers and infants in the peri- and post-natal period. She has represented several clients before the Social Security Administration in appealing denials of applications for disability benefits. She has also worked on several appeals in criminal cases in the District of Columbia.Brigid is a graduate of the University of Tulsa, where she earned her B.S. in biochemistry before attending law school at Stanford Law School. Prior to law school, Brigid worked as an Environmental Policy Analyst in the Office of the Secretary at the U.S. Department of Transportation. She has also worked as a benchtop scientist in a number of laboratories, including FDA’s National Center for Toxicological Research.<h4>Representative Experience</h4><ul><li>Counseled online marketplaces regarding FDA compliance and enforcement for a variety of products.</li><li>Advised development-stage companies on regulatory considerations and FDA engagement strategies related to development and launch of products based on disruptive technologies.</li><li>Advised consumer technology companies with respect to potential FDA regulation under the medical device provisions of the FDCA;</li><li>Served as FDA regulatory counsel to clients evaluating compliance issues under reporting provisions of Corporate Integrity Agreements and related negotiated resolutions of government investigations.</li><li>Helped a large, publicly traded drug company comply with the FDA’s new track-and-trace pedigree requirements for prescription drugs.</li><li>Led regulatory team on numerous initial public offerings (IPO), stock and asset purchase agreements, acquisitions, mergers, and other transactions for life science company.</li><li>Provided strategic advice, conducting regulatory assessments and negotiating key FDA-related terms in connection with due diligence for transactions and post-acquisition integration activities.</li><li>Developed policy positions related to FDA regulation of laboratory-developed tests (LDTs) for multiple clients in this space.</li><li>Represented manufacturers in matters involving regulatory letters, inquiries, advisory comment proceedings, competitor complaints and citizen petitions focused on their products and policy issues affecting their strategic priorities.</li><li>Advised on issues related to promotion of drugs and medical devices, including communication of pharmacoeconomic/healthcare economic information (HCEI), communications by medical science liaisons (MSLs).</li><li>Provided solutions-oriented advice to development-stage companies confronting FDA regulatory issues for the first time, including good clinical practices (GCP), investigator-initiated research (IIR), pre-approval communications and strategies for obtaining FDA approval.</li><li>Collaboratively advised client on FDA, ethical, and product liability issues associated with early termination of a clinical study involving an implanted medical device.</li></ul>

Brigid Bondoc

Elena Klonoski is an associate in Morrison Foerster’s Boston office and a member of the firm’s FDA + Healthcare Regulatory and Compliance practice.Elena works with life sciences and food companies to address their most challenging issues. She works broadly across the spectrum of U.S. Food & Drug Administration (FDA)-regulated products, including pharmaceuticals, medical devices, dietary supplements, and food products. Her healthcare regulatory work includes compliance with federal regulation governing health information technology and state law governing the practice of medicine.In addition to her FDA-focused work, Elena works with the firm’s Investigations + White Collar Defense practice on healthcare-related enforcement matters. Prior to joining Morrison Foerster, Elena was a legal intern and extern at the Harvard Law School Food Law and Policy Clinic (FLPC). She prepared materials for and presented on FLPC’s 2023 Farm Bill recommendations to Congressional staff members. Elena was also a legal intern at a cannabis advisory firm, where she researched and wrote internal memos and drafted client letters on various cannabis business legal questions. Before law school, Elena worked at a nonprofit organization in Massachusetts where she organized large-scale events that promoted local food companies.Elena earned her J.D. from Boston University and her B.A. cum laude from Connecticut College. She is a member of the Alpha Kappa Delta International Honor Society of Sociology and received Honors Study and Distinction in the Major Field.

Elena Klonoski

Associate

Life Sciences + Healthcare

FDA + Healthcare Regulatory and Compliance