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Firm News 1 result

Firm News | 3 min read | 01.16.24

Respected Healthcare Regulatory and Privacy and Cybersecurity Team Joins Crowell

New York – January 16, 2024: Linda Malek, Jason Johnson and Blaze Waleski are joining Crowell & Moring’s Health Care and Privacy & Cybersecurity groups and will be based in the New York office.
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Client Alerts 31 results

Client Alert | 7 min read | 10.01.26

SEC and FDA Formalize Information-Sharing Framework for Public Companies

On August 31, 2026, the U.S. Securities and Exchange Commission (SEC) and the U.S. Food and Drug Administration (FDA) signed a Memorandum of Understanding (MOU) establishing a formal framework for the two agencies to share non-public information concerning FDA-regulated products and the companies and individuals engaged in their manufacture, distribution, and sale. The MOU was signed by SEC Chairman Paul S. Atkins and Acting FDA Commissioner Kyle Diamantas. It takes immediate effect and runs for three years, subject to renewal, modification, or termination. In a press release, Chairman Atkins described FDA-related disclosures by public companies as having “a significant impact on our markets” and identified the FDA as “a valuable partner in our efforts to administer and enforce applicable disclosure requirements under the federal securities laws.” Acting Commissioner Diamantas framed the MOU as protecting “both the patients who rely on FDA-regulated products, and the public trust that drives health care innovation.”
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Client Alert | 7 min read | 09.22.26

ORI's Guidance on AI Misconduct: Disclose, Verify, and Preserve, or Face Consequences 

The U.S. Department of Health and Human Services’ (HHS) Office of Research Integrity (ORI) published its long-anticipated Guidance on Generative Artificial Intelligence in August. The guidance explains how generative AI (GenAI) use is evaluated under the revised research misconduct regulations (42 CFR Part 93), which took effect January 1, 2025, and became applicable to new allegations on January 1, 2026. The new guidance builds on prior guidance documents regarding the definitions of fabrication, falsification, and plagiarism, as well as revised evidentiary standards. As of April 30, 2026, institutions were required to have compliant policies on file with ORI as part of their annual report covering 2025. 
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Client Alert | 6 min read | 09.03.26

FDA Seeks Input for Regulating GenAI-Powered Medical Devices

The U.S. Food & Drug Administration (FDA) is seeking feedback on a regulatory framework that could be used to evaluate generative artificial intelligence (GenAI)-enabled medical devices. Such devices could create new types of risks because their outputs can vary and evolve, unlike more traditional software-enabled devices. An August 18, 2026, discussion paper (“Considerations for the regulation of GenAI-enabled medical devices”) discusses potential regulatory considerations for GenAI-enabled medical devices. 
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Press Coverage 9 results

Press Coverage | 07.15.26

Compliance Lessons From NYDFS’ Delta Dental Settlement

Cybersecurity Law Report

Publications 5 results

Events 2 results

Event | 02.25.25, 5:00 PM EST - 8:00 PM EST

Charting a Path for Compliance in Life Sciences

Join us for an interactive and educational event tailored for biotech leaders seeking to ensure security compliance while leveraging the power of Amazon Web Services (AWS). This session will dive into the critical elements of designing secure, scalable, and compliant systems for biotech operations, from research and development to clinical trials and beyond.
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Event | 03.13.24 - 03.14.24

Clinical Trials Masterclass

Crowell & Moring Partners Linda Malek and Jason Johnson, members of the firm's Health Care and Privacy & Cybersecurity Groups, will be speaking at Entrepreneurship Lab Bio and Health Tech NYC’s Clinical Trials Masterclass , taking place on March 13-14 in New York, NY.

They will both speak on "Best Practices in Recruiting for Health Equity: Designing a Successful Protocol for Recruitment" at 9:45 a.m. EST. Linda will also speak on "Future of Clinical Trials" and "Presentation of Attendee Clinical Trial Site Checklist: Feedback from Professionals", which will take place at 8:40 a.m. EST and 10:50 a.m. EST, respectively. Jason's talk, "Presentation of Attendee Clinical Trials with focus on recruiting," will begin at 10:50 a.m. EST. 

Webinars 3 results

Webinar | 10.28.26, 2:00 PM EDT - 3:00 PM EDT

AI Governance & Vendor Diligence for Providers

Health care providers are deploying AI at an unprecedented pace—from ambient documentation and AI-assisted diagnostics to remote patient monitoring—but rapid adoption brings significant legal, regulatory, and reputational risk. A growing patchwork of state AI laws, evolving federal frameworks, and emerging litigation are reshaping what providers must do to deploy these tools responsibly.

Webinar | 10.16.25, 2:00 PM EDT - 3:00 PM EDT

The Artificial Intelligence Agenda from Capitol Hill to State Capitals: Where We Are and Where We Are (Probably) Going

The landscape of AI governance and regulation is shifting. Following the release of the White House’s “America’s AI Action Plan” in July 2025 and the President’s signing of related Executive Orders, the White House has emphasized (at least rhetorically) a preference for innovation, adoption, and deregulation. But that does not tell the entire story. The Administration remains committed to exercising a heavy hand in AI, including by banning the U.S. government’s procurement of so-called “woke AI,” intervening in the development of data centers and the export of the AI technology stack, imposing an export fee for certain semiconductors to China, and assuming a stake in a U.S. semiconductor company. State legislatures are also racing to implement their own regulations, particularly around AI’s use in critical areas, such as healthcare, labor and employment, and data privacy. The many sources of regulation raise the specter of a fragmented compliance environment for businesses. This webinar will delve into the Administration’s AI strategy, going beyond the headlines to analyze:
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Webinar | 09.25.25

HOOPS 2025

We invite you to join the Health Care Group at Crowell for our Health Care Opportunities, Oversight, Policy, and Strategy (HOOPS) Summer Webinar Series. 

Speaking Engagements 5 results

Speaking Engagement | 10.16.25

"The Artificial Intelligence Agenda from Capitol Hill to State Capitals: Where We Are and Where We Are (Probably) Going," Crowell & Moring Webinar.

On October 16, 2025, Partner Matthew F. Ferraro, Partner and CHS Managing Director Jason Johnson, and Counsels Jacob Canter and Anna Z. Saber hosted a webinar on the shifting dimensions of AI governance and regulation. They discussed federal policy, state laws, international efforts, and key court cases and how these many sources of regulation serve to fragment the AI compliance environment for businesses and how firms can respond. Click here to view the webinar on demand.
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Blog Posts 10 results

Blog Post | 07.17.25

CBP Rescinds PGA Filing Exemption for Certain Low-Value FDA-Regulated Product

Crowell & Moring’s International Trade Law

Podcasts 1 result

Podcast | 06.14.24

Payers, Providers, and Patients – Oh My!: AI in Health Care Series, Part 1: AI Use in Clinical Research Institutions

In this episode, hosts Megan Beaver and Savanna Williams talk to Jason Johnson and Linda Malek about the evolving regulatory landscape related to artificial intelligence (AI) in health care. In particular, Jason and Linda discuss the use of AI by organizations engaged in clinical research including key issues and emerging themes in this field.
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