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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 26 results

Client Alert | 7 min read | 05.27.26

Colorado Hits Reset on AI Regulation: SB 26-189 Repeals and Reenacts the Colorado AI Act

Colorado’s original AI Act (SB 24-205), signed in May 2024, imposed broad obligations on developers and deployers of “high-risk AI systems” — including requiring risk management programs, impact assessments, and affirmative steps to prevent algorithmic discrimination across employment, housing, lending, insurance, health care, and education decisions. The operative date for SB 24-205 was extended twice, and a court temporarily suspended enforcement in early 2026, following a lawsuit filed by xAI, which the U.S. Department of Justice (DOJ) intervened to support. Industry feedback on SB 24-205 was generally negative. In response to this environment, Colorado’s legislature undertook a rewrite, drafting and passing SB 26-189 in a matter of weeks. SB 26-189 reflects the legislature’s effort to preserve the policy goal of filling the AI oversight vacuum given the lack of a comprehensive federal law, but within a more workable compliance framework.
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Client Alert | 5 min read | 05.12.26

NYDFS Ramps Up Health Care Cybersecurity Enforcement With $2.25 Million Settlement

On April 29, 2026, the New York Department of Financial Services (NYDFS) announced the finalization of a $2.25 million settlement with Delta Dental of New York and Delta Dental Insurance Co., resolving allegations that the affiliated companies failed to comply with the state’s stringent cybersecurity, consumer data protection, and incident reporting requirements. For health insurers, managed care organizations, and their third-party service providers operating in New York, the announcement comes as the latest signal that the NYDFS intends to aggressively enforce its cybersecurity regulations — which are widely considered the strictest in the nation following a 2023 overhaul. These regulations, codified at 23 NYCkRR 500 (Cybersecurity Requirements for Financial Services Organizations), apply to any entity licensed under New York insurance law, including health insurers, managed care organizations, and their third-party service providers.
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Client Alert | 6 min read | 05.11.26

FDA’s AI in Early Phase Clinical Trials RFI: An Opportunity to Help Set the Rules of the Road

Consistent with recent FDA initiatives directed at leveraging AI technologies and improving early-phase clinical trial conduct, the FDA has issued a Request for Information (RFI) for input on a proposed AI-enabled optimization pilot program for early-phase clinical trials. The issues for which FDA is requesting information fall into two categories:  (A) Pilot program design and implementation and (B) Program evaluation metrics and success criteria.
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Press Coverage 8 results

Publications 2 results

Events 3 results

Event | 06.08.26, 1:00 PM CDT - 2:00 PM CDT

HCCA Research Compliance & SCCE Higher Education Compliance Conference

Crowell & Moring Partner Jason Johnson, a member of the firm's Health Care Group, will be speaking at HCCA Research Compliance & SCCE Higher Education Compliance Conference, taking place on Monday, June 8t, 2026 at San Antonio, Texas. His presentation, "Understanding Changes to the Research Misconduct Rule," will take place at 1:00–2:00 PM CDT.

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 2 results

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 4 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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