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Firm News 2 results

Firm News | 9 min read | 06.06.24

Crowell Attains Leading Rankings in Chambers USA 2024

Washington – June 6, 2024: Crowell & Moring earned 78 rankings for 67 lawyers, as well as 41 national and statewide practice area rankings, in the Chambers USA 2024 guide. The rankings are driven by independent interviews of clients and lawyers at peer firms.
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Firm News | 4 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 9 results

Client Alert | 5 min read | 03.28.25

HHS Announces “Dramatic Restructuring”

On March 27, 2025, HHS announced a “dramatic restructuring” of its various agencies and offices in accordance with President Trump's Executive Order, “Implementing the President’s ‘Department of Government Efficiency’ Workforce Optimization Initiative.” HHS also published a Fact Sheet.
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Client Alert | 3 min read | 03.03.25

HHS Suggests It Will Provide Less Notice and Opportunity for Comment on Grant and Contract Rules

On February 28, the Department of Health and Human Services (HHS) announced that it was rescinding the Richardson Waiver, a policy in place since 1971 which said HHS would provide notice of proposed rulemaking in certain cases where it was not otherwise required to do so by law. This announcement signals a policy shift for the agency and suggests that where permitted by law, HHS will generally now issue rules relating to “agency management or personnel or to public property, loans, grants, benefits, or contracts” without providing notice and comment to stakeholders, and may otherwise find good cause to forego notice and comment procedures.
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Client Alert | 7 min read | 02.19.25

Trump Administration Seeks Input from Public on National Artificial Intelligence Action Plan

Significant shifts in U.S. technology policy are taking shape at the start of the new administration. This is especially true in the field of artificial intelligence (AI), where President Trump revoked President Biden’s Executive Order 14110, titled “Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence,” as part of his flurry of Day One executive actions. The administration is now moving quickly to put its own stamp on this area in an effort to strengthen U.S. AI leadership and competitiveness and outpace other nations, particularly the People’s Republic of China.
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Press Coverage 6 results

Press Coverage | 01.07.25

FDA Warns Of Cyber Risks In Guidance For AI-Enabled Devices

Healthcare Info Security

Press Coverage | 10.23.24

Why Vetting AI Vendor Security Is Critical In Healthcare

Healthcare Info Security

Publications 2 results

Events 4 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 | 10.24.24, 5:30 PM EDT - 7:30 PM EDT

Do We Need a New Approach for Investing and Raising Funds in This Election Cycle?: A Fireside Chat and Networking Event for Emerging Companies and Investors

Join us for a networking event co-hosted by NYBIO and Crowell & Moring on October 24 between 5:30 and 7:30 pm. We will kick off the evening with a fireside chat moderated by Linda Malek, partner in the Healthcare and Privacy/Cybersecurity practices at Crowell in discussion with Andrew Lam, Managing Director and Head of Biotech Private Equity, Ally Bridge Group and Prem Premsrirut, Founder and CEO, Mirimus Inc. and Executive Director of Micoy Therapeutics.

Event | 06.12.24, 8:00 AM CDT - 9:00 AM CDT

Higher Education & Healthcare Research Compliance Conference

Crowell & Moring Partner Linda Malek, a member of the firm's Health Care and Privacy & Cybersecurity Groups, will be speaking at the HCCA/SCCE Higher Education & Healthcare Research Compliance Conference, taking place June 10-12 in New Orleans. Her presentation, "Research Compliance 2024 Year In Review," will take place at 8:00 AM CDT.

Webinars 3 results

Webinar | 04.22.25, 11:00 AM EDT - 12:00 PM EDT

The Evolving AI Legal and Policy Landscape: Mid-2025 Update

With the launch of Crowell’s Evolving AI Legal and Policy Landscape tracker in 2023, we formed a team of attorneys and policy professionals tasked with monitoring and reporting on the most notable developments around AI. Join us for a roundtable discussion regarding worldwide legal and policy developments since July 2024 and what you need to know in 2025. Our presenters Jillian Ambrose, Sari Depreeuw, Kate Growley, and Linda Malek will explore...

Webinar | 02.25.25, 1:00 PM EST - 2:30 PM EST

First 100 Days: Navigating New Frontiers: Life Sciences in the Trump Era

Please join us for a post-Election webinar with the heads of our Government Affairs group who will address the myriad of areas in the Life Sciences industry that will likely be impacted by the new administration, including FDA, NIH, drug pricing, imports, and exports.

Webinar | 07.25.24, 12:00 PM EDT - 1:00 PM EDT

The Evolving AI Legal and Policy Landscape: Mid-2024 Update

Since the November 2022 release of ChatGPT, generative AI has been a regulatory accelerator for governance of AI writ large. Individuals, organizations, industries, and governments across the world have grappled with the implications of AI, including how it is and could be regulated using existing and new legal frameworks. For example, since our December 2023 update:
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Speaking Engagements 5 results

Blog Posts 7 results

Blog Post | 10.17.24

FDA Calls Out a Migraine TV Ad for Misleading Viewers

Crowell Health Solution’s Trends in Transformation

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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