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Firm News 3 results

Firm News | 11 min read | 06.05.25

Crowell Attains Leading Rankings in Chambers USA 2025

Washington – June 5, 2025: Crowell & Moring earned 80 rankings for 71 lawyers, as well as 43 national and statewide practice area rankings, in the Chambers USA 2025 guide. The rankings are driven by independent interviews of clients and lawyers at peer firms.

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 12 results

Client Alert | 3 min read | 05.07.25

NIH Continues Grant Awards Overhaul With New Limitations on Foreign Subawards

On May 1, the NIH issued an update on its grants policy, establishing a “new award structure” that would prohibit foreign subawards from being nested under the parent grant, replacing them with direct awards linked to a prime award. Effective immediately, NIH will no longer issue awards that include a subaward to a foreign entity until the new structure is implemented. The notice did not limit this new structure for foreign recipients to any particular jurisdiction, potentially impacting a wide range of grants and limiting international collaboration with U.S. researchers through the subaward model.
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Client Alert | 23 min read | 05.05.25

Key Developments in AI and Digital Health Signal Growing Federal Activity (Q1 2025)

Digital health companies, investors, and other healthcare organizations should follow policy developments with a strategic lens towards their market opportunities for key potential growth and risk mitigation. On a quarterly basis, we provide relevant legislative and regulatory updates on artificial intelligence (AI) and digital health policy developments. This update outlines major health policy developments that occurred at the end of 2024 through the first three months of 2025.
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Client Alert | 6 min read | 04.18.25

Ready To Know Your Data? DOJ Issues Implementation and Enforcement Guidance for Data Security Program Protecting Bulk Sensitive Data

On April 11, 2025, the U.S. Department of Justice (DOJ) issued guidance regarding the implementation and enforcement of the newly enacted final rule, “Preventing Access to U.S. Sensitive Personal Data and Government-Related Data by Countries of Concern or Covered Persons,” now referred to as the Data Security Program (DSP). The release included an Implementation and Enforcement Policy, a Compliance Guide, and Frequently Asked Questions (FAQs). Collectively, these documents are designed to help entities subject to the DSP understand and comply with the obligations set out under the Final Rule.
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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 5 results

Event | 08.04.25, 2:00 PM EDT - 3:00 PM EDT

Cultivating Research Integrity Summit

Crowell & Moring Partner Linda Malek, a member of the firm's Health Care and Privacy & Cybersecurity Groups, will be speaking at the Cultivating Research Integrity Summit, taking place on August 4, 2025 in Reading, Pennsylvania. Her presentation, "Artificial Intelligence and Research Integrity," will take place at 2:00 PM ET.

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.

Webinars 4 results

Webinar | 06.26.25 - 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. 

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.

Speaking Engagements 6 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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