Insights

Professional
Practice
Industry
Region
Trending Topics
Location
Type

Sort by:

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.
...

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.
...

Client Alerts 4 results

Client Alert | 9 min read | 11.06.24

Proposed Rule on Protecting Bulk Sensitive Data and Its Impact on Health Care

On October 29, 2024, the Department of Justice (DOJ) published a Notice of Proposed Rulemaking (NPRM) to implement Executive Order 14117 “Preventing Access to Americans’ Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern” (the E.O.).  The E.O. addresses the national security threat posed by the continued effort of certain countries of concern to access and exploit certain kinds of Americans’ sensitive personal data, which includes health data and genetic data. This builds on DOJ’s Advance Notice of Proposed Rulemaking (ANPRM) published on March 5.  Comments are due on November 29, 2024.
...

Client Alert | 4 min read | 10.29.24

AI’s Cybersecurity Risks: New York Provides Guidance on Developing Cybersecurity Programs to Address Emerging AI Concerns

On Wednesday, October 16, 2024, New York’s Department of Financial Services (DFS) announced new guidance aimed at identifying and providing a blueprint for protecting against AI-specific cybersecurity risks.  Motivated primarily by advancements in AI that substantially impact cybersecurity—including facilitating new ways to commit cybercrime—DFS’s guidance aims to specifically protect New York businesses but applies to all companies concerned with increasing their cybersecurity and managing risks posed by emerging technologies. The guidance addresses “most significant” AI-related threats to cybersecurity that organizations should consider when they are developing a cybersecurity program, internal protocols, or implementing cybersecurity controls—as well as recommendations for those cybersecurity programs.
...

Client Alert | 3 min read | 08.28.24

Natural Intelligence: NIST Releases Draft Guidelines for Government Contractor Artificial Intelligence Disclosures

On August 21, 2024, the National Institute of Standards and Technology (NIST) released the Second Public Draft of Digital Identity Guidelines (hereinafter, “Draft Guidelines”) for final review. The Draft Guidelines introduce potentially notable requirements for government contractors using artificial intelligence (AI) systems. Among the most significant draft requirements are those related to the disclosure and transparency of AI and machine learning (ML). By doing so, NIST underscores its commitment to fostering secure, trustworthy, and transparent AI, while also addressing broader implications of bias and accountability. For government contractors, the Draft Guidelines are not just a set of recommendations but a blueprint for future AI standards and regulations.
...

Press Coverage 4 results

Press Coverage | 10.23.24

Why Vetting AI Vendor Security Is Critical In Healthcare

Healthcare Info Security

Press Coverage | 03.22.24

Feds Double Down On Webtracking Guidance

POLITICO

Publications 1 result

Events 3 results

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.

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 1 result

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:
...

Speaking Engagements 3 results

Blog Posts 5 results

Blog Post | 10.17.24

FDA Calls Out a Migraine TV Ad for Misleading Viewers

Crowell Health Solution’s Trends in Transformation

Blog Post | 08.12.24

FDA Publishes FAQs Around Its Recent Laboratory Developed Tests Final Rule

Crowell Health Solution’s Trends in Transformation

Blog Post | 08.01.24

FDA Issues Guidance on Using Electronic Health Records and Medical Claims Data in Clinical Studies

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.
...