Insights

Professional
Practice
Industry
Region
Trending Topics
Location
Type

Sort by:

Firm News 39 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 | 3 min read | 04.09.24

Senior Congressional Health Counsel Stephen Holland Joins Crowell & Moring

Stephen Holland, former senior health counsel on the Committee on Energy & Commerce, U.S. House of Representatives, has joined Crowell & Moring, bringing more than a decade of legislative experience on Capitol Hill.

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 175 results

Client Alert | 8 min read | 10.10.24

HHS ORI Final Rule on Research Misconduct

On September 12, 2024, the Department of Health and Human Services’ (“HHS”) Office of Research Integrity (“ORI”) released a final rule updating 42 CFR Section 93, Public Health Service Policies (“PHS”) on Research Misconduct (“Final Rule”). The research misconduct rule was promulgated almost 20 years ago without subsequent revision, until now. It affects all recipients of Public Health Service funding for biomedical or behavioral research, requiring them to update their policies and procedures governing research misconduct to remain in compliance with the regulation.
...

Client Alert | 12 min read | 09.13.24

Tri-Agencies Finalize NQTL Comparative Analysis Standards in Final Rule

On Monday, September 8, 2024, the United States Department of the Treasury, Department of Labor, and Department of Health and Human Services (collectively, the “Tri-Agencies”) issued a final rule (“the Final Rule”) implementing new regulations applicable to nonquantitative treatment limitations (“NQTLs”) under the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act (“MHPAEA”). The Final Rule codifies many of the requirements set forth in the (the “Proposed Rule”), while pulling back on some of the Tri-Agencies’ more controversial proposals. 
...

Client Alert | 6 min read | 08.29.24

HHS Proposes Using Procurement Policy to Push Health IT Standards

The Department of Health and Human Services (HHS) continues its push on health data interoperability with a proposed rule, HHS Acquisition Regulation: Acquisition of Information Technology; Standards for Health Information Technology.  Specifically, HHS proposes to modify the Health and Human Service Acquisition Regulation (HHSAR) to implement an HHS-wide policy to align requirements related to the procurement of health IT with standards and implementation specifications adopted by the Office of the National Coordinator for Health IT (ONC) or compliance with the voluntary ONC Health IT Certification Program.  This proposed rule was published on August 9, 2024, just 4 days after the ONC proposed HTI-2 rule was published in the Federal Register.
...

Press Coverage 5 results

Publications 1 result

Events 2 results

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 | 05.07.24 - 05.09.24

HOOPS 2024

Please join us for this year’s Health Care Opportunities, Oversight, Policy, and Strategy (HOOPS) Webinar Event | Navigating the Rapid Developments in Health Care on May 7-9th.

Speaking Engagements 5 results

Blog Posts 3 results

Blog Post | 11.16.23

NIH Requests Information on Developing Consent Language for Research Using Digital Health Technologies

Crowell Health Solution’s Trends in Transformation

Blog Post | 05.05.23

FDA Decentralized Clinical Trials Draft Guidance

Crowell Health Solution’s Trends in Transformation

Podcasts 5 results

Podcast | 07.12.24

Payers, Providers, and Patients – Oh My!: AI in Health Care Series, Part 2: Artificial Intelligence, HIPAA and Data Privacy

In this episode, hosts Payal Nanavati and Megan Beaver talk to Jodi Daniel and Lidia Niecko-Najjum about how HIPAA and existing data privacy protections are shaping health care organizations’ use of artificial intelligence. Jodi and Lidia discuss the various regulations at play and also provide practical takeaways.
...

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.
...

Podcast | 02.23.24

Payers, Providers, and Patients – Oh My!: Enabling Widespread Adoption of Decentralized Clinical Trials

In this episode, hosts Payal Nanavati, Jodi Daniel, and Cara Tenenbaum talk to Ben Moscovitch, Devon Adams, and Noah Goodson about recent policy developments on decentralized clinical trials (DCTs). They also discuss the Crowell Health Solutions’ white paper on DCTs, which issues to federal agencies a number of policy recommendations to advance DCT adoption and increase clinical trial diversity.
...