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Department of Health and Human Services (HHS) Regulatory Agenda Regulatory Oversight

BakerHostetler

Federal Government Addresses AI Transparency and Safety in Healthcare

BakerHostetler on

On Oct. 30, President Biden signed an executive order calling for a coordinated government approach to establish new safeguards for AI safety and security in healthcare. In response to the executive order, on Dec. 14 the...more

Holland & Knight LLP

New Artificial Intelligence Executive Order Contains Numerous Healthcare Implications

Holland & Knight LLP on

President Joe Biden on Oct. 30, 2023, signed a sweeping executive order (EO) and invoked the Defense Production Act to establish the first set of standards for using artificial intelligence (AI) in healthcare and other...more

Latham & Watkins LLP

President Biden’s Executive Order on Artificial Intelligence - Initial Analysis of Private Sector Implications

Latham & Watkins LLP on

The Order marks an ambitious effort to stand up a whole-of-government approach to encouraging the benefits and managing the risks of artificial intelligence, with many of its most significant private-sector implications...more

Troutman Pepper

HHS Proposes Rescheduling Cannabis to Schedule III – What It Means for the Industry

Troutman Pepper on

It has been widely reported and confirmed publicly that, on August 29, the U.S. Department of Health and Human Services (HHS) sent a letter to the Drug Enforcement Administration (DEA) recommending that cannabis be moved from...more

McDermott Will & Emery

Special Report: FDA 2019 Year in Review

McDermott Will & Emery on

The US Food and Drug Administration’s (FDA’s) 2019 regulatory agenda focused on digital health, streamlined product approvals, evolving evidentiary thresholds for product approvals and strategic enforcement. The agency...more

Burr & Forman

Top Three Challenges Health Care Payers and Providers Will Face in 2020

Burr & Forman on

Health care providers operate in one of the most highly regulated industries in terms of compliance and governmental oversight. As a result, providers face a number of regulatory and compliance challenges each year....more

Hogan Lovells

Will FDA be forced to implement a drug importation program?

Hogan Lovells on

Over a year ago, HHS Secretary Alex Azar requested that FDA establish a working group to explore how drug importation “could help address price hikes and supply disruptions.” The FDA working group was not assigned the task of...more

Hogan Lovells

HHS Seeking Input on HIPAA Changes

Hogan Lovells on

The Department of Health and Human Services (HHS) announced a Request for Information (RFI) regarding how the HIPAA Privacy, Security, and Breach Notification Rules could be modified to reduce regulatory burdens and to...more

Akerman LLP - Health Law Rx

TV Drug Commercials Must Disclose the Drug's List Price if HHS Adopts Proposed Rule

We are all familiar with prescription drug television commercials where it sounds like they hired a professional auctioneer to recite the drug side effects so fast you can hardly understand them....more

Farrell Fritz, P.C.

NYS Department of Health Report Green Lights Legalization of Marijuana

Farrell Fritz, P.C. on

In January 2018, during the Executive budget address, Governor Cuomo directed the Department of Health (DOH) to review the health, criminal justice and economic impacts of regulating recreational marijuana in New York. ...more

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