News & Analysis as of

Regulatory Oversight Biden Administration Department of Health and Human Services (HHS)

Health Care Compliance Association (HCCA)

‘I Really Wanted to Stay’: Amid Success, Regrets, OHRP’s Kaneshiro Hopes Agency Will Be Rebuilt

When Jerry Menikoff retired at the end of 2022 after leading the HHS Office for Human Research Protections (OHRP) for 14 years, he left behind an agency limping along with 20 employees, less than half of what it needed. For...more

Hogan Lovells

FDA Announces Plans for Post-Market Chemical Review Program

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently announced plans to update its post-market food chemical review program. In its announcement, FDA explained that its forthcoming plans will take a proactive approach to...more

McDermott+

The Leaked OMB Passback Document: What It Is and Isn’t

McDermott+ on

Last week, a sensitive internal government document was leaked to the public: the White House Office of Management and Budget’s (OMB’s) passback to the US Department of Health and Human Services (HHS) laying out proposed...more

Holland & Knight LLP

Regulation of AI in Healthcare Utilization Management and Prior Authorization Increases

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Over the past two years, federal and state government agencies have moved to regulate the deployment of artificial intelligence (AI) in the healthcare setting, including in the utilization management (UM) and prior...more

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 Locke

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

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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

Pillsbury Winthrop Shaw Pittman LLP

Follow the Money: AI Winners in President Biden’s FY 2024 Budget Request

Artificial intelligence wins big in President Biden’s FY 2024 budget request with billions in new funding proposed for AI-related research, hardware, software and services at the departments of Defense, Energy, Homeland...more

McDermott Will & Emery

McDermott’s Healthcare Enforcement Quarterly - Q1 2022

McDermott Will & Emery on

The healthcare enforcement landscape is shifting quickly. This issue of McDermott’s Healthcare Enforcement Quarterly examines emerging trends and key issues for organizations that may become subject to enforcement scrutiny,...more

McDermott Will & Emery

Healthcare Enforcement Roundup - Volume 1, 2021

Stay current on the healthcare enforcement issues impacting your business’ compliance strategies. In this installment of the Healthcare Enforcement Roundup, we address: • Key areas of enforcement scrutiny in 2021,...more

Polsinelli

HHS and OMB Confirmation Watch: Implications for Health Care and Federal Budgets

Polsinelli on

The confirmations of Cabinet secretaries and federal agency directors by the U.S. Senate are critical and early milestones in any new President’s administration. Permanent department leadership allows the executive branch to...more

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