News & Analysis as of

Department of Health and Human Services (HHS) Shareholders

Mintz - Health Care Viewpoints

Telehealth Update: DEA/HHS Temporary Rule, Medicare Coverage of Telehealth Services, Potential for Increased Oversight, and What...

Telehealth companies and other industry stakeholders have had a watchful eye towards the end of 2024 and the impending “telehealth cliff” as COVID-era Drug Enforcement Agency (DEA) flexibilities and Medicare expanded...more

King & Spalding

FDA Publishes White Paper on Artificial Intelligence & Medical Products

King & Spalding on

On March 15, 2024, FDA published a white paper titled “Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together” (the AI White Paper) on the use of artificial intelligence (AI) across the...more

Foley & Lardner LLP

Clinical Research: FDA Issues Draft Guidance on Informed Consent

Foley & Lardner LLP on

The U.S. Food and Drug Administration (FDA), in collaboration other agencies, recently published draft guidance (Guidance) on effectively presenting key information regarding informed consent in FDA-regulated clinical...more

Gardner Law

Highlights from OIG’s New Compliance Program Guidance

Gardner Law on

The U.S. Department of Health and Human Services Office of Inspector General (HHS OIG) released an important new compliance resource in November 2023. The HHS OIG’s new General Compliance Program Guidance (GCPG) is intended...more

McDermott Will & Emery

Private Investors and Digital Health Attracting OIG Attention: General Compliance Program Guidance to Watch

McDermott Will & Emery on

On November 6, 2023, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) published the General Compliance Program Guidance (GCPG) as a revised reference guide for the healthcare compliance...more

Holland & Hart LLP

OIG Issued Updated General Compliance Program Guidance for Healthcare Providers and Stakeholders

Holland & Hart LLP on

On Monday, November 6, 2023, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) released its General Compliance Program Guidance (“GCPG”) for the general healthcare compliance community and...more

Mintz - Health Care Viewpoints

Telehealth Update: DEA Extends Flexibility in Prescribing Controlled Substances via Telehealth Through 2024

On October 10, 2023, the Drug Enforcement Administration (DEA) published another temporary rule extending the COVID-era telemedicine flexibilities that allow physicians and other prescribers to prescribe controlled substances...more

Sheppard Mullin Richter & Hampton LLP

OIG’s Modernization of Compliance Program Guidance: What to Expect

The Department of Health and Human Services Office of Inspector General (OIG) recently announced changes to its process for informing healthcare industry stakeholders of new or updated Compliance Program Guidance (CPG)....more

Jackson Lewis P.C.

FDA Names First Acting Director Of Medical Device Cybersecurity

Jackson Lewis P.C. on

The U.S. Food and Drug Administration (FDA) named University of Michigan Associate Professor Kevin Fu Acting Director of Medical Device Security in its Center for Devices and Radiological Health. This is a newly created...more

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