Newsletters

02.27.24

The FDA and the Future of AI Oversight

In January 2024, the U.S. Government Accountability Office (GAO) issued a report highlighting current obstacles to the U.S. Food and Drug Administration’s (FDA) timely and effective regulation of artificial intelligence (AI) and machine learning (ML) in medical devices and other emerging ...


11.16.23

HHS OIG Unveils First New Compliance Program Guidance for Health Care Stakeholders Since 2008

Many health care stakeholders have long relied on the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) guidance regarding an effective compliance program when developing their own compliance programs, especially when contracts and less prescriptive federal and ...


08.11.22

New DOJ and OIG Actions Warn the Telemedicine Industry About Suspect Arrangements

On July 20, the U.S. Department of Health and Human Services Office of the Inspector General issued a new Special Fraud Alert on practitioner arrangements with telehealth, telemedicine or telemarketing companies to warn the industry—particularly providers—about key characteristics of ...


03.09.22

Public Charge Proposed Rule Seeks to Codify Longstanding Guidance

On February 17, the Department of Homeland Security released a proposed rule that would largely codify long-standing federal guidance regarding DHS’ authority to refuse a noncitizen’s application for admission or application for visa adjustment on grounds that they are ...


11.05.21

Administration Releases CMS and OSHA Emergency Rules Requiring Vaccination for Health Care Workers

The Biden-Harris Administration announced the release of two interim final rules.