On December 6, 2023, Senate Budget Committee Ranking Member Chuck Grassley (R-Iowa) and Chair Sheldon Whitehouse (D.-R.I.) announced a new bipartisan investigation into private equity ownership in hospitals—just ahead of a new plan by the Biden-Harris Administration to crack down on anticompetitive practices in health care.
Under the Biden plan, announced December 7, the Department of Justice (DOJ), the Federal Trade Commission (FTC), and Department of Health and Human Services (HHS) will seek input on how private equity is affecting the health care of Americans and the ...
In October 2023, the FDA released draft guidance entitled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers Guidance for Industry” (“2023 Draft Guidance”).[1] The 2023 Draft Guidance supersedes previous draft guidance from 2014 entitled “Distributing Scientific and Medical Publications on Unapproved New Uses–Recommended Practices” (“2014 Draft Guidance”), which was a revision of a 2009 final guidance entitled “Good Reprint ...
For the first time since 2008, the Advanced Medical Technology Association (“AdvaMed”) has updated its “Code of Ethics on Interactions with Health Care Professionals.” These updates were announced on January 9, 2019 and will become effective on January 1, 2020.
AdvaMed’s goal in updating the Code was to address the evolving nature of interactions between the medical device industry and health care professionals (“HCPs”), bring existing examples up-to-date, and enhance user-friendliness. Topics that were previously covered in multiple areas of the Code are now ...
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Recent Updates
- First Circuit Clarifies When Clinical Labs Can Rely on Physician Orders
- Understanding the False Claims Act Statute of Limitations—and the Debate Over the “Last Overt Act” Rule
- Podcast: The Down-Low on Data for Value-Based Enterprises and Their Participating Providers – Diagnosing Health Care
- Second Circuit Affirms Denial of Preliminary Injunction in Challenge To N.Y. Law Restricting Weight Loss and Muscle Building Supplement Sales to Minors
- The DOJ’s Bulk Sensitive Data Rule and Your Obligation to “Know Your Data”