FDA Issues Final Rule, Confirming IVDs are Devices Under the FD&C Act
The United States Food and Drug Administration (FDA) recently published a final rule, making it explicit that in vitro diagnostic…
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HHS ONC Issues Draft Federal Health IT Strategic Plan, Seeking Input
The United States Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information…
New York City Health Care Transparency Law Now in Effect
Earlier this year, New York Local Law 844-A took effect, directing New York City Mayor Eric Adams to establish an Office of…
Former Stimwave CEO Convicted on Two Counts of Health Care Fraud
Laura Perryman, the former CEO of Stimwave was recently convicted on two counts of health care fraud: one count of health care…
JAMA Analysis Finds Open Payments Database to Be “Not Much More than a…
A research letter recently published in JAMA, the first longitudinal study of industry payments to United States physicians,…
FDA Will Hold Listening Session on Future of Advisory Committees
The United States Food and Drug Administration (FDA) recently announced a planned listening session on June 13, 2024, as part of…
Sandoz Reaches $265 Million Price-Fixing Settlement
Sandoz and its subsidiary Fougera Pharmaceuticals recently announced a $265 million settlement with a class of direct drug…
FTC, DOJ, and HHS Issue Request for Information on Private Equity…
The United States Federal Trade Commission (FTC), Department of Justice (DOJ) Antitrust Division, and Department of Health and…
FTC Announces $195 Million Judgment Against Simple Health Plans LLC
Recently, the United States Federal Trade Commission (FTC) announced a $195 million judgment against Simple Health Plans, LLC and…
New York Doctor Indicted on Health Care Fraud and Kickback Scheme
Alexander Baldonado, a medical doctor in New York, was recently charged via a grand jury superseding indictment with engaging in a…