A new draft guidance published by FDA suggests steps that firms in a distribution chain, including manufacturers and distributors, should take to ensure they are…
In final guidance published on September 6, the U. S. Food and Drug Administration (FDA) provided manufacturers with recommendations for ensuring interoperable medical devices are…
The Centers for Medicare and Medicaid Services (CMS) has proposed the elimination of bundled payment program initiatives whose implementation has already been twice delayed, as previously…
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) does not provide for a private right of action allowing affected individuals to sue to…
On July 13, the U.S. Department of Justice (DOJ) announced a nationwide takedown of unprecedented size, involving more than 1,000 law enforcement personnel including 350 Office of…
The Centers for Medicare and Medicaid Services (CMS) has issued a proposed rule that would update the physician payment system under the Medicare Access and CHIP Reauthorization Act…
CoPilot Provider Support Services, Inc. has agreed to pay $130,000 in penalties as part of a settlement with the New York Attorney Generals Office for waiting…
A new report published by the Department of Health and Human Services Office of Inspector General (OIG) concludes that the Centers for Medicare & Medicaid…
In March, as discussed here, the Centers for Medicare & Medicaid Services (CMS) published an interim final rule that delayed the effective date of planned…
Cyberattacks on healthcare systems are becoming more frequent and increasingly devastating. As demonstrated by the recent crippling ransomware attacks on hospital computers (discussed here), the…