Erin HealyA new draft guidance published by FDA suggests steps that firms in a distribution chain, including manufacturers and distributors, should take to ensure they are…
FDA Finalizes Guidance for Medical Device Interoperability
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…
CMS Proposes Changes to Bundled Payment Initiatives
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…
NJ Court Recognizes Privacy Law Claim Based on HIPAA Violation
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…
DOJ Takedown Is Biggest Healthcare Fraud Enforcement Action In History
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…
CMS Proposes to Exempt More Small Practices from MACRA
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…
Healthcare IT Company Settles with NY AG over Untimely Breach Notice
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…
OIG Tells CMS to Recover Improper EHR Incentive Payments
A new report published by the Department of Health and Human Services Office of Inspector General (OIG) concludes that the Centers for Medicare & Medicaid…
CMS Sets January 1, 2018 Effective Date for Expansion of Bundled Payment Programs
In March, as discussed here, the Centers for Medicare & Medicaid Services (CMS) published an interim final rule that delayed the effective date of planned…
Defending Against Cyberattacks: New Guidance on Securing Wireless Infusion Pumps
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…