At the close of 2024, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) issued a Notice of Proposed Rulemaking (the Proposed Rule) to amend the Security Rule regulations established for protecting electronic
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FDA Sued Over Laboratory Developed Tests Final Rule
*This post was authored by Nicole Benevento, law intern at Robinson+Cole. Nicole is not admitted to practice law.
The Food and Drug Administration (FDA) is being sued in two lawsuits after releasing its Final Rule on Laboratory Developed Tests (LDTs). The…
OCR Active with Settlements and Enforcement Actions in November and Early December
The Office for Civil Rights of the Department of Health and Human Services (OCR) was busy negotiating and settling enforcement actions in November and early December. Since October 31, 2024, the OCR has settled five separate cases of alleged HIPAA…
OIG Audit Scrutinizes Hospital Compliance with Price Transparency Rule
*This post was co-authored by Paul Palma, legal intern at Robinson+Cole. Paul is not admitted to practice law.
In November 2024, the Department of Health and Human Services Office of Inspector General (OIG) published the results of its audit assessing…
CMS Finalizes Standard for Identifying Overpayments and Grace Period for Investigations of Related Overpayments
As part of its 2025 Physician Fee Schedule Final Rule (PFS Rule), the Centers for Medicare & Medicaid Services (CMS) finalized two crucial updates to federal Medicare overpayments regulations (sometimes referred to as the “60-Day Rule”) that (1)…
Massachusetts Supreme Court Rules Online Tracking Technologies Do Not Violate State Wiretap Law
By Conor Duffy
In a highly anticipated decision on an issue facing courts across the country, the Massachusetts Supreme Judicial Court held in late October that Massachusetts hospitals’ use of online tracking technologies that collect and transmit browsing activities of website visitors does…
DEA Extends Telehealth Lifeline for Patients
*This post was co-authored by Paul Palma, legal intern at Robinson+Cole. Paul is not admitted to practice law.
On November 15, 2024, the Drug Enforcement Administration (DEA) and the Department of Health & Human Services (HHS) jointly announced an extension…
Microsoft Report Highlights Attacks Against Healthcare Organizations
On October 22, 2024, Microsoft issued a threat trend research report entitled “US Healthcare at risk: Strengthening resilience against ransomware attacks.” In it, Microsoft declares that ransomware attacks against the healthcare sector are “emerging as one of the most significant”…
OCR Settles Fourth Ransomware Investigation
The Office for Civil Rights of the Department of Health and Human Services (OCR) announced on September 26, 2024, that it had entered a settlement with Cascade Eye and Skin Centers (together, Cascade) for $250,000 following an investigation of a…
Middle District of Florida Judge Finds False Claims Act’s Qui Tam Provision Unconstitutional
*This post was co-authored by Paul Palma, legal intern at Robinson+Cole. Paul is not admitted to practice law.
On September 30, 2024, Judge Kathryn Kimball Mizelle of the U.S. District Court for the Middle District of Florida issued an order…