On August 26, 2025, U.S. Dept. of Health and Human Services (“HHS”) Secretary Robert F. Kennedy, Jr. announced a significant shift in enforcement authority for the confidentiality of substance use disorder (“SUD”) patient records regulations under 42 CFR Part 2 (“Part 2”). The delegation empowers the Office for Civil Rights (the “OCR”) to administer and […]
On April 20, 2024, New York State approved several updates to its consumer protection laws, including enactment of Public Health Law § 18-C. Section 18-C provides new requirements for patient consent for treatment and payment of medical services. The updates (discussed further below) went into effect on October 20, 2024. However, due to the volume […]
On November 20, 2024, the Office of Inspector General (OIG) released its updated Industry-Specific Compliance Program Guidance (ICPG) for nursing facilities, marking an important step in its broader compliance initiative. This guidance builds upon and updates the 2000 Compliance Program Guidance (CPG) and the 2008 Supplemental Compliance Program Guidance (Supplemental CPG) for Nursing Facilities, carrying […]
As healthcare regulatory attorneys, we’ve seen firsthand the confusion and challenges that arise when health-related entities fall outside the purview of the Health Insurance Portability and Accountability Act (HIPAA). One crucial, newly released, regulation that often gets overlooked is the Federal Trade Commission’s (FTC) Health Breach Notification Rule (HBN Rule). This rule is particularly relevant […]
In July 2021, the U.S. Departments of Health and Human Services, Labor, and the Treasury (the Departments) released an interim final rule, “Requirements Related to Surprise Billing, Part I” (Part I IFR). In October 2021, the Departments released a second interim final rule, “Requirements Related to Surprise Billing, Part II” (Part II IFR). On August […]
On April 11th, 2022, New York became one of 25 U.S. states to grant permanent full practice authority to Nurse Practitioners (NP). The 2022 State of the State proposal additionally allows NPs with more than 3,600 hours of experience to practice without a contractual practice-agreement relationship with a doctor. With full practice authority, nurse practitioners […]
HIPAA itself does not contain a private right of action for individuals following unauthorized disclosures of medical information. Yet, HIPAA does not prohibit individuals from seeking remedies through state or other law. Each U.S. state’s tort law system can potentially allow individuals to pursue reparations when they are harmed by a data breach. With the […]
On April 6th, 2022, a HIPAA-regulatory Request for Information (RFI) was released by the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) soliciting feedback from the public for future rulemaking. The RFI seeks information on how the industry views “recognized security practices,” and on OCR’s compensating individuals based on harm they […]
Participants in the healthcare industry have seen a multi-front threat related to their information security practices/healthcare data – increased enforcement and fines by the Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR); increased scrutiny from plaintiffs’ attorneys and State Attorneys General; and increased threats from malicious actors. Recent reports underscore this […]
On April 22, 2022, the Department of Health and Human Services (“HHS”), in conjunction with several other federal agencies, filed a notice of appeal in opposition to a Texas federal judge’s summary judgment ruling regarding the No Surprises Act (“NSA”). The underlying lawsuit was filed by the Texas Medical Association (“TMA”) and Adam Corley (a […]
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