In response to the shifting legal landscape around reproductive health care, the U.S. Department of Health and Human Services, Office for Civil Rights (OCR) finalized amendments to the HIPAA Privacy Rule to strengthen privacy protections for highly sensitive protected health information (PHI) related (or potentially related) to reproductive health care. OCR announced the final rule
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Mental Health Parity and Addiction Equity Act Final Rules (“Final Rules”) Are Released: Plans and Issuers Must Prepare for January 1, 2025 Effective Date (US)
The long-awaited Final Rules amending the Mental Health Parity and Addiction Equity Act (“MHPAEA”) were released on September 9, 2024, with the bulk of the requirements going into effect on January 1, 2025. As we previously reported here, in August 2023, the Departments of Labor, Health and Human Services (“HHS”) and Treasury (together, the…
Texas Attorney General Settles with Healthcare AI Firm Over False Claims on Product Accuracy and Safety
The Office of the Attorney General of Texas (“OAG”) announced a “first-of-its-kind healthcare generative AI” settlement with Pieces Technology, Inc. (“Pieces”). The settlement related to the Texas OAG allegations that Piece’s advertising and marketing claims about the accuracy of its generative artificial intelligence (GenAI) products in violation of the Texas Deceptive Trade Practices – Consumer…
Stark Law & Mailing Physician-Dispensed Prescriptions: From COVID-19 Waivers to Federal Legislative Action
In August 2024, a federal district court dismissed a lawsuit filed by the Community Oncology Alliance (“COA”), holding that the “in-office ancillary services” exception to the Stark Law does not permit physicians to dispense medications through the physician’s office and then mail prescriptions to the patient’s home. COA v. Becerra, Case No. 23-cv-2168, Doc. 40, United…
The Changing Labor Landscape for Healthcare Employers
In 2024, healthcare employers have faced several new challenges and developments regarding traditional labor obligations. Unions are becoming more prominent in healthcare, including by unionizing doctors at unprecedented rates and by becoming more involved in government-funded projects. At the same time, federal agencies are imposing significant new labor obligations on healthcare employers, regardless of whether…
FTC Non-Compete Ban Set Aside Nationwide
On August 20, 2024, a Texas federal judge permanently barred the implementation of a controversial Federal Trade Commission (FTC) regulation that would have invalidated tens of millions of existing non-compete agreements and precluded the adoption of new covenants. We discussed the FTC’s non-compete regulation earlier this year. The decision comes as a relief to…
Singapore Issues Game-Changing Synthetic Data Guide for AI
On July 15, 2024, Singapore’s Personal Data Protection Commission Singapore (PDPC) released a Proposed Guide on Synthetic Data Generation (Guide). The Guide is a resource within the Privacy Enhancing Technology (PET) Sandbox which aims to assist organisations in understanding the techniques and potential applications of Synthetic Data generation, particularly in the context of artificial intelligence…
Singapore Consults on Cybersecurity Guidelines for AI Systems
As a digital technologies hub in the Asia Pacific region, Singapore is making a big push to advance Artificial Intelligence (AI) technologies across various sectors, including healthcare.
The promise of AI in managing Singapore’s ageing population and enhancing patient care and treatment more broadly cannot be overstated. This spans the ability to better predict and…
Medicare Part D Preemption: Supreme Court Review Uncertain
On July 29, 2024, Pharmaceutical Care Management Association (“PCMA”) filed an opposition to Oklahoma’s petition for writ of certiorari in the United States Supreme Court, seeking review of the Tenth Circuit decision PCMA v. Mulready, 78 F.4th 1183 (10th Cir. 2023). Oklahoma seeks review of both ERISA and Medicare Part D preemption.[1]
Mulready held…
A New Era in Healthcare Regulation & Compliance
Loper Bright Shifts Statutory Interpretation Powers Back to the Courts.
On June 28, 2024, the Supreme Court overturned the Chevron doctrine with its decision in Loper Bright Enterprises v. Raimondo. Under Chevron, courts have historically deferred to a federal agency’s interpretation of ambiguity in statutes that the agency administers. Courts premised Chevron deference on the notion that…