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Risk Management Regulatory Reform Healthcare

Polsinelli

Virtual Oversight, Real Impacts: “Incident-To” and Beyond in CMS’s CY 2026 PFS Proposed Rule

Polsinelli on

Key Takeaways - CMS proposes to significantly expand the use of virtual direct supervision for incident-to services, removing prior limitations based on Professional Component (PC)/Technical Component (TC) indicators and...more

BakerHostetler

HHS Issues a Request for Information on Deregulation and Innovation: Considerations for Legal and Compliance Teams

BakerHostetler on

On May 14, 2025, the U.S. Department of Health and Human Services (HHS) issued its Request for Information (RFI) “Ensuring Lawful Regulation and Unleashing Innovation To Make American Healthy Again,” which HHS describes as...more

Epstein Becker & Green

Breaking Down the Shifting Vaccine Policy Landscape – Diagnosing Health Care Video Podcast

Epstein Becker & Green on

Important changes are unfolding in the vaccine space. How have vaccine exemptions posed a significant risk to populations across the country? What are the long-lasting effects of the new administration's federal health...more

Smart & Biggar

Health Canada publishes guidance on submitting risk management plans

Smart & Biggar on

As we previously reported, agile licensing amendments to the Food and Drug Regulations and Medical Devices Regulations were registered on November 29, 2024. We are continuing to update our previous article to reflect new...more

Frost Brown Todd

Proposed HIPAA Security Rule Requires AI Governance

Frost Brown Todd on

In terms of healthcare data breaches, 2024 was the worst year ever, with the records of at least 53% of the U.S. population involved and two of the biggest healthcare data breaches of 2024 ranking in the top 10 of all time. ...more

Benesch

Dental/DSO Intelligence Monthly Report: January 2025

Benesch on

Moving into 2025, the dental industry faces a series of transformative shifts driven by evolving patient expectations, the rise of Dental Support Organizations (DSOs) and persistent operational challenges. The industry will...more

Jones Day

China Finalizes Its First Anti-Corruption Guidelines for the Health Care and Life Sciences Industry

Jones Day on

On January 14, 2025, China's State Administration for Market Regulation ("SAMR"), the primary regulatory agency in China for overseeing market supervision, issued its Compliance Guidelines for Health Care Companies to Prevent...more

Ballard Spahr LLP

HHS Proposes Significant Updates to HIPAA Security Rule

Ballard Spahr LLP on

On January 6, 2025, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) published a Notice of Proposed Rulemaking (“NPRM”) to amend the Health Insurance Portability and Accountability Act...more

A&O Shearman

AEPD and EDPS publish report on data protection issues arising from the handling of neuro data

A&O Shearman on

On 27 June 2024, the Spanish supervisory authority (‘AEPD’) and the European Data Protection Supervisor (‘EDPS’), announced the joint publication of a report addressing the data protection challenges associated with neuro...more

Health Care Compliance Association (HCCA)

Privacy Briefs: January 2024

New York has released proposed cybersecurity regulations for hospitals. The regulations, which were published in The State Register on Dec. 6 and will undergo a 60-day public comment period ending on Feb. 5, are designed to...more

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