News & Analysis as of

Regulatory Agenda Compliance Health Care Providers

Skadden, Arps, Slate, Meagher & Flom LLP

The European Health Data Space – What EU Health Care Providers and Data Holders Need To Know

- On 26 March 2025, the European Health Data Space (EHDS) Regulation entered into force. The regulation establishes a comprehensive framework for health-data sharing and access in the EU, with the dual aim of supporting the...more

Whiteford

Client Alert: CMS Again Delays Updates to its Guidance to Surveyors for Long Term Care Facilities Under Appendix PP of the State...

Whiteford on

On March 10, 2025, the Centers for Medicare & Medicaid Services (“CMS”) announced a further delay in the implementation of proposed updates to its Guidance to Surveyors for Long-Term Care Facilities under Appendix PP of the...more

McDermott Will & Schulte

SB 5387 Aims to Codify Restrictive CPOM Doctrine in Washington

On January 21, 2025, the Washington state legislature introduced Senate Bill (SB) 5387, aiming to codify a restrictive state prohibition on the corporate practice of healthcare, commonly referred to as a corporate practice of...more

ArentFox Schiff

FDA Announces End to Semaglutide Shortage, Impacting Compounders and Telehealth Providers Offering Injectable GLP-1 Drugs

ArentFox Schiff on

Last week, the US Food and Drug Administration (FDA) announced the end of a years-long shortage of semaglutide injection products — a popular glucagon-like peptide 1 (GLP-1) weight loss and diabetes medication. As a result,...more

Sheppard Mullin Richter & Hampton LLP

Updated: The Future of Gender-Affirming Care – New Legal and Regulatory Considerations for Hospitals Providing These Services

As legal and policy developments continue to evolve, hospitals and health care professionals that provide gender-affirming care face new uncertainties regarding federal funding, compliance, and patient access. While these...more

Husch Blackwell LLP

California Legislature Takes Another Swing at Private Equity Participation in Healthcare

Husch Blackwell LLP on

Last fall, private equity and hedge fund investors were given a reprieve from the prospect of increased oversight of healthcare transactions when California Governor Gavin Newsom unexpectedly vetoed Assembly Bill 3129 (AB...more

Rivkin Radler LLP

NYS OMIG Publishes 2025 Work Plan

Rivkin Radler LLP on

On January 29, the New York State Office of the Medicaid Inspector General (OMIG) published its 2025 Work Plan, which provides a preview of the OMIG’s program integrity initiatives for the upcoming year. While this post...more

Morrison & Foerster LLP

China Issues First Compliance Guidelines to Combat Commercial Bribery Risks - UPDATED February 2025

On January 10, 2025, China’s State Administration for Market Regulation (“SAMR”) put into effect its Compliance Guidelines for Healthcare Companies to Prevent Commercial Bribery Risks (“Compliance Guidelines”)....more

Foley & Lardner LLP

The Colorado AI Act: Implications for Health Care Providers

Foley & Lardner LLP on

Artificial intelligence (AI) is increasingly being integrated into health care operations, from administrative functions such as scheduling and billing to clinical decision-making, including diagnosis and treatment...more

ArentFox Schiff

California Claps Back on Insurer Use of AI to Deny Needed Medical Care Decisions

ArentFox Schiff on

California is leading the way in ensuring that determinations of medically necessary health care services are made by licensed physicians and not artificial intelligence (AI) algorithms....more

Verrill

Prescription for Change: Massachusetts Pharmacies Undergo Regulatory Revamp

Verrill on

Pharmacies doing business in Massachusetts must act now – The Massachusetts Board of Registration in Pharmacy (the “Board”) has announced a series of new and long-awaited pharmacy licensure regulations that took effect in...more

Foley & Lardner LLP

DEA Unveils Long-Overdue Special Registration for Telemedicine in Proposed Rule

Foley & Lardner LLP on

In the final days of the Biden administration, the Drug Enforcement Administration (DEA) released a proposed rule that would allow practitioners with a Special Registration to prescribe Schedule III-V, and in limited...more

Akin Gump Strauss Hauer & Feld LLP

FDA Finalizes Guidance on Communication of Unapproved Uses of Approved or Cleared Medical Products

On January 6, 2025, the FDA released final guidance for industry entitled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions...more

Goodwin

How to (Finally) Get Your SIUU Out: FDA Issues Final Guidance on Communicating Off-Label Scientific Information

Goodwin on

On January 7, 2025, FDA announced the availability of a final guidance document titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical...more

Husch Blackwell LLP

New Legislation Revises Massachusetts' Determination of Need Statute

Husch Blackwell LLP on

On January 8, 2025, Massachusetts Governor Maura Healey signed into law “An Act Enhancing the Health Care Market Review Process.” Part of this sweeping healthcare oversight law includes changes to the Determination of Need...more

Health Care Compliance Association (HCCA)

Recognized Security Practices ‘Saved’ Covered Entity $60K of $300K Fine, But Which Ones Remain a Mystery

Covered entities (CEs) and business associates (BAs) may receive a “discount” for having recognized security practices (RSPs) in place when the HHS Office for Civil Rights (OCR) calculates financial penalties for Security...more

Health Care Compliance Association (HCCA)

Privacy Briefs: November 2024

Change Healthcare Inc. has amended its initial breach report to the HHS Office for Civil Rights (OCR) to state that 100 million individuals were impacted by its mammoth ransomware attack and breach. However, as of Oct. 24,...more

Foley & Lardner LLP

Artificial Intelligence in Health Care: Key Considerations for Oncology

Foley & Lardner LLP on

Artificial intelligence (AI) has the power to revolutionize health care. In oncology, there are now opportunities to apply AI to support diagnostics, predictive analytics, and administrative functions. This hot topic was...more

Holland & Knight LLP

New Artificial Intelligence Executive Order Contains Numerous Healthcare Implications

Holland & Knight LLP on

President Joe Biden on Oct. 30, 2023, signed a sweeping executive order (EO) and invoked the Defense Production Act to establish the first set of standards for using artificial intelligence (AI) in healthcare and other...more

Bradley Arant Boult Cummings LLP

Mississippi Half-Step Uptown Toodeloo: Department of Health Proposes Robust Revisions to Medical Cannabis Regulations

Those long-awaited proposed revisions to the Mississippi Department of Health’s medical cannabis program regulations dropped last Thursday afternoon. Thankfully, the department released a red-lined version, highlighting...more

Health Care Compliance Association (HCCA)

Report on Patient Privacy Volume 23, Number 2. ONC’s Tripathi: HIPAA Doesn’t Impede Sharing, Requirements Under Info Blocking...

Report on Patient Privacy Volume 23, no 2 (February 2023) When Micky Tripathi’s mom was recently transferred to a rehab facility to recover from a broken hip, the hospital, “right in front of me…printed off her record,...more

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