News & Analysis as of

New Guidance Regulatory Requirements Health Care Providers

Amundsen Davis LLC

Federal Public Benefits and Immigration Status: What HHS’s Guidance Means for Mental Health Providers

Amundsen Davis LLC on

Mental health services are often partially funded with federal money, whether through grants or federal health care plans. Recently, the Department of Health and Human Services (“HHS”) updated its guidance clarifying how...more

Stoel Rives - Health Law Insider®

Oregon Staffing Plans Must Cover All Licensed Hospital Space

Oregon’s Hospital Staffing Law has enjoyed no lack of coverage (and commentary) in the last year.  The Oregon Health Authority (OHA) has posted numerous guidance documents, FAQs, video shorts, and recorded webinars to bring...more

Stevens & Lee

CMS Issues Updated Hospital Price Transparency Guidance and Related RFI

Stevens & Lee on

The Centers for Medicare & Medicaid Services (CMS) released new Updated Hospital Price Transparency Guidance (Guidance) to “strengthen the Hospital Price Transparency requirements, requiring hospitals to post the actual...more

Stevens & Lee

NY Department of Health Provides Guidance Regarding Material Transactions Law

Stevens & Lee on

Under the Material Transactions Law, certain health care entities involved in a transaction that increases gross, in-state revenue to at least $25 million must provide written notice of the transaction to the New York State...more

Polsinelli

CMS Extends Revalidation Deadline for Skilled Nursing Facilities to August 1, 2025

Polsinelli on

In its April 17 MLN Newsletter, the Centers for Medicare and Medicaid Services (CMS) once again extended the deadline for skilled nursing facilities (SNF) to submit their off-cycle revalidation from May 1 to August 1, 2025....more

King & Spalding

NY Department of Health Issues Clarifying FAQs on Healthcare Transaction Notice Law

King & Spalding on

Earlier this month, the New York State Department of Health (DOH) released its first formal guidance under Public Health Law (PHL) Article 45-A, the state’s recently enacted healthcare transaction notice law. Issued in the...more

Sheppard Mullin Richter & Hampton LLP

New Ohio Transparency Pricing Rules for Hospitals Comes with Limits to Targeted Advertising

Starting April 3, Ohio hospitals will have to navigate new requirements under House Bill 173. This law mandates greater transparency in healthcare pricing. It also includes rules for selling or targeted advertising related to...more

McDermott+

Breaking Down the New No Surprises Act FAQs Post-TMA III

McDermott+ on

On January 14, 2025, the US Departments of Labor, Health and Human Services (HHS), and the Treasury (collectively, the Departments), along with the Office of Personnel Management (OPM), jointly issued Part 69 of a series of...more

Morgan Lewis - As Prescribed

FDA’s Recent Guidance on Accelerated Approval and Implications for Rare Diseases

In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed and Health Law Scan, focusing on issues impacting the rare disease community....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

Akin Gump Strauss Hauer & Feld LLP

FDA Unveils Draft Guidance on Developing Drugs and Biological Products for Weight Reduction

On January 7, the FDA made available draft guidance on the development of drugs and biological products for weight reduction within the Center for Drug Evaluation and Research intended for reduction and long-term maintenance...more

Robinson+Cole Health Law Diagnosis

OCR Updates Online Tracking Technologies HIPAA Guidance

On March 18, 2024, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) updated its guidance on the “Use of Online Tracking Technologies by HIPAA Covered Entities and Business Associates” (Guidance)....more

Health Care Compliance Association (HCCA)

[Event] Regional Compliance & Ethics Conference - February 22nd - 23rd, Anchorage, AK

Looking for compliance education and networking in your area? SCCE & HCCA’s Regional Compliance & Ethics Conferences bring compliance practitioners from all disciplines together for convenient, local compliance education....more

Society of Corporate Compliance and Ethics...

[Event] Regional Compliance & Ethics Conference - February 22nd - 23rd, Anchorage, AK

Looking for compliance education and networking in your area? SCCE & HCCA’s Regional Compliance & Ethics Conferences bring compliance practitioners from all disciplines together for convenient, local compliance education....more

Society of Corporate Compliance and Ethics...

[Event] Regional Compliance & Ethics Conference - March 8th, Washington, DC

Looking for compliance education and networking in your area? SCCE & HCCA’s Regional Compliance & Ethics Conferences bring compliance practitioners from all disciplines together for convenient, local compliance education....more

Health Care Compliance Association (HCCA)

[Event] Regional Compliance & Ethics Conference - March 8th, Washington, DC

Looking for compliance education and networking in your area? SCCE & HCCA’s Regional Compliance & Ethics Conferences bring compliance practitioners from all disciplines together for convenient, local compliance education....more

Health Care Compliance Association (HCCA)

[Event] Regional Healthcare Compliance Conference - September 15th, Minneapolis, MN

Looking for compliance education and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance education that covers a wide variety of current and emerging...more

Robinson+Cole Health Law Diagnosis

New York State Department of Health Releases Administrative Guidance for LCHSAs’ Licensure Amendments

The New York State Department of Health (DOH) recently released a “Dear Administrator Letter” (DAL) DHCSB 22-02 for Licensed Home Care Services Agencies (LCHSAs).  The DAL addresses guidance and procedures for LCHAs as they...more

McDermott Will & Schulte

[Ongoing Program] On Location: New CMS Hospital Co-Location Guidance in the Spotlight - February 17th, 12:30 pm - 1:30 pm ET

Hospital and health systems rely on vendors and other partners to provide vital services that support patient care, efficient operations and smooth administrative functions. However, the regulations governing different types...more

Jones Day

California Attorney General Issues Bulletin on Health Data Breach Reporting Requirements

Jones Day on

The California Attorney General ("AG") has issued guidance reminding health care providers of their duty to report health care data breaches and to comply with other state and federal data privacy laws....more

Sheppard Mullin Richter & Hampton LLP

New Set Of Guidance From FDA Provides Clarity On Digital Health Policies, Machine Learning

On September 26, 2019, the US Food and Drug Administration (FDA) published six guidance documents clarifying its scope of authority and enforcement discretion policies in light of the 21st Century Cures Act (Cures Act). The...more

Verrill

BORIM Issues Guidance on Recent Changes to Practice of Medicine Regulations

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The Massachusetts Board of Registration in Medicine (“BORIM”) recently finalized revisions to 243 CMR 2.00 (Licensure and the Practice of Medicine). These changes took effect on August 9, 2019. Because of the uncertainty...more

Hogan Lovells

The EMA has adopted new guidelines on good pharmacovigilance practices in paediatric populations

Hogan Lovells on

The EMA Good Pharmacovigilance Practices consist of several chapters of the Notice to Applicants that are regularly updated. A new GVP Considerations Chapter (IV) regarding specific considerations for the paediatric...more

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