News & Analysis as of

New Guidance Healthcare Regulatory Requirements

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

Rivkin Radler LLP

NYS Reinforces Its Scrutiny Over Healthcare Transactions

Rivkin Radler LLP on

We recently discussed increasing state regulation of healthcare mergers and acquisitions in the face of the current Administration’s clear policy of federal deregulation. We noted that 15 states had implemented oversight laws...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

Arnall Golden Gregory LLP

AGG Talks: Cross-Border Business Podcast - Episode 27: U.S. Healthcare Reimbursement Guidance for Foreign Life Sciences Companies

In this episode, Mike Burke, AGG Corporate partner and co-chair of the firm’s International practice, is joined by Andrew Tsui, AGG Healthcare Litigation partner, to explore the intricacies of reimbursement in the U.S....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

McDermott Will & Emery

FDA Reveals AI Development Cheat Sheet in Highly Anticipated Draft Guidances

McDermott Will & Emery on

Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle...more

McDermott Will & Emery

End of an Era: FDA Retires 2017 Interim Policies for Bulk Drug Lists

On January 7, 2025, the US Food and Drug Administration (FDA) issued two parallel guidance documents for the Section 503A and Section 503B bulk drug lists, announcing the end of FDA’s 2017 interim policies. Under the new...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

Troutman Pepper Locke

New FDA Guidance on AI and Medical Products

Troutman Pepper Locke on

n March 15, the U.S. Food and Drug Administration (FDA) published a paper titled “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” This paper describes the FDA’s strategy for...more

McDermott Will & Emery

CMS Releases Guidance on Coverage Criteria, Use of AI and More

McDermott Will & Emery on

On February 6, 2024, the US Centers for Medicare & Medicaid Services (CMS) released a set of frequently asked questions (FAQs) related to Medicare Advantage (MA) coverage criteria and utilization management (UM) requirements....more

Proskauer - Health Care Law Brief

HHS Publishes Roadmap of New Strategy for Cybersecurity in the Healthcare Sector

The U.S. Department of Health and Human Services (HHS) recently issued a strategy paper highlighting key aspects of its plan to revamp cybersecurity requirements in the healthcare industry. Citing a 93% increase in large data...more

McDermott Will & Emery

FDA Issues Final Guidance on Informed Consent in Clinical Investigations

On August 15, 2023, the US Food and Drug Administration (FDA) finalized Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors (final guidance). This document finalizes, with new examples and limited...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

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