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Transparency Healthcare

Bass, Berry & Sims PLC

Healthcare Regulatory & Compliance Summit 2025 Recap

Health Policy Fireside Chat: What to Expect from the New Administration - Bill Mathias, Member at Bass, Berry & Sims, engaged in a fireside chat with Colin Roskey, Principal at FHP Strategies, former Deputy Assistant...more

MoFo Life Sciences

AI Transparency in Healthcare: Navigating a Changing Regulatory Landscape

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Transparency of artificial intelligence (AI) systems in healthcare is quickly becoming a central concern for regulators due to potential impacts on patient safety, healthcare quality, bias mitigation, and public trust. To...more

A&O Shearman

UK: Health Data Research Service to provide single point of access to NHS data in the United Kingdom

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The U.K. Government has announced the creation of a new U.K-wide Health Data Research Service that will provide a secure single access point to national-scale data sets. The Wellcome Trust and the Government will invest up to...more

Spilman Thomas & Battle, PLLC

The Health Record - Healthcare Law Insights, V 2, Issue 4, April 2025

Welcome to our fourth issue of 2025 of The Health Record -- our healthcare law insights e-newsletter. In this edition, we look at prior authorization transparency and physician decision-making; the impact of Medicaid cuts...more

Health Care Compliance Association (HCCA)

New NIH Head: Indirect Payments ‘Tips’; Republican Senator Calls Them ‘Grift’

Research universities have had one less worry (at least temporarily) since Judge Angel Kelley of the U.S. District Court for the District of Massachusetts granted a preliminary restraining order prohibiting NIH from imposing...more

Gardner Law

Why Compliance Audits Are Non-Negotiable

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In today’s heightened enforcement environment, compliance auditing isn’t just a best practice—it’s a necessity. Federal and state laws and industry guidance, including the Office of Inspector General (OIG) Compliance Program...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

Nelson Mullins Riley & Scarborough LLP

Gold Dome Report - Legislative Day 25 - February 2025

Amidst the usual suits and blazers, white dresses and tuxedos have been appearing with increasing frequency around the Georgia State Capitol this spring. Apparently word is out amongst the city’s photographers that the...more

Pillsbury Winthrop Shaw Pittman LLP

California’s AI Laws Are Here—Is Your Business Ready?

California leads the way with new AI laws promoting transparency, privacy and ethical practices across various industries. January 1, 2025, marked the start of a series of significant AI laws going into effect in California....more

McDermott+

McDermott+ Check-Up: January 31, 2025

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Senate Finance, HELP Committees Hold RFK Jr. Nomination Hearings. RFK Jr., nominated for Secretary of Health and Human Services (HHS), testified before the Senate Finance Committee on January 29 and before the Senate Health,...more

Ropes & Gray LLP

The Biden Administration’s Swan Song on Digital Health: Two FDA Guidances on Artificial Intelligence and FDA’s Defense of its...

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In the waning days of the Biden administration, the FDA released a flood of new guidance documents and other agency actions, including several important items related to digital health. On January 7, FDA published two new...more

Cozen O'Connor

California Passes Flurry of Year-End AI Legislation

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In 2024, the California legislature passed 17 laws related to artificial intelligence (AI). These new laws cover various themes and industries, including but not limited to deepfakes, training data disclosures, health care,...more

Stevens & Lee

Higher Prices, Reduced Access, Lower Quality Care: HHS, FTC, DOJ Report Harshly Criticizes Provider Consolidation and Private...

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In March 2024, the Federal Trade Commission (FTC), the Department of Justice (DOJ) and the Department of Health and Human Services (HHS) (collectively, Agencies) issued a request for information (RFI) seeking public comment...more

Mintz - Health Care Viewpoints

Massachusetts Aligns with National Trends and Enacts Sweeping Legislation to Regulate Pharmaceutical Benefit Managers

On the heels of a nationwide push to regulate pharmacy benefit managers (PBMs), Massachusetts enacted a landmark piece of legislation to increase transparency and oversight within the pharmaceutical supply chain, specifically...more

Knobbe Martens

FDA Issues Draft Guidance for the Use of Artificial Intelligence (AI) in Medical Devices and Drug Development

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The Food and Drug Administration (FDA) has recently issued two draft guidance documents aimed at providing recommendations for the use of AI in medical devices and drug and biological product development.These guidance...more

Mintz - Health Care Viewpoints

California Attorney General Issues Warning on Artificial Intelligence in Health Care

On January 13, 2025, California Attorney General Rob Bonta (the California AG) issued two Legal Advisories regarding the utilization of artificial intelligence (AI). The first Legal Advisory provides guidance to consumers and...more

Gardner Law

Sunshine Act Compliance: How to Take Action to Meet Reporting Requirements and Avoid Costly Penalties

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The clock is ticking for medical device and pharmaceutical companies to fulfill their obligations under the Physician Payments Sunshine Act (the "Sunshine Act"). With the reporting deadline of March 31 looming and CMS...more

DLA Piper

FDA Issues Artificial Intelligence-Enabled Device Software Functions Draft Guidance

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The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations on January 7, 2025....more

Cozen O'Connor

Pennsylvania Perspective for Monday, January 13, 2025

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New Leadership for PA General Assembly Committees- The Pennsylvania General Assembly has appointed new chairs for its 52 standing committees, which play a crucial role in discussing, amending, and approving legislation,...more

Cozen O'Connor

The State AG Report – 12.19.2024

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Here are curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: •Illinois AG’s and FTC’s Settlement Takes a $25 Million...more

Foley & Lardner LLP

The Intersection of Agentic AI and Emerging Legal Frameworks

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The evolution of artificial intelligence (AI) has introduced systems capable of making autonomous decisions, known as agentic AI. While generative AI essentially “creates” – providing content such as text, images, etc. –...more

Gardner Law

Navigating the Complex Regulatory Landscape for AI/ML-Enabled Medical Devices

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The rapid advancement of Artificial Intelligence (AI) and Machine Learning (ML) is revolutionizing the healthcare industry. However, as these innovative devices emerge, understanding the complex regulatory landscape becomes...more

King & Spalding

The Trifecta: What to Expect from a Second Trump Administration and a Republican Congress

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Republicans have swept the 2024 elections, returning Donald Trump to the White House as the 47th President and flipping the Senate to a Republican majority. Having narrowly maintained control of the House of Representatives,...more

Foley & Lardner LLP

Massachusetts “Patients First Act” Implementation and Enforcement Re-Extended

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The Massachusetts Senate proposed an amendment on Monday December 2, 2024, that would delay implementation and enforcement of the 2021 Patients First Act addressing health care cost transparency. Section 31 of the amendment...more

HaystackID

AI Healthcare Controversy Highlights Critical eDiscovery Challenges

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A landmark healthcare AI controversy has emerged as a watershed moment for eDiscovery professionals, revealing unprecedented challenges in investigating AI-driven decision-making systems within legal proceedings. The case,...more

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