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Regulatory Requirements Transparency Healthcare

Stikeman Elliott LLP

Ontario’s More Convenient Care Act, 2025: A New Strategy for the Healthcare Sector

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On May 5, 2025, the Ontario government introduced Bill 11, the proposed More Convenient Care Act, 2025 (“MCCA”), a legislative initiative aimed at supporting the province’s long-term healthcare goals for first reading. Bill...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

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

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

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

DLA Piper

FDA Issues Artificial Intelligence-Enabled Device Software Functions Draft Guidance

DLA Piper on

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

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

Ankura

Is there room for AI in the ICU? Guiding Principles and Compliance Considerations

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Artificial Intelligence (AI) offers unprecedented opportunities to enhance patient care, streamline clinical documentation, and support medical decision-making processes. More and more healthcare professionals find themselves...more

A&O Shearman

Zooming in on AI - #9: Understanding California's New AI Legislation

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California Governor Gavin Newsom recently passed several AI-related bills, which address the application of AI across several industries and clarify key definitions regarding AI. Below, we provide an overview addressing some...more

Epstein Becker & Green

ONC’s “Information Blocking Enhancements” Under the HTI-1 Rule Are in Effect

On Monday, March 11, 2024, the Office of the National Coordinator for Health Information Technology’s (ONC) Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information...more

Fenwick & West LLP

New Federal Requirements for AI and IT System Implementation in Healthcare

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On October 30, 2023, the Biden administration issued Executive Order 14110 on the Safe, Secure and Trustworthy Development and Use of Artificial Intelligence (the “Executive Order”). As detailed in our previously published...more

Sheppard Mullin Richter & Hampton LLP

Illinois Proposes Heightened Oversight for Healthcare Transactions

Starting January 1, 2024, healthcare facilities and provider organizations engaging in certain transactions in Illinois, such as mergers and acquisitions, will have new reporting requirements. Illinois recently joined a...more

Health Care Compliance Association (HCCA)

[Event] 2020 Virtual Columbus Regional Conference - May 1st, Columbus, OH

Our Virtual Regional Healthcare Compliance Conferences provide updates on the latest news in regulatory requirement, compliance enforcement, and strategies to develop effective compliance programs. Watch, listen, and ask...more

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