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Regulatory Oversight Healthcare Risk Management

Benesch

Dental/DSO Intelligence Monthly Report: July 2025

Benesch on

As government scrutiny of the healthcare industry intensifies, enforcement agencies are casting wider nets to recover funds based on narrowly interpreted violations. This puts not only healthcare providers but also those...more

Epstein Becker & Green

HealthBench: Exploring Its Implications and Future in Health Care

Epstein Becker & Green on

As we noted in our previous blog post, HealthBench, an open-source benchmark developed by OpenAI, measures model performance across realistic health care conversations, providing a comprehensive assessment of both...more

Gardner Law

The Importance of a Clinical Trial Strategy

Gardner Law on

Developing a medical product, such as a medical device, comes with important milestones that can cause a project to sink or swim. One major milestone is amassing the clinical data needed to support pre-market submissions....more

Wiley Rein LLP

[Podcast] Contracting for Success: Key Legal Considerations When Segmenting Pharmacy Benefit Programs

Wiley Rein LLP on

In this episode of The Wiley Contracting Chronicles, co-hosts Jordan Ross and Brooke DeLoatch take a deeper dive into program segmentation within pharmacy benefit programs. After outlining the concept in their previous...more

Troutman Pepper Locke

A Model’s Credibility Is in the Details: FDA Draft Guidance on the Use of AI Models in Drug and Biological Product Development

Troutman Pepper Locke on

In January, the U.S. Food and Drug Administration (FDA) issued its first guidance on the use of artificial intelligence (AI) models in drug development and in regulatory submissions titled, “Considerations for the Use of...more

Foley Hoag LLP - White Collar Law &...

New Massachusetts Healthcare Law Targets Private Equity, REITs, and MSOs; Expands State False Claims Act

On January 8, 2025, Governor Maura Healey signed House Bill 5159 into law, toughening the rules and increasing the risks for private equity (PE) companies, real estate investment trusts (REITs), and management services...more

Health Care Compliance Association (HCCA)

Artificial intelligence: Compliance considerations for provider organizations

Artificial intelligence (AI) is nothing new to the healthcare industry, as many organizations and clinicians have utilized such tools in some capacity for many years. Imaging-related AI to support radiologists is not...more

Stinson LLP

FDA Launches New Webpage to Report Regulatory Misconduct

Stinson LLP on

Earlier this week, the FDA launched a new webpage to simplify the process of reporting violations of the law by medical device manufacturers and individuals marketing medical devices. Unlike the MedWatch system for reporting...more

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