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Health Care Providers › Manufacturers › Regulatory Oversight

Morgan Lewis - Health Law Scan

OIG’s Advisory Opinion No. 25-08: Negative Opinion Highlights Potential Broad Reach of AKS

Morgan Lewis - Health Law Scan on

In a relatively rare move, the US Department of Health and Human Services Office of Inspector General (OIG) recently issued an unfavorable Advisory Opinion (No. 25-08) (Opinion) reinforcing the agency’s expansive view of the...more

Hogan Lovells

Evolution of FDA regulation of AI-based technology

Hogan Lovells on

Hogan Lovells partners Kelliann H. Payne and John J. Smith, M.D., J.D. recently joined Richard Frank, MD, PhD, Chief Medical Officer, Siemens Healthineers, and other industry leaders in person and virtually at the Health Care...more

MoFo Life Sciences

FDA’S Plan For AI/ML-Based Software As Medical Devices: Progress And Concerns

MoFo Life Sciences on

U.S. Food and Drug Administration (FDA) has acknowledged the prevalence of Artificial Intelligence/Machine Learning (AI/ML)-Based Software as Medical Devices (SaMDs) and has been taking steps towards advancing its regulatory...more

Hogan Lovells

Harmonizing cybersecurity for medical devices: International collaboration moves forward

Hogan Lovells on

On 1 October 2019 the International Medical Device Regulators Forum (IMDRF) Medical Device Cybersecurity Working Group released a draft document titled "Principles and Practices for Medical Device Cybersecurity" (IMDRF...more

McDermott Will & Schulte

Reviewing Key Principles from FDA's Artificial Intelligence White Paper

McDermott Will & Schulte on

In April 2019, the US Food and Drug Administration (FDA) issued a white paper, “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device,”...more

American Conference Institute (ACI)

[Event] Dietary Supplements – Insights on the Legal, Regulatory and Compliance Challenges – June 18th-19th, New York, NY

American Conference Institute (ACI) on

This in-depth two day event will help you prepare for “one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years. We will explore the FDA’s plans for the industry, as...more

Holland & Knight LLP

FDA Commissioner Speaks Out on Compliance and Enforcement

Holland & Knight LLP on

On Dec. 12, 2018, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced tougher compliance and enforcement policies for drug manufacturers, dietary supplement manufacturers, stem cell clinics and...more

Troutman Pepper Locke

NJ Prescribers Now Subject to New Limits on Payments From Pharma Manufacturers

Troutman Pepper Locke on

A recently finalized New Jersey rule imposes new limits on prescriber acceptance of gifts and compensation from pharmaceutical manufacturers and their agents, and will likely have a significant impact on many prescriber...more

Hogan Lovells

New Jersey Issues Rules to Chill Drug Manufacturer Payments to Prescribers

Hogan Lovells on

The New Jersey Attorney General plans to finalize new limits on payments and other benefits that New Jersey licensed prescribers may accept from pharmaceutical manufacturers, although the expected final rule is less...more

Hogan Lovells

France tightens grip on industry payments to HCPs (again)

Hogan Lovells on

On 19 January 2017, major modifications were adopted in France to the regulations on interactions between the industry and healthcare professionals (and other stakeholders). These new regulations, a.k.a. "anti-benefits...more

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