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Health Care Providers › Enforcement › Medical Devices

Arnall Golden Gregory LLP

“Longstanding and Clear”: OIG Continues Characteristic Close Scrutiny of Below-Market Benefits to Referral Sources

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The United States Department of Health and Human Services, Office of Inspector General (“OIG”) recently released two unfavorable advisory opinions, OIG Advisory Opinion No. 25-04 and -08 (the “Opinions”) to medical device...more

Sheppard Mullin Richter & Hampton LLP

Finally, FDA’s Final Word on Unapproved Use Communications

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On January 7, 2025, the U.S. Food and Drug Administration (“FDA” or “Agency”) released a long-awaited guidance titled, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of...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

Foley & Lardner LLP

Scientific Information on Unapproved Uses of Medical Products: FDA’s Final Guidance on Firm Communication to Health Care Providers

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The U.S. Food and Drug Administration (FDA) recently announced final guidance for firms in the medical device and product industry titled, “Communications From Firms to Health Care Providers Regarding Scientific Information...more

Holland & Knight LLP

Safeguarding Health Information: Takeaways from HHS and NIST 2024 HIPAA Security Conference

Holland & Knight LLP on

President Ronald Reagan famously quipped, "I think you all know that I've always felt that the nine most terrifying words in the English language are: I'm from the Government, and I'm here to help."1 At an Oct. 23-24, 2024,...more

Gardner Law

Navigating HIPAA and State Privacy Laws for Drug and Device Manufacturers

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The Health Insurance Portability and Accountability Act of 1996 as amended and implemented through regulations at 45 C.F.R. §§ 160 and 164 (“HIPAA”) regulates the privacy and security of health information. For drug and...more

American Conference Institute (ACI)

[Event] FCPA & Anti-Corruption for the Life Sciences Industry - July 21st - 22nd, Boston, MA

American Conference Institute (ACI) on

ACI is excited to welcome you back in-person to the 14th Advanced Forum on FCPA & Anti-Corruption for the Life Sciences Industry, taking place on July 21–22, 2022 in Boston! Legal and compliance professionals from...more

Foley Hoag LLP - White Collar Law &...

Health Care Enforcement – A Look Ahead

Foley Hoag LLP - White Collar Law &... on

This is the first post in this year’s series examining important trends in white collar law and investigations. Join us in the weeks ahead as we provide updates on new developments and emerging trends in a number of white...more

Foley & Lardner LLP

FDA Publishes Enforcement Policies to Address Coronavirus Personal Protective Equipment Shortages

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In the wake of the COVID-19 pandemic, the FDA has sought to expand the availability of needed personal protective equipment (PPE) for the general public and healthcare professionals. Recently, for example, FDA published two...more

Seyfarth Shaw LLP

FDA Eases Enforcement to Help Make More Ventilators Available

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The U.S. Food and Drug Administration (the “FDA”) issued Guidance[1] on March 22, 2020 to continue its efforts to maintain an adequate supply of devices to treat patients who develop respiratory failure or respiratory...more

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