News & Analysis as of

Manufacturers Healthcare Facilities

Arnall Golden Gregory LLP

OIG Greenlights Manufacturer’s Travel-Related Financial Assistance Offering

On June 17, 2024, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted a favorable Advisory Opinion 24-03 (“AO 24-03”) involving a pharmaceutical manufacturer’s proposed patient...more

Alston & Bird

Class Action & MDL Roundup 2023 Q4 - Not All Cases Survive and Advance

Alston & Bird on

Welcome to the Class Action & MDL Roundup, our quarterly review of decisions and settlements in the class action arena. In this edition, student-athletes win an NIL round, Canadians in California isn’t personal...more

Quarles & Brady LLP

Are You Ready for Alabama’s New Designated Representative Requirements?

Quarles & Brady LLP on

In a previous update, Quarles discussed a new Alabama law that requires individuals serving as the designated representative for an Alabama-licensed facility to register with the Alabama Board of Pharmacy ("the Board”) as of...more

Bass, Berry & Sims PLC

OIG Issues Favorable Advisory Opinion (No. 21-01) on Free Drug Program

On March 18, the Office of Inspector General (OIG) issued a favorable Advisory Opinion No. 21-01 (Opinion) regarding a free drug program sponsored by a pharmaceutical manufacturer of a personalized cell and gene therapy...more

Steptoe & Johnson PLLC

The COVID-19 Jobs Protection Act: Liability Immunity for Health Care Facilities on the Horizon in West Virginia

Steptoe & Johnson PLLC on

On February 19, 2021, the West Virginia Senate passed SB 277, the “COVID-19 Jobs Protection Act.” The purpose of the Act is stated to “eliminate the liability of the citizens of West Virginia and all persons including...more

ArentFox Schiff

New Safe Harbors Offer Opportunities for Innovative Arrangements, Including Digital Health

ArentFox Schiff on

Recent updates to the federal Anti-Kickback Statute give providers additional flexibility to enter into innovative arrangements, but before doing so, providers must ensure they understand the safe harbor requirements...more

Arnall Golden Gregory LLP

Georgia General Assembly Passes COVID-19 Liability Protections

In the last hours of its unusual 2020 legislative session, the Georgia General Assembly passed legislation providing COVID-19 liability protections for healthcare facilities, healthcare providers, property owners, sports...more

Stinson LLP

Kansas Act Purports to Provide Immunity from COVID-19 Related Claims

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On June 4, 2020, the Kansas Legislature passed the COVID-19 Response and Reopening for Business Liability Protection Act. It now goes to Governor Laura Kelly for signature....more

Spilman Thomas & Battle, PLLC

Pennsylvania's Governor Wolf Signs Order Regarding Transfer of Supplies and Information Between Medi

Yesterday, Governor Wolf signed an order to allow the administration to transfer supplies and information between medical facilities. The order mandates that private, public, and quasi-public health care providers and...more

Mintz

FDA Responds to Device Software Vulnerabilities by Releasing New Draft Cybersecurity Guidance

Mintz on

On October 18, 2018, FDA released a new draft guidance, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, which describes the Agency’s current thinking and recommendations on designing...more

Holland & Knight LLP

FDA, DHS Increase Coordination Over Medical Device Cybersecurity Risks to Patient Safety

Holland & Knight LLP on

The U.S. Food and Drug Administration (FDA) is moving aggressively in the month of October to continue to raise concerns about cybersecurity risks to medical devices, with three recent updates. The FDA just released new draft...more

Holland & Knight LLP

Congress Continues Push on Medical Device Cybersecurity Mandates - FDA Issues Medical Device Safety Action Plan; DHS Continues to...

Holland & Knight LLP on

Cybersecurity risks to the health and medical device sector continue to be front and center both in Congress and the executive branch, with increasing risks coming from nation states, nonstate actors and other attackers. The...more

Morrison & Foerster LLP

FDA Embraces Internet of Things: New Draft Guidance on Postmarket Cybersecurity for Medical Devices

The FDA’s recently issued draft guidance on “Postmarket Management of Cybersecurity in Medical Devices” seeks to address some of the increasing concerns that medical device providers, regulators, and consumers have about...more

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