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Tucker Arensberg, P.C.

DOJ and HHS Launch New False Claims Act Working Group to Target Healthcare Fraud

Tucker Arensberg, P.C. on

The U.S. Department of Health and Human Services (HHS) and the Department of Justice (DOJ) have jointly announced the launch of a reinvigorated DOJ-HHS False Claims Act Working Group aimed at enhancing interagency...more

Jackson Lewis P.C.

FDA Names First Acting Director Of Medical Device Cybersecurity

Jackson Lewis P.C. on

The U.S. Food and Drug Administration (FDA) named University of Michigan Associate Professor Kevin Fu Acting Director of Medical Device Security in its Center for Devices and Radiological Health. This is a newly created...more

Hogan Lovells

PREP Act declaration amended to clarify coverage of certain products not directly used for COVID-19

Hogan Lovells on

On Monday, the U.S. Department of Health and Human Services (HHS) issued a second amendment (the Amendment) to the March 10, 2020 Declaration under the Public Readiness and Emergency Preparedness (PREP) Act for Medical...more

Baker Donelson

New Health Care Provider Opportunities in Fourth COVID-19 Bill and HHS Plans to Distribute Additional Funds

Baker Donelson on

On April 23, 2020, the House of Representatives passed the Paycheck Protection Program and Health Care Enhancement Act, which previously passed the Senate on April 21, 2020, and is expected to be signed into law by the...more

Hinshaw & Culbertson - Health Care

HHS Limits Liability for Corporations and Health Care Providers Relating to COVID-19 Countermeasures

Hinshaw & Culbertson - Health Care on

In an effort to encourage the rapid development, design, and production of drugs, medical devices, and biological products to fight COVID-19, the U.S. Department of Health and Human Services (HHS) recently issued a...more

Hogan Lovells

HHS Issues Advisory Opinion Encouraging a Broad Reading of its PREP Act Declaration

Hogan Lovells on

On April 14, 2020, the Department of Health and Human Services (HHS) General Counsel issued an advisory opinion (“the Opinion”) on the March 10, 2020 Public Readiness and Emergency Preparedness Act (“PREP Act”) Declaration...more

Butler Snow LLP

HHS Declares Liability Immunity for Certain COVID-19 “Countermeasures”; Response Act Expands Protections for Mask Makers

Butler Snow LLP on

Earlier this week, we discussed current trends and future implications of COVID-19 on businesses operating in the products arena, noting the most direct impact so far on the pharmaceutical and medical device spaces....more

Troutman Pepper Locke

HHS Provides Liability Immunity for Coronavirus Countermeasures

Troutman Pepper Locke on

Makers, distributors, program planners and administering entities of coronavirus (COVID-19) countermeasures are protected from liability under a declaration issued by the Department of Health and Human Services (HHS)...more

King & Spalding

FDA Issues Proposed Rule and Draft Guidance on Drug Importation

King & Spalding on

In late December 2019, the Food and Drug Administration (FDA), an agency operating within the Department of Health and Human Services (HHS), issued two documents—a Proposed Rule and a Draft Guidance—intended to establish two...more

Mintz - Intellectual Property Viewpoints

HHS HIV Drug Lawsuit: Setting Precedent for Other High Priced Medications or Government Collaborations?

Mintz - Intellectual Property Viewpoints on

On November 6, 2019, the bonds between the U.S. government and pharmaceutical companies were stretched when the U.S. Department of Health and Human Services (“HHS”) filed a patent infringement lawsuit against Gilead Sciences...more

Jones Day

The FDA and Cybersecurity: How the Agency is Addressing Cybersecurity Risks to Medical Devices

Jones Day on

The Situation: As medical devices become more connected to each other and to the internet, an increasing number of patients are exposed to cybersecurity risks. The Result: Over the last five years, the Food and Drug...more

White and Williams LLP

HHS Issues Voluntary Cybersecurity Guidelines for the Healthcare Industry

White and Williams LLP on

On December 28, 2018, the U.S. Department of Health and Human Services (HHS) released “Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients,” a detailed set of voluntary guidelines illustrating...more

White and Williams LLP

OIG Recommendations to the FDA for Medical Device Cybersecurity: Foretelling Additional Regulation and Requirements for Controls?

White and Williams LLP on

With more and more medical devices connected to the Internet of Things (IoT), there is increasing concern over the potential vulnerabilities for cyberattacks against such devices. This vulnerability represents not only...more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA Strives to Adapt Regulatory Approach to Rapidly Evolving Digital Health Space

Skadden, Arps, Slate, Meagher & Flom LLP on

Just two months after taking office, in July 2017, Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced the agency’s Digital Health Innovation Action Plan, which recognized that “digital technology has...more

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