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Department of Health and Human Services (HHS) › Manufacturers › Cybersecurity

Morgan Lewis

Key Messaging from ‘Aging Technology, Emerging Threats: Examining Cybersecurity Vulnerabilities in Legacy Medical Devices’

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On April 1, 2025, the subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce held a hearing on cybersecurity vulnerabilities in legacy medical devices. The hearing was largely a...more

Alston & Bird

FDA Extends Pause on Non-mission-critical Domestic Surveillance inspections to February 4 – Medical Products Supply Chain Week in...

Alston & Bird on

In this week’s issue, OSHA withdrew its emergency temporary standard (ETS), which required a mandatory vaccination policy for large private employers with an exception for employers that adopt a policy requiring mandatory...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

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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