News & Analysis as of

Hospitals Cybersecurity Food and Drug Administration (FDA)

Morgan Lewis

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

Morgan Lewis on

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

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - January 2025 #4

News Briefs - 80 Percent of Health Organizations Hit with Cyberattack - More than 80 percent of healthcare organizations detected a cyberattack on their technology infrastructure within the past year, according to a survey by...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - December 2024 #2

News Briefs - Congress Taking on Healthcare Policies Set to Expire - Congress has begun discussions on important healthcare policies set to expire on December 31....more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - December 2024 #1

News Briefs - FDA Guidelines Require TV Drug Ads to Be Simpler, More Direct - Those ever-present TV drug ads showing patients hiking, biking, or enjoying a day at the beach could soon have a different look: New rules require...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - October 2024 #3

News Briefs - FTC Finalizes Providers' Reporting Rules Prior to M&A - The Federal Trade Commission finalized changes to a rule that will require healthcare companies, including hospitals and providers, to provide more...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - May 2024 #1

News Briefs - Hospitals, Physicians at Odds Over FTC Noncompete Ban - The Federal Trade Commission's final rule banning noncompetes nationwide has implications for hospitals and physician practices, with representatives from...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - March 2024 #4

News Briefs - Lawmaker Introduces Health Care Cybersecurity Improvement Act - Senator Mark Warner (D-VA) has introduced the Health Care Cybersecurity Improvement Act of 2024, which would allow for advance and accelerated...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - November 2023 #3

News Briefs - Senate Committee Advances Bill on 'Ghost Providers,' PBMs - In a unanimous 26-0 vote, the Senate Finance Committee passed a comprehensive draft package that puts pharmacy benefit manager reform and mental health...more

Skadden, Arps, Slate, Meagher & Flom LLP

The Nucleus: Life Sciences Enforcement and Regulatory Updates

In this issue of our newsletter on developments impacting the life sciences industry, we examine topics including how the increased DOJ and FDA focus on cybersecurity issues could lead to new theories of False Claims Act...more

Faegre Drinker Biddle & Reath LLP

The Omnibus Appropriations Act Grants FDA Formal Authority to Require Cybersecurity Action by Medical Device Manufacturers

Cyberattacks affecting internet-connected medical devices like insulin pumps, intracardiac defibrillators, mobile cardiac telemetry, pacemakers and intrathecal pain pumps have increased in recent years. And such attacks show...more

Wilson Sonsini Goodrich & Rosati

Digital Health Report: Fall 2019

Beware of “Most Favored Nations” Clauses in Commercial Contracts - Imagine that your digital health company has developed a groundbreaking product. You are eager to monetize the product, so you sign non-disclosure...more

Robinson+Cole Data Privacy + Security Insider

URGENT/11 Cybersecurity Vulnerabilities Could Affect Medical Devices and Hospital Networks

On the heels of an FDA committee report concerning cybersecurity issues with medical devices, the U.S. Food and Drug Administration (FDA) issued an alert regarding cybersecurity vulnerabilities, referred to as “URGENT/11,”...more

Holland & Knight LLP

Impact of the New Health Industry Cybersecurity Practices: 2019 Outlook

Holland & Knight LLP on

• The U.S. Department of Health and Human Services on Dec. 28, 2018, announced the release of the "Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients" that provides a "Call to Action" to make...more

K&L Gates LLP

K&L Gates Triage: Artificial Intelligence in Health Care

K&L Gates LLP on

Artificial Intelligence (AI) systems, including the use of algorithms and computer software to analyze complex data and perform certain decision making functions without direct human involvement, are rapidly developing in...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

Polsinelli

Mobile Health Devices and Cybersecurity: Federal Guidance for Management of Threats in Medical Devices

Polsinelli on

New Technology = New Threats - With new technology comes new security concerns. But when that new technology is in the medical field, the cybersecurity vulnerabilities can be particularly devastating. The...more

Mintz - Health Care Viewpoints

Drug Pumps Are Vulnerable to Hacking, FDA Warns

Last Friday, the Food and Drug Administration (FDA) issued a statement warning that certain drug infusion pumps that administer medication to patients are vulnerable to being hacked. The statement focused on the Symbiq...more

Mintz - Privacy & Cybersecurity Viewpoints

Privacy Tuesday – August 2015

While you enjoy what is left of the summer of 2015, we will kick off your week with a few privacy and security bits and bytes....more

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