News & Analysis as of

Department of Homeland Security (DHS) Medical Devices

Pierce Atwood LLP

PFAS in Maine: Legislature Amends the PFAS in Products Law

Pierce Atwood LLP on

On April 16, 2024, Maine Governor Janet Mills signed into law significant amendments to the PFAS in Products Law. Initially passed in 2021, the PFAS in Products Law required manufacturers of products with intentionally added...more

Lowenstein Sandler LLP

The BIOSECURE Act: Proposed New Legislation Could Affect U.S. Companies’ Plans to Contract With Chinese Biotechnology Companies

Lowenstein Sandler LLP on

The U.S. Senate and the U.S. House of Representatives are both considering legislation that could have a serious impact on the ability of U.S. biotechnology, drug, and medical device companies to do business with...more

Hogan Lovells

DHS updates essential workforce guidance to cover transportation supply chain

Hogan Lovells on

On 23 March 2020 the U.S. Department of Homeland Security's (DHS) Cybersecurity & Infrastructure Security Agency (CISA) published revisions to its guidance regarding the "Essential Critical Infrastructure Workforce." One of...more

K2 Integrity

Deterring the Counterfeits: Finding an Antidote for Global Businesses

K2 Integrity on

When thinking of counterfeit products, minds may wander to a person on the street selling near-authentic looking bags, sunglasses, and watches, for a fraction of the price of what would be paid at a store. But what if there...more

Robinson & Cole LLP

Data Privacy + Cybersecurity Insider - July 2019

Robinson & Cole LLP on

DHS Warns Businesses of Risk of Iranian-Backed Wiper Malware Attacks - The tension with Iran has generally increased, and it has been reported that the U.S. has launched a cyber-attack against Iran. In retaliation, the risk...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

Knobbe Martens

FDA & DHS Coordinate Efforts to Address Cybersecurity

Knobbe Martens on

The U.S. Food and Drug Administration (FDA) announced an agreement with the U.S. Department of Homeland Security (DHS) to strengthen the partnership between the agencies and “stay a step ahead of constantly evolving medical...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

Robinson+Cole Data Privacy + Security Insider

Security Vulnerabilities Identified In Wireless Syringe Infusion Pumps

The U.S. Department of Homeland Security (DHS) recently issued a warning that Smiths Medical Medfusion 4000 wireless syringe infusion pumps contain a security vulnerability that can be exploited by hackers to alter the...more

Robinson+Cole Data Privacy + Security Insider

Siemens Medical Equipment Vulnerable to Cyber-Attacks

The Department of Homeland Security and Siemens Healthineers has identified cybervulnerabilities in the Windows 7-based versions of Siemens PET/CT systems, SPECT systems, SPECT/CT Systems and SPECT Workplaces/Symbia.net and...more

Mintz - Health Care Viewpoints

St. Jude Cybersecurity Vulnerability Extended to Provider-Owned Devices

Earlier this week, the U.S. Department of Homeland Security (DHS) updated a prior advisory revealing cybersecurity vulnerabilities in St. Jude Medical’s Merlin@home transmitter....more

Locke Lord LLP

Privacy & Cybersecurity Newsletter

Locke Lord LLP on

New York’s Cybersecurity Requirements for DFS Licensees: A New Item at the Top of the To Do List - With a compliance date a few months away, licensees of the New York Department of Financial Services (DFS) must start...more

Benesch

Stark Law - Is Relief in Sight?

Benesch on

On July 15, 2015, the Centers for Medicare and Medicaid Services (“CMS”) published proposed revisions to the regulations implementing the physician self-referral law, or Stark Law. If enacted, these revisions could allow...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

Snell & Wilmer

FDA Issues Unprecedented Alert Over Medical Device Cyber Security Risk

Snell & Wilmer on

A fictional cyber-terrorist weaponizing a medical device by hacking into it has become a familiar plot premise in recent Hollywood dramas.  Unfortunately, the risk of harm from medical device hacking has now become an...more

Baker Donelson

FDA's Cybersecurity Alert Puts Medical Device Users on Notice

Baker Donelson on

On July 31, 2015, the United States Food and Drug Administration (FDA) issued a cybersecurity alert to health care facilities currently using certain infusion pumps manufactured by Hospira, Inc. The alert warns health care...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 - Health Care Viewpoints

FDA Reports Results of Annual Crack Down on Illegal Internet Pharmacies

Last week, FDA announced that more than 1,050 websites had illegal drugs and devices seized or received warning letters as part of the Eighth Annual International Internet Week of Action (IIWA). IIWA is an international...more

Cooley LLP

Blog: FDA Cybersecurity Workshop for Healthcare

Cooley LLP on

On October 21-22 the U.S. Food and Drug Administration (FDA), in collaboration with the U.S. Departments of Health and Human Services and Homeland Security, conducted a public workshop entitled “Collaborative Approaches for...more

King & Spalding

Medical Devices and Cybersecurity Risks - DHS investigates at-risk devices

King & Spalding on

On October 2, 2014, the U.S. Food and Drug Administration (FDA) issued its final guidance on cybersecurity for medical device manufacturers, titled “Content of Premarket Submissions for Management of Cybersecurity in Medical...more

Sheppard Mullin Richter & Hampton LLP

Cybersecurity: FDA Risks for Medical Devices

On Thursday, June 13, 2013, the U.S. Food and Drug Administration (“FDA”) released a draft guidance on measures to help ensure the cybersecurity of medical devices. ...more

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