AI in the Operating Room: Liability Issues for Device Makers — The Good Bot Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 201: SHL Medical’s Investment in the Carolinas with Kimberlee Steele of SHL Medical
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
Meet Meaghan Luster: Patent Litigation Associate at Wolf Greenfield
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 177: Brain Health and Research with Dr. Fridriksson, Neuroscientist, Professor, & Vice President of Research at the Universit
Transparency and the Open Payments Program
Medical Device Legal News with Sam Bernstein: Episode 19
Medical Device Legal News with Sam Bernstein: Episode 18
Medical Device Legal News with Sam Bernstein: Episode 17
Health + Tech - Improving Cancer Care With Digital Health Tools
Medical Device Legal News with Sam Bernstein: Episode 14
Health + Tech - How Digital Health Tools Help Create Greater Consumer Focus in Healthcare
Medical Device Legal News with Sam Bernstein: Episode 11
Medical Device Legal News with Sam Bernstein: Episode 9
Medical Device Legal News with Sam Bernstein: Episode 8
Episode 132: Dr. Ehsan Jabbarzadeh, Co-Founder, Obsidio, and Professor, USC
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 118: Matthew Roberts and Darra Coleman, Health Care Attorneys, Nexsen Pruet
Healthcare Headlines: Episode 8 – Healthcare Lending Deal Landscape Trends and Forecasts for the Future
Healthcare Headlines: Episode 7 — Evolving Landscape of Healthcare Provider & Medical Product Liability
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
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
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
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
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
• 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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