Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 236: Advocating for Accessible Diagnoses with Sydney Severance of Operation Upright
Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 233: Prioritizing Women’s Health Through Innovation with Lindsey Calcutt of Incora Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 228: Designing & Manufacturing Auto-Injectors with Kimberlee Steele of SHL Medical
Building a Business at the Intersection of Neurodata and Innovation With Rob Cooley
AGG Talks: Cross-Border Business Podcast - Episode 26: U.S. Enforcement Trends Targeting Foreign Pharmaceutical and Medical Device Manufacturers
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 209: North Carolina’s Life Sciences Industry with Laura Gunter of NCLifeSci
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 208: Extended Reality Technology and the ThinkReality Headset with Mattney Beck of Lenovo
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
Artificial Intelligence (AI) continues to revolutionize industries and is poised to bring transformative change in healthcare delivery, drug discovery, diagnostics, and data analysis and communication. This technology is...more
Last week, the U.S. Cybersecurity and Infrastructure Security Agency (“CISA”) and the U.S. Food and Drug Administration (“FDA”) released warnings about an embedded function they found in the firmware of the Contec CMS8000,...more
On June 26, 2024, FDA issued a new draft guidance on clinical trial diversity, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies” (Draft Guidance), to assist...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. ...more
On Monday, October 24, the Food and Drug Administration (FDA) issued a new draft guidance titled, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared...more
The FDA has been continuing to work on protecting medical devices from the threats of cybersecurity. In April of this year, the Agency released the latest draft guidance addressing cybersecurity in the medical device...more
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
The U.S. Food and Drug Administration took the unprecedented step this week of issuing an alert to health care providers and device manufacturers about potentially serious security flaws that may allow hackers to remotely...more
In my 25 years in the data privacy and cybersecurity profession, this is the first time that I believe a medical device has been recalled because of a cybersecurity risk. This week, Medtronic recalled its 508 Insulin pumps...more
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
On August 29, the FDA announced a recall of 465,000 implantable pacemakers, citing concerns that hackers may be able to take control of the pacemakers’ settings. This would open patients up to danger from improper pacing or...more
On December 13, 2016, President Obama signed into law the 21st Century Cures Act (Act), one of the most important pieces of health care and life sciences legislation in several decades. The Act is intended to spur the rapid...more
On June 10, 2016, the U.S. Food and Drug Administration (FDA) issued a draft guidance advising manufacturers on appropriate and responsible dissemination of patient-specific information from medical devices....more
Proposals are Intended to Enhance Protections for Higher Risk Clinical Research and Privacy Safeguards, including Uses of Biospecimens and Identifiable Private Information - On September 8, 2015, the Department of Health...more
The increasing amounts of health information being generated, stored and collected have heightened the special risks medical device manufacturers have long faced. In addition to the nexus to patient health and safety, if a...more