Can Food Really Be Medicine? Transforming Health Care One Bite at a Time – Diagnosing Health Care Video Podcast
Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
AGG Talks: Cross-Border Business Podcast - Episode 22: What Global Companies Need to Know About Navigating FDA Regulations and U.S. Market Entry
AI and Pharmacovigilance Under the FDA's New Emerging Drug Safety Technology Program – The Good Bot Podcast
GLP-1 Drugs and Cultivated Meat: What’s the Impact on the Food and Agriculture Industry?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 202: Life Sciences Startups and Industry Developments with Gil Price, Life Sciences Leader
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Video: Food for Thought and Thoughts on Food: Innovating USDA Science with Sanah Baig, Deputy Under Secretary for Research, Education, and Economics
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Litigating Nutrition: Class Action Battles Over Dietary Supplements – Speaking of Litigation Video Podcast
Changes in FDA, Cannabis Policies and AI Developments
Ad Law Tool Kit Show – Episode 2 – Marketing FDA-Regulated Products
Medical Device Legal News with Sam Bernstein: Episode 18
Medical Device Legal News with Sam Bernstein: Episode 17
A Look Into the FDA and USDA Regulatory Regimes
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
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
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
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
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
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
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
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
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
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
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
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
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
• 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
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
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
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
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
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