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
As some studies estimate that nearly 23% of the adult population lives with a mental illness, the integration of artificial intelligence (AI) into mental health care has transformative potential in terms of accessibility,...more
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
Artificial intelligence (AI) is transforming the medical technology (“medtech”) and healthcare industries through the integration of advanced AI agents. Unlike traditional AI systems that perform discrete, predefined tasks,...more
Welcome to our second issue of 2025 of Decoded - our technology law insights e-newsletter. For those of you with an interest in the Corporate Transparency Act, Brienne Marco and Joe Unger report that the recent injunction...more
Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on recent developments in the U.S. Food and Drug Administration's ("FDA") regulatory...more
As the first state law to regulate the results of Artificial Intelligence System (AI System) use, Colorado’s SB24-205, “Concerning Consumer Protections in Interactions with Artificial Intelligence Systems” (the Act), has...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the Calendar Year (CY) 2025...more
Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on HHS' recent final rule on the confidentiality of substance use disorder patient...more
On December 6, 2023, HHS released a concept paper that outlines the Department’s cybersecurity strategy for the healthcare sector titled, “Healthcare Sector Cybersecurity Strategy.” HHS reports that cyber incidents in...more
If artificial intelligence (AI) is the vehicle that will revolutionize health care, data is the fuel that will propel the revolution. Health AI startups have recognized an unprecedented opportunity to create a transformative...more
Progress of Pre-Submissions for Medical Devices Now Trackable Through CDRH Portal - Medical device manufacturers must submit applications for certain classes of medical devices for approval by the Food and Drug...more
Washington state recently passed the My Health My Data Act (the Act), which will almost certainly lead to an explosion of consumer lawsuits and follow-on insurance coverage disputes. The measure is intended to protect...more
In this month’s Privacy & Cybersecurity Update, we look at Washington state’s passage of the first-ever state-level health data privacy law and the finalized California Consumer Privacy Act regulations. We also examine a...more
This is the second article in a three-part series where Ankura privacy experts analyzed the 40 examples of non-compliance with the California Consumer Privacy Act (CCPA) published by the California Office of Attorney General...more
US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more
As the telemedicine regulatory and reimbursement environment becomes more cohesive and providers and patients alike embrace technology, opportunities for telemedicine collaborations are likely to grow. Like any collaboration,...more
Tongue-in-cheek references to Pokémon Go as a health App aside, maybe the tech industry is on to something. In the U.S., seven out of every ten deaths are due to chronic diseases, such as diabetes or heart disease. Perhaps...more
The U.S. Department of Health and Human Services Office for Civil Rights (OCR) kicked off the holiday season by publishing a settlement agreement under the Health Insurance Portability and Accountability Act of 1996 (HIPAA)...more
Is your Fitbit data covered by HIPAA? It depends upon where you got it (kind of). If you go to the store and pick up a Fitbit on your own, the data it generates is governed by the user agreement that you click through...more
Lions and Tigers and Bears, Oh My! The Unexpected Laws that May Affect Your Telehealth Business - An increasing number of health care providers are exploring telemedicine, either as an adjunct to their primary physical...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
On July 10, the U.S. House of Representatives approved the 21st Century Cures Act (the Act), a bill intended to support advancements in medical innovation. The Act includes measures aimed at spurring medical research,...more
The rise of social media has introduced new opportunities and new legal challenges for companies in the health care industry. Attorneys Seth Northrop and Sharon Roberg-Perez discuss the legal issues faced by care providers,...more
The development and use of mobile technologies and devices is expanding at an incredibly fast pace and is changing, and in fact revolutionizing, the way patients and healthcare providers interact. Mobile medical technologies...more
I am often called upon to address the nature of how regulatory controls may apply to the organization of healthcare companies in their ability to create, deliver, and capture value (their ‘business models’). While no...more