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
On June 24, 2025, in a hearing before the U.S. House of Representatives Committee on Energy and Commerce, the Secretary of Health and Human Services (HHS), Robert F. Kennedy Jr. revealed that his department plans to soon...more
Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health....more
Key Points - - It remains to be seen what priorities Robert F. Kennedy Jr. and Marty Makary might set if confirmed as HHS secretary and FDA commissioner, respectively. - The Trump administration will likely focus on drug...more
As the New Year begins, questions surrounding how recent election results will impact technology regulation across industries loom large. It’s hardly a bold prediction that artificial intelligence (“AI”) and the regulation...more
News Briefs - Number of Official Physician Union Drives Soared Over Two Years - While fewer than 10 percent of U.S. physicians are unionized, the number of official union drives among private-sector doctors have skyrocketed...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
Hosted by the American Conference Institute, the 19th Annual FCPA & Anti-Corruption Conference for the Life Sciences Industry returns for another exciting year with carefully researched programming based on critical findings...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
Medtech companies are evolving rapidly as more and more of them develop products that collect and leverage substantial patient and provider data. Companies that once only developed hardware-based solutions for...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
Report on Patient Privacy 22, no. 9 (September, 2022) - More than 92% of patients believe privacy is a right and their health data should not be available for purchase, according to a survey from the American Medical...more
AHA Expresses Member Support for PATCH Act, Medical Device Security "In a letter addressed to Senators Bill Cassidy (R-LA) and Tammy Baldwin (D-WI), who first introduced the PATCH Act, the AHA said that the association and...more
Report on Patient Privacy 22, no. 1 (January, 2022) - As the COVID-19 pandemic enters its third year, real “security fatigue” with pandemic-related issues will combine with cybercriminals’ increasingly sophisticated...more
As the collection and use of health data drastically expands, the agency issued a recent guidance to officially put health apps and connected medical devices “on notice.” On September 15, the Federal Trade Commission...more
2020 AG Elections- Ten AG elections were held on November 3, 2020. As of this writing, six incumbent AGs won their elections, and Republicans held the open-seats in Indiana and Montana. In the two undecided races, Democratic...more
In 2019, U.S. Department of Justice (DOJ) enforcement activity targeting drug and device manufacturers jumped sharply over the prior year, reflecting an increased focus on fraud and abuse in the life sciences sector. More...more
The Department of Health and Human Services (HHS) has released a publication entitled the "Health Industry Cybersecurity Practices (HICP): Managing Threats and Protecting Patients." The HICP was prepared in response to the...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
On December 28, 2018, the U.S. Department of Health and Human Services (“HHS”) closed out the year by releasing long-awaited voluntary cybersecurity guidelines for the health care industry. The four-volume publication,...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
The House of Representatives Energy and Commerce Committee issued a report late last week that the information security of the Department of Health and Human Services (HHS) has substantial weaknesses. Several incidents that...more