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
Podcast: Dietary Supplements – Navigating the Regulatory Maze – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 164: Emily Chee, US General Manager of Novartis Gene Therapies
Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care
Medical Device Legal News with Sam Bernstein: Episode 14
Medical Device Legal News with Sam Bernstein: Episode 11
Medical Device Legal News with Sam Bernstein: Episode 10
Medical Device Legal News with Sam Bernstein: Episode 9
Medical Device Legal News with Sam Bernstein: Episode 8
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
The year 2023 was a busy one for regulatory, compliance, and enforcement developments in the healthcare and life sciences industries, and 2024 promises to be even busier. We tapped MoFo’s Life Sciences + Healthcare Compliance...more
FDA law firm Gardner Law and EU-based Fieldfisher discuss regulatory, compliance, and privacy matters relevant to high-tech healthcare products. - - Harnessing AI and Connected Devices in Medical Innovation in an...more
The Washington My Health My Data Act ("MHMDA") may not have been written by Earth, Wind, & Fire, but it is certainly poised to make medical device and pharmaceutical manufacturers move to a new beat like a classic disco hit....more
Many privacy professional may have missed it, but In the run-up to the New Year — while many U.S. companies were focused on complying with the California Privacy Rights Act (CPRA) — Congress passed an appropriations bill that...more
Universities Share Lessons Learned from Ransomware Attacks "According to a recent Sophos poll of IT professionals, 44 percent of educational institutions suffered ransomware attacks in 2020, and 58 percent of those hit...more
In this month’s Privacy & Cybersecurity Update, we examine the FTC chair’s comments suggesting a potential shift in its approach to data privacy regulation, the European Data Protection Board’s request for comment on its...more
Hear about the latest in research compliance - Do you want to learn… - How to prepare for upcoming changes in Medicaid? - Ways to build and maintain a better research compliance work plan for your program? - How...more
EHR Vendor Breach Lawsuit Seeks Security Improvements - "Patient portal hacking incident last summer affected nearly 320,000." Why this is important: On October 22, 2021, QRS Inc., a medical practice management system...more
China Passes Major Data Protection Law as Regulatory Scrutiny on Tech Sector Intensifies - A final version of the law has not been published but a previous draft included rules around requiring consent for data protection...more
On June 18, 2021, the U.S. Food and Drug Administration (FDA) issued the draft guidance “Remanufacturing of Medical Devices,” which aims to help clarify the point when manipulation or repair of a medical device becomes...more
Attend HCCA’s annual Research Compliance Conference to receive the latest insights and guidance on emerging research compliance risks and solutions. This virtual event, held June 14 – 16, will be live and interactive. Learn...more
All companies in this day and age must devote some attention to cybersecurity risks. Regardless of industry, almost every entity maintains some form of personally identifiable information that requires protection (e.g.,...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 Food & Drug Administration has recently released for comment a draft expansion of guidance regarding Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. Although the FDA issued existing...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
CONGRESS RECONVENES, WITH A FOCUS ON OPIOIDS - Lawmakers return today to Capitol Hill after a two-week recess, and multiple committees in both the House and Senate are poised to examine the opioid crisis and potential...more
Connected medical devices deliver numerous benefits not available before, including improved monitoring of patient welfare and a wealth of vital data. But for all the advantages available through these devices, their...more
In this episode, Erica Jackson discusses recent guidance from the Food & Drug Administration (FDA) on the consideration of real-world data and real-world evidence in regulatory decision-making related to medical devices and...more
New York Attorney General Eric Schneiderman recently announced settlements with three mobile health app developers resolving allegations that they made deceptive advertisements and had irresponsible privacy practices. The...more
As the healthcare industry continues to embrace the Internet of Things, cybersecurity may present unprecedented health and privacy risks to patients. Wireless-enabled medical devices are increasingly common. For some...more
Once a month, AGG’s terrific FDA team publishes a newsletter updating readers on the latest regulatory news affecting food/drug companies–including those from Ireland and Northern Ireland. The August newsletter is here and...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
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
Reportedly for the first time ever, the FDA recently issued a declaration that hospitals should not use a medical device manufactured by Hospira Inc. because of security flaws that could allow hackers to penetrate hospital...more