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
Podcast: Dietary Supplements – Navigating the Regulatory Maze – Diagnosing Health Care
Last fall at the Safeguarding Health Information: Building Assurance Through HIPAA Security 2024 conference, U.S. Department of Health & Human Services Office for Civil Rights (OCR) promised that before year’s end, it would...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
The Cryptocurrency Revolution and President Biden's Formal Recognition - Out of the ashes of the 2008 financial crisis, Bitcoin sprang up like an insurgency, targeting both the unbridled activity of large financial...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
In Washington: POLITICO reporter Burgess Everett tweeted that Senate Majority Leader Mitch McConnell (R-KY) says “negotiators should drop both state and local aid and liability shield provisions in order to reach consensus...more
On October 28th, the Federal Bureau of Investigation, the Department of Health and Human Services, and the Department of Homeland Security’s Cybersecurity and Infrastructure Security Agency alerted hospital administrators and...more
The Editors' Note - Welcome to the third issue of Decoded, Spilman's e-newsletter focusing on technology law, including data security, privacy standards, financing technologies, and digital-based means of conducting...more
Blockchain Solutions Advance in Manufacturing, Food, Pharma and Grant Management - Last week, one of the world’s largest industrial cobalt producers announced plans to join the Responsible Sourcing Blockchain Network (RSBN)....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 October 1, 2018, the Food and Drug Administration (FDA) issued its “Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook” to address continued threats to medical devices that could affect...more
We have previously reported on the ongoing cybersecurity issues with St. Jude defibrillators [view related posts here, here, and here]. On June 29, 2018, the Food and Drug Administration (FDA) classified the required firmware...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
From insulin pumps and pacemakers to defibrillators, medical devices increasingly rely on wireless and internet connectivity for efficient operations. Unfortunately, these interconnections also leave devices vulnerable to an...more
Cybersecurity has become a hot button topic for many in the medical device industry following the announcement of several high-profile medical device vulnerabilities and in light of the recent WannaCry ransomware attack that...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
A research report released last week on the supposed cyber vulnerabilities of St. Jude Medical’s devices not only jeopardizes a pending $25 billion acquisition of the company by Abbott Laboratories, it opens a worrisome new...more
Cyber attacks have broken free from their initial molds of carting off with consumer credit card numbers or stealing someone’s identity. The act of digitally digging into cyberspace has hit the U.S. Department of Health &...more
The cybersecurity ramifications of the Internet of Things (IoT) are perhaps nowhere more crucial—potentially a matter of life and death, in fact—than in the realm of medical devices. Until recent times, a potential hack of...more
Did you know that right now we have about 5 billion connected smart devices in use? Is it surprising that it is predicted that by 2020 that number will skyrocket to 25 billion? Of all these connected devices, a significant...more
October is National Cyber Security Awareness Month (yes, that’s a thing), so it seems fitting to write about an unprecedented alert recently released by the FDA to health care providers that warned of a medical device’s...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
Healthcare providers would be wise to keep in mind that if a patient is harmed by a hacked medical device, Exhibit A in the negligence suit against them may be that provider’s risk analysis, or lack thereof....more
A fictional cyber-terrorist weaponizing a medical device by hacking into it has become a familiar plot premise in recent Hollywood dramas. Unfortunately, the risk of harm from medical device hacking has now become an...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