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
This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia’s war against Ukraine, health threats, and cyber threats. It does not...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 recent years, products liability law has been significantly impacted by advancements in technology, particularly with the rise of artificial intelligence (AI) and automation. As more companies adopt these technologies to...more
On December 29, 2022, President Biden signed a new statute that will significantly impact medical device cybersecurity regulation. Section 3305 of the Consolidated Appropriations Act of 2023 (“Section 3305”) authorizes the...more
On November 14, 2022, under contract with the United States Food and Drug Administration (FDA), the MITRE Corporation (MITRE), an organization that administers the National Cybersecurity Center of Excellence, a federally...more
Earlier this week, the Federal Bureau of Investigation (FBI) published another notification alerting health care providers of increasing cyber threats to medical devices operating on unpatched or outdated devices. In its...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
Report on Medicare Compliance 31 no. 18 (May 16, 2022) - In a version of the future that hopefully never comes, malware is able to remove malignant-looking tumors from CT or MRI scans before they were reviewed by...more
Report on Patient Privacy 22, no. 3 (March, 2022) - Typically a “legacy” describes the lasting impact of an influential person or movement, most often in a positive sense. Not so with medical devices. When legacy is applied...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
We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more
Ransomware Attacks Predicted to Occur Every 11 Seconds in 2021 with a Cost of $20 Billion - Confirming what we are seeing in the field, cybersecurity firm Cybersecurity Ventures has predicted that, globally, businesses in...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 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
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
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 U.S. Food and Drug Administration (FDA) announced an agreement with the U.S. Department of Homeland Security (DHS) to strengthen the partnership between the agencies and “stay a step ahead of constantly evolving medical...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
Wearable technology and medical devices have vulnerabilities just like anything else that is digital. ICS-CERT recently issued an advisory about vulnerabilities in Medtronic’s MyCareLink patient heart monitors. ...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
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
On January 4, 2018, the National Health Information Sharing and Analysis Center (NH-ISAC) posted an announcement regarding the cybersecurity threats Meltdown and Spectre that were recently identified....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
On December 28, 2016, the Food and Drug Administration (FDA) issued guidance on Postmarket Management of Cybersecurity in Medical Devices. The guidance clarified aspects of the reporting requirements under Part 806 (21 CFR...more