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
Health + Tech - How Digital Health Tools Help Create Greater Consumer Focus in Healthcare
Medical Device Legal News with Sam Bernstein: Episode 11
Medical Device Legal News with Sam Bernstein: Episode 9
Medical Device Legal News with Sam Bernstein: Episode 8
Episode 132: Dr. Ehsan Jabbarzadeh, Co-Founder, Obsidio, and Professor, USC
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 118: Matthew Roberts and Darra Coleman, Health Care Attorneys, Nexsen Pruet
Healthcare Headlines: Episode 8 – Healthcare Lending Deal Landscape Trends and Forecasts for the Future
Healthcare Headlines: Episode 7 — Evolving Landscape of Healthcare Provider & Medical Product Liability
On June 17, 2024, the U.S. Food and Drug Administration’s (FDA) Digital Health Center of Excellence (DHCE), published a blog article highlighting the promise of artificial intelligence (AI) in healthcare. In the article, the...more
Further to the guiding principles on the use of artificial intelligence (AI) and machine learning (ML) technologies jointly published by the U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s...more
Below is Part II of our New Jersey Statutory update. As you can see from the below, several statutes were passed imposing requirements on health insurance payers, including new requirements for prior authorization request and...more
On May 21, 2024, the European Union finalized the adoption of the groundbreaking EU Artificial Intelligence Act, a comprehensive and sector-agnostic legislation that extends globally. This 420-page Act aims to regulate the...more
Medical Devices Directorate Performance Annual Report - In September 2023, Health Canada published the Medical Devices Directorate Performance Annual Report for April 1, 2022, through March 31, 2023. The report provides...more
Senators Focus Attention on Litigation Funding’s Opacity - Building on the momentum we previously noted related to litigation funding, on September 14, Senator John Kennedy introduced the Protecting Our Courts from Foreign...more
On Wednesday, May 10, 2023, the Food and Drug Administration (FDA) announced the publication of a new discussion paper titled “Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological...more
First mentioned in a 2019 discussion paper entitled “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD),” the idea of a defined set of...more
As artificial intelligence technology evolves on a seemingly minute-by-minute basis, the U.S. FDA’s regulatory approach continues to evolve in an effort to keep pace. “The promise of artificial intelligence in medicine is...more
To increase transparency regarding payments to physicians by drug and medical device companies, Governor Newsom signed AB 1278, which imposes certain additional disclosure obligations on physicians. Beginning on January 1,...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
From June 26th, 2022, the “Italian Sunshine Act” entered into force. This is a piece of legislation aimed at preventing corruption and fostering transparency in the health sector by imposing disclosure obligations on...more
Physician-owned companies that generate revenue from the sale of medical devices ordered by their physician owners have in recent years been the target of federal fraud and abuse enforcement actions. OIG Advisory Opinion...more
On April 8, 2022, FDA issued new, long-awaited draft guidance “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (Draft Cybersecurity Guidance). 1 This draft guidance...more
The Food and Drug Administration recently sought comments on the role of transparency for artificial intelligence and machine learning-enabled medical devices. The FDA invited comments in follow up to a recent workshop on the...more
On October 14, 2021, the Food and Drug Administration (FDA) held a virtual public workshop on transparency surrounding Artificial Intelligence/Machine Learning (AI/ML) enabled medical devices. The workshop focused on the...more
In the weeks leading up to FDA’s October 14, 2021 Transparency of AI/ML Enabled Medical Devices Workshop (Workshop), we took a brief look at the history of FDA’s regulation of medical device software and the agency’s more...more
EU Regulation on Artificial Intelligence - On April 21, 2021 the European Commission published its Proposal for a Regulation on Artificial Intelligence, the first ever legal framework on AI. With its Proposal the European...more
The US Food and Drug Administration (FDA) published an Action Plan for artificial intelligence (AI) and machine learning (ML) software on January 12, 2021 that provides near-term actions to develop a regulatory framework for...more
In an August 20, 2020, press release, the Food and Drug Administration (FDA) provided an update on the medical device reports (MDRs) received by the agency relating to breast implants, including breast implant-associated...more
UPDATE: The Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 was made on March 1, 2021 and repeals and replaces the Interim Order Respecting Drugs, Medical...more
Many countries around the world are being forced to watch as the only tool they have to suppress COVID-19 — social distancing — causes unprecedented damage to their economies. Because suppression measures may be required...more
On November 15, 2019, the Centers for Medicare and Medicaid Services ("CMS") finalized changes to the Open Payments Program as part of the CY 2020 Physician Fee Schedule Final Rule....more
The U.S. Food & Drug Administration (FDA) has released a final guidance document entitled, “Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications,...more
On June 21, the Food and Drug Administration (FDA) released a report titled “Statement on agency’s efforts to increase transparency in medical device reporting.” This report describes updates to FDA’s Medical Device Reporting...more