Innovation in Compliance: Unpacking Healthcare Compliance with Maria Villanueva
False Claims Act Insights - Physician, Refer Thyself: How Stark Law and FCA Intersect
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 190: Healthcare Tech and Human Resources with Shannon Frazier, HR Executive Director at Lenovo
Video: Braidwood v. Becerra – Challenging the Affordable Care Act’s Preventive Services Coverage Provision – Thought Leaders in Health Law
Greetings and Felicitations: The Future of Healthcare…Is Now: Part 3 – The Specifics of Managing Obesity
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 153: William Kenley, CEO, and Juana Slade, Chief Diversity Officer and Director of Language Services, AnMed Health
Greetings and Felicitations: The Future of Healthcare…Is Now: Part 2- Revolutionizing Healthcare: Personalized Medicine
Private Equity VS Real Estate Transactions | #6 What’s the Best Order to Sell?
Episode 152: Matt Littlejohn, CEO, MUSC Health Midlands
Private Equity VS Real Estate Transactions | #4 Optimizing Total Asset Value
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 151: Erin Ford, EVP & COO, and David Stefanich, Board Chair, SCBIO
Private Equity VS Real Estate Transactions | #3 Real Estate Valuations Explained
AGG Talks: Home Health & Hospice - Reimbursement Audits and Appeals
Podcast - Counsel That Cares - The Value of Value-Based Cancer Care
Episode 150 - Jane Pine Wood, Senior Vice President & Chief Legal Officer, BioReference
Podcast - The Latest on Antitrust and Non-Compete Agreements in Healthcare
Strategies to Manage Costs of Medical Care in a PA Workers’ Compensation Claim
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 149: Patrick Goodwill, CEO, Magnetic Insight
Podcast - Noteworthy Value-Based Care Mergers and Acquisitions Transactions
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 146: Ann Lewis, CEO, CareSouth
News Briefs - State Governments Taking Steps to Make Rules on Healthcare AI - In the absence of federal guardrails on artificial intelligence in healthcare, state governments are figuring out their own rules of the road....more
I may be jumping the gun here, but I’m anxious to understand how the new flurry of AI medical devices is performing in the marketplace, or more specifically, whether the devices are failing to perform in a way that...more
Welcome to our seventh 2024 issue of Decoded - our technology law insights e-newsletter. We have a few events we want to pass along to those interested in technology, but also other areas of law and business....more
Welcome to our third issue of The Health Record - our healthcare law insights e-newsletter! We are winding down the summer with our talented group of law students and they have continued to research and write, shadow...more
Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on recent developments in the U.S. Food and Drug Administration's ("FDA") regulatory...more
In a landmark decision on June 28, 2024, the Supreme Court overturned a 40-year-old legal precedent known as Chevron deference. Established in 1984, Chevron deference mandated that judges defer to federal agencies concerning...more
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
Welcome to the June edition of Akin Intelligence. This month, the General Services Administration (GSA) launched its first AI-focused cohort of Presidential Innovation Fellows (PIF), bringing together experts from across the...more
Modern conveniences from washing machines to GPS simplify our lives. In healthcare, however, new technology has not always streamlined delivery. A prime example is the introduction of Electronic Health Records (EHRs) over the...more
As the first state law to regulate the results of Artificial Intelligence System (AI System) use, Colorado’s SB24-205, “Concerning Consumer Protections in Interactions with Artificial Intelligence Systems” (the Act), has...more
The food, drug and medical device industries comprise some of the most closely regulated sectors in the United States. The US Food & Drug Administration (FDA) actively exercises authority by constantly changing legislation...more
Profound Medical (Nasdaq: PROF) has received FDA 510(k) clearance for its second AI model aimed at treating prostate cancer. Profound Medical is a Toronto-based company, which specializes in developing and marketing...more
The purpose of this quarterly tracker is to identify key federal and state health AI policy activity. Below reflects federal legislative and regulatory activity to date related to AI, and state legislative activity introduced...more
n March 15, the U.S. Food and Drug Administration (FDA) published a paper titled “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” This paper describes the FDA’s strategy for...more
Artificial intelligence or AI isn’t going anywhere, and the FDA is the latest agency to recognize its potential to revolutionize healthcare by advancing medical product development, improving patient care, and expanding the...more
HHS Cybersecurity Performance Goals and the Healthcare Industry - The healthcare industry is a major target for cyberattacks because of all of the personal information collected from patients. Recognizing that the healthcare...more
Every year, I look forward to the SXSW Interactive Health & MedTech Track, which showcases and explores the future of healthcare technology being created by innovators, entrepreneurs, and tech enthusiasts. This year is no...more
Rare Disease Day took place on February 29, 2024. Created in 2008, Rare Disease Day is observed on the “rarest day of the year”—February 29 in leap years (February 28 in non-leap years)—as a way to galvanize the global rare...more
In January 2024, the U.S. Government Accountability Office (GAO) issued a report highlighting current obstacles to the U.S. Food and Drug Administration’s (FDA) timely and effective regulation of artificial intelligence (AI)...more
AI is here to stay. The development and use of artificial intelligence (“AI”) is rapidly growing in the healthcare landscape with no signs of slowing down. From a governmental perspective, many federal agencies are embracing...more
Most years are eventful for businesses regulated by the US Food and Drug Administration (“FDA”), and 2023 was no exception. 2024 promises more of the same – it being a Presidential election year, some FDA decisions (increased...more
Speaking at CES 2024 earlier this year, U.S. Food and Drug Administration (FDA) Commissioner Robert Califf expressed significant concerns about the FDA’s ability to effectively regulate artificial intelligence (AI) in the...more
The Fenwick life sciences team recently returned from the 2024 JP Morgan Healthcare conference. As we reflect back on the week, there were several key themes and trends that we expect will continue to resonate and evolve over...more
Congress — Big Agenda & Little Time - With the holidays behind us, Congress returned this week for the second half of the 118th Congress with a long list of items to address and, as the 2024 campaign season ramps up, limited...more
Last year, both Congress and the Biden-Harris administration noticeably increased their attention on Artificial Intelligence (AI). Key congressional committees explored AI implications for health care & life sciences, and the...more