False Claims Act Insights - An FCA Perspective on Artificial Intelligence in the Healthcare Industry
The State of Healthcare Enforcement
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 247: Reimagining Cell Therapy for Solid Tumors with Ming-Wei Chen and Fangheng Zhou of RephImmune
What’s in Your Operating Agreement? Legal Tips for Healthcare Providers
10 For 10: Top Compliance Stories For the Week Ending, July 26, 2025
Key Discovery Points: Don’t Get Caught with Your Hand in the Production Cookie Jar
Work this Way: An Employment Law Video Podcast | Episode 50: Creating a Competitive Advantage Through Employee Benefits with Connor Shaw of Gallagher
False Claims Act Insights - Will Recent Leadership Changes Lead to FCA Enforcement Policy Changes?
Podcast: Addressing Patient Complaints About Privacy Violations
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 236: Advocating for Accessible Diagnoses with Sydney Severance of Operation Upright
Podcast - Navigating the New Landscape of Private Equity in Healthcare
Taking the Pulse: A Health Care and Life Sciences Video Podcast | Episode 235: Revolutionizing Cancer Care with Eric Perrault of Kiyatec
Evolving AI Legislation: Federal Policies, Task Forces, and Proposed Laws — The Good Bot Podcast
CareYaya: A Revolutionary Approach to Elder Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 234: Life-Saving Collaboration in the Life Sciences Industry with John Crowley, President & CEO of BIO
False Claims Act Insights - Trump DOJ Sharpens Its Focus on Healthcare Fraud
Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
Breaking Down the Shifting Vaccine Policy Landscape – Diagnosing Health Care Video Podcast
Criminal Health Care Fraud Enforcement: Projections for 2025 and Beyond – Diagnosing Health Care Video Podcast
Healthcare Industry Segment-Specific Compliance Program Guidances (ICPGs)
No legislation has garnered more attention in the life sciences industry in recent past than the so-called Drug Price Negotiation Program of the Inflation Reduction Act (the "Program"). ...more
In the waning days of the Biden administration, the FDA released a flood of new guidance documents and other agency actions, including several important items related to digital health. On January 7, FDA published two new...more
In the days leading up to President Trump’s inauguration, the Biden FTC rushed to initiate major lawsuits and to tie a bow on various antitrust policy efforts. In a series of dissenting statements, the minority Republican...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
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
The U.S. Federal Trade Commission (FTC) took the next step in its long-standing effort to encourage lower prices and increase competition in the pharmaceutical industry. As part of the Biden administration’s whole government...more
The National Institute of Standards and Technology (NIST) released for public comment a “Draft Interagency Guidance Framework for Considering the Exercise of March In-Rights” (“March-In Framework”) on December 8, 2023...more
The Biden-Harris Administration recently announced various actions to lower healthcare and prescription drug costs. In one action, the National Institute of Standards and Technology (NIST) released in December 2023 a draft...more
Last week, McDermott+Consulting launched an election 2024 resource page, where you can find a 2024 health policy outlook and other insights into the November election. While regulations aren’t necessarily top-of-mind when...more
It’s no secret that Democrats are traditionally trustbusters, but the Biden Administration is taking things to a whole new level, bringing novel—and arguably weak—cases that nonetheless slow or block tie-ups among healthcare...more
On December 7, 2023, the Biden administration announced a blueprint for a framework that may be a tough pill to swallow for the pharmaceutical industry. This framework suggests that drug prices should be a crucial factor in...more
On October 30, 2023, President Biden issued an executive order (EO) to guide federal agencies on the development and use of artificial intelligence (AI). The administration views AI as holding numerous benefits but at the...more
This week marks the one-year anniversary since the enactment of the Inflation Reduction Act (IRA), which included sweeping reforms empowering the Secretary of Health and Human Services (HHS) to set prices for certain...more
Earlier this month — July 9, 2022 — marked the one-year anniversary of President Biden’s Executive Order on Promoting Competition in the American Economy (Executive Order). The Executive Order was notable in its breadth and...more
On November 19, 2021, the U.S. House of Representatives (“the House”) narrowly passed the Build Back Better Act (H.R. 5376, or “the Act”), a spending bill appropriating nearly $2 trillion for measures to expand the country’s...more
In an ambitious, far-reaching Executive Order signed on July 9, 2021, President Biden announced a renewed focus by the federal government on the promotion of fair competition amongst American businesses. Specifically, Biden’s...more
On July 9, 2021, President Biden signed the Executive Order on Promoting Competition in the American Economy (EO), which states that "excessive market concentration threatens basic economic liberties, democratic...more
Wilson Sonsini is pleased to present the latest edition of The Life Sciences Report. This issue features an article on managing IP development and capture at growing medtech start-ups that offers insight from executives at...more
Today, Friday May 28, President Joe Biden unveiled his Fiscal Year (FY) 2022 budget request, the first of his presidency. The $6 trillion proposal calls for $1.7 trillion in discretionary spending and $4.0 trillion in...more
This is the sixth in our First 100 Days series examining important trends in white collar law and investigations in the early days of the Biden administration. Our previous entry discussed ESG initiatives by the SEC. Up next...more
On November 30, 2020, the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) published a final rule (“Final Rule”) that removes safe harbor protection under the discount safe harbor to...more