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)
DOJ Addresses AI in Corporate Compliance Programs — The Good Bot Podcast
AGG Talks: Cross-Border Business Podcast - Episode 27: U.S. Healthcare Reimbursement Guidance for Foreign Life Sciences Companies
Daily Compliance News: March 20, 2025, The Fluid Edition
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
The landscape for rare disease treatments appears to be evolving rapidly, thanks to a confluence of regulatory momentum and a booming market forecast. Statements from key federal figures in recent months combined with market...more
On May 20, 2025, the Occupational Safety and Health Administration (OSHA) updated its Site-Specific Targeting (SST) inspection program. The SST inspection program is OSHA’s primary planned inspection initiative for...more
New York’s Medicaid financing strategy—particularly its use of a managed care organization (MCO) tax—has come under renewed federal scrutiny amid recent legislative proposals and regulatory developments. The federal...more
Recently, an Artificial Intelligence (“AI”) Telephone Consumer Protection Act (“TCPA”) lawsuit was filed against a healthcare marketer in the United States District Court for the Northern District of Illinois. In Finley v....more
As of mid-2025, private equity (PE) investors remain intensely interested in health care services and technology companies despite higher borrowing costs, heightened regulatory scrutiny, and an increasingly complex state...more
Patient engagement. Information blocking. Interoperability. These buzz words are flying around the health information technology (HIT) world as the Trump administration starts to make its mark on the HIT policy landscape....more
Developing a medical product, such as a medical device, comes with important milestones that can cause a project to sink or swim. One major milestone is amassing the clinical data needed to support pre-market submissions....more
On 4 June, the Council of the European Union (Council) adopted its negotiation position on the proposals for a new regulation and directive that make up the so-called ‘pharma package’. The pharma package now moves to the next...more
On May 21, Governor Bill Lee signed House Bill 979 (HB 979) into law. Notably, provisions of this law aim to address physician shortages and improve access to specialized medical care in rural and underserved areas in...more
Byonyks, a medical device company focused on advancing dialysis care, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Byonyks X1 APD Cycler, an automated peritoneal...more
This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal, and regulatory landscape. On June 9, HHS Secretary Robert F. Kennedy, Jr., announced that he is “retiring”...more
Health care entities, such as professional corporations (PCs) and professional limited liability companies (PLLCs) (known as “restricted limited liability companies” in Pennsylvania), encounter a complex legal analysis when...more
On June 9, 2025, Oregon enacted the most restrictive corporate practice of medicine (CPOM) law in the country (SB 951), which imposes substantial restrictions on the ownership and control of professional medical entities...more
On May 7, 2025, the US District Court for the Northern District of Texas upheld the US Food and Drug Administration’s (FDA’s) decision to remove two tirzepatide injection medications from the FDA’s drug shortage list. This...more
The Centers for Medicare & Medicaid Services (CMS) recently published a press release rescinding its June 2022 guidance concerning hospitals’ obligations to pregnant women under the Emergency Medical Treatment & Labor Act...more
*UPDATE* Oregon Senate Bill 951, described in the alert below originally published on May 30, 2025, was signed into law by Oregon Governor Tina Kotek on Monday, June 9, and will apply to all new investments beginning January...more
Over the past 3 years, as chronicled in several Proskauer alerts, an increasing number of states have sought to regulate physician practice management (“PPM”) and private equity transactions in the health care sector,...more
CMS announced in a letter released on Tuesday, May 27, 2025 (CMS Letter) that it will ramp up financial oversight of states to detect misuse of federal Medicaid funds “[t]o ensure that federal money is not used to pay for or...more
The Evolution of Health Care AI Benchmarking - Artificial Intelligence (AI) foundation models have demonstrated impressive performance on medical knowledge tests in recent years, with developers proudly announcing their...more
Members of the health care community may recall that the 2025 legislative session of the Connecticut General Assembly started out with Governor Lamont signing into law an emergency certificate of need (CON) process for...more
Congress is weighing a sweeping proposal that could significantly reshape how artificial intelligence (AI) is regulated across the United States. At the end of May, the United States House of Representatives passed, by a vote...more
On May 22, 2025, the Centers for Medicare & Medicaid Services (CMS) released new guidance for compliance with the hospital price transparency rule and published a request for information (RFI) seeking ways to bolster hospital...more
The Centers for Medicare & Medicaid Services (CMS) released new Updated Hospital Price Transparency Guidance (Guidance) to “strengthen the Hospital Price Transparency requirements, requiring hospitals to post the actual...more
On May 27, 2025, HHS Office of Inspector General (OIG) issued a report outlining its finding that Medicare payments for evaluation management (E&M) services provided on the same day as eye injections were at risk for...more
Hong Kong lacks comprehensive AI legislative framework but is developing sector-specific guidelines and regulations, and investing in AI. Laws/Regulations directly regulating AI (the "AI Regulations") At present, Hong...more