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
This series explores legal issues related to physician burnout and potential solutions. Our first post addressed how healthcare organizations can foster the psychological safety and emotional wellbeing of their physicians....more
International Geneva – A global governance ecosystem of over 40 international organizations, 178 country representations and 700+ non-governmental organizations....more
Real World Impact: This is the first in a series of Alerts that will provide guidance to employers on navigating the complicated mix of concerns that can arise when dealing with employee mental health issues....more
On 27 June 2024, the Spanish supervisory authority (‘AEPD’) and the European Data Protection Supervisor (‘EDPS’), announced the joint publication of a report addressing the data protection challenges associated with neuro...more
As artificial intelligence (AI) continues to advance rapidly, organizations of all types are seeking to deploy this powerful tool to increase the effectiveness and efficiency of their operations, improve service to their...more
In December 2023, the National Association of Insurance Commissioners (NAIC) adopted a Model Bulletin on the Use of Artificial Intelligence (AI) Systems by Insurers. The model bulletin reminds insurance carriers that they...more
Enacting what is perhaps the first comprehensive regulation of artificial intelligence (AI) at the state level in the United States, Colorado’s governor signed the Artificial Intelligence Act, Senate Bill (SB) 24-205, on May...more
President Joe Biden’s October 2023 Executive Order on AI directed agencies to institute a significant number of actions on AI. On April 29, 2024, the White House announced that federal agencies had completed “all of the...more
Cyberhackers—potentially frustrated by their limited ability to extort ransom from health care entities in attacks—have started extorting the patients themselves, threatening them with the release of information or...more
The Cybersecurity and Infrastructure Agency (CISA) is seeking comment on a proposed rule to implement reporting requirements for critical infrastructure entities, including health care entities, on cyberattacks and ransomware...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
The Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) final rule, issued by the US Department of Health and Human Services (HHS) Office of...more
The most successful compliance programs are constantly evolving and always in motion. They are both action-oriented and flexible. How do you build a program that’s action-oriented and flexible? You implement a detailed work...more
Most healthcare providers understand the importance of having a designated Compliance Officer. Someone needs to lead the organization’s compliance initiatives and be responsible for advising the CEO and governing body of...more
The False Claims Act (FCA) permits private individuals to bring lawsuits in the name of the United States—called qui tam—against those they believe have defrauded the federal government: 31 U.S.C. § 3730(b). The FCA thereby...more
Amending prior requirements, medical device manufacturers and importers have two years to comply with FDA's Quality Management System Regulation final rule, a similar approach to prior good manufacturing practices but with...more
Sometimes we forget that even small and medium-sized providers can run afoul of antitrust laws and regulations. Often these activities are well-intentioned. It’s not uncommon for competing providers to want to work together...more
Today marks one month since United Health Group’s (UHG) Change Healthcare reported that it had been hit by a cybersecurity attack. The attack has caused a major disruption to the US healthcare system, significantly impacting...more
Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on HHS' recent final rule on the confidentiality of substance use disorder patient...more
What is the new Washington My Health My Data Act (MHMDA)? MHMDA aims to provide stronger privacy protections for “consumer health data” by: - Requiring additional disclosures for the collection, use, and sharing of...more
The compliance officer is one of the most important positions within the organization, but also one of the most challenging. You’re expected to be a teacher, a coach, a project manager, a good listener, and a role model....more
The healthcare industry is a major target for cyberattacks because of all of the personal information collected from patients. Recognizing that the healthcare industry is such a ripe hunting ground for cybercriminals, the...more
As recently described by The New England Journal of Medicine, the liability risks associated with using artificial intelligence (AI) in a health care setting are substantial and have caused consternation among sector...more
For the year ending September 30, 2023, federal False Claims Act settlements and judgments exceeded $2.5 billion, much of which came from the health care industry. The largest, at over $487 million, stems from a finding by a...more
As you may know, we have been submitting FOIA requests asking FDA to share data from its various programs. In October, FDA granted our April FOIA request in which we asked the agency to add back demographic data fields that...more