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Transparency Healthcare

Mitratech Holdings, Inc

DOJ Unveils Whistleblower Rewards Program: What Every Business Needs to Know

The Department of Justice has launched the Corporate Whistleblower Awards Pilot Program to fight corporate crime. See how it impacts your organization. The U.S. The Department of Justice (DOJ) has just rolled out the...more

Spilman Thomas & Battle, PLLC

The Health Record - Healthcare Law Insights, Issue 4, August 2024

Welcome to our fourth issue of The Health Record - our healthcare law insights e-newsletter. In this edition, we address a variety of topics including a recent SCOTUS ruling and the potential impact on CMS, issues of patient...more

Akin Gump Strauss Hauer & Feld LLP

The Health Over Wealth Act Takes Aim at Private Equity Investment in Health Care

Key Points - Congress is increasing oversight and legislative activity related to the role of private equity in health care. Sen. Markey and Rep. Jayapal jointly introduced the Health Over Wealth Act on July 25, which aims to...more

Gardner Law

FDA Highlights the Promise of AI in Healthcare

Gardner Law on

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

Akin Gump Strauss Hauer & Feld LLP

Akin Intelligence - June 2024

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

Husch Blackwell LLP

Healthcare Founders Face New Exit Considerations

Husch Blackwell LLP on

Exiting a business, whether you are a serial entrepreneur looking to move on to the next project or a healthcare provider like a physician or therapist who has nurtured your practice for decades, can be difficult. After all,...more

American Conference Institute (ACI)

U.S. Implications of the EU AI Act

The European Union (EU) is leading the global charge with AI regulations. U.S. companies are not beyond their regulatory reach, however, and should be preparing their AI risk mitigation efforts accordingly....more

Ankura

Will Regulatory Scrutiny Impact Private Equity Investment in Healthcare?

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Private Equity in Healthcare - Over the past decade, private equity investors have shown a particular interest in acquiring or investing in various healthcare providers and services. This includes physician practices across...more

McCarter & English, LLP

New Jersey Statutory Update Part II

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

Gardner Law

CMS Audits on the Horizon: Prepare for Increased CMS Audits Under the Sunshine Act

Gardner Law on

Historically, the Centers for Medicare and Medicaid Services (“CMS”) has not aggressively pursued enforcement activity under the Sunshine Act. However, this may change in 2024. Late last year, CMS updated its Open Payments...more

McCarter & English, LLP

New Jersey Regulatory Update Part II

Part II of our New Jersey Regulatory Update further identifies proposed and adopted regulations that may impact healthcare providers, from additional financial transparency rules impacting facilities to rules attempting to...more

Sheppard Mullin Richter & Hampton LLP

CMS Issues Final Rule on Medicaid and CHIP Managed Care Access, Finance, and Quality

On April 22, 2024, the U.S. Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) issued a Final Rule (CMS-2439-F), effective July 9, 2024, aimed at advancing healthcare access,...more

McDermott Will & Emery

ICO Publishes New Transparency Guidance for Health and Social Care Sector

McDermott Will & Emery on

Healthcare sector organisations are increasingly deploying new technologies that use large amounts of personal information to support both direct care and secondary purposes, such as planning and research. Although these...more

King & Spalding

Senators Introduce New Bill for Transparency and Oversight in Health Care Transactions and Investment

King & Spalding on

On April 3, 2024, Senators Ed Markey (D-Mass) and Elizabeth Warren (D-Mass) released draft legislation titled the “Health Over Wealth Act” (the Proposed Bill). This Proposed Bill is another attempt to regulate private...more

Bass, Berry & Sims PLC

Welfare Plan Class Action Litigation Underscores Importance of Minding Your Fiduciary Duties

Bass, Berry & Sims PLC on

As mentioned in our recent blog post, the recently filed class action lawsuit against Johnson & Johnson (Lewandowski v. Johnson & Johnson et. al., D.N.J., No. 1:24-cv-00671 (Feb. 5, 2024)) over alleged excessive prescription...more

Foley & Lardner LLP

Private Equity: Proposed Health Over Wealth Act -What This Means for You

Foley & Lardner LLP on

On April 3, 2024, Senators Edward Markey (D-Mass.) and Elizabeth Warren (D-Mass.), chaired a Senate Health, Education, Labor, and Pensions (HELP) Subcommittee on Primary Health and Retirement Security field hearing titled,...more

Mintz - Health Care Viewpoints

PBM Policy and Legislative Update - Winter 2024

The PBM regulatory landscape continues to evolve rapidly at both federal and state levels, making it critical for our clients involved in the PBM space to stay apprised of developments in the industry. Our team actively...more

Foley Hoag LLP

Healthcare Issues to Watch Following the FY2024 Spending Deal

Foley Hoag LLP on

Six months into the fiscal year, Congress has finally passed FY2024 appropriations. It was a painstaking process, which many expected to include policy victories that both sides could celebrate. Instead, the spring work...more

Epstein Becker & Green

ONC’s “Information Blocking Enhancements” Under the HTI-1 Rule Are in Effect

On Monday, March 11, 2024, the Office of the National Coordinator for Health Information Technology’s (ONC) Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information...more

McDermott+

President Biden Releases FY 2025 Budget: What’s NOT in It?

McDermott+ on

Earlier this week, President Biden released his Fiscal Year (FY) 2025 President’s Budget. As a reminder, every year, the White House releases a budget that serves as its official funding request to Congress for the following...more

Pillsbury Winthrop Shaw Pittman LLP

Congress Continues to Address AI in Bipartisan Fashion, Launching House AI Task Force as Latest Step

House leadership announced the launch of the Task Force on Artificial Intelligence (AI), a bipartisan group that will develop a report outlining AI regulatory priorities and setting guiding principles to help shape the AI...more

Foley & Lardner LLP

Leveraging Risk Management Frameworks for AI Solutions in Health Care

Foley & Lardner LLP on

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

ArentFox Schiff

Progress Towards PBM Reform: Insights, Political Considerations, and Outlook for 2024-2025

ArentFox Schiff on

As we predicted at the end of the 117th Congress, 2023 was a year of progress for advocates of Pharmacy Benefit Manager (PBM) reform. Abusive practices by PBMs received sustained, bipartisan focus in Congress throughout...more

Wiley Rein LLP

Health Care AI and Drug Prices: Highlights From Two Senate Hearings

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Health Care was a hot topic in the U.S. Senate on February 8, as two important Senate Committees – the Committee on Finance and the Committee on Health, Education, Labor, and Pensions (HELP) – held hearings, respectively, on...more

Fenwick & West LLP

New Federal Requirements for AI and IT System Implementation in Healthcare

Fenwick & West LLP on

On October 30, 2023, the Biden administration issued Executive Order 14110 on the Safe, Secure and Trustworthy Development and Use of Artificial Intelligence (the “Executive Order”). As detailed in our previously published...more

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