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Polsinelli

California Legislators Pass AB 3129 to Require Notice and Consent for Private Equity and Hedge Fund Investments in Health Care

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The California legislature passed AB 3129 late Saturday night, the last day of the legislative session. The final bill included some amendments in the final days of the legislative session that carved out certain types of...more

McDermott+

CMS Hosts Health Equity Conference: Key Insights and Perspectives

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Last week, the Centers for Medicare & Medicaid Services (CMS) held the second annual CMS Health Equity Conference. The event drew several hundred in-person attendees, including my colleague Kayla Holgash, and thousands of...more

Foley Hoag LLP - Security, Privacy and the...

FTC's Updated Health Data Breach Rule Covers Apps, Other New Tech

The FTC has updated its HBNR to clarify that the rule also restricts marketing practices involving personal health information. This update to the HBNR was announced on April 26, 2024, and follows several recent enforcement...more

McDermott Will & Emery

2024 Chart of Additional Healthcare Regulations

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During this election year, McDermottPlus is actively monitoring annual regulations that federal agencies are expected to release, as well as “ad hoc” regulations that will be released at the discretion of federal agencies. ...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | March 2024 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for March 2024. We summarize a US Court of Appeals for the Second Circuit decision interpreting the intent standard under the federal...more

Akin Gump Strauss Hauer & Feld LLP

Akin Intelligence - March 2024

Welcome to the March edition of Akin Intelligence. This month, the EU AI Act was approved by the European Parliament, moving one step closer to becoming the first major AI law. In the U.S., the DOJ brought criminal charges...more

McDermott Will & Emery

FDA Publishes Proposed Rule on Sections 503A and 503B Compounding

On March 20, 2024, the US Food & Drug Administration (FDA) issued a proposed rule titled Drug Products or Categories of Drug Products that Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the...more

Polsinelli

California’s AB 3129 Continues National Trend of Scrutinizing Private Equity Investments in the Health Care Industry

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The California legislature is considering a bill that could severely impact the ability for private equity companies and hedge funds to operate in the California health care industry. AB 3129, introduced by Assembly Member...more

McDermott+

Healthcare Preview for the Week of: March 18, 2024

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At midnight on Friday, funding runs out for the remaining six FY 2024 annual spending bills: State – Foreign Operations, Defense, Homeland Security, Labor – Health and Human Services, Legislative Branch, and Financial...more

Nelson Mullins Riley & Scarborough LLP

Gold Dome Report - Legislative Day 36 - March 2024

The General Assembly reconvened for Legislative Day 36 on Monday with lawmakers and lobbyists hoping to keep a little luck of the Irish going into the penultimate week of the legislative session. With only four legislative...more

Epstein Becker & Green

Proposed CA Assembly Bill 3129: Notice & Consent for Private Equity, Hedge Funds Acquiring/Changing Control of Health Care...

Epstein Becker & Green on

As our December 2023 Insight noted, California’s SB 184 (enacted in June 2022) and accompanying regulations contain pre-transaction notice requirements by “specified health care entities” for certain “material change...more

Fenwick & West LLP

The Women’s Health Marathon Starts with a Sprint

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The first stage of First Lady Dr. Jill Biden’s White House Initiative on Women’s Health Research kicked off on March 6, 2024, when the Department of Health and Human Services ARPA-H Sprint for Women’s Health held a proposer...more

Nelson Mullins Riley & Scarborough LLP

Gold Dome Report - Crossover Day Wrap-Up - March 2024

Legislators worked late into the night on Thursday to ensure legislation made the Crossover Day deadline. This #GoldDomeReport offers a recap of all the measures that passed out of the House and Senate and live on to seek...more

Nelson Mullins Riley & Scarborough LLP

Gold Dome Report - Committee Work Day - February 2024

There may be a calm before most storms, but there certainly isn’t one before Crossover Day in the Georgia General Assembly. Contrary to the popular idiom, House members spent late Tuesday and Wednesday pleading, cajoling,...more

Nelson Mullins Riley & Scarborough LLP

Gold Dome Report - Legislative Day 26 - February 2024

The Georgia General Assembly kicked off Crossover Week on Monday, intensifying the mad dash for legislators and lobbyists working to ensure their bills pass their origin chamber and live to see Legislative Day 29. Expect...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | January 2024 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for January 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the new Innovation in...more

Nelson Mullins Riley & Scarborough LLP

Gold Dome Report - Legislative Day 25 - February 2024

The Georgia State Capitol hallways and hoppers continued to overflow on Thursday. Law Enforcement Day at the Capitol converged with an onslaught of hundreds of charter school students to fill the People’s House with Georgians...more

Fenwick & West LLP

The Shifting Regulatory Landscape for Level-Funded Plans: An Alternative for Group Health Insurance

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In the constantly changing health insurance landscape, level-funded health plans are steadily gaining ground as a viable middle approach between fully insured health plan and self-funded health plans—arguably offering...more

Polsinelli

Revisiting Government March-In Rights Under Bayh-Dole: The FTC Weighs In

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On February 6, 2024, the Federal Trade Commission (“FTC”) commented in support of what would be a historic expansion of government march-in rights under the Bayh-Dole Act in response to the release of the National Institute...more

Manatt, Phelps & Phillips, LLP

Georgia Proposes a Bill to Regulate Physician and Insurer AI Use

The health care industry, like most industries, is exploring how to reap the benefits of increasingly powerful artificial intelligence-based technologies while managing the risks they pose. Federal and state policymakers are...more

Nossaman LLP

Colorado’s Peer Review Privilege In Peril

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The confidentiality of medical staff peer review has long been a cornerstone of hospital operations, fostering an environment where physicians can candidly evaluate medical care without the looming specter of malpractice...more

Manatt, Phelps & Phillips, LLP

Vermont Considers Bringing Its Version of Washington’s ‘My Health My Data Act’ To New England

The Vermont Legislature is considering its version (S.173) of Washington’s My Health My Data Act to regulate non-HIPAA health data. If enacted, the Vermont law would take effect on January 1, 2025. The bill is premised on a...more

Health Care Compliance Association (HCCA)

Privacy Briefs: January 2024

New York has released proposed cybersecurity regulations for hospitals. The regulations, which were published in The State Register on Dec. 6 and will undergo a 60-day public comment period ending on Feb. 5, are designed to...more

McDermott Will & Emery

Biden Administration Proposes New Framework for Exercising March-In Rights on Government-Funded Inventions; Drug Pricing May Be...

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Under the University and Small Business Patent Procedures Act of 1980 (35 U.S.C. §§ 200-212), commonly referred to as the Bayh-Dole Act, the federal government can exercise “march-in” authority in certain circumstances to...more

McDermott Will & Emery

Trending in Telehealth: December 21, 2023 – January 3, 2024

Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more

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