Enforcement Relief: What New Regulatory Reforms Could Mean for Hospices
The California legislature recently passed a bill targeting private equity and hedge fund transactions with health care providers. If signed into law, AB 3129 will require a private equity group or hedge fund to notify and...more
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
Effective immediately, on August 22, 2024, the Office of Health Care Affordability (OHCA) adopted revisions to the cost and market impact review (CMIR) regulations (Revised Regulations), which govern California’s pre-closing...more
Stakeholders are continuing to analyze the implications of the mammoth proposed rule on “Medicare and Medicaid Programs: [Calendar Year (CY)] 2025 Payment Policies under the Physician Fee Schedule and Other Changes to Part B...more
On December 17, 2024, recent amendments to the Food and Drug Regulations (FDR) and the Medical Devices Regulations (MDR) relating to the recall of drugs and medical devices will come into force....more
Welcome to our third issue of The Health Record - our healthcare law insights e-newsletter! We are winding down the summer with our talented group of law students and they have continued to research and write, shadow...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
On June 14, House Energy and Commerce Committee (E&C) Chair Cathy McMorris Rodgers published a “framework for discussion” proposing reforms to the National Institutes of Health (NIH)....more
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
The healthcare sector is undergoing a transformative phase due in large part to the integration of digital technologies into every-day care. At the forefront of this revolution is Remote Patient Monitoring (“RPM”), a...more
On May 9, 2024, Connecticut Governor Ned Lamont signed into law Public Act No. 24-4, “An Act Concerning Emergency Department Crowding,” (The Act). The Act requires all Connecticut hospitals with an emergency department to, no...more
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
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
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
The Washington State Supreme Court significantly expanded the scope of potential hospital tort liability for the allegedly negligent actions of nonemployee, independently contracted emergency room service physicians, and...more
In a prior blog post, we noted the trend of states enacting legislation implementing reporting requirements for certain healthcare transactions. On March 13, 2024, Indiana joined this trend as Indiana Governor Eric Holcomb...more
Recently, a matter involving the North Carolina Attorney General (AG) Josh Stein made headlines when it was announced that Affiliated Monitors Inc. would take over monitorship of HCA Healthcare. This relates to HCA’s...more
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
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
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
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
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
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
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
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