California’s new Office of Health Care Affordability (OHCA) is set to begin advance regulatory review of certain health care transactions beginning January 1, 2024. As further explained in our previous post, subject to certain exceptions, a broad range of health care entities (collectively, Health Care Entities) will soon be subject to potential prospective transaction review. OHCA initially published proposed regulations for the new transaction review process in early August (for more details, see our prior post and podcast).  As further discussed in our previous post, these proposed regulations were revised in October and made available on the OHCA website, with a comment period that ended on October 17, 2023. In response to October’s public comments, OHCA has further revised the proposed regulations (Revised Regulations), which are available here. This time however, OHCA has also provided notice of proposed emergency regulatory action, indicating that this version of the regulations will be submitted to the California Office of Administrative Law (OAL) for approval. Once submitted, the public will have five days to provide comments to the OAL. If the OAL approves the regulations, it will file them with the California Secretary of State and the regulations will become effective as emergency regulations for five years as of the filing date. During this period, OHCA will proceed with regular rulemaking action addressing prospective health care transaction review.

Governor Gavin Newsom recently signed multiple bills into law as part of California’s ongoing efforts to safeguard access to reproductive and gender affirming health care. The new laws are intended to increase protections for health care providers and patients, increase health care provider availability, and improve patient privacy. In a recent press release, California Legislative Women’s Caucus Vice Chair Assemblymember Cecilia Aguiar-Curry noted: “Last year, we enacted 14 bills and budget funding to expand and protect reproductive rights and services in our state. This year, we build on that momentum with legislation that ensures California remains a national leader in the fight for reproductive justice.”

Many health care entities with assets or operations in California will face advance regulatory review of transactions by the state’s new Office of Health Care Affordability early next year. Mintz Members Lara Compton, Daniel Cody, and Kathryn Edgerton discuss the emergency rulemaking process, proposed regulations requiring pre-closing notice of deals, and key considerations for health organizations.

Covered entities, business associates, and any entities that collect health information about consumers online should carefully review the latest joint letter from the Office for Civil Rights (OCR) and the   Federal Trade Commission (FTC). On July 20, 2023, the agencies sent a joint letter to approximately 130 hospital systems and telehealth providers warning them about “serious privacy and security risks related to the use of online tracking technologies” such ad Google Analytics and Meta/Facebook Pixel. That letter was subsequently shared publicly and should be reviewed by any entity subject to regulation by either agency.   

Washington greatly expanded the protection for consumers’ identifiable health information by enacting the “My Health My Data Act” (MHMDA), in an effort to close the gap between HIPAA protections and the laws protecting the privacy and security of other consumer health care data. While MHMDA resembles the acts in both California and Illinois, it broadly applies to health information outside of traditional health care settings. In this article we answer frequently asked questions about MHMDA’s applicability and requirements.

Washington greatly expanded the protection for consumers’ identifiable health information by enacting the “My Health My Data Act” (MHMDA), in an effort to close the gap between HIPAA protections and the laws protecting the privacy and security of other consumer health care data. While MHMDA resembles the California Consumer Privacy Act as amended by the California Privacy Rights Act (CCPA) and the Illinois Biometric Information Privacy Act (BIPA), it broadly applies to health information outside of traditional health care settings. Regulated Entities should consider undertaking additional steps that we outline now to prepare for the March 31, 2024, and June 30, 2024 (small businesses) compliance deadlines.

Governor Gavin Newsom signed multiple pieces of mental health treatment-related legislation into law in 2022 that have or will begin to go into effect this year. These laws address mental health commitment timing and hearing rights, involuntary mental health treatment, the CARE program, and substance use disorder treatment client rights. This is a good time for relevant facilities and groups to audit the effectiveness of updated policies and evaluate and address any operational issues that may have cropped up during implementation.

Although DOJ and the Office of the Inspector General for the Department of Health and Human Services have joint authority to promulgate regulations implementing EKRA, we do not anticipate the publication of any such regulations. Based on the current enforcement activity and court decisions, we recommend recovery homes, clinical treatment facilities, and laboratories perform a risk assessment of employee compensation arrangements and update as necessary; conduct fair market value assessments of service arrangements; and train staff regarding the requirements of EKRA.