The California Senate on Feb. 12, 2025, introduced SB351 – a bill nearly identical to a portion of AB3129 from the previous legislative session. The bill, largely aimed at codifying corporate practice of medicine (CPOM) and...more
The U.S. Drug Enforcement Agency (DEA) announced on Jan. 16, 2025, three new rules intended to implement patient protections and permanently extend certain COVID-era telemedicine prescription flexibilities. These new rules...more
The U.S. Drug Enforcement Agency Administration (DEA) and U.S. Department of Health and Human Services (HHS) (collectively, the Agencies) on Nov. 11, 2024, issued a third extension of their telemedicine flexibilities for the...more
Holland & Knight hosted a virtual roundtable discussion on Nov. 4, 2024, with an esteemed panel featuring Sheila Tatayon, assistant deputy director of Health Systems Compliance and chief counsel for California's Office of...more
11/11/2024
/ Administrative Agencies ,
Administrative Procedure ,
Administrative Review ,
Approval Requirements ,
Confidential Information ,
Corporate Practice of Medicine ,
Corporate Sales Transactions ,
Health Care Providers ,
Material Change Doctrine ,
New Legislation ,
Reporting Requirements
With the surge of artificial intelligence (AI) development in recent years, state legislatures, including California's, have contemplated how to balance patient safety and quality of care with the need for and expectation of...more
10/11/2024
/ Artificial Intelligence ,
Consumer Protection Laws ,
Electronic Communications ,
Governor Newsom ,
Governor Vetoes ,
Health Care Providers ,
Health Insurance ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Hospitals ,
Machine Learning ,
New Legislation ,
Patient Privacy Rights ,
Physicians ,
Regulatory Oversight ,
Standard of Review
California Gov. Gavin Newsom on Sept. 28, 2024, vetoed Assembly Bill (AB) 3129, a law that would have required private equity and hedge funds – and in some cases, their platform companies – to obtain the California Attorney...more
The U.S. Food and Drug Administration's (FDA) March 21, 2024, warning letter to Agena Bioscience Inc. (Agena), a genetic diagnostic test developer, generated a lot of immediate commentary among regulatory lawyers and...more
9/17/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
CLIA ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Enforcement Priorities ,
Final Rules ,
Food and Drug Administration (FDA) ,
Genetic Materials ,
Genetic Testing ,
Inspections ,
Laboratory Developed Tests ,
Life Sciences ,
OIG ,
Pharmaceutical Industry ,
Social Security Act ,
Warning Letters ,
Work Plans
For most healthcare providers and businesses, signing a Business Associate Agreement (BAA) is a standard practice. When contracting to provide services with an entity governed by the Health Insurance Portability and...more
8/22/2024
/ Business Associates ,
Business Associates Agreement (BAA) ,
Contract Drafting ,
Contract Negotiations ,
Contract Terms ,
Covered Entities ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Security Rule ,
OCR ,
PHI ,
Standard Form Contracts
There will be no statewide ban on the "friendly physician model" directly coming out of the Envision Healthcare Corp. (Envision) lawsuit in California. In this lawsuit, American Academy of Emergency Medicine Physician Group...more
From the West Coast Healthcare Desk is an ongoing series of Holland & Knight Healthcare Blog articles and alerts focused on healthcare industry developments and points of interest in the West Coast healthcare marketplace....more
6/25/2024
/ Business Operations ,
Contract Management ,
Contract Terms ,
Corporate Practice of Medicine ,
Health Care Providers ,
Healthcare Facilities ,
Investment Opportunities ,
Investors ,
Physicians ,
Private Equity ,
Private Equity Firms ,
Proposed Legislation
From the West Coast Healthcare Desk is an ongoing series of Holland & Knight Healthcare Blog articles and alerts focused on healthcare industry developments and points of interest in the West Coast healthcare marketplace....more