The Centers for Medicare & Medicaid Services (CMS) has announced that the Center for Medicare and Medicaid Innovation is testing an outcome-aligned payment model known as the Advancing Chronic Care with Effective, Scalable...more
12/22/2025
/ APIs ,
Centers for Medicare & Medicaid Services (CMS) ,
Digital Health ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Innovation ,
Medicare ,
Payment Systems ,
Popular ,
Regulatory Requirements
On December 11, 2025, the White House issued an Executive Order (EO), “Ensuring a National Policy Framework for Artificial Intelligence,” that establishes a new federal policy on artificial intelligence (AI). The EO states...more
A significant change in California’s Office of Health Care Affordability (OHCA) transaction-notice requirements will take effect on January 1, 2026.
AB 1415 establishes new pre-closing notification requirements for...more
Artificial intelligence (AI) is increasingly being used in mental healthcare for functions such as clinical decision support, notetaking and transcription, symptom screening and triage, administrative and operational...more
10/10/2025
/ Artificial Intelligence ,
Data Privacy ,
Digital Health ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
New Legislation ,
Popular ,
Privacy Laws ,
Regulatory Requirements ,
State Legislatures
Executive Summary -
- Offering equity in MSOs to physicians can be permissible but must be structured to comply with both federal and state laws. Failure to comply with applicable fraud and abuse laws may result in civil...more
8/20/2025
/ Anti-Kickback Statute ,
Business Entities ,
Corporate Practice of Medicine ,
Fraud and Abuse ,
Healthcare Fraud ,
Investors ,
Physicians ,
Popular ,
Risk Management ,
Safe Harbors ,
Stark Law
On June 5, 2025, Nevada Governor Joe Lombardo signed AB 406, a law regulating the use of artificial intelligence (AI) for mental and behavioral healthcare. AB 406 comes as other states, such as Utah and New York, have taken...more
On June 9, 2025, Oregon enacted the most restrictive corporate practice of medicine (CPOM) law in the country (SB 951), which imposes substantial restrictions on the ownership and control of professional medical entities...more
This latest edition features articles on succeeding in the current life sciences funding market, strategic and legal considerations in digital health combinations, the corporate practice of medicine and guidance for...more
Join medical device and digital health entrepreneurs, CEOs of venture-backed companies, and business development executives from large Medtech and digital health companies, as well as angels, venture capitalists, and...more
5/8/2025
/ Acquisitions ,
Antitrust Violations ,
Artificial Intelligence ,
CEOs ,
Digital Health ,
Emerging Growth Companies ,
Equity Compensation ,
Events ,
Executive Compensation ,
Exit Strategies ,
Food and Drug Administration (FDA) ,
Innovation ,
Investors ,
Med Tech ,
Medical Devices ,
Mergers ,
Patents ,
Startups ,
Venture Capital
Branded drug manufacturers, including Eli Lilly and Company (Eli Lilly), have been pursuing various legal actions against compounding pharmacies and telehealth companies that provide compounded diabetes and weight-loss drugs,...more
On March 25, 2025, Utah Governor Spencer Cox signed HB 452, which establishes new rules for the use of artificial intelligence (AI) mental health chatbots accessible to any “Utah user,” defined as, “an individual located in...more
As digital health companies blossom from ideas into reality, navigating state regulations on the corporate practice of medicine (CPOM) is typically one of the first and most crucial legal hurdles to clear if the digital...more
On January 13, 2025, California Attorney General Rob Bonta issued a legal advisory (the Advisory) providing guidance to healthcare providers, insurers, vendors, investors, and other healthcare entities that develop, sell, and...more
2/27/2025
/ Algorithms ,
Anti-Discrimination Policies ,
Artificial Intelligence ,
Compliance ,
Consumer Protection Laws ,
Data Privacy ,
Health Care Providers ,
Machine Learning ,
Popular ,
Privacy Laws ,
State Attorneys General
Revenue cycle management companies (RCM Companies) help healthcare organizations manage billing, coding, claim submissions, and collections. Partnering with an RCM Company can enhance efficiency, accuracy, and...more
On January 15, 2025, the federal Drug Enforcement Administration (DEA) issued a notice of proposed rulemaking (NPRM) regarding prescribing controlled substances via telemedicine. The NPRM seeks to impose special registrations...more
Certain telehealth flexibilities, including geographic requirements, have officially been extended. Just before midnight on Friday, December 20, 2024, by a vote of 366-34, the U.S. House of Representatives passed the American...more
The federal Drug Enforcement Agency (DEA) and the U.S. Department of Health and Human Services (HHS) have extended COVID-19 telemedicine flexibilities for prescribing controlled substances. Until December 31, 2025, a...more
California’s 2024 legislative session has been marked with exciting developments and a clear focus on setting the rules of the road for artificial intelligence (AI), with some measures becoming law and others stalling out...more
Last weekend, California Governor Gavin Newsom vetoed Assembly Bill (AB) 3129, which would have required healthcare investors to notify and obtain written consent from the California Attorney General (AG) before investing in...more
Pre-Closing Notice or Consent: If signed by Governor Newsom, Assembly Bill 3129 (AB 3129) will mandate that, starting January 1, 2025, certain healthcare investors provide a 90-day written notice to, or obtain consent from,...more
Wilson Sonsini’s 31st Annual Medical Device & Digital Health Conference will address topics of critical importance to medical device and digital health companies, including early and late-stage venture financing, partnering...more
5/15/2024
/ Acquisitions ,
Artificial Intelligence ,
Best Practices ,
Business Strategies ,
Business Valuations ,
Compensation ,
Data Privacy ,
Digital Health ,
Early Stage Companies ,
Events ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Technology ,
Innovation ,
Investment Management ,
Investment Opportunities ,
Investment Portfolios ,
Investors ,
Life Sciences ,
Med Tech ,
Medical Devices ,
Mergers ,
Reimbursements ,
Startups ,
Strategic Partnerships ,
Venture Capital
This latest issue features an article on Enliven Therapeutics’ reverse merger with Imara and concurrent financing, including an interview with Enliven co-founder and CEO Sam Kintz; a piece on trends in digital health...more
Wilson Sonsini’s 30th Annual Medical Device Digital Health Conference will address topics of critical importance to medical device and digital health companies today, including key healthcare regulatory considerations, the...more
5/24/2023
/ Acquisitions ,
Angel Investors ,
Artificial Intelligence ,
Business Development ,
Business Opportunities ,
Business Strategies ,
Business Valuations ,
Celebrity Endorsements ,
Data Privacy ,
Digital Health ,
Early Stage Companies ,
Endorsements ,
Entrepreneurs ,
Events ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Technology ,
Influencers ,
Innovation ,
Investors ,
IP Portfolio ,
Life Sciences ,
Machine Learning ,
Marketing ,
Med Tech ,
Medical Devices ,
Mergers ,
Partnerships ,
Professional Networking ,
Startups ,
Venture Capital