On October 30, President Joe Biden signed an Executive Order (“EO”) 14110 entitled the, “Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence,” which establishes a policy framework to manage the risks of artificial intelligence (“AI”); to direct agency action to regulate the use of health AI systems and tools; and to guide AI
Senate HELP Committee Ranking Member Requests Stakeholder Feedback on AI and Health Data Privacy and Security Policies
Last week, Ranking Member Bill Cassidy (R-LA) of the Senate Committee on Health, Education, Labor and Pensions (“HELP”) issued two separate requests for information (“RFIs”) asking for stakeholder feedback on artificial intelligence (“AI”) and health data privacy policy issues to identify current challenges and receive recommendations to inform potential legislation. With deadlines set for the end of September, each RFI provides a short window for organizations to submit comments.Continue Reading Senate HELP Committee Ranking Member Requests Stakeholder Feedback on AI and Health Data Privacy and Security Policies
WHO Announces Global Initiative Focused on Digital Health
On August 19, 2023, the World Health Organization (“WHO”) announced a new initiative to operationalize the implementation of the Global Strategy on Digital Health 2020-2025 and to further enable digital health system transformation. The Global Initiative on Digital Health (“GIDH”) is a WHO managed network of stakeholders organized to facilitate the implementation of WHO norms and standards for digital health system transformation and to enable a global ecosystem to promote country capacity and strengthen international cooperation in digital health. The GIDH aims to amplify recent and past gains in global digital health while strengthening mutual accountability to enhance the impact of future investments.Continue Reading WHO Announces Global Initiative Focused on Digital Health
CMS Proposes Transitional Medicare Coverage Pathway for Emerging Technologies
On June 21, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed notice with comment period outlining a transitional Medicare coverage pathway for emerging technologies through the national coverage determination (“NCD”) process in addition to several guidance documents that describe CMS’ approach to coverage reviews and evidence development, including the National Coverage Analysis Evidence Review and Clinical Endpoints Guidance: Knee Osteoarthritis.Continue Reading CMS Proposes Transitional Medicare Coverage Pathway for Emerging Technologies
CMS Announces New Demonstration Model Focused on Primary Care
On June 8, 2023, the Centers for Medicare & Medicaid Services (“CMS”) announced a new Center for Medicare and Medicaid Innovation (“the Innovation Center”) model focused on improving access to primary care and advancing care management and care coordination.Continue Reading CMS Announces New Demonstration Model Focused on Primary Care
Coalition for Health AI Introduces Blueprint for Trustworthy AI in Healthcare
On April 4, The Coalition for Health AI (“CHAI”) released the “Blueprint for Trustworthy AI Implementation Guidance and Assurance for Healthcare,” (“CHAI Blueprint”) which addresses the lack of industry-accepted standard governing the development and implementation of artificial intelligence (“AI”) tools in health care, outlines key elements to establish standards on trustworthy AI, issues recommendations for health systems to deploy AI tools in clinical settings, and proposes specifications to be included in a potential assurance standards guide.Continue Reading Coalition for Health AI Introduces Blueprint for Trustworthy AI in Healthcare
FTC Continues to Enforce Against Data Practices of Healthcare Apps
The Federal Trade Commission (“FTC”) has taken a number of actions this year against healthcare apps based on data practices that FTC alleges are a violation of federal law. The latest enforcement action, on May 17, 2023, is against Easy Healthcare Corporation (“Easy Healthcare”), which operates the Premom ovulation tracker application (“Premom”), for allegedly violating
AI in Health Care: AI Bill of Rights, Future Regulations, and What Business Should Consider Now
Rapid developments and competition in artificial intelligence (AI) will drive proliferation of new AI technologies in health care in the coming years, along with a number of legal and ethical issues.
ChatGPT 3.5 created a huge splash, rife with controversy, when it was released in November 2022. Launched by the San Francisco-based startup OpenAI, ChatGPT is a natural language processing (NLP) model (a type of machine learning (ML)), that automatically learns and recognizes patterns. ChatGPT uses a neural network architecture to generate human-sounding responses to questions, providing users with large amounts of potentially useful information in seconds. According to a recent review, ChatGPT demonstrated that it was capable of passing all three parts of the U.S. Medical Licensing Exam (USMLE), which tests medical students on topics including the basic sciences, clinical knowledge and patient treatment and diagnosis, without any specialized training. ChatGPT also showed proficiency in medical charting, diagnosing, and performing nonclinical tasks. OpenAI recently launched ChatGPT 4.0, which offers expanded capabilities and improved performance on various professional and academic assessments.Continue Reading AI in Health Care: AI Bill of Rights, Future Regulations, and What Business Should Consider Now
Clinicians Request Continued Medicare Coverage of Remote Patient Monitoring Services at Contractor Advisory Committee Meeting
On February 28, Medicare Administrative Contractors (MACs) contractors—Novitas Solutions (Jurisdictions H and L), First Coast Service Options (Jurisdiction N), Noridian Healthcare Solutions (Jurisdictions E and F), CGS Administrators (Jurisdiction 15), Palmetto GBA (Jurisdictions J and M), and WPS Government Health Administrators (Jurisdictions 5 and 8)—held a multi-jurisdictional Contractor Advisory Committee (CAC) meeting to obtain feedback