On November 2, 2023, the Centers for Medicare & Medicaid Services (“CMS”) released the calendar year (“CY”) 2024 Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems Final Rule (“CY 2024 OPPS/ASC Final Rule”). The final rule with comment period finalizes payment rates and policy changes affecting Medicare services furnished in hospital
How President Biden’s Executive Order on Safe, Secure, and Trustworthy Artificial Intelligence Addresses Health Care
On October 30, President Joe Biden signed an Executive Order (“EO”) 14110 entitled, “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 innovation across all sectors, including in the health and human services sectors. OMB simultaneously released a draft memorandum that would specifically direct department and agency action by establishing new agency requirements in AI governance, innovation, and risk management and adopting specific minimum risk management practices for uses of AI. OMB is seeking public comment on the memorandum by December 5, 2023, which includes a list of questions requesting feedback on specific issues.
NIH Requests Information on Developing Consent Language for Research Using Digital Health Technologies
On October 11, the National Institutes of Health (“NIH”) issued a request for information (“RFI”), which proposes sample language regarding the use of digital health technologies in research for inclusion in informed consent documents and requests public feedback on the utility and usability of the proposed language. Comments on the RFI are due by December 12, 2023.
How President Biden’s Executive Order on Safe, Secure, and Trustworthy Artificial Intelligence Addresses Health Care
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.
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.
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Medicaid Redetermination Flexibilities and Data Sharing Under HIPAA
The end of the COVID-19 public health emergency (PHE) has pushed government benefit programs to reassess the use of their data that will ultimately improve access to health care benefits and streamline their processes to provide health and social services. With the end of pandemic-era policies like continuous enrollment, beneficiaries have been losing coverage while states face challenges reviewing Medicaid eligibility and may benefit from data sharing across government programs. Prior to the end of the PHE, KFF estimated that between 8 million and 24 million beneficiaries would be disenrolled. As of August 23, close to 5.4 million Medicaid beneficiaries have been disenrolled; and 74% of disenrollees have had their coverage terminated due to procedural reasons (e.g. changed addresses, did not receive a form, or did not have enough information about the renewal process).[i] This means that individuals are disenrolled because they did not complete the renewal process within a specific time frame or the state has outdated contact information.
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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.
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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.
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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