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Allison Kwon supports Crowell Health Solutions, a strategic consulting firm affiliated with Crowell & Moring, to help clients pursue and deliver innovative alternatives to the traditional approaches of providing and paying for health care, including through digital health, health equity, and value-based health care. She is a health care policy consultant in the Washington, D.C. office.

On November 2, Crowell hosted an in-person roundtable discussion, featuring government officials, industry experts and other stakeholders, to discuss the development of artificial intelligence (AI) and machine learning (ML) systems and tools in the healthcare sector as well as the government’s role in regulating such technology. Policy makers, thought leaders, healthcare innovators, and business executives came together for a lively and engaging conversation. Continue Reading Crowell Presents “AI and Health Care: Perspectives from Policymakers and Movers in the Industry” 

On August 18, 2023, the World Bank issued a publication entitled, “Digital-in-Health: Unlocking the Value for Everyone (“World Bank Report”),” which recommends to governments a new digital-in-health approach where digital technology and data are infused into every aspect of health systems management and health service delivery to improve individuals’ health outcomes. The stated goal of the World Bank Report is to provide governments and other stakeholders with practical guidance on how to build digital health infrastructure, regardless of a country’s digital maturity or fiscal challenges.Continue Reading World Bank Issues Digital Health Recommendations in Report

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

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.Continue Reading How President Biden’s Executive Order on Safe, Secure, and Trustworthy Artificial Intelligence Addresses Health Care

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.Continue Reading NIH Requests Information on Developing Consent Language for Research Using Digital Health Technologies

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

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

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

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