Issue Brief (Page 2)
07/13/25
Analysis of Patient & Caregiver Organizations’ CMS Health Tech RFI Responses
On May 13, 2025, CMS and ASTP/ONC released a 26-page Request for Information (RFI), asking the public how the federal government can use technology to transform the healthcare ecosystem and advance HHS’ commitment to Make America Healthy Again. Maverick reviewed responses from patient and caregiver organizations that cited fragmented, inaccessible data as a barrier to meaningful use of digital health tools.
06/22/25
CMS Health Tech Modernization RFI Response Analysis
On May 13, 2025, CMS and ASTP/ONC released a 26-page Request for Information (RFI), asking the public how the federal government can use technology to modernize the healthcare ecosystem. The RFI is further evidence of a highly technology-focused HHS team.
06/1/25
FAQs: The National Academy of Medicine’s Artificial Intelligence Code of Conduct
The National Academy of Medicine (NAM) published “An Artificial Intelligence Code of Conduct for Health and Medicine,” (AICC) as a guide for responsible AI development and use in health care. The AICC aligns existing principles from academic, industry, and governmental agencies into a shared set of values and commitments.
05/25/25
The Make America Healthy Again (MAHA) Commission’s Assessment on Childhood Chronic Disease
On May 22, 2025, the Make America Healthy Again (MAHA) Commission released a 68-page report on childhood chronic disease trends in the U.S. The report will serve as a framework for reshaping the federal government’s response to chronic disease, advocating for a more holistic approach to public health and individual well-being.
05/15/25
CMS’ Request for Information: Health Technology Ecosystem
On May 13, 2025, CMS released a 26-page Request for Information (RFI), asking the public how the federal government can support digital health technology to advance HHS’ commitment to Make America Healthy Again.
04/4/25
Industry-led AI Governance: Emerging Frameworks
In the absence of coordinated federal action, private stakeholders are determining how best to govern health AI solutions. This brief examines four industry-developed frameworks for assessing AI and large language models (LLMs) in healthcare.
01/20/25
On January 6, 2025, the FDA released a 23-page draft guidance on the use of artificial intelligence (AI) in regulatory decision-making for drugs and biological products.
01/19/25
FAQs: FDA Draft Guidance on AI-Enabled Medical Devices
On January 6, 2025, the FDA released a 67-page draft guidance to explain what the agency will be looking for in AI products submitted for regulatory review as a medical device. It includes regulatory expectations related to labeling, post-market performance monitoring, and the use of model cards for transparency.
01/19/25
FAQs: FDA Clinical Decision Support Software
On December 20, 2024, the FDA released FAQs on Clinical Decision Support (CDS) software regulatory pathways. These are the FDA’s seven FAQs on CDS software regulation, translated and abbreviated by the Maverick team for ease of reading.
01/3/25
Trump Administration Healthcare Leadership
The following is a brief background about each named administration leader, most of whom will require confirmation by the U.S. Senate before taking office. We also include a brief description of each agency, office, or program for which the President-elect has identified individuals to serve in key positions.