Issue Brief
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On January 6, 2025, the FDA released a 23-page draft guidance on the use of artificial intelligence (AI) in regulatory decision-making for drugs and biological products.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FAQs: FDA Draft Guidance on AI-Enabled Medical Devices
On January 6, 2025, the FDA released a 67-page draft guidance to explain what the agency will be looking for in AI products submitted for regulatory review as a medical device.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.
01/3/25
FAQs: HIPAA Security Proposed Rule
On July 10, 2024 (officially published in the Federal Register on August 5, 2024), the Office of the National Coordinator for Health IT (ONC) proposed a new rule designed to support CMS’ Advancing Interoperability and Improving Prior Authorization Processes final rule. The new proposed rule is titled “Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2).”
12/17/24
House AI Task Force Report: Healthcare Applications Chapter
In February 2024, leaders from the U.S. House of Representatives convened a bipartisan task force to present recommendations for a future AI regulatory framework. The following is a summary of the healthcare chapter of the report, relevant findings, recommendations, and who contributed to the report.
12/8/24
Project 2025: Healthcare Proposals
The Heritage Foundation, a conservative think tank, published the Project 2025 Mandate for Leadership in April 2023. It was designed as a transition plan and policy agenda for the second Trump administration, recommending broad changes to economic and social policies and an overhaul of the federal government and agencies.
08/15/24
On July 10, 2024 (officially published in the Federal Register on August 5, 2024), the Office of the National Coordinator for Health IT (ONC) proposed a new rule designed to support CMS’ Advancing Interoperability and Improving Prior Authorization Processes final rule. The new proposed rule is titled “Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2).”
07/11/24
FAQs: U.S. Supreme Court Reversal of Chevron Doctrine
On June 28, 2024, the U.S. Supreme Court issued its decision in the Loper Bright Enterprises v. Raimondo case. The decision is expected to have a dramatic impact on how federal agencies interpret congressional statutes, including health care laws.
04/29/24
FAQs: FTC Breach Notification Final Rule
On April 26, 2024, the Federal Trade Commission (FTC) updated one of its old regulations, the Health Breach Notification Rule, to strengthen privacy protections for consumers who share their personal health information on digital health apps.