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FDA Draft Guidance on AI-/ML-based Software

Recently, the FDA released a draft guidance entitled Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions. The FDA will hold a webinar on this draft guidance on April 13. Comments due July 3.


CMS Summary of "Make Your Voice Heard" RFI: Reducing Burden & Increasing Efficiencies

The Centers for Medicare and Medicaid Services (CMS) released a summary of results from its Make Your Voice Heard Request for Information. Check out the details.

Digital Health Technologies Framework

The FDA issued Framework for the Use of Digital Health Technologies in Drug and Biological Product Development. The Digital Health Technology (DHT) framework document aims to guide the use of DHT-derived data in regulatory decision-making for drugs and biological products.

ARPA-H Governance

Department of Health and Human Services (HHS) Secretary Xavier Becerra recently announced that ARPA-H will be exempt from the policies and requirements of the National Institutes of Health. See the Federal Register notice.

Legislation and Politics

CMS Data Breach

House Committee on Energy and Commerce Chair Cathy McMorris Rodgers (R-WA) and House Committee on Oversight and Accountability Chair James Comer (R-KY) are investigating the response of CMS to a data breach impacting personally identifiable information of nearly 254,000 Medicare beneficiaries. The breach occurred in October 2022, but CMS did not make a determination that it was a "major incident" as defined in the Federal Information Security Modernization Act, until December 2022. Find out more.

Legislation to Reform NIAID

Representative Chip Roy (R-TX) and Senator Rand Paul (R-KY) introduced legislation to eliminate the former position of Anthony Fauci, MD, as the director at the National Institute of Allergy and Infectious Diseases (NIAID). Additionally, the bills (H.R. 1768 and S. 960) would split the NIAID into three separate national research institutes each led by Senate confirmed directors limited to no more than two 5-year terms. The new structure would be comprised of: National Institute of Allergic Diseases, National Institute of Infectious Diseases, and National Institute of Immunologic Diseases. Get the details.


U.S. Senators Bill Cassidy, M.D. (R-LA) and Jeff Merkley (D-OR) introduced legislation to reform how Medicare Advantage (MA) plans assess patients' health risks. The No Unreasonable Payments, Coding, or Diagnoses for the Elderly (No UPCODE) Act is aimed to eliminate incentives for MA plans to overcharge Medicare for care. For details and the text of the legislation, read the press release.

VA EHR Overhaul

Senate leaders are poised to introduce legislation to overhaul the Department of Veterans Affairs' (VA) Electronic Health Record Modernization (EHRM) program. Senator Patty Murray (D-WA), Senator Sherrod Brown (D-OH), and Senator Jon Tester (D-MT), Chair of the Senate Committee on Veterans' Affairs, have announced their intent to introduce legislation to provide VA reforms and oversight in the implementation of a new EHRM. Read the details.

Around the Web

AMIA's Washington Download is your source for health informatics policy news and information from around the Beltway, covering action from the Hill, the Administration, and important AMIA collaborators.