AMIA’s goal is to improve the legislative and regulatory environment for health informatics research, practice and education through AMIA member expertise. The primary pathway through which AMIA achieves this goal is by engaging Federal Agencies and Congress on public calls for input, such as Notices of Proposed Rulemakings (NPRMs) or Request for Information (RFIs). Below, AMIA responses are arranged by Federal Agency and Congressional Committee.
In comments submitted this week to the U.S. Food and Drug Administration (FDA), the nation’s informatics professionals applauded the agency for developing a regulatory Modification Framework for Artificial Intelligence (AI)/Machine Learning (ML)-based software as a medical device (SaMD). The American Medical Informatics Association (AMIA) offered additional observations and recommendations for […]