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).
Learn more about the comment process
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 […]
In comments submitted to the Centers for Medicare & Medicaid Services (CMS), AMIA recommended a phased approach for making payer and insurance plan data available through open application programming interfaces (APIs) to beneficiaries. AMIA also called on the CMS Innovation Center (CMMI) to develop new models to provide structural funding […]
In comments submitted to ONC and CMS, AMIA recommended that the Department of Health and Human Services orient its documentation burden reduction strategy towards a long-term goal of decoupling clinical documentation from billing, regulatory, and administrative compliance requirements. AMIA highlighted the unique opportunity to leverage informatics tools and methodologies to […]
In response to a Request for Information from the Centers for Disease Control and Prevention, AMIA urged HHS officials to focus on narrow use cases, such as CDS or eCQMs, when conceptualizing a national collaborative for health IT testing. AMIA also outlined the pros/cons of focusing on CDS versus eCQMs […]
AMIA strongly encouraged the Trump administration to leverage an existing strategy on Artificial Intelligence Research and Development (AI R&D), rather than begin from scratch. It additionally emphasized a need for federal investments in areas of strong societal importance not aimed at consumer markets, especially related to human-AI collaboration and the […]
In comments submitted to the Office of the National Coordinator for Health IT (ONC), the AMIA questioned the constrained scope of the EHR Reporting Program, strongly recommending that it measure performance to improve CEHRT security, interoperability, and usability, and not be used simply to provide data for “acquisition decision makers.”
In response to the CMS CY2019 Physician Fee Schedule NPRM, AMIA applauded federal officials for aligning physician and hospital EHR requirements and advancing policies that further incentivize the adoption of health IT for patient care. AMIA also supported CMS efforts to reduce documentation burden through new options to use time […]
In response to an HHS request for information on the creation of a new Healthcare Sector Innovation and Investment Workgroup, AMIA strongly recommended the inclusion of representatives of the health informatics community. Additionally, AMIA called for HHS to orient the Workgroup towards innovating and investing in areas that are strategically […]
AMIA responded to an FDA request for input with a preliminary review of relevant research into the specific benefits and risks to health associated with software functions that the 21st Century Cures Act excluded from the definition of medical device. While some health IT applications to healthcare delivery have unambiguously […]
In comments submitted to the Food & Drug Administration (FDA) today, the American Medical Informatics Association (AMIA) said new draft guidance is well-timed to initiate a broad discussion over the future of clinical decision support (CDS) and patient decision support (PDS) software.