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).
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AMIA responses are arranged by Federal Agency and Congressional Committee.
In comments submitted to officials from four federal agencies, AMIA supported the continued development of the Federal Data Strategy. AMIA reiterated the support that it lent to the first draft Strategy in 2018, while making several additional recommendations, including the creation of an OMB Data Council, the development of […]
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 Office of the National Coordinator for Health Information Technology (ONC), AMIA applauded the agency on its thoughtful and thorough “21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program proposed rule.” AMIA advised ONC to establish an overall “share now, standardize […]
In comments submitted to the Department of Health & Human Services (HHS) Office of Civil Rights (OCR), AMIA recommended that the Office ensure that HIPAA both requires and permits information-sharing upon patient and clinician request, as well as robust penalties for failing to deliver data pursuant to the patient “right […]
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 […]
In comments submitted to the NIH, AMIA supported an expansive update to its 2003 data sharing policy, recommending a phased approach to implement new data management and sharing requirements for NIH-funded research. It also noted that quality data management and sharing plans are prerequisite to the NIH’s goals of making […]
Partnering with AHIMA, AMIA recommended that policymakers modernize HIPAA by either establishing a new term, “Health Data Set,” which includes all clinical, biomedical, and claims data maintained by a Covered Entity or Business Associate, or by revising the existing HIPAA “Designated Record Set” definition and require Certified Health IT to […]
In response to a Request for Comment from the National Telecommunications and Information Administration, AMIA urged the administration to seek harmonization of federal data privacy policies, while also ensuring that consumer access to and control over his or her data be the baseline for its policies.
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.”