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submitted to the Food & Drug Administration (FDA) today, the American Medical Informatics Association (AMIA) said new draft guidance is well-timed to initiate a broad discussion over the future of clinical decision support (CDS) and patient decision support (PDS) software.
Under the 21st Century Cures Act, the Office of the National Coordinator for Health IT (ONC) is supposed to implement an EHR reporting program. However, recent budget proposals would cut ONC’s funding – something ONC officials have said would prevent them from fully implementing this safety provision. The Cures Act […]
In response to a request for information (RFI) from the National Library of Medicine (NLM), AMIA detailed numerous key challenges and opportunities for data science in health and biomedicine. AMIA further provided policy and research ideas in support of the NLM fulfilling a 2015 Advisory Committee recommendation to become the […]
AMIA provided comments to a VA proposed rule that would allow its providers to furnish telehealth services, regardless of the state or location where they or the beneficiary is physically located. AMIA supported the proposal, while emphasizing that any telehealth applications use nationally recognized health IT standards and enable use […]
In comments submitted to the National Library of Medicine, AMIA said members envision a future where NLM leads the medical and research enterprise in demonstrating how real-world and “big” health data can be leveraged to develop new concepts of human disease, design novel therapies, and train future clinicians and researchers.
In comments submitted to PCORI, AMIA voiced strong support for its draft Data Sharing Policy for awardees. AMIA recommended that suggested that PCORI consider requiring a preliminary data sharing plan as part of award applications, and earmarking specified amounts of grant funding for data preparation and curation, among other recommendations.
In comments submitted to the NIH, AMIA called for change to its Data Sharing policy in order to ensure that research data can be systematically and strategically collected, managed and shared. Specifically, AMIA recommended that Data Sharing Plans be subject to peer-review and made scorable elements of applicable grants.
In comments submitted to the FDA, AMIA supported the use of real-world data and real-world evidence to support regulatory decision-making for medical devices.
In comments submitted September 29, AMIA recommend several ways the NIH could assess the value of biomedical digital repositories and knowledgebases. The metrics span categories related to "utilization" and "impact" to "service quality" and "governance." AMIA recommended another category be included relate to data quality and data completeness.
In conjunction with a public meeting held by the FDA August 15, 2016, AMIA submitted public comments supporting the direction of the its Prescription Drug User Fee Agreement Commitment Letter. Specifically, AMIA supports FDA’s work to utilize Real World Evidence in regulatory decision-making, incorporating the patient’s voice in drug development […]