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 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 the Centers for Disease Control and Prevention, AMIA recommended CDC pursue activities with the notion of CDS-as-a-Service as the conceptual goal. CDC must ensure that a coordinated strategy presents stakeholders with a unified vision for how public health CDS can be leveraged, AMIA said.
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 voiced supported for several aspects of MDUFA IV meant to enhance use of consensus standards; develop patient engagement strategies and improve the science of patient input; utilize real world evidence (RWE) to improve regulatory decision-making; and development of a policy framework for Digital […]
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 to the FDA, AMIA said it supports FDA’s efforts to develop modern, flexible and adaptive regulatory approaches to the oversight of NGS-based tests as part of the Precision Medicine Initiative (PMI). This support notwithstanding, AMIA noted a lack of standards – for ontologies, metadata and other technical […]
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 HIMSS and 36 other organizations, AMIA submitted recommendations on how the Office of Management & Budget should update the Standard Occupational Classification codes, which help Federal statistical agencies understand and forecast national data on occupations. The groups strongly recommended separate codes for Health Informatics, Health IT and […]
In comments submitted to CMS, AMIA recommend CMS proceed with proposals for a 90-day reporting period for hospitals in 2016, and it supported policies that are meant to align requirements for hospitals participating in MU with requirements for clinicians participating in MIPS.