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 HHS March 19, 2018, AMIA recommended that HHS proceed swiftly with implementation of revisions to the Common Rule, known as the 2018 Requirements. AMIA recommended that 2018 Requirements be made effective July 19, 2018 and that the compliance date be set as January 19, 2019. This […]
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submitted to the Food & Drug Administration (FDA) today, the American Medical Informatics Association (AMIA) said new draft guidance is well-timed to initiate a broad discussion over the future of clinical decision support (CDS) and patient decision support (PDS) software.
In response to a CMS Innovation Center request for information (RFI) on its potential new direction, AMIA offered several suggestions focusing on the interdependency of payment and delivery reforms, supported by health IT and health informatics. AMIA suggested additional guiding principles with which to approach new Innovation Center model design […]
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 Networking and Information Technology Research and Development (NITRD) Program, the nation’s leading biomedical and health informaticians applauded federal officials for developing a draft strategic framework for health IT research and development (R&D). AMIA provided a series of recommendations highlighting the need for R&D related to […]
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 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 […]