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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).  Below, AMIA responses are arranged by Federal Agency and Congressional Committee.

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AMIA Response to NLM Strategic Plan

January 31, 2017

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.

AMIA Response to CDC RFI on Clinical Decision Support

January 31, 2017

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.

AMIA Response to PCORI Data Sharing Plan

January 24, 2017

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.

AMIA Comments Regarding FDA’s Medical Device User Fee Agreement Letter (MDUFA IV)

November 2, 2016

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 […]

AMIA Response to FDA Draft Guidance on the Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics

October 6, 2016

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 […]

AMIA Response to NIH RFI on Metrics to Assess Value of Biomedical Digital Repositories

October 5, 2016

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.

AMIA Responds to Proposed Updates to Standard Occupational Classification Codes

September 27, 2016

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 […]