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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).

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AMIA responses are arranged by Federal Agency and Congressional Committee.

Showing 31 - 40 out of 63

AMIA Applauds Flexibilities, Supports 2015 CEHRT Timeline in IPPS Proposed Rule

June 13, 2017

In comments to CMS, AMIA supported proposals to reduce the number of required quality measures and new proposed reporting period flexibilities, while also recommending additional such flexibilities for the 2018 Hospital IQR Program and the Medicare and Medicaid EHR Incentive Programs. AMIA additionally agreed with the proposed rule’s analysis that […]

AMIA Responds to FCC Notice on Broadband-Enabled Health Technology

May 24, 2017

In comments submitted to the Federal Communications Commission, AMIA recommended FCC view broadband access as a social determinant of health and pursue policies that enable patients to participate in the fast-changing mobile health ecosystem.  AMIA also recommended several potential areas of collaboration and provided a set of relevant scholarship to […]

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AMIA Response to FDA Draft Guidance on the Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics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

August 16, 2016

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 […]

AMIA Response to CMS Quality Payment Program NPRM

June 27, 2016

On June 27, 2016 AMIA submitted comments to CMS regarding proposed policies related to the new Medicare Quality Payments Program, which replaces the Sustainable Growth Rate and reforms how nearly 1.3 million clinicians are paid through Medicare.  AMIA described a set of principles and recommendations CMS should consider during implementation […]