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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 41 - 50 out of 92

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AMIA Response to FDA Draft Guidance on the Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics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

AMIA Response to ONC Request for Information on Interoperability Measurement

May 24, 2016

On May 23, 2016, AMIA submitted comments to the Office of the National Coordinator recommending they develop a patient-centric approach to measuring nationwide health IT interoperability.  As part of this recommendation, AMIA described a new methodology and approach to measuring interoperability that they said should be developed immediately.  AMIA also […]

Statement on the Improving Health Information Technology Act of 2015 Legislation

February 9, 2016

The following statement was released today by Douglas B. Fridsma, M.D., PhD., FACP, FACMI, President and CEO, American Medical Informatics Association (AMIA).

AMIA appreciates the work and bipartisanship demonstrated by Chairman Alexander, Ranking Member Murray and the entire HELP Committee in crafting the Improving Health Information Technology Act of 2015 […]