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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 88

AMIA Response to FDA Draft Guidance on the Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics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

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 […]

AMIA Response to CMS Stage 3 Open Comment Period

December 14, 2015

On December 14, AMIA submitted comments to CMS regarding the need to redesign Meaningful Use (MU) in the face of changing reimbursement models.  Specifically, AMIA asked regulators to change MU requirements to better align with programs required by the Medicare Access and CHIP Reauthorization Act (MACRA) of 2015.