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AMIA Response to FDA Draft Guidance on the Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics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

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 […]

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 […]