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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).

Learn more about the comment process

AMIA responses are arranged by Federal Agency and Congressional Committee.

Showing 11 - 20 out of 23

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 Comments on NIST Usability Guidance

November 10, 2011

AMIA acknowledged NIST’s efforts to highlight the importance of usability testing for electronic health records (EHRs) through its issuance of the proposed guidance. AMIA expressed concerns about several aspects of the draft guidance including the following: a limited and narrow identification of EHR users; the need to consider more comprehensive […]

AMIA Comments on FDA Mobile Medical Apps Draft Guidance

October 19, 2011

AMIA recently issued comments in response to a U.S. Food and Drug Administration (FDA) draft guidance on mobile medical applications. In the comments, AMIA president Ted Shortliffe noted, among other things, the need for additional clarification, definitions, terms, and terminology in the guidance. Click below to read AMIA's full comments.

AMIA Identifies Areas to Strengthen Federal Health IT Strategic Plan

May 6, 2011

AMIA has weighed in on the Federal Health IT Strategic Plan in response to the HHS Office of the National Coordinator’s (ONC) call for comments on the overarching strategy for realizing health IT goals set forth by the U.S. Congress and the Administration. AMIA states in its comments to ONC […]