AMIA Public Comments

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.

Regulatory Comments

In comments submitted to the FDA, AMIA supported the use of real-world data and real-world evidence to support regulatory decision-making for medical devices.
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...
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...
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...
In comments submitted to CMS, AMIA recommend CMS proceed with proposals for a 90-day reporting period for hospitals in 2016, and it supported policies that are meant to align requirements for hospitals participating in MU with requirements for clinicians participating in MIPS.

Congressional Comments

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...
On January 11, 2016, AMIA submitted comments to the National Qualify Forum’s Health IT Safety Committee, supporting the framework and newly-developed domains to measure the safety and safe use of health IT.  Numerous AMIA members participated in this effort, and AMIA believes these measures should...
AMIA Comments on Proposed Risk-Based Regulatory Framework and Strategy for Health Information Technology Report On behalf of the American Medical Informatics Association (AMIA), I am pleased to submit these comments in response to the above-referenced request. AMIA is the professional home for...