Food and Drug Administration Safety and Innovation Act (FDASIA)

July 7, 2014

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 biomedical and health informatics and is dedicated to the development and application of informatics in support of patient care, public health, teaching, research, administration, and related policy.

AMIA’s goals work to enhance health and healthcare delivery through the transformative use of information and communications technology. AMIA’s 4,000 members work throughout the health system in various clinical care, research, academic, government, and commercial organizations. Through their work, our members advance the use of health information and communications technology in clinical care and clinical research, personal health management, public and population health, and translational science with the ultimate objective of improving health.