Health IT Now Statement on FDA Digital Health Innovation Plan
WASHINGTON, DC (June 15, 2017): Health IT Now – a broad-based coalition of patient groups, provider organizations, employers, and payers supporting health information technology to improve patient outcomes – responded today to the Food and Drug Administration’s (FDA) announcement of a “new Digital Health Innovation plan” to “advance policies that promote the development of safe and effective medical technologies that can help consumers improve their health.”
Health IT Now Executive Director Joel White released the following statement:
“While we are awaiting more exact details on the full scope of the FDA’s plan, the vision outlined today by Commissioner Gottlieb is deeply encouraging and shows the Commissioner intends to make good on his goal of embracing new technologies. This is all about a modern FDA that better serves the needs of patients,” said HITN Executive Director Joel White. “Health IT Now has long believed that the regulatory process for new devices and therapies must take into consideration the rapid development cycles of health IT. Through this Digital Health Innovation Plan, the FDA appears to be making a strong effort to do exactly that.”
White continued, “We urge the FDA to use real-world data in product development, expansion, and postmarket surveillance, while working to ensure that requirements on data use are clear and not burdensome for product sponsors. Finally, we encourage the FDA to consider novel uses of technology in the development process, such as organs-on-a-chip, that are already being used in preclinical predictions of human drug responses. We are excited about the FDA’s Digital Health Innovation Plan because it holds great potential to ensure that the health IT policies of today are suited to accommodate the innovations of tomorrow.”
About Health IT Now: Health IT Now (HITN) is a broad-based coalition of patient groups, provider organizations, employers, and payers that supports incentives to deploy health information technology to improve care, patient outcomes, and to lower costs. Learn more at www.healthitnow.org.