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Health IT Now Responds to FDA Digital Health Pre-Certification Pilot Program Announcement

WASHINGTON, DC (July 27, 2017): Health IT Now – a broad-based coalition of patient groups, provider organizations, employers, and payers supporting health information technology to improve patient outcomes – welcomed the Food & Drug Administration’s (FDA) newly announced Pre-Cert for Software Pilot Program. 

Health IT Now previously advocated for the successful inclusion of provisions from the MEDTECH Act in the 21st Century Cures law, which removes certain low-risk health software from FDA jurisdiction.

HITN Executive Director Joel White released the following statement: 

“The FDA’s pre-certification program will test whether low risk software should get expedited review. If done well, this program has the potential to provide clarity and a fast track process to new consumer and patient applications. This should encourage more product development and more investment in patient tools that will improve health. We want to reward excellence and ease approval burdens on developers,” said Health IT Now Executive Director Joel White. “We know that it is entirely possible to maintain the FDA’s gold standard when it comes to reviewing new medical technology, while also speeding the process of bringing these devices to market. While several key details have yet to be announced, it appears this pilot program may strike that balance.” 

White continued, “By allowing proven, trusted developers to use a more streamlined submission process, our nation’s digital health device and software manufacturers can spend more time engineering new product and less time worrying about regulatory hurdles. Health IT Now thanks Commissioner Gottlieb for his commitment to a modernized, 21st century FDA and we look forward to our continued work together to ensure the appropriate, fair regulation of health IT.” 
 

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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.

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