WASHINGTON, DC (August 8, 2017): Health IT Now – a broad-based coalition of patient groups, provider organizations, employers, and payers supporting health information technology to improve patient outcomes – sent a letter to Food & Drug Administration (FDA) Commissioner Scott Gottlieb outlining the advocacy group’s priorities for implementation of the 21st Century Cures Act, including:
Third-Party Certification: In the letter, HITN asserts its strong support for “a streamlined approval process for health IT products classified as medical devices,” noting that such products have rapid development and update cycles. HITN praised the FDA’s Pre-Cert for Software Program and urged FDA to implement the pilot program in a manner that “promotes certainty and reduces duplication, lowers costs, promotes the use of standards across the market, and creates incentives to standardize technologies to guarantee data integrity while reducing potential risks to end users.”
Real-World Evidence: HITN emphasizes its support for the use of real-world evidence (RWE) in both post-market surveillance and pre-market regulatory decision making, writing that “Ultimately, it will be up to the FDA to decide whether and in what circumstances RWE can be used. However, removing some of the ambiguity from the process would create efficiencies in the process itself that we hope might lead to greater recognition and use of reliable sources of RWE.”
Preclinical Innovation: HITN urges the FDA to include preclinical innovation as a subject in its statutorily required public meeting and subsequent guidance document on novel clinical trial designs, noting “It would be a missed opportunity for the FDA and stakeholders to not include the transformative potential of technology in the entire drug development process, including preclinical testing.”
About Health IT Now: Health IT Now (HITN) is a broad-based coalition of patient groups, provider organizations, employers, and payers that support incentives to deploy health information technology to improve care, patient outcomes, and to lower costs. Learn more at www.healthitnow.org.