Statement from FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., on new steps to advance digital health policies that encourage innovation and enable efficient and modern regulatory oversight

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Statement from FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., on new steps to advance digital health policies that encourage innovation and enable efficient and modern regulatory oversight

Today, the U.S. Food and Drug Administration released a suite of guidances to continue to encourage innovative approaches to the development of digital health tools, and to ensure the agency’s approach to overseeing these technologies advances along with it. Patients, their families and their health care professionals are increasingly embracing digital health technologies to inform everyday decisions, from tools that more easily report blood glucose levels to smart watches that can detect atrial fibrillation. These tools provide patients with a wealth of easily-accessible information that can help them make better and more efficient decisions, take steps to improve their lifestyles and health choices, and experience better outcomes. We believe that an appropriate regulatory framework that takes into account the realities of how technology advances plays a crucial role in the...

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