FDA Releases Guidance to Support Adoption of Digital Tools

Agency says caregivers and patients becoming more comfortable with modern approaches

Last week, the U.S. Food and Drug Administration released a suite of guidelines 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, families, and health care professionals are increasingly embracing digital health technologies to inform everyday decisions. 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 efficient development of digital health technologies,” read an FDA statement. “We’ve maintained, since we issued our Digital Health Innovation Action Plan in 2017, that our approach to regulating these novel, swiftly evolving products must foster, not inhibit, innovation.”

The plan outlined the FDA’s efforts to reimagine the approach to ensure all Americans have timely access to high-quality, safe and effective digital health products.

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