“Patients, their families and their healthcare 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,” according to the FDA. “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.”
FDA REALIZES CRUCIAL ROLE OF DIGITAL HEALTH TECHNOLOGIES
The way the FDA regulates products is designed to foster, not inhibit, innovation, according to the agency. Its goal is to advance digital health policies that provide regulatory oversight, yet also promote the use of rapidly evolving digital products. The agency’s approach to regulating these heath tools has not changed since the release of its Digital Health Innovation Action Plan in 2017.
“Our plan outlined our efforts to reimagine the FDA’s approach to ensure all Americans have timely access to high-quality, safe and effective digital health products,” according to the agency. As part of the 2017 plan, the FDA launched several initiatives. This includes testing a digital health software precertification pilot program, called Pre-Cert, and taking steps to modernize its policies.
The new guidelines help address key provisions of the 21st Century Cures Act, according to the FDA. As part of the guidelines, the FDA provides clarity about where it sees its role in advancing safe and effective digital health technologies.
“We’ve taken the goals we were entrusted with by Congress under the Cures Act and are building on these provisions to make sure that we’re adopting the full spirit of the intent to provide a practical oversight framework that is risk based,” the FDA explained.