WASHINGTON – Home health technology industry leaders believe the U.S. Food and Drug Administration’s proposed regulation around mobile medical apps is a step in the right direction.
“With the significant increase in the adoption of mobile health care apps, it is necessary to have regulated guidelines and the oversight to ensure the safety and effectiveness of medical devices—including mobile medical apps,” said Leena Palav, senior vice president and chief compliance officer at AMC Health, a provider of remote monitoring solutions. “But in order for these regulations to have the greatest impact, we need to ensure that the digital health guidelines are not released in isolation because this can be confusing to the industry.”
Dr. Scott Gottlieb, FDA Commissioner, said in a viewpoint published this month in JAMA that regulation can encourage development and utilization of mobile medical apps. He said that the health care industry has historically been slow to implement disruptive technology tools, in part because of uncertainty surrounding regulation.
To address the issue, the agency released a Digital Innovation Plan last year, which included plans for a pilot program that would allow makers of low-risk software-based medical devices to self-certify their products and avoid the traditional premarket review process. Nine companies including Apple, Fitbit and Johnson & Johnson were selected to participate in the pilot, which is expected to start next year.
The FDA also announced plans to not regulate mobile apps intended to maintain or encourage healthy living.
“For the sake of patient safety, we believe any digital solution used to diagnose and/or treat a medical condition should be held to a regulatory standard,” said Larissa D’Andrea, senior director of government affairs at sleep solutions provider ResMed. “If done right, such regulation will instill greater patient and provider confidence in connected health solutions and encourage their adoption.”