FDA to regulate some medical-related apps
Instead of having all health apps follow stringent requirements, the U.S. Food and Drug Administration announced on Tuesday that it will focus its attention on mobile medical apps that might harm patients if they do not work as intended.
The organization added that most health and medical apps only pose a low risk of injury for consumers, and the majority will not be as strictly regulated.
"Some mobile apps carry minimal risks to consumer or patients, but others can carry significant risks if they do not operate correctly. The FDA's tailored policy protects patients while encouraging innovation," said Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in a press release.
Medical mobile apps can aid doctors in diagnosing patients without having them come into the office. They can also help patients manage their chronic conditions.
The FDA has received more than 100 applications for approval from app-makers in the last 10 years, and about 40 apps have gotten approved. Many more apps currently are for sale that have not been regulated by the government agency.
The FDA will be concentrating on regulating mobile medical apps that are intended to be used as an accessory to an already-regulated medical device, including apps that allow medical professionals to make diagnoses based on medical images or charts sent to them through a smartphone or mobile tablet. The agency also took a closer look at apps that turn the smartphone into a medical device, like an electrocardiography (EKG) machine that checks if a person is having abnormal heart rhythms.
"We have worked hard to strike the right balance, reviewing only the mobile apps that have the potential to harm consumers if they do not function properly," Shuren said. "Our mobile medical app policy provides app developers with the clarity needed to support the continued development of these important products."
Apps that fall into the two categories above will be reviewed using the same regulatory standards and risk-based approach that other traditional medical devices have to go through. The FDA will not regulate the sale or consumer use of smartphones or tablets, and it will not have oversight over mobile app distributors like iTunes.
Bradley Merrill Thompson, a lawyer with Epstein, Becker & Green who represents medical-device companies, told the Wall Street Journal that he applauded the FDA's regulation standards.
"They took the ambiguous area and made it much more spelled out," he said. "The usual situation with FDA is a dozen or so institutions file comments, and FDA changes a few words before finalizing the guidance document. In this case, FDA made massive changes."
He added that a lot of companies want to create medical devices, and these new regulations may give incentive for them to join the market.
One app that has been released on the market is SpiroSmart. It uses a smartphone's microphone to take lung measurements of breath capacity. This could help people with asthma, chronic obstructive pulmonary disease and cystic fibrosis check their stats, especially because home testing systems called spirometers can cost up to a few thousand dollars. Researchers at Seattle Children's and the University of Washington are seeking FDA approval for the app.
Another app and device can reportedly turn a smartphone into a handheld biosensor so people can test their food for allergens. The device, which was developed at the University of Illinois at Urbana-Champaign, uses lenses and filters on a cradle mirror to detect toxins, bacteria, spot water contamination and identify allergens. The smartphone then processes the information. The additional device contains about $200 of optical parts, but may do tests as well as a $50,000 laboratory device can.
There's also apps like HealthTap, which connects users with medical professionals so they can ask pressing medical questions from wherever they are located. In addition to free public questions, the app allows people to send in test results for a small fee so doctors can provide a more detailed medical explanation.
Dr. Joseph M. Smith, chief medical and science officer at West Health Institute, a nonprofit medical research organization, echoed Thompson's approval to the New York Times.
"This is very welcome news for the innovator and investment community," Smith said.
