If you are using smartphone apps that act as blood sugar monitors or digital stethoscopes, that may soon change. The Food and Drug Administration is aiming to regulate these medical assistants in a similar manner to ultrasound machines and heart stents. According to the FDA, such applications could pose a potential risk to users and soon may have to meet FDA medical devices standards before being approved for use.
The regulations target a digital market that Ilkka Korhonen, a former senior manager of Nokia Corp.’s wellness business program, estimates may climb to $6 billion in 2015.
“This area is growing exponentially,’’ said Bakul Patel, an FDA adviser. “We’re looking at the mobile applications that would pose a risk if they didn’t work as intended.’’