The "relatively easy touch" with which the FDA has approached mobile medical apps appears "reasonable and has not surprised many," according to healthcare market research firm Kalorama Information, which studies mobile medical app markets. The firm had previously estimated an $84 million market for mobile medical apps, and expects continued growth.
The FDA announced that it will "lightly regulate" apps that simply display, sort or transmit patient-specific medical data in its original format. Those will be considered Class I, meaning they are not considered high risk. For example, mobile medical apps that record or track fitness information would be Class I.
“You’ll hear a sigh of relief from the makers of medical applications for iPads and smartphones,” said Bruce Carlson, publisher of Kalorama. “It appears that they’ve avoided treating mobile EMR systems as a medical device of a higher standard, which might have stifled innovation and made it harder for small concerns to compete. For the most part they are going to regulate you if you try to mimic a device already regulated by the FDA.”
The FDA will regulate a “small subset of mobile medical apps,” generally those that have sensors that attach to the patient or that serve as an adjunct viewer for an already-regulated system.
The type of systems that may be regulated under the proposed rules, according to the firm, would be those that use a smartphone or tablet to make a diagnosis, uch as review of an ultrasound exam or apps that, in conjunction with attachments, allow the smartphone or Tablet to function as an ECH system or glucose meter. But applications that allow doctors to read a patient’s records, help people maintain a good diet or weight or provide information will, for the most part, skip regulatory hurdles.
The FDA is seeking public input on this approach over the next 90 days and will update the guidance based on feedback received, though serious changes are not expected.