EMR and mobile medical app companies have little to fear concerning the guidelines put out by the FDA, according to healthcare market research firm Kalorama Information.
Kalorama, which studies mobile medical app markets, previously estimated an $84 million market for mobile medical apps and expects accelerated growth rates in this segment of the mobile apps industry.
The FDA announced that it will only lightly regulate apps that simply display, sort or transmit patient-specific medical data in its original format, FDA officials said. Those will be considered Class I, meaning they are not considered high risk. Examples include apps that record or track fitness information.
"I think you'll hear a sigh of relief from the makers of medical applications for iPads and smartphones," said Bruce Carlson, publisher of Kalorama Information. "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 would be those that use a smartphone or tablet to make a diagnosis by reviewing an ultrasound image off a PACS, for example. Or apps that, with the help of attachment devices, would allow the device to function as an ECG machine or a 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.
