SOURCE: Kalorama Information

Kalorama Information

July 28, 2011 10:08 ET

Proposed FDA Regulations "Appear Reasonable" for EMR and Mobile App Companies: Kalorama

NEW YORK, NY--(Marketwire - Jul 28, 2011) - The relatively easy touch with which the Food and Drug Administration 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 accelerated growth rates in this segment of the mobile apps industry.

The agency 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. This means they are not considered high risk. For example, mobile medical apps that record or track fitness information would be Class I.

"I think you'll hear a sigh of relief from the makers of medical applications for iPads and smart phones," 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. Or those 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.

More information on the industry, including market forecasts and competitor profiles, can be found in Kalorama Information's "Worldwide Market for Mobile Medical Apps." Information on this title can be found at Kalorama Information's website at:

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Kalorama Information supplies the latest in independent medical market research in diagnostics, biotech, pharmaceuticals, medical devices and healthcare; as well as a full range of custom research services. We routinely assist the media with healthcare topics. Follow us on Twitter ( and LinkedIn (

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