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

16 Aug 2011 • by Natalie Aster

New York – 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.

Report Details:

Worldwide Market for Mobile Medical Apps

Published: December 2010
Pages: 60
Price: US$ 1,500.00

41 Million Dollar Market for Mobile Phone Medical Apps

The growing number of healthcare professionals utilizing mobile phone medical applications or "apps" in everyday business activities is contributing to rapid growth in this nascent market segment. Although much smaller than other popular mobile app segments, mobile medical apps are slowly gaining market share as revenues are expected to more than double in 2010 over 2009.

The market for mobile medical apps was worth about $41 million in 2009, which translates to about 1.5% of the total mobile app market, and Kalorama estimates 2010 sales to come in at $84.1 million. Medical apps compete for market share with very large and popular app categories such as gaming, entertainment, social networking, and navigation. Despite the higher price tag for most medical apps (averaging $15 per app), the number of downloads fall short—keeping medical apps on the lower end of revenues in comparison to other categories.

However, the use of smartphones has been rapidly expanding in the healthcare industry, since they provide a range of programs, convenience and efficiency that can't be achieved with traditional computers and pocket drug references. It was estimated that in 2004, around 25% of practicing physicians in the U.S. used a PDA or smartphone. This increased to approximately 35-40% in 2008. By 2010, more than 50% of physicians are using smartphones or PDAs on a regular basis for everyday treatment activity.

"Not only is the medical community using smartphones and their applications for basic tasks, but they report using them to complete some of the work that would have previously been done on a desktop or laptop computer," says Melissa Elder, an analyst with Kalorama Information and author of the report. "With one of the main focuses in healthcare today centered on the reduction of costs, any tool that can help medical personnel become more efficient is a boon to the industry."

Smartphone applications can be developed for numerous types of processes including education, health management, data management, health information, and other workflow processes. There are literally hundreds of thousands of apps available for smartphones users. For example, the Apple App Store offers more than 250,000 apps for its users. Within specific categories like health management, some smartphone providers offer up to 2,000 apps. These help monitor heart rates, manage diabetes, record exercise schedules, and link with larger computer systems for managing health records.

"The use of smartphones in professional healthcare is still taking shape, but some providers have seen the potential and are taking advantage of the technology," says Elder.

More information can be found in the report “Worldwide Market for Mobile Medical Apps” by Kalorama Information. The report provides a detailed overview of PDA and smartphone use in healthcare, with market size and growth estimates, leading smartphone operating systems and applications for healthcare providers, handheld device technology adoption by physicians and issues facing IT in healthcare.

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

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