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The FDA has decided will not regulate health apps designed to collect disease information. They're not ready to be useful for rheumatology. Nonetheless, your patients are undoubtedly using them.
Want advice about the best mobile apps for your patients with rheumatic disease? Don't look to the Food and Drug Administration (FDA).
The FDA yesterday announced in a draft document what kind of mobile devices it intends to regulate. Applications that track symptoms or fitness, or give health advice, aren't on the list.
Basically any device, including a wearable, that is noninvasive and does no physical harm is free to try its luck in the market.
Where does that leave rheumatologists and their patients? Of at least 100,000 health-related apps are on the market, only a handful are designed for rheumatologic conditions. And these few don't meet the mark for rheumatology.
“Right now, there aren’t many must-have apps for rheumatology, though a lot are under development and will gain more prominence over time,” Simon Helfgott MD, associate professor of rheumatology at Brigham & Women’s Hospital, told Rheumatology Network. “The problem is that a lot of what we measure in rheumatology isn’t easily quantifiable.”
What you can glean out of data from an app is going to be "narrow and limited for at least the next 4 or 5 years," he added.
Why aren't current apps useful for rheumatology? Speakers in a panel about these devices at the 2014 Annual College of Rheumatology meeting gave several reasons
They don't include useful measures: Few include "gold standard outcomes" in rheumatology, such as the health assessment questionnaire (HAQ), said Maura D. Iversen PT, head of physical therapy department at Northeastern University in Boston. (She's working on one.)
There's no guidance as to quality of content, security, functionality, and usefulness, observed Elizabeth Breeden PharmD, Assistant Professor of Pharmacy Practice at Lipscomb University in Nashville. (She expressed hope for evidence-based assessment from FDA last November, but that now looks unlikely.)
There's no solid information about outcomes: We don't know whether the devices are either accurate or effective in motivating patients, observed Linda C. Li PhD PT, Associate Professor Arthritis Research Centre of Canada in Richmond BC.
They aren't integrated with electronic medical record (EMR) systems.
But you may still need to pay attention to them.
"Right now, I’m faced with a lupus patient who has 20 concerns, and now has fit tracker, and now has all her information ... and she wants me to acknowledge all that and discuss all that," said a member of the audience at the ACR session. "That’s an hour office visit, which we really cannot do and pay our bills at the end of the day."
Maybe the patient could send that information before the visit, Breeden responded. But then it would have to be entered manually into the EMR.
"It’s very much like everyone is seated at the dinner table and waiting for food, and you’re just now making the grocery list," she added.
An app that works across platforms on multiple devices with multiple EHRs is still between 5 and 10 years away, Helfgott told RheumNet.
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Matthew Fay and Whitney L.J. Howell contributed information for this article.