April 4, 2014
Patients of Kevin Pho, a primary care physician in Nashua, NH, increasingly use health apps on their mobile devices. Many of these apps track health metrics, such as weight or calories eaten, while others go a step further and help patients make sense of their symptoms or suggest diagnoses.
By 2015, an estimated 500 million people worldwide will use a health app, turning the industry into a $26 billion business by 2017. Despite the promise of these apps, he’s not ready to recommend them to my patients. The sheer number of health apps is staggering, with more than 40,000 apps categorized as "health and fitness" or "medical" in Apple's app store alone.
But how many are actually useful? An analysis by the IMS Institute for Healthcare Informatics found that only about 40% of those apps—16,000—are "truly related to health care" and oriented toward the consumer patient. Of those, two-thirds offered patients legitimate medical information.
On Google Play, half of health apps are downloaded fewer than 500 times. Five apps accounted for nearly 15% of all downloads.
The Food and Drug Administration is trying to get a handle on the effectiveness and safety of these apps. For now, the FDA says apps that meet the definition of a medical device will need FDA approval—for example, a mobile app that can be used as an electrocardiography machine.
But this, obviously, leaves tens of thousands of other medical apps unregulated, which should raise some safety concerns:
Danger of misdiagnoses. Consider those apps that claim to diagnose melanoma, a lethal form of skin cancer, by taking pictures of suspicious moles and analyzing them. A study from the Journal of the American Medical Association Dermatology looked at four apps and found that three misread actual melanomas as "unconcerning" 30% of the time.
No scientific evidence. One study looked at all cancer-related apps and found that almost half did not contain scientifically validated data.
Lack of doctor involvement. Another study found that only 13 of 49 apps intended to help educate and treat patients with peripheral vascular disease involved any medical professional in its content or design.
Privacy concerns. Medical apps are not bound by strict privacy laws, and therefore sensitive patient information might be shared with advertisers. The non-profit Privacy Rights Clearinghouse found that 72% of free and paid medical apps had security and privacy risks.
Health and Human Services Secretary Kathleen Sebelius sees a future where control over patients' health will be within hand's reach. FDA-approved apps, such as those that allow diabetics to monitor sugar readings, are positive first steps. But reaching Sebelius' vision requires testing more apps in clinical trials to prove their effectiveness, and ensuring they adhere to strict privacy regulations. Only then will more physicians recommend them to patients and the true potential of health apps be realized.
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