Are Health Apps the Cure for Anything That Ails You?
Currently health apps do not have to pass any standards for scientific validity. In fact, some could be harmful!
This article gives an overview of current regulation and evaluation efforts by the government, medical societies, and others.
Excerpts from the Health Care Blog item Are Health Apps the Cure for Anything That Ails You?
With about 9,000 consumer health apps currently available in the iTunes store, it seems like almost all smart phone users can download their way to better health these days.
“Apple isn’t testing apps for their scientific validity,” said Dan Cohen, a social worker who has reviewed apps for their effectiveness.
Given the stakes, it’s no surprise that the government is starting to regulate these smart phone applications. Just last month, the Federal Trade Commission brought its first cases against the makers of two health apps. Each claimed to cure acne with colored lights emitted from cell phones.
“Smart phones make our lives easier in countless ways, but unfortunately when it comes to curing acne, there’s no app for that,” the FTC chairman said, when announcing the crackdown. The agency cited the makers of AcneApp, which had sold about 11,600 downloads of its $1.99 app, and the developers of AcnePwner, which sold 3,300 downloads of its 99 cent app.
The Food and Drug Administration (FDA), meanwhile, proposed regulations this summer for apps that could be considered medical devices. The agency, which sought comments on its proposals until Oct. 19, may focus on apps that are accessories to established medical devices used by doctors, such as smart phone apps that can display X-rays.
It could also regulate apps that transform smart phones into medical devices by using sensors or other attachments. Already, the FDA has approved gadgets that turn smart phones into blood pressure-monitoring cuffs and pocket ultrasound machines.
Apps that connect to consumer devices, such as blood glucose meters, may be regulated, too, if the apps display or analyze the meters’ readings, the FDA says.
The majority of health apps will almost certainly not be considered medical devices and will escape government scrutiny. But some app developers are voluntarily going through the laborious FDA clearance process, in part, to convince the medical community that their products have real clinical value.
WellDoc, a Baltimore-based health care company, got FDA approval last year for its DiabetesManager, which provides automated diabetes coaching for patients. The app also was tested in a randomized clinical trial conducted by the University of Maryland’s medical school, which found that patients had a statistically significant improvement in their blood glucose levels after using the app for a one-year period.
Scientists have found flaws with other apps.
When a George Washington University professor conducted the first content analysis of behavior-modification apps, she discovered that few of the 47 smoking-cessation apps available in 2009 followed evidence-based health guidelines. Lorien Abroms, a public health professor, concluded that the apps had “serious weaknesses” because they did not link to quit lines or clinics or suggest ways for smokers to get social support from family and friends.
- Smartphone Apps Can’t Cure Acne (bellasugar.com)
- FDA Proposes Health ‘App’ Guidelines (jflahiff.wordpress.com)
- FTC Charges mHealth Apps With False Advertising – No Scientific Evidence for Curing Acne So There’s Not An App for That (ducknetweb.blogspot.com)
- FTC Approves Final Settlement Orders Against Marketers Who Claimed Their Mobile Apps Could Cure Acne (ftc.gov)
- Should Mobile Medical Apps Require FDA Approval? (informationweek.com)
- FDA Review of Some Medical Apps May Be Increased (socialtimes.com)
- Is It Really FDA Approved? (everydayhealth.com)
- Mobile Medical Apps Supervision By FDA, Agency Seeking Input (medicalnewstoday.com)
- FTC: Smartphone apps do not cure acne (news.consumerreports.org)
- Can the iPad cure what ails us? (macworld.com)
- Apps for What Ails You (technologyreview.in)
- FDA will have a plan for healthcare mobile apps in 2012. In the meantime… (medcitynews.com)
No comments yet.