- Top Health and Fitness iPhone Apps (by Art Writ, MD)
- mobilehealth news (an industry blog)
- [Free Webinar] What Makes a Health App Effective?
- When is a Mobile App a Mobile Medical App? (projecthealthdesign.typepad.com)
- The Growing Hipness of Mobile Wellness (futurelab.net)
- Should Mobile Medical Apps Require FDA Approval? (informationweek.com)
- Sign of the times: Johns Hopkins shuttering its medical library (zdnet.com)
- Apple Makes Finding Medical Apps for Professional A Little Easier (jflahiff.wordpress.com)
- Health and Wellness Information and Tracking Apps (jflahiff.wordpress.com)
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)
Want to know how a medication might affect your breast milk? Got a question about a disability, aging, mental health?
There’s an app for all that—and a whole lot more.
The variety and availability of smartphone applications—or apps—have exploded in recent years as multi-tasking consumers increasingly use their phones to keep up with the latest on news, finance, and health. Apple says its iPhone App Store has more than 350,000 apps, and Android, BlackBerry, Windows, and other smartphones account for tens of thousands more. With so many apps on the market, it’s no wonder the number of health care related apps has also spiraled.
The Food and Drug Administration (FDA) is now proposing guidelines that outline the small number of mobile apps the agency plans to oversee—medical apps that could present a risk to patients if the apps don’t work as intended. The proposed guidelines were posted on the Federal Register website Thursday.
Consumers may weigh-in on the guidelines during a public comment period that ends Oct. 19
For more information, visit FDA’s Mobile Medical Apps page.
FDA policy advisor Bakul Patel says some of the new mobile apps are designed to help consumers manage their own health and wellness—like the National Institutes of Health’s LactMed app, which gives nursing mothers information about the effects of medicines on breast milk and nursing infants.
Other apps are aimed at helping health care providers improve and facilitate patient care—like the Radiation Emergency Medical Management (REMM) app, which gives health care providers guidance on diagnosing and treating radiation injuries. There are even apps to aid diagnosis of rashes and heart irregularities.
FDA has already cleared a handful of mobile medical apps used by health care professionals, such as a smartphone-based ultrasound and an application for iPhones and iPads that allows doctors to view medical images and X-rays.
There’s an app for that!
“There are advantages to using medical apps, but consumers and health care professionals should have a balanced awareness of the benefits and risks,” Patel says.
Apps can give consumers valuable health information in seconds and are opening innovative ways for technology to improve health care, Patel says. However, the small group of mobile medical apps FDA proposes to oversee present a potential risk—these apps may impact how a currently regulated medical device (such as an ultrasound) performs, he adds.
FDA is proposing to oversee mobile medical apps that:
- Are used as an accessory to an FDA-regulated medical device. For example, an app could enable a health care professional to view medical images on an iPad and make a diagnosis;
- Transform a mobile platform into a regulated medical device. For example, an app that turns a smartphone into an electrocardiography, or ECG, machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.
If you want to provide input on FDA’s proposal, you can submit your comment online athttp://www.regulations.gov/ or in writing to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
“We want to hear from as many consumers, advocacy groups, health care professionals, and software creators and distributors as possible to help us finalize the proposed guidelines,” Patel says.
This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.
Posted July 19, 2011
Please Note Well!—At this time it seems that consumer health apps (as Mobile MedlinePlus) will not be covered in the regulations.