Consumer-facing health apps are increasingly prevalent, but they’re anything but infallible. According to a recent literature review of published app safety investigations, these offerings have been shown to include issues ranging from poor content or information to faulty functionality.
“Health apps may have significant potential to improve population health,” the study’s authors wrote. “However, to ensure that this potential is met, it is important that apps are safe, effective, and reliable.”
Among the 74 safety articles viewed by the authors, 89% were quality and functionality reviews of either individual or related health apps. Forty-six percent of the included reviews tackled disease management, while 35% covered wellness management, and 8% explored self-diagnosis apps. Most of the app types included in these articles fell under the FDA’s low-risk medical device classification (57%), followed by wellness (34%) and high-risk medical device (9%) classifications.
The researchers identified 67 unique safety concerns regarding the quality of information provided by these health apps. These generally fell within five categories: incorrect information, incomplete information, variation in content, incorrect outputs and inappropriate response to consumers’ needs. Examples of these ranged from a sexually transmitted infection app telling users that “Genital warts are bad. If they form in a bunch on your genitals, you will have a very bad time getting them treated and your relationships will shatter” (incorrect information) to a blood pressure measurement app being unable to detect blood pressures in hypertensive ranges (incorrect output).
Additionally, 13 different safety concerns were identified that pertained to the functionality of these apps and also fell within five major categories: gaps in features, lack of validation for user input, delayed processing, response to health dangers and faulty alarms. Examples provided of the latter included medication self-management apps with alarms that were too quiet or did not sound when the phone’s screen was turned off.
The review also highlighted 52 findings of actual or reported consequences from the apps, five of which could have potentially harmed the patient. Additionally, there were 66 worrying shortcomings in the app design and construction process, such as a lack of expert involvement; no basis in evidence; and poor validation for diagnostic, screening or assessment tools.
HOW IT WAS DONE
The researchers’ literature review collected articles regarding safety concerns in consumer-facing health apps published between January 2013 and May 2019. The 74 articles included in the final analysis were culled from a list of 2,388 unique titles and abstracts regarding app analyses, pilot tests, randomized controlled trials and systematic reviews. Researchers then went on to extract information regarding the app type, health area, engagement strategy, and the safety concerns and consequences highlighted in the included articles.
WHAT’S THE HISTORY
Consumer health apps have been the subject of academic scrutiny from a number of different directions. More than one investigation have suggested that many of these health apps don’t yield positive health outcomes, don’t drive meaningful health behavior changes and are often sharing users’ personal data with very little precautions or transparency to users.
“The gaps in app development, safety concerns, and consequences found in this review call for increased stakeholder engagement, vigilant regulatory frameworks, and more focused research. The reporting of safety concerns and consequences should be mandated in reporting guidelines. These improvements will build trust and increase the confidence of both providers and consumers,” the researchers concluded.