Consumers are faced with thousands of mobile health apps these days, but are provided with little evidence-based research to show their worth, making it difficult for physicians to even make a recommendation. One mobile application management company, Happtique, has been working to certify medical, health and fitness apps for users based on standards that address operability, privacy, security and content issues.
“At this time there is no way that a user or consumer can know whether a fitness, health or medical app is reliable or safe,” said David Lee Scher, MD, a senior medical advisor at Happtique and regular blogger for mHIMSS.org. While the Food and Drug Administration reviews apps that fit within a specific functional definition, he said, Happtique's certification program includes broader categories of both clinical and consumer apps and focuses on issues related to user experience. The certification process will include technical assessments of an app based on privacy, security and operability standards through outsourced third parties, he said.
The next step in the certification process, according to Scher, will be to have a specialist review an app from content and user experience standpoints. If the app doesn’t meet certification standards, its developer will be notified, and Scher said that feedback can provide a “blueprint” for the developer going forward.
Physicians and consumers will be able to know that an app has been certified by Happtique because it will be labeled as such, said Scher. The seal will also be visible in Happtique's health and medical app catalogue on the Web, which has been categorized by provider type and disease state.
Happtique's most ambitious task will be to conduct trials of the apps to look at outcomes, Scher said. He pointed out that Johns Hopkins has already begun doing this, but many trials and investigating organizations will be necessary.
'What the Global mHealth Initiative is working to do,” said Alain Labrique, MD, director of the Johns Hopkins Global mHealth Initiative, "is provide the fundamental research that tests mobile and wireless technology as part of integrated solutions to identify how much that technology can improve a health outcome.”
When research can demonstrate that patients using a mobile health app have better health outcomes than those who don't use the app, Labrique said, that in turn will provide a strong incentive for insurance companies and the medical community to recognize that technology as a valid approach for helping to manage a specific disease. “But without a robust evidence base, these successes will remain anecdotal,” he added.
“Certifying apps will be very challenging because of the app ecosystem,” Labrique said. He said Happtique's certification efforts, while ambitious, could be a “positive move forward to establish a bar for performance, design and content standards.”
Happtique is also conducting a pilot study of its patent-pending mRx technology, said Scher, which is designed to enable physicians and other health practitioners to electronically prescribe medical, health and fitness apps to patients and clients. He said the pilot, which is currently accepting physician prescriber volunteers, will look at the usability of mRx along with practitioner and patient satisfaction. The study will track how many apps are prescribed and how many times the “fill” button is clicked after an app prescription is sent; however, it will not measure app use or clinical outcomes.
Labrique said it's important that physicians and consumers do their homework and “choose their app wisely.” If one looks at the role of an app in a “holistic way” – such that it is part of a “broader set of tools that help how we provide care to patients and enable patients to better care for themselves,” he said – it will be easier to determine if the app is accomplishing its job.
