Putting mobile health apps to the test

Consumers have thousands of mobile health apps to choose from, but there's little evidence-based research to show their worth, making it difficult even for their physicians to make a recommendation. This fall mobile application management company Happtique aims to help change that by beginning the process of certifying medical, health and fitness apps for users based on standards that address operability, privacy, security and content issues.

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David Lee Scher“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, senior medical advisor at Happtique. Scher explained that while the Food and Drug Administration currently reviews apps that fit within a specific functional definition, the Happtique certification program includes broader categories of both clinical and consumer apps and focuses on issues related to user experience. The certification process will include technically assessing the app based on privacy, security, and operability standards through outsourced third parties, explained Scher.

The next step, according to Scher, will be to have a specialist in the app's field review it from content and user experience standpoints. If an app doesn’t meet certification standards, the app developer will be given constructive feedback, which Scher said will 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 there will be a label on the app itself, a seal, that will mark it 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 actually look at outcomes, he added. Scher 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.” Labrique said when research can demonstrate that patients using a mobile health app – compared to those patients that don't – have better health outcomes, 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.

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“Certifying apps will be very challenging because of the app ecosystem,” Labrique said, and could even prove to be a “Sisyphean task.” Although ambitious, he believes Happtique's certification efforts to 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 enables physicians and other health practitioners to electronically prescribe medical, health and fitness apps to their 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 usage or clinical outcomes.

Labrique said for now it is important for physicians and consumers to do their homework and “choose their app wisely.” He added that if you look at the role of the 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,” it will be easier to determine if the app is accomplishing its job.


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