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screen-shot-2013-04-25-at-84750-am-304Good morning, it’s 7:00AM. You reach to kill the alarm, then fumble to pick-up your iPhone and peek at your email. Now, while you’re at it, why not check your activity stats on MapMyWalk. 6 miles walked this week, not bad. Sound familiar? Maybe it’s you? It’s me as well, and there’s many more just like us using health, wellness and fitness mobile apps. According to a recently published report from Mobiquity, 70% of consumers are using health and fitness monitoring apps on a daily basis and 63% plan to expand their use over the next five years. In fact, there’s an estimated 97,000 apps currently available, with more and more designed for use as vital sign monitoring tools – also known as mHealth apps. According to marketing research firm Research2Guidance, the mHealth technology category is estimated to grow 61%, driving roughly $26 billion in revenues by 2017. And with name players such as Apple, Samsung and Google having all recently announced platforms for developing a wide spectrum of healthcare apps for current and future devices, this growth might even be underestimated. However, along with the rapid emergence and personal on-the-go use of these apps, there’s perhaps a more surreptitious problem with mobile healthcare apps. Recently concern has been growing over the risk that these apps may injure or mislead users by providing data and guidance that’s incorrect, and in some instances making it harmful to users. If this does become a wider issue, what are regulators doing to protect us? Medical devices are generally regulated by the U.S. Food and Drug Administration (FDA), and although the FDA reviews some apps, many experts say the FDA’s power and resources aren’t enough to cover the growing amount of health apps that are transforming consumer health. “The FDA is reportedly understaffed and under-resourced to oversee these things, particularly given the number of the thousands of apps that are [most likely] under FDA’s jurisdiction,” according to health law expert Nathan Cortez, an associate professor of law at Southern Methodist University Dedman School of Law in Dallas, Texas. Cortez and his colleagues make the case (in an editorial recently published in The New England Journal of Medicine) that health and medical apps hold the promise of improving health, reducing medical errors, avoid costly interventions, and broadening access to care. But to reach their potential, these apps must be safe, effective and trusted. And part of the secret sauce for reaching this goal is for the majority of them to provide valuable utility that allows the user to better and safely optimize their health and wellness more so than if they weren’t using the app. None the less, as this category becomes more competitive, there are valuable steps healthcare developers should follow to lower the risk of producing an ineffective and maybe, an unsafe app.

1) Design for High Utility: health apps must be designed to address and help navigate specific problems or provide high levels of utility. If they don’t do this well, the app will overwhelmingly not be considered useful and deleted from the users device. For instance, if your app utility only monitors one physiologic parameter without providing the user with clinical warnings, then the app’s utility over the long haul is suspect. Compounding the problem for the publisher is if those users post negative social media reviews and ratings, then naturally that’ll damage total downloads and maybe cut into new version downloads when that version is ready. The remedy is simple: pack loads of useful and insightful utility that individuals can access and put to use in key situation – maybe during their workouts, etc. A good rule of thumb is to better understand before you design the app where individuals will use your app so the data is available when needed, making it that much more valuable.
2) Research and Test: once you have your alpha application ready to use, observe how your target users group interacts with the app, especially keeping an eye on how the use the app in the confines of the device. Notice where, how, when and what they do immediately after they’ve read the information the app presents. And just as important, how easy is the app to use? Keep in mind that usability tests that score positively on an iPhone 5 may be issues on a Samsung Galaxy 4 as the device is physically wider – for instance, a user’s thumb may not be able to reach the opposite corner on that screen when compared to the iPhone 5.
3) Physician and Clinician Involvement: a recent study conducted between 2009 and 2012 evaluated 222 pain-related smartphone apps which showed that many were developed without the input of a health professional – some had inaccurate information, and some of their features weren’t as robust as they could be. “Many of them were giving advice and offering coping strategies, but we don’t know if they’re effective,” said Lorraine S. Wallace, Ph.D., who led the study. In addition, the apps could potentially be dangerous for users if the coping strategy – for instance, exercise – isn’t right for them, she said. Yes, involving the correct specialists and clinicians in the design of the app adds more to the budget, but it substantially brings down the risk of publishing an app that might mislead or maybe harm someone.
4) HIPAA Compliance: ascertain whether the app falls under these rules. Make sure you have a clear understanding of who will be using the application as well as what information will be on the application, any connected databases and if the user’s information is identifiable. If you’re still not sure, then you should consult an expert that can properly advise you on HIPAA regulations as it relates to data and medical devices.
5) Design for Cross Usage: this applies if you’ve built multiple versions (mobile, web, etc.) of the app as reports show that 90% of consumers start a task on one device and finish it on another. It’s valuable to think about the user flow between devices and how the application might be used on each device. Your goal here is to make the use seamless and equally utilitarian across devices and platforms.

Finally, in regards to the guidelines, think about how deeply you want to get involved in each. However, keep in mind that doing your deepest due diligence on numbers 3 and 4 is good for everyone.

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