- Education: help providers understand the risks inherent in new technologies, the danger of over-reliance on such technologies, as well as the importance in following best practices. Providers should learn to integrate new and unfamiliar technologies slowly, or use software trusted by peers.
- Expertise: as I've discussed earlier, the developer of every mobile health app should enlist appropriate domain expertise to ensure success. Providers interested in mobile health should make themselves available where possible. Lack of provider involvement in the app development process should be seen as a red flag.
- Environment: a culture of safety and quality accompanied by continual improvement describes the promise of a learning healthcare system. Mobile technology is positioned to deliver on this promise.
I want to stress that of the three categories of health IT functionality described in the FDASIA report (Administrative, Health Management, and Medical Device), the suggestions above are most applicable to decision support apps in the Health Management category. This is the current grey area, but also likely to be the largest of the three in terms of app volume. These apps will still be subject to FDA enforcement discretion (reactive as opposed to proactive), which I feel is appropriate.
On the other hand, apps that purport to be medical devices would fall into the third category, which I feel should be carefully regulated since they would pose far more risk. Examples of such apps currently in the App Store include Instant Blood Pressure & Pulse Oximeter. Instant Blood Pressure includes a disclaimer at the bottom of the app page ("for recreational use only. It is not an FDA cleared medical device. Consult a doctor if you have any health concern.") while Pulse Oximeter does not. I personally tested pulse oximeter a couple months ago and found it lacking.
I believe that the only practical way to catch these apps prior to release would be to work directly with app store curators (e.g., Apple and Google) to add an additional layer of review to screen for apps that claim medical device functionality. If they are found to meet the definition of a medical device, they should be referred to the FDA prior to app store approval.
We still have a long road ahead of us and I applaud the work of the FDA as well as the perspectives of the authors of the NEJM article. Reaching an appropriate balance of innovation and risk while achieving our goals of improved patient care, safety, and cost savings will be critical to ensure a thriving healthcare system well into the future.