If clinician turnout at last week’s mHealth Networking Conference in D.C., is any indication of things to come, doctors and other healthcare providers will not only play a critical role in supporting consumer uptake of mobile health apps and wireless medical devices, but in helping to slow the proliferation of symptom-driven apps that are prone to misinterpretation by patients.
Of course, it won’t be as easy as it sounds, especially for clinicians with an eye toward developing apps of their own. First, as TMCnet.com reports, they’ll need to come to terms with the pros and cons of adopting smartphones as a platform for interactive health information and advice. The article references a presentation—“Future Directions in Symptom-Driven Consumer Applications”—by Ed Daniels, a consultant for Point of Care Partners, who weighed in on some critical issues in the consumer self-help mobile-enabled movement. Topping the list of considerations, according to Daniels: symptom-driven app developers need to be aware that some of the core features of their solutions have already been patented, which raises the possibility of exposure to patent infringement charges and IP licensing fees. Then there’s the ever-growing regulatory environment. Advanced mobile apps that employ the capabilities of a smartphone to automatically collect, record and report patient health data may soon be subject to scrutiny and regulation by the FDA. Although the FDA doesn’t currently regulate mobile health apps, the more sophisticated mobile solutions are starting to look like medical devices–which are subject to FDA registration and approval, the article states. When you factor in smartphones that connect to biosensors for the purpose of automatically collecting patient data, the distinctions blur very quickly. The rule of thumb, according to Daniels: “If software is intended to provide cure, mitigation, treatment, or prevention of disease then the FDA may consider it a medical device.”