In February, just as many of us were recognizing the threat posed by COVID-19, CTA published a set of guiding principles for mobile health solutions. Although a coincidence, the timing was perfect. In the months that followed mobile health services took on new importance as social distancing and business closures kept people from visiting doctor offices for most everything but COVID-19. But this didn’t mean people without COVID-19 issues went without health care. Patients whose needs could be addressed remotely turned to services like Teladoc, Doctor on Demand, and others for help.
CTA’s new guiding principles address just this type of service, and other health care services where consumers use their own equipment to monitor their health and share data with their doctors. The principles cover accuracy of consumer devices, interoperability between consumer devices and health care systems, and privacy.
The CTA principles do not cover medical products approved by the U.S. Food and Drug Administration (FDA). They cover consumer devices like fitness trackers and mobile health apps that help people monitor basic health, fitness and wellness.
One principle that seems even more important in a world of accelerated remote doctoring is the need for interoperability. CTA defines interoperability as the ability to seamlessly exchange and cooperatively use mobile health data between connected consumer devices, mobile health applications, and third-party online systems including health care organization electronic medical record systems. CTA covers four different types of interoperability – foundational, structural, semantic and organizational.
Foundational interoperability is interconnectivity between systems. Structural interoperability means a common syntax is used by all parties when exchanging information. Semantic interoperability means the systems exchanging information use a common vocabulary. Organizational interoperability means all of the above plus clear policy, social and organizational components needed to ensure efficient communication between organizations and individuals.
Of course, interoperability only matters if the systems being used provide accurate data and respect patient privacy. On the accurate data front CTA lists a number of metrics, including standards for ensuring accurate measurement of those metrics, when such standards are known. For example, CTA has standards for measuring the accuracy of step counters (ANSI/CTA-2056), physical activity monitors (ANSI/CTA-2074), heart rate monitors (ANSI/CTA-2065), consumer stress (ANSI/CTA-2068) and sleep (ANSI/CTA/NSF-2052.1, ANSI/CTA/NSF-2052.2 and ANSI/CTA/NSF-2052.3). Other organizations have standards for measuring accuracy of relevant metrics, too. They’re also included in the principles. There are quite a few metrics for which no known accuracy standards exist.
On the privacy front CTA defines baseline recommendations for responsible collection and use of data from mobile health solutions. These include being open and transparent about information that’s collected, being careful about use of personal information, making it easy for consumers to access and control the sharing of their personal information, building strong security into the technology, and being accountable. Each of these high-level principles has specific recommendations underneath it.
CTA began work on the principles long before COVID-19 appeared on the radar. Social distancing put remote medicine in the spotlight. The CTA principles were created for just this situation, where consumers use their own health, fitness and wellness equipment and share the data they collect with their doctors. It’s our hope that the new principles will help consumers and doctors alike as they work together to achieve optimal outcomes.
Download CTA-2073, Guiding Principles of Practice and Transparency for Mobile Health Solutions.