The question of FDA regulation of medical device applications, also known as “apps”, intended for use on mobile devices such as smart phones and tablets is an open-ended one that MDCI has tackled in previous blog posts. A new frontier for medical device apps appears to have opened up, with the announcement by Ford that it is working with several different developers to produce apps for its Sync in-car vehicle interface.
Ford is most interested in medical monitoring apps that are designed to help improve the quality of life for drivers, as well as protect their safety. Currently, Ford is working with SDI Health and pollen.com to create an app that would monitor pollen conditions to keep allergy and asthma sufferers aware of pollen forecasts and index levels. Ford and Medtronic are also collaborating on a medical device app that would connect Medtronic’s glucose-monitoring devices to the Sync system wirelessly via Bluetooth. In turn, Sync would display glucose levels to drivers on the vehicle’s LCD screen and provide a warning if the values fell below safe levels. Sync could also use the WellDoc DiabetesManager service to compare current readings to those taken earlier in the day.
These health-related apps represent the tip of the iceberg when it comes to Ford’s future medical device software integration plans, which could include products that will measure stress behind the wheel with an eye towards using that data to actively manage vehicle systems. Although the company states that it is at least one to two years away from integrating any of these apps with Ford Sync (although they are all currently available on the market), it is worth considering the regulatory and practical questions surrounding what could become a growth market for medical device companies looking to develop driver-targeted applications.
There are, of course, questions surrounding the security of the patient data that these devices will collect. Perhaps more so than mobile phones, vehicles are more likely to be shared amongst multiple drivers, which could lead to issues with protecting the privacy and security of stored health data if it is kept locally within the automobile. The WellDoc service uses a cloud-based storage system that ensures no patient data is stored within the vehicle itself, but not all apps offer this type of records management. Privacy concerns additionally come into play when the vehicle is brought in to be serviced at a dealership or private mechanic, and there is also the question of ensuring that patient medical histories are accurately accessed, especially with regards to apps which compare glucose levels over time. With multiple drivers in the picture, there can be no assumptions made about who is behind the wheel when it comes to this type of critical data.
On a more positive note, it is possible that by integrating medical device apps more effectively into the everyday lives of patients that compliance could be improved when it comes to managing a chronic health condition, such as allergies or diabetes. The voice interface used by the Ford Sync system could also simplify interaction between apps and the individuals using them for health monitoring purposes.
The automotive industry has until now not been typically considered a viable frontier for medical device app developers, but the emergence of Ford’s Sync system, combined with similar software infrastructures provided by other manufacturers, indicates that a new chapter in medical device development could be just around the corner.
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adapted and republished with permission from MDCI