‘Mobile health’ (mHealth), which is defined loosely as health care delivered wirelessly, is set to transform health care. A perfect example is the Ford Motor Company’s ‘Car That Cares,’ which it announced at the 2012 International Consumer Electronics Show in Las Vegas in January. The car’s in-vehicle health monitoring system was developed through a collaboration with Microsoft, BlueMetal Architects, and Healthrageous and is designed to support passengers’ personal health and disease management programs. The vehicle’s dashboard is equipped to collect real time biometric and other data, along with voice inputs, to help the passenger comply with his or her health and wellness program through digital coaching (“How much did you eat for breakfast? Did you take your pills?”). The system can also wirelessly connect to other health-related smartphone apps and portable medical devices such as a car seat that measures blood pressure, to alert the passenger to health changes. These apps and devices can then connect to the passenger’s health care provider and electronic health record. The Car That Cares is still in the research phase, giving the public and the regulators time to catch up with this new concept.
Ford indicated that the Car That Cares will never be used to diagnose conditions. But if the system can ‘alert’ the passenger to a change in blood pressure, could it also determine the treatment (e.g., “double your dose”)? Could the system be used to take a picture of a rash on the driver’s forearm and determine the nature of the rash? Not surprisingly, the FDA is very interested in mHealth technologies. Last year, it issued a “Draft Guidance for Industry and Food and Drug Administration Staff: Mobile Medical Applications” to provide guidelines on how smartphone apps and mobile devices fit within the FDA’s regulatory structure for approving new devices. The ‘draft’ document was helpful but the industry needs more in-depth guidance from the FDA on what it considers to be a regulated mobile device. For instance, are the Car That Care’s in-vehicle, embedded apps that collect health information regulated or not, and if so how? The industry also needs to hear from other regulatory bodies, including the FCC, which regulates general purpose devices like smartphones and HHS, which regulates privacy when information is sent to or from providers and plans.
For those old enough to remember, the television show “My Mother The Car” raised the specter that you may not be alone in your car. The Car That Cares takes that premise to a whole new level.