With the growing popularity of tablets and smartphones--and the explosion of E-health record products for clinicians and patients--we're seeing lots of useful, innovative mobile health tools hit the market. Will the threat of increased fedetal regulation stifle this rush of innovation? That's a question a lot of developers are probably asking themselves as they hear the latest news from the FDA. Until fairly recently, most mobile health apps have been geared to consumers, including those who want handy access to information online about a health topic of interest--or to track details about their own health and wellness. But a growing number of mobile health apps are also aimed at patients with chronic conditions, measuring parameters like blood glucose, blood pressure, and the like. These readings are often compiled for the consumer's own informal tracking, but sometimes they're shared with doctors or other clinical third parties.
Increasingly sophisticated applications allow the data to be transmitted to clinicians for more intensive monitoring. Such monitoring allows caregivers to provide invaluable preventative advice when a patient is showing early signs of trouble. As these apps become increasingly more sophisticated--some can send data to patients' health records or help clinicians make diagnoses or treatment decisions--experts worry that some devices and applications may do more harm than good, especially if they don't meet basic standards of reliability, safety, and security. These considerations have prompted the Food and Drug Administration to take a closer look at mobile health devices and applications. To date, the FDA hasn't gotten too deep into making rules or enforcing regulations as they relate to mobile health app development. But that's likely to change soon
