Apple has the uncanny ability to make things look cool and accessible. The company announced that the iPhone 6 and Apple Watch will help set the future of mobile healthcare. Mobile health technologies—also known as mHealth—have been touted as an avenue to make people take better care of their health and manage chronic disease. But the market is over-saturated, under-regulated and littered with reliability issues. In addition, data security fears bring about a slew of legal concerns.
In 2013, there were more than 43,000 health-related applications in the iTunes App Store. More than 16,000 related to patient health and treatment. Since the FDA has only awarded premarket 510(k) clearance to roughly 100 apps or devices, it is clear that some are really missing the mark.
Let’s say you’re at risk for heart failure, and your doctor recommends an app on the Apple Watch that uses the device’s heart rate monitor to analyze your heart for irregularities and arrhythmias. The app is supposed to send regular updates to your doctor and warn of any problems; however, something goes wrong and you have a heart attack because you weren’t notified about an arrhythmia showing for the last three weeks.
What should you do? Sue the software company that made the app? Sue the doctor for medical malpractice for recommending the app? You’re likely going to have a rough time doing so. The key to establishing negligence and medical malpractice against a doctor is proving that they fell below a standard of care that any reasonable doctor would have done in similar circumstances—a concept far more complicated than it seems.