Apple Just Announced ResearchKit: iOS Software For Collecting Medical Information That'll Be Severely Limited Because of the FDA
How the FDA will limit the usefulness of Apple's latest innovation.
Apple CEO Tim Cook just announced ResearchKit, a new suite of open source apps for the iPhone that will allow medical researchers to gather data from users on conditions like asthma and Parkinson's disease.
The presentation by Apple's Senior Vice President of Operations Jeff Williams at Apple's "spring forward" event today left many unanswered questions about how ResearchKit will work, but it seems like it's designed primarily as a conduit for sending medical information to doctors at research institutions to help them conduct clinical trials.
This is certainly a valuable service, but ResearchKit seemingly won't take advantage of the true potential of iPhones and wearable devices: Allowing software to analyze survey and biometric data, so that users can interpret their own medical information without a human doctor. Doing so this would require getting approval for each function from the U.S. Food and Drug Administration (FDA), which is a slow and expensive process. In f
act, the coming Apple Watch was stripped of many biometric collection features in part to avoid running afoul of the agency.
In January, the FDA released draft rules for devices like the iPhone, limiting their use to only making "general wellness claims." Otherwise, they need approval from the agency.
Last September, I wrote about how wearable devices like the Apple Watch could revolutionize health care, if only the FDA would get out of the way.