Dive Brief:
- Apple's just-launched ResearchKit is facing challenges from some researchers, according to reports in Politico and Bloomberg Business News. The chief complaints are that the software's consent forms may not be clear enough and that its apps won't capture data fully and accurately. Further, researchers are concerned the product doesn't protect the privacy of patients properly.
- One researcher told Politico that he was able to sign up for several different clinical trial apps for diabetes, Parkinson's and asthma through ResearchKit, even though he does not have any of those medical conditions.
- "Just collecting lots of information about people—who may or may not have a particular disease, and may or may not represent the typical patient—could just add noise and distraction," Lisa Schwartz, professor at the Dartmouth Institute for Health Policy and Clinical Practice, in an e-mail to Bloomberg Business. "Bias times a million is still bias."
Dive Insight:
Another challenge the product faces is that this research tool is useful only on a population of individuals who can afford iPhones, which automatically decreases the level of socioeconomic diversity in the study. In addition, the platform, which is intended to facilitate data capture, could lead to dishonesty among participants and actually sully the data that researchers receive.
Finally, the FDA has cautioned that like other medical devices Apple's new research platform should not be associated with unfounded medical claims. The consumer tech industry has for years been launching 1.0 versions of products that are essentially beta-releases that people buy. But while releasing immature products may be acceptable for consumer tech, it won't fly in the healthcare industry.
It will take more than ambitious Apple marketers to move a wobbly ResearchKit forward. It's not surprising that researchers are intrigued by the possibilities of simplifying the clinical trial process, which is extremely onerous and expensive, but until Apple addresses some of ResearchKit's failings it will remain little more than a 'proof of concept' product.