The announcement of Apple's ResearchKit shocked the health research community, as it theoretically opened the door to easily enroll consenting participants in clinical trials. Stanford (Calif.) University researchers reported more than 11,000 participants signed up for a cardiovascular study using ResearchKit less than 24 hours after the new app was announced, according to Bloomberg.
However, despite the trove of data researchers can collect from Apple's latest offerings, a number of security issues still remain unresolved.
First, ResearchKit is accessing and storing highly personal biometric data about individuals. The biometric data collection itself is less of a concern than is the link between ResearchKit and HealthKit, according to Gizmodo. The connection between the two Kits means researchers could potentially access all the data collected and stored via HealthKit, which gathers a huge range of data above and beyond simple biometrics from third-party apps that are built to work with ResearchKit.
According to Gizmodo, it remains unclear who has access to this type of data, especially when considering HealthKit is integrated with Epic's EHR database. "This is all to say that it's not just researchers and Apple databases handling your health data when you use these new products….And as we learned from the massive iCloud hack last year, Apple's security is not impregnable," reads the report.
Secondly, ResearchKit can be considered an mHealth app, and the U.S. Food and Drug Administration does not regulate all mHealth apps. The FDA regulates apps that offer medical diagnoses and advice, which doesn't fall under the scope of ResearchKit. However, an Ars Technica report suggests that the types of clinical research apps already being used in ResearchKit, such as the app that measures participants' gaits to diagnose Parkinson's disease, are blurring the line between what should fall under FDA regulation and what doesn't.
Additionally, Apple has made clear privacy regulations surrounding ResearchKit, but has yet to mention substantial information regarding security, according to the Gizmodo report. "It's always important to remember: Just because your data is private does not mean it's secure," according to the report.
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