Apple’s ResearchKit Puts Clinical Trials in Your Pocket

Building HIPAA compliant software has never been easy. Modern apps served from the cloud, and enabled for mobile devices presents even greater challenges. But imagine the potential for medical research, given the hundreds of millions of smartphones deployed globally, each equipped with dozens of sensors.

Last year when Apple introduced HealthKit for developers, the iPhone leapt suddenly into the ranks of integrated health tracker, along the lines of Fitbit and Jawbone activity trackers. But the iPhone has one major advantage over most other health tracking devices: built-in internet connectivity.

Whereas with Fitbit, Jawbone, Nike Plus, wifi-enabled scales, blood pressure monitors, and similar devices, users need to complete a multi-step setup process, but the iPhone is ready to send useful data about number of steps walked or run, flights climbed, and many other sensor events straight to the cloud.

The FitBit requires additional software installation.
The FitBit Ultra requires additional software installation.

 

By providing the iOS Health app for free as part of iOS 8, Apple has given consumers a powerful new toolkit for tracking health data. The only problem is, this data is unavailable to researchers. There has been no way for researchers, doctors, hospitals or health administrators to access health data collected via HealthKit, even if a patient were willing to give consent. Until now…

The iOS Health App
The iOS Health App

ResearchKit, officially launching next month, provides a simplified, streamlined user interface framework for health apps to perform HIPAA-compliant clinical trial consent. According to Apple’s ResearchKit website, “With a user’s consent, ResearchKit can seamlessly tap into the pool of useful data generated by HealthKit — like daily step counts, calorie use, and heart rates — making it accessible to medical researchers.”

Apple has partnered with some impressive names in medical research, listing these on its website: The American Heart Association, Army of Women, Avon Foundation for Women, BreastCancer.org, Dana-Farber Cancer Institute, Massachusetts General Hospital, Michael J Fox Foundation for Parkinson’s Research, Icahn School of Medicine at Mount Sinai, Penn Medicine, University of Oxford, University of Rochester Medical School, Sage Bionetworks, Stanford Medicine, Susan G Komen, UCLA Jonsson Comprehensive Cancer Center, Weill Cornell Medical College and Xuanwu Hospital Capital Medical University.

So what can ResearchKit do for the researcher? The ResearchKit developer framework is divided into three primary modules: Surveys, Informed Consent, and Active Tasks. A touch-based signature panel allows an app user to perform informed consent right on their mobile device. The survey module provides a builder tool to specify types of questions and answers akin to SurveyMonkey, Google Forms or Wufoo, etc. The Active Tasks module is where active data collection begins.


ResearchKit Signature Panel and Activity Completion

With an active task, ResearchKit allows the user to complete a physical task while the iPhone’s sensors perform active data collection. This data can then be securely transmitted to the cloud for inclusion in the study. For example, Stanford’s MyHeart Counts app has already had tens of thousands of enrollees in just the short time since its launch in March, a feat unequaled by any clinical trial.

This is just the beginning. Data collection will not be limited to the sensors native to the iPhone. External devices, communicating over bluetooth for example, can provide more data such as heart rate, temperature, and weight.

According to VentureBeat, “Google also announced last year that it is developing a contact lens that can measure glucose levels in a person’s tears and transmit these data via an antenna thinner than a human hair.” The New York Times also reports this device is being developed by Google in partnership with Novartis.

Glucose Monitoring Smart Contact Lens
Glucose Monitoring Smart Contact Lens