Abstract
A renewed interest by consumer information technology giants in the healthcare domain is focused on transforming smartphones into personal health data storage devices. With the introduction of the open source ResearchKit, Apple provides a framework for researchers to inform and consent research subjects, and to readily collect personal health data and patient reported outcomes (PRO) from distributed populations. However, being research backend agnostic, ResearchKit does not provide data transmission facilities, leaving research apps disconnected from the health system. Personal health data and PROs are of the most value when presented in context along with health system data. Our aim was to build a toolchain that allows easy and secure integration of personal health and PRO data into an open source platform widely adopted across 140 academic medical centers. We present C3-PRO: the Consent, Contact, and Community framework for Patient Reported Outcomes. This open source toolchain connects, in a standards-compliant fashion, any ResearchKit app to the widely-used clinical research infrastructure Informatics for Integrating Biology and the Bedside (i2b2). C3-PRO leverages the emerging health data standard Fast Healthcare Interoperability Resources (FHIR).
Highlights
In March 2015, Apple Inc. announced ResearchKit, an open source programming framework that begins to commoditize the creation of iPhone research apps
Participant responses and device-collected activity data and health data stored in HealthKit are likewise represented as Fast Healthcare Interoperability Resources (FHIR) resources when transmitted to the i2b2 backend
The app creates a universally unique identifier (UUID) upon first launch, which is stored in the device's keychain, a cryptographically secured location on iOS devices [10]
Summary
In March 2015, Apple Inc. announced ResearchKit (http://researchkit.org), an open source programming framework that begins to commoditize the creation of iPhone research apps This foray by a consumer information technology (IT) giant into the realm of clinical research follows clear signals by the tech industry of interest in the health IT ecosystem, including release of the Apple HealthKit, Google Fit, and Samsung S Health. This first iteration of ResearchKit was designed to provide a complete system to conduct a study where patients are recruited directly via a smartphone app. Eight official new apps utilizing ResearchKit have become available to the public
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