Apple ResearchKit, released in March 2015, is a software framework enabling medical and health researchers to create applications for studies. It allows investigators to develop mobile apps that use iPhone capabilities to collect data, track movement, and take measurements. ResearchKit facilitates large-scale, opt-in surveys and observational studies, gathering additional data from participants. This platform makes participation more accessible, enabling broad collection of real-world health data.
Unpacking ResearchKit’s Purpose
ResearchKit is an open-source software framework, accessible for developers and researchers to build mobile applications for medical research. It provides pre-constructed modules that facilitate various study aspects.
One primary component is informed consent, helping researchers present study details and obtain digital consent. The framework includes predefined consent pages covering data gathering, privacy, data use, and time commitment, also allowing for custom pages.
The framework also facilitates customizable questionnaires through its survey module. Researchers can build surveys by inserting various question types, such as true or false, multiple choice, dates, sliding scales, and open-ended text entry.
Active Tasks are interactive modules designed to collect objective data using the iPhone’s built-in sensors. These tasks measure motor activities, fitness, cognition, speech, hearing, hand dexterity, and vision, by collecting inputs from the device’s accelerometer, gyroscope, screen, and microphone. These features streamline the research process on mobile devices, making data collection efficient and engaging for participants.
How ResearchKit Powers Health Studies
Researchers leverage ResearchKit to conduct health studies by tapping into a broad and diverse participant pool. This platform enables the collection of real-world, continuous data directly from participants’ own devices, offering insights into daily variations in symptoms and treatment effects.
For example, the mPower study utilized ResearchKit for an observational study on Parkinson’s disease, collecting data through surveys and frequent sensor-based recordings. This approach allows for remote administration of classic research tools like surveys and uses sensors to provide quantitative measures of symptoms with minimal interruption to daily life.
ResearchKit has supported studies across various conditions, including asthma, breast cancer, cardiovascular disease, diabetes, and autism. A cardiovascular health study at Stanford University enrolled over 10,000 participants within 24 hours of its launch. The Asthma Mobile Health Study achieved secure bidirectional data flow with 7,593 participants across the United States, collecting longitudinal data on symptoms, triggers, and medication adherence.
The app-based approach enhances participant engagement, making it convenient for individuals to contribute to medical research. This impacts the speed and scope of medical research, allowing for the rapid collection of diverse health data.
Ensuring Data Privacy and Security
Protecting sensitive health data is a primary concern in studies using ResearchKit, with several measures ensuring privacy and security. Participants maintain explicit control over what data they choose to share, deciding if and how their information is used.
Data collected through ResearchKit apps is encrypted during both transmission and storage, safeguarding it against unauthorized access. This encryption is built upon Apple’s hardware encryption technologies, with each file assigned a protection class to control accessibility.
Anonymization and de-identification processes are also employed, separating personal identifiers from health data so researchers cannot link information back to individual participants. For example, a Parkinson’s study might collect gait data but intentionally avoid GPS coordinates to maintain de-identification.
Studies using ResearchKit must undergo approval by independent ethical review boards (IRBs), which ensure adherence to ethical guidelines and data protection standards. Apple itself does not see or collect health data from ResearchKit apps; this information goes directly to the researchers conducting the study.