Providing researchers access to an abundance of data
ResearchKit was designed to make data sharing easier between researchers and participants. Medical researchers use ResearchKit to create studies and enroll participants, who then share data from their iPhones and Apple Watches for the researchers to analyze.
It's an open source framework, meaning anyone can build or customize features within the app. ResearchKit was designed for medical researchers, so it adheres to Fast Healthcare Interoperability Resource (FHIR) specifications. FHIR specifications outline consistent data standards that facilitate the use of open source apps and enable interoperability among hospitals and other health care providers.
Apple's appeal as a partner in research is obvious: It has captured about 40% of the smart phone market and almost 50% of the smart watch market. Consumers can buy an app on Apple's app store, track data through their Apple Watches, and monitor the results on their iPhones. ResearchKit bridges the gap between researchers' need for data in medical research and the abundance of data that lives in consumers' apps and wearables.
Apple's newest venture into health care research
The Research app is a newer version of ResearchKit. Data is collected through metrics tracked on iPhones and Apple watches, and then shared between researchers and participants.
Unlike ResearchKit, researchers won't be creating individual studies for the app. Instead, Apple will conduct three new studies, partnering with multiple academic and health care organizations.
- The Women's Health Study, conducted with the Harvard T.H. Chan School of Public Health and NIH's National Institute of Environmental Health Sciences, aims to better understand women's reproductive health. The study tracks menstrual cycles and includes surveys to measure participants' unique experiences. Researchers will use the data from this study to better understand women's health issues such as infertility, osteoporosis, polycystic ovary syndrome, and menopausal transitions.
- The Heart and Movement Study, a partnership with Brigham and Women's Hospital and the American Heart Association, tracks movement and heart rhythms through workouts logged on the Apple Watch. The data provides warning signs of illnesses such as atrial fibrillation, heart disease, and declining mobility. Ultimately, the goal of this study is to determine preventive measures that will help participants monitor their conditions and live healthier lives.
- The Hearing Study, a partnership with the University of Michigan, tracks how noise and stress affect hearing. Loud noises in the participant's environment are tracked through headphones and the Noise app on the iPhone and Apple Watch. Participants are randomly assigned to two groups: an intervention group that receives notifications about loud noises and a control group that does not. Results of the study will be shared with the World Health Organization to help reduce hearing loss through the development of safe listening practices.
Improvements over traditional research studies
Although just announced, the new studies show potential improvements over traditional research studies in two ways.
The ease of enrollment opens the studies up to more participants. Historically, research studies have been localized and limited in diversity, resulting in a few thousand participants at best. Fewer participants limit the applicability and validity of the study's conclusions. The convenience of an app expands the pool of participants (Apple's original heart study with the ResearchKit app drew 400,000 participants). A wider range of participants means better informed conclusions accounting for different ages, ethnicities, and geographical locations.
The data is collected in real time, all the time. No longer will studies be confined to limited time trials or artificial conditions. Mobile devices and wearables track consenting participants all the time, enabling the production of longitudinal studies that include data during key health care events, like heart attacks and seizures.
Challenges persist as access to personal data expands
However, even with these potential improvements, researchers still face the same challenges they would in more traditional studies.
In any health-related study, privacy is a major concern—and that is especially true when so much personal data can be collected from mobile apps and wearables. Realizing this could be a problem, Apple protects the data and results of the studies through strict privacy regulations. At every step of the study, participants have control over how and when their data is used. While enrolling in the app, participants are presented with a list of studies and can opt into as many as they choose. Apple promises that none of their data will be sold or shared with third parties. Participants can leave the study if they feel uncomfortable or change their minds. At the conclusion of the study, Apple updates participants about how their data supports the research.
And while accessing data may be easier than ever before, it's still a challenge to actually turn that data into valuable action. Part of Apple's challenge in each of these studies will be helping researchers use these vast amounts of data to create actionable guidelines and preventive measures.