Apple ResearchKit Data to Be Used in Three Clinical Studies

Ken Terry

October 16, 2015

Three major academic medical centers — Duke Medicine, Johns Hopkins, and Oregon Health & Science University — have announced they will use Apple's ResearchKit for studies on autism, epilepsy, and melanoma, according to an Apple news release.

ResearchKit is an open source platform that allows medical researchers, with patient permission, to collect data from mobile health (m-health) apps and devices used in conjunction with iPhones and iPads. More than 100,000 patients are already participating in over 50 ResearchKit studies, Apple said.

Duke University and Duke Medicine will launch a study of childhood autism for parents who have concerns about autism and other developmental issues. The Duke team wants to find out whether an iPhone camera can be used to detect signs of developmental problems at a younger age than is now possible. The app being used in this study employs "emotion detection" algorithms to measure a child's reaction to videos shown on the iPhone. Duke is partnering with Peking University in China and other international partners.

The long-term aim of the study is to develop an automated method of screening for conditions such as autism and anxiety, noted Ricky Bloomfield, MD, director of mobile technology strategy for Duke Medicine, in the Apple release.

Johns Hopkins University School of Medicine has developed the EpiWatch app, designed for use with the Apple Watch. According to the press release, "The study will test whether the wearable sensors included in Apple Watch can be used to detect the onset and duration of seizures."

Study participants will use the custom watch app to capture accelerometer and heart rate sensor data and send alerts to a friend or a relative. The app will document all seizures and the participant's responsiveness to the event. Participants will also be able to compare their conditions with those of other epilepsy sufferers taking part in the study.

Oregon Health & Science University is studying whether iPhone images can be used to learn about mole and melanoma growth and better manage their skin health by photographing and measuring mole size over time. Research participants can document mole changes and share those with health professionals. Researchers will use the images captured from tens of thousands of iPhone users to help create detection algorithms than can potentially be used to screen for melanoma.

"Beginning of a Pipeline"

These studies are not just about academic research. MobiHealth News quoted Bud Tribble, MD, PhD, vice president of technology at Apple, as saying, "One way to think about ResearchKit is as the beginning of a pipeline that will lead to more apps that are screening, diagnostic, management and treatment apps." The research phase is necessary, he pointed out, before commercial entities can ask the US Food and Drug Administration to clear these apps for sale.

As for permission to use such m-health and related devices in research, Gregory Krauss, MD, professor of neurology at Johns Hopkins University School of Medicine, told MobiHealth News, "The tracking part of this [EpiWatch study] is clearly condoned. The seizure detection research is research. Participants have consented to provide anonymous research during this study. After a year the question will be: Will we need to file this as a medical device doing seizure detection? This is an evolving area of great interest for us."

The EpiWatch participants will be able to view their data on the dashboard of the ResearchKit app. The Johns Hopkins team anticipates that the dashboard will help the patients have more informed conversations with their providers.

The apps that researchers create in ResearchKit can be used with a wide range of third-party apps and devices. In fact, the Oregon team is using an existing mole-tracking app called Mole Mapper that is available for free in the Apple store.

Researchers can access data on such parameters as weight, blood pressure, and glucose levels from the Health app in iPhones that have IOS 8 and compatible apps. ResearchKit also has access to data from the accelerometer, microphone, gyroscope, and GPS sensors in iPhones. Those measurements can yield insights into a participant's gait, motor impairment, fitness, speech and memory, Apple said.


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