We are currently living in an age in which it’s nearly impossible to imagine going anywhere without your smartphone. While you are carrying your phone around, whether in your hand, pocket, or purse, it is constantly collecting and tracking data. This data, which has an immense potential to impact medical research, is not being used and is rarely even viewed. Apple decided to leverage the fact that millions of people have iPhones collecting data, and to use it to the benefit of clinical research. In March 2015, Apple released ResearchKit, an open source software that allows for researchers and developers to easily create an app that can be used for clinical research purposes. In May, we posted an article on the Medrio Blog introducing this new technology, and now that it has been almost a year since its release, we wanted to take a look at the immense impact that this tool has already proven to have made in the clinical research community.
ResearchKit makes it easier for researchers and doctors to recruit study participants without being limited by geography, demographics, or non-diverse populations while simultaneously allowing them to collect and access all health related data from the participant’s iPhone. The platform was released last year with five trial apps that focused on diabetes, asthma, Parkinson’s, breast cancer, and cardiovascular disease. Overnight, 10,000 people had signed up for Stanford’s cardiovascular study after ResearchKit was announced. After its release, Quintiles announced that they had contributed open source code to ResearchKit.1 Their contributions will help the apps that are created through ResearchKit to further engage patients that are participating in the clinical research. As of today, 5 additional applications have been added focusing on autism, Hepatitis C, epilepsy, concussions, and melanoma, with more in the development process.
The ResearchKit applications can be downloaded and used on an iPhone 5, 5s, 6, and 6 Plus or on the latest-generation iPod. Once the app is download, the user gives their consent and data is pulled from Apple’s iHealth app, which accompanied a September 2014 iOS update. Activity data can also be pulled from users with an Apple Watch. Each study tracks different data. While one app may rely on activity data, another may be focused only on data collected from a survey. Some of the applications may ask about current medications, and others may require that you perform certain in-app tasks each day (the Parkinson’s mPower app requires that you say “ahhh” into your phone, which tests for variations in your voice over a period of time).2
Mt. Sinai Hospital was one of the very first to partner with Apple in this endeavor. They released their initial findings in October that were incredibly impressive. Eric Schadt, a genomic scientist at Mt. Sinai said, “We are delighted with the initial results we’ve seen after six months of using Apple’s ResearchKit framework for our Asthma Health app.” Within the first six months of releasing the app, 49,000 people downloaded it and they were able to enroll more than 8,600 participants in the study, which otherwise would have taken years.3 This kind of recruitment is something that would be nearly impossible without Apple’s groundbreaking technology. Clinical research often does not include at-risk and under-served populations, and ResearchKit is already demonstrating that it can help bridge that gap.
As with everything that creates a buzz, there are some concerns being raised and criticisms being voiced. For instance, minors are not eligible to participate in any of the studies without parental consent, but in some studies it’s possible to change your age after it has been submitted. Falsification of data is not the only concern; so is the issue of privacy. While Apple states that they will never see your data, some are questioning the validity of this. Nir Eyal, a medical ethicist at Harvard University, says that if the data has the possibility of being re-identified, than there is a chance that a patient’s privacy can be invaded in some form. Another highly discussed concern centers around informed consent. While these applications make it easy to understand the study through images, videos, and a final test to make sure the patient understands how the study will work, there is still no way for the patient to ask any questions.4 These issues are currently being worked on and addressed by the research organizations and universities involved in creating the applications.
Even with the concerns, Apple’s ResearchKit represents a huge advancement in clinical research. As of January 2016, Apple is expanding its health technology division, and there are rumors that they would like to continue to advance in the medical device space. They promise to release a new product soon, and there are high hopes their next innovation will continue to revolutionize clinical research. For now, the ResearchKit remains a pioneering new tool for researchers and physicians, and it is set to continue its impact this year.
1 “Quintiles Contributes Open Source Code to ResearchKit.” Quintiles Contributes Open Source Code to ResearchKit. Applied Clinical Trials, 09 Nov. 2015.
2 Boehret, Katherine. “ResearchKit, Apple’s Medical Data Experiment, Explained.” Recode. N.p., 20 May 2015.
3 Loria, Kevin. “Apple’s New Health Software Is Starting to Transform Medical Research.” Tech Insider. Tech Insider, 12 Oct. 2015.
4 Duhaime-Ross, Arielle. “Apple’s New ResearchKit: “Ethics Quagmire” or Medical Research Aid?” The Verge. The Verge, 10 Mar. 2015.