Researchers have been putting up fliers around college campuses and city centers to get people to participate in medical studies for decades. But the methods for obtaining this type of quantitative data has always been a challenge and has been largely unchanged.

But now Apple is involved.

As a part of a major effort to help researchers learn more about various diseases like Parkinson’s and diabetes, Apple announced earlier this week its vision for collecting data from patients via iPhone. Because the device is sensor-laden and is usually kept in a pocket, data isn’t collected every three or so months like in many research trials; the tool will update with new information every few seconds.

ResearchKit, which is what the tool is called, works with Apple’s existing HealthKit platform. Patients with certain conditions can opt in to participate in various clinical studies and surveys (daily, weekly, monthly and so on) that can be evaluated and analyzed by medical researchers. The goal is to ultimately improve patients’ health and the ability to care for them.

“ResearchKit was probably the biggest surprise coming out of the Apple event,” Scott Snyder, president and chief strategy officer at mobile engagement provider at Mobiquity told Mashable. “Other than working with HealthKit parters like the Mayo Clinic for HealthKit, Apple has shied away from getting involved with healthcare. But ResearchKit opens up the possibility of data from 700 million iOS devices to be mined for patterns and behaviors that create a whole new world for healthcare research.”

Those possibilities, in theory, could be a huge step forward for the medical field. For example, researchers could potentially determine if those who live in higher-noise areas are more susceptible to stress-related illnesses or even seizures, and if diet and activity have a significant impact on tremors or flares in certain disease areas, Synder suggested.

“These are just hypotheses today, given the difficulty and expense of running credible studies,” he said. “But we will have a massive living laboratory to answer some of these key questions, especially when the lifestyle data can be merged with longitudinal health data.”

A series of activities might include tapping different parts of the iPhone’s touchscreen to gauge response rate, multitasking skills and more, as well as voice tests like saying “ahh” into the microphone.

The studies, which will be available to people in places where studies are not typically conducted, will mostly take advantage of the iPhone’s built-in sensors.

Partnerships

Mount Sinai’s Icahn School of Medicine in New York City is one of Apple’s early partners for ResearchKit. The institution is bringing its Asthma Health app (by tech startup LifeMap Solutions), which helps asthma patients manage their condition, to the platform.

After joining the study, verifying eligibility and signing a consent form, asthma patients can access the app daily to monitor their condition. The app then alerts users of environmental risk factors and medication adherence. It also offers an e-diary for tracking symptoms and educational content to increase awareness and insight into their disease.

“The goal is that app users will experience less asthma-related distress with better symptom control, improved quality of life and fewer unexpected medical visits by helping them take charge of their own health,” said Corey Bridges, CEO of LifeMap Solutions. “By keeping an eye on how patients are using the app to varying degrees of success, Mount Sinai will be able to assess the exact impact that such apps can have as part of a regular treatment plan.”

Bridges said Apple and Mount Sinai started talking about the potential of ResearchKit last June — nearly nine months before the platform’s arrival.

“It’s one thing for an app to keep track of how far you’ve run or how many calories you’ve burned, but another for a new platform to combine various health data sources to analyze a holistic view of health for patients self-managing chronic conditions,” Bridges said. “We will release separate apps that function as an intelligent health and wellness coach that leverages cutting-edge medical and behavioral research.”

Because Apple’s platform is open-source, developers can continue to build onto the platform. So far, partners include Penn Medicine, the University of Oxford, Xuanwu Hospital of Capital Medical University in China and Stanford University.

After six hours we have 7406 people enrolled in our Parkinson’s study. Largest one ever before was 1700 people. #ResearchKit

— John Wilbanks (@wilbanks) March 10, 2015

And participation adoption rates are soaring. According to John Wilbanks of Stanford University, nearly 7,500 people enrolled in the school’s Parkinson’s study just six hours after ResearchKit was announced. Previously, the largest pool of participants was 1,700.

Concerns

Privacy is unquestionably a major issue at play with ResearchKit. Apple said during its event on Monday that data would be submitted anonymously and never be seen by Apple. Users would have to opt in to sharing their personal information.

Security practices will be key to ResearchKit’s success. Participants don’t want to have their personal health information hacked, exposed and traced back to them.

For some, like Andrew Flanagan, CEO of Telcare — an online service which helps encourage conditions like diabetes — Apple’s entrance into this space is walking a murky line when it comes to ethics.

“While this type of thinking is what’s needed to create a new era of digital healthcare, issues concerning security, FDA clearance, and the ability for health providers and patients to receive, communicate and act on the data captured in near real-time are all challenges that need to be addressed in order for these new technologies to have a meaningful impact on individual health,” he said.

“Apple’s ambitions are lofty and we’ve already seen the company pull back the reins on what it had initially planned [for the Apple Watch]. Going that deep into electrocardiogram-like heart-health monitoring and reporting, for example, is too complicated for most companies, even Apple. Most don’t want to deal with the red tape and various regulatory issues.”

But Michael V. McConnell, Professor of Medicine (Cardiovascular) at Stanford, said the responsibility is more on those conducting the studies and not Apple.

“Apple has helped develop a platform to facilitate phone/mobile medical research, but the primary ethical responsibility is with the institutions designing and overseeing the studies, and their faculty and institutional review boards (IRBS),” he said.

McConnell added that Stanford is taking serious steps to make sure all data sent and collected via the app is private and secure.

“Data for these apps are sent encrypted from the phone app to a secure sever run by Sage Bionetworks, a non-profit which has experience supporting medical research studies and handling anonymized data servers for analysis,” he said. “The personal information is separated from the research study data, so the secure server where the study data is stored for analysis is anonymized.”

Because the technology is so new, there will undoubtedly be a learning curve, from both the patient and researcher standpoint. McConnell said Stanford will be looking at “feedback from participants and researchers to make these tools and this type of research better.”

Apple CEO says there’s no business model behind ResearchKit. We’re not in it for the ROI.

— Philip Elmer-DeWitt (@philiped) March 10, 2015

Apple says ResearchKit isn’t about turning a profit, but rather on making the iPhone a greater asset to the medical community.

While it’s uncertain as of now how powerful of a tool ResearchKit will become, and, assuming participants are satisfied with Apple’s attention to privacy, if it truly has potential to be a game changer.

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