Apple ResearchKit Sees Thousands Sign Up Amid Bias Criticism

12 Mar 2015 | Author: | No comments yet »

7 Ways Apple’s New Software Could Change Medical Research For The Better.

SAN FRANCISCO — Apple’s new ResearchKit software platform turns the iPhone into a diagnostic tool drawing medical data from millions of potential customers, creating a boon for researchers and a headache for privacy advocates.(Bloomberg) — Stanford University researchers were stunned when they awoke Tuesday to find that 11,000 people had signed up for a cardiovascular study using Apple Inc.’s ResearchKit, less than 24 hours after the iPhone tool was introduced. “To get 10,000 people enrolled in a medical study normally, it would take a year and 50 medical centers around the country,” said Alan Yeung, medical director of Stanford Cardiovascular Health. “That’s the power of the phone.” With ResearchKit, Apple has created a pool of hundreds of millions of iPhone owners worldwide, letting doctors find trial participants at unprecedented rates.That announcement also brought the potential for a healthier future with apps and technology used for health and fitness and an even more innovative technology that’s guaranteed to take the world by storm for its practicality and it’s privacy risks.Apple’s ResearchKit sounds promising, in theory: the software platform is designed to let medical researchers create iPhone apps for their studies that will help them recruit participants — without said participants ever setting foot in the lab.

With iPhone users’ permission, Apple will be able to take data gleaned from its Health app and share it with doctors and scientists to use in medical research, said Chief Executive Officer Tim Cook at an Apple event Monday in San Francisco. Already five academic centers have developed apps that use the iPhone’s accelerometers, gyroscopes and GPS sensors to track the progression of chronic conditions like Parkinson’s disease and asthma. And for researchers who rely on data like this to study everything from chronic disease to healthful lifestyles, all of that information has been going to waste for years, locked away in the proprietary data clouds of telecommunication companies. The information could include a user’s weight, blood pressure and activity levels, as well as information on conditions such as diabetes, cardiovascular disease, asthma and breast cancer. But on March 9, Apple Senior Vice President of Operations Jeff Williams made waves in the scientific community with the announcement of his company’s new open source iPhone software, ResearchKit.

In other words, Apple Watch users can easily volunteer to be a participant for research studies, by using apps recently developed for studies of asthma, breast cancer, cardiovascular disease, diabetes and Parkinson’s disease. Building on a HealthKit app that debuted with iPhone 6, Apple announced Monday that it had worked with a range of doctors, hospitals and developers to create five new opt-in apps that its smartphone users can use to share personal health data to improve medical research.

The software’s consent forms may not be clear enough, or its applications won’t capture data fully and accurately and protect the privacy of participants, they say. “Just collecting lots of information about people — who may or may not have a particular disease, and may or may not represent the typical patient — could just add noise and distraction,” said Lisa Schwartz, professor at the Dartmouth Institute for Health Policy and Clinical Practice, in an e-mail. “Bias times a million is still bias.” For starters, the average iPhone user is more likely to have graduate and doctoral degrees than the average Android user, and has a higher income as well, according to polling company CivicScience Inc. But those things can also be ethical liabilities: both Apple and ResearchKit researchers will have to make extra efforts to ensure that participants are eligible for studies, that they are knowledgeable about the risks, and that their data is secure. For the first time, instead of you using the phone to do (nominally) useful stuff, other people will be using your phone, and the useful stuff will be you—or at least, data you generate.

But in addition to benefiting iPhone users who simply want to make sense of all the health data they’re tracking, the new software gives researchers a platform to access the millions of bits of health data on users’ iPhones. The ResearchKit announcement was a big deal yesterday, so it’s understandable that the five ResearchKit apps that Apple announced yesterday are currently featured in a banner at top of the App Store. As the iPhone’s technology has advanced, the data it can capture on its customers’ activity has gone far beyond the basics, like the number of steps a user has taken in a day. By transforming and enlarging the research recruitment process from the scope of just a few hundred in a local setting, Apple has now made it possible for thousands to be recruited for research that could save millions of lives.

A video that Apple screened during its presentation here — which was otherwise focused entirely on the debut of Apple Watch — featured a university researcher noting that after sending out tens of thousands of letters soliciting participants for a recent breast cancer survivor study, only 300 or so women replied. And apps on a phone may be more restricted in the types of questions they can ask than standard trials, which allow researchers to ask open-ended questions in face-to-face encounters. Research institutions like Stanford Medicine, UCLA’s Jonsson Comprehensive Cancer Center, Icahn School of Medicine at Mount Sinai, Massachusetts General Hospital and University of Rochester signed up to create apps that feed discrete bits of your tracked health information into databases for specific research projects.

But they’re rare, because they’re hard to do, and thousands of subjects is nothing compared to, say, the 700 million or so people who own iPhones. “It really is a new way of doing business,” says Euan Ashley, a doctor at Stanford who helped create MyHeart Counter, an app designed to monitor physical activity and other risk factors for heart disease. “We’re going to start to see patterns that we weren’t able to see before. One app, called the Parkinson mPower app, helps people with Parkinson’s Disease track their symptoms by asking users to play games and complete dexterity exercises.

While contributing to the greater good, the Apple Watch could also be an easy target for hackers; something not unheard of with last year’s iCloud celebrity photo leaks. Hopefully we can represent all the different subgroups and have tremendous diversity across the population.” Other diseases under investigation—Parkinson’s, asthma, diabetes, and breast-cancer treatment recovery—also have apps available. Jones, are your teeth itching?” — may prompt false memories and make people more apt to report them, a problem that an open-ended question wouldn’t have triggered, Gibson said. Another, called the GlucoSuccess app, draws information from the data a person tracks about their diet, exercise and medicine to see how all of these different factors influence blood sugar levels.

In recent history, health information has also been shown to be far more valuable to hackers, garnering up to 10 times the dollar amount of financial data. Even though the data will, by definition, come only from people who can afford an iPhone, researchers building the apps say the relatively large number of iPhone users nationwide—estimated at 63.2 million in 2014—will help reduce what’s called “selection bias,” the problem of research studies looking only at one kind of person. “If you can do something at scale, then the challenges of selection bias becomes smaller,” Ashley says. By using its internal components or secondary devices connected wirelessly via Bluetooth, the iPhone can silently measure users’ behavior, without relying on them to keep track or be honest about what they’re doing. “People don’t want to say they did zero exercise — they want to say they did something.” Stanford’s Yeung said. “They don’t really tell us the truth.” The U.S.

Following the news, many researchers who spoke to The Huffington Post could barely contain how thrilled they were about the new iPhone feature, calling it “revolutionary,” “groundbreaking” and a “new dawn” when it comes to scientific research. There is no 100 percent guarantee that this won’t happen, but Apple has met with the Federal Trade Commission to discuss its commitment to protecting the information and identities of its customers, namely by prohibiting the sharing of collected data with third parties. One test asks the user to tap the screen as fast as they can for 20 seconds, another uses the iPhone’s GPS and motion sensor to assess gait and balance. Consumers should question any medical advice that comes from the apps, because it isn’t likely to be peer-reviewed, said Adrian Gropper, chief technology officer of Patient Privacy Rights, a nonprofit group. The company has also made ResearchKit an open source system, meaning the code used to develop the software is pubic information and that any bugs can be easily identified and reported immediately.

While this information helps researchers, it also helps patients, Williams said, adding that “it’s known that exercise can significantly slow or halt the acceleration of Parkinson’s, and with this app you can easily track your exercise as compared to the results from those tests.” As the apps continue to evolve, the hope is that programmers will figure out a way to turn your own data into insights tailor-made for one’s life and health goals. It’s easy to lie about your age online, and Mount Sinai Hospital, the research group behind the app, appears to have dropped the ball in preventing it. That distinction goes to the Android phone, which is more affordable than the iPhone and dominates an estimated 80 percent of the global smartphone market.

All of the ResearchKit apps use a combination of questionnaires and basic data your phone collects—for example, using your phone’s accelerometer to count how many steps you’ve taken as a measure of physical activity. Williams and three other vice presidents met with Food and Drug Administration Commissioner Margaret Hamburg and her staff about mobile medical applications in December 2013. Ida Sim, of University of California, San Francisco. “[ResearchKit] is a good way to start doing research in those populations, but people who are of lower socioeconomic status and lower income tend to be on Android and other platforms, so we’ve got to be looking for approaches to complement the exciting work Apple is doing.” Most everything we know today comes from decades upon decades of data collection — through experiments or observational surveying — that build upon previous discoveries. Then participants will be randomized to different types of coaching, through games or with more basic reminders, and three months later will be asked to repeat the one-week intensive tracking and stress test.

The same is true of the Parkinson’s disease app “mPower” and the breast cancer app “Share the Journey,” according to Sage Bionetwork’s Chief Commons Officer, John Wilbanks, who worked on the apps. “It’s tough, you know — it’s certainly possible to have a system where you only get one shot with the eligibility criteria in our studies, but we chose not to do that,” Wilbanks says. But gathering data isn’t the same as understanding it. “What needs to happen is more evaluation about how these apps are going to be used to achieve these meaningful changes in health,” says Mitesh Patel, a health researcher at the University of Pennsylvania who studies wearables and health-related smartphone apps. That has a lot to do with the nature of the population Sage Bionetworks is serving, Wilbanks says. “With Parkinson’s disease, or post-chemo cognition, people tap in the wrong place, and so we don’t want that to disqualify anyone.” Sure — but perhaps if a user were to change her answer about her age, it might be wise to automatically require an ID photo for age verification. Wilbanks doesn’t think that impersonation will be a significant problem. “We are less worried about fraud and trolling and impersonation because there’s a fair amount of work involved in being in this study, and doing it just for fraudulent purposes is kind of a strange behavior,” he says. “People might do it for shits and giggles for a week or two, but I can’t see someone doing voice testing and gait testing for 52 weeks when there’s no sort of public pay off.” The disease-specific issues raised by Wilbanks make sense, and it is possible that people who wish to impersonate others will get bored with the charade. Though no one knows exactly why this happens, there are some limitations at play that could contribute to the lack of diversity: research subjects need flexible work and family schedules, the ability to navigate complex bureaucracy and easy transportation — luxuries unavailable to the working class, for example.

Apps that motivate people to change their behavior—to eat better and to exercise more, say—may still have a huge impact, Patel says. “The most important thing is how to use this data to create behavior,” he says. “If you’re not changing someone’s behavior, what’s the point?” What’s more, researchers are limited in the amount of money they can spend to find participants, and most stick close to their university or hospital for willing subjects.

That’s really our goal.” What’s more, some communities of color are wary of medical trials for historical reasons, according to Sim, who is co-director of Biomedical Informatics at UCSF. Sherer said he didn’t know the cost of developing the app, but the foundation’s biomarker study, a traditional trial with almost 800 participants over five years, has cost about $60 million. “I don’t think we want to give the perception that this type of research will replace the more standard, physician-based, direct interaction with the patient” in traditional trials, Sherer said. “But I do think this provides a complementary type of research in a different way. Unfortunately, “we can’t promise perfect anonymity,” Wilbanks says. “The biggest risk in these studies is to your privacy; we’re going to de-identify it, but because we’re going to make it available for lots of research, there exists a chance that someone could re-identify you.” In the medical research world, data isn’t shared with other clinics or universities unless the participants give their consent at the beginning of the study, says Michael McConnell, cardiologist at Stanford University and the principal investigator behind the Researchkit-made “MyHeart Counts” app.

Of course it’s possible that a research group might one day decide to sell the information — for instance, to a pharmaceutical company. “There seems to be nothing preventing researchers from bringing in commercial companies or selling data, with user approval, to commercial bodies,” Eyal says. “That’s not a problem in its own right, but especially given that the system is based on millions of altruistic volunteers, it would only be appropriate if funding bodies and [review boards] made sure that studies that use this system address major sources of human disease burden — and that products that come out of it will be accessible widely around the world.” Of course, ResearchKit is open-source, so pharmaceutical companies might actually prefer to get in on the action directly. What should we test?’” said Sim. “The public could start seeing research as something that isn’t imposed on [them], but as an activity that we all do together so that we can learn together.” In traditional clinical trials and population studies, participants are paid for their efforts.

In that case, these apps would essentially provide a portal for pharmaceutical companies wishing to gather personal health information from iPhone users — and profit from it. Informed consent is crucial for any medical study; it’s the step that lets a participant know what they’re in for and what risks are involved in taking part. Normally, researchers go through informed consent with participants in person, one-on-one. “That interaction is pretty crappy,” says Sage Bionetworks’ Wilbanks. All the numbers are great, but without turning the numbers into something that really helps somebody… people [won’t] feel that they’re getting something more than they’re giving.” Yeung already has plans for that feature in the Stanford app. All four of the apps mentioned in this article have an informed consent procedure, and all four have gained institution review board (IRB) approval prior to their release.

IRBs are committees that are charged with approving, monitoring, and reviewing research that involves humans; they determine if a study is ethical and safe. Right now, though, we’re in some pretty murky ethical waters — and displaying the words “Apple won’t see your data” is a half-inflated life preserver, at best.

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