Apple Toughens Up Rules For Medical Research Apps

13 Mar 2015 | Author: | No comments yet »

5 things to know about Apple’s medical apps.

Turns out that people are super willing to participate in medical research studies when you make it easy and convenient. Apple has made some adjustments to its developer guidelines today, adding new rules that app makers must follow to have their software included in the iOS App Store.San Francisco: Amid all the talk of Apple Watch, a new MacBook laptop and a partnership with HBO, a set of Apple tools aimed at promoting medical research didn’t get much attention.Stanford 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.

According to Bloomberg, thousands of iPhone users have already embraced ResearchKit, which was designed to help doctors and scientists gather data more frequently and accurately using iPhone apps. The tools, called ResearchKit, promise to help researchers study asthma, Parkinson’s and other diseases by recruiting test subjects through iPhone apps. 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. Unveiled on Monday as part of Apple’s special event in California, ResearchKit essentially lets health and fitness apps communicate with each other, with your permission. At least two of the apps that Apple announced on stage Monday — and helped create — already offer a point of contact, though developers hope they can take communication even further.

Nor do they understand the strengths and weaknesses of existing treatments for Parkinson’s—nor even the unmet needs of people who have the disease. These tools could give researchers more data to work with by making it easier for people to offer themselves up to science, but even supporters say the data won’t be appropriate for every study.

After you give the go-ahead, ResearchKit can access data from the iOS Health app such as your weight, blood pressure, glucose levels, and asthma inhaler use, which are measured by third-party devices and apps. ResearchKit is a new developer framework from Apple that seeks to harness the vast user base of the iPhone to help recruit people for medical studies. 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. 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.

That’s something that we are going to try to figure out next, for instance, can we come with some sort of peer-to-peer system where people can ask questions.” The company worked with Apple to build two ResearchKit-compatible apps, MyHeart Counts and Share the Journey. The framework allows developers to take advantage of the iPhone’s various sensors to help monitor activity levels or collect information from Apple’s HealthKit platform.

Another new developer guideline spells imminent death for apps that rip music, videos, and other content from services like YouTube, SoundCloud, and Vimeo without obtaining permission. Until then there are only five apps that are using the new framework including studies on Parkinson’s disease, Asthma, diabetes, and breast cancer—as well as the aforementioned heart health study. 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. An iPhone user who wants to participate downloads that app and fills out a questionnaire to determine eligibility and establish a base line for further comparisons. Apple’s new watch, announced this week (see article), measures its wearer’s heart rate and can supposedly work out whether he is standing, sitting or going up or down the stairs.

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. And apps 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.

Other new additions, according to 9to5Mac, help solidify the rules around where and how developers can use Apple Pay, the company’s mobile payments system. Moreover, such devices can easily be linked by Bluetooth to other bits and pieces, such as Fitbits or Pebble watches, that the user is wearing—and even to high-tech versions of good old bathroom scales. But longer term, ResearchKit could still be a big help to medical researchers even if it only helps recruit people in direct contact with the research institution. 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 flare-ups in certain disease areas, Snyder 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.

Some questioned whether ResearchKit apps will adequately protect user privacy, while others say that the system could result in misleading data if a user accidentally hits the wrong button or lets someone else use their phone. 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. The institution is bringing its Asthma Health app (by tech startup LifeMap Solutions), which helps asthma patients manage their condition, to the platform.

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.” Stanford researchers are using their ResearchKit app to study ways to encourage people to modify their behavior to improve heart health. This week Apple—in an announcement a little more sotto voce than that of its watch—introduced the world to a suite of software called the ResearchKit, which will make it possible to create scientific apps that work with its mobile devices more easily and cheaply. So far, partners include Penn Medicine at the University of Pennsylvania, the University of Oxford, Xuanwu Hospital of Capital Medical University in China and Stanford University. 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.

But she says ResearchKit could help with many common ailments involving heart disease, obesity and diabetes, as apps could be used as an objective tracker of lifestyles. Fox Foundation, a charity concerned with Parkinson’s disease that has worked on one of the first apps to use the ResearchKit, says another crucial part of the system is that it lets scientists streamline the process of obtaining informed consent for their research. A team at the Icahn School of Medicine at Mount Sinai, working with digital health company LifeMap Solutions Inc., is studying whether having an iPhone app that educates asthma patients and reminds them to use their inhaler can improve symptoms and reduce doctor visits. While the app currently requires patients to manually enter information, the team is working on an add-on to a standard inhaler that will send a Bluetooth signal to a patient’s phone, logging use automatically, said Corey Bridges, LifeMap’s chief executive officer. The more that data gathering can be automated, the more the app may be able to reduce the risk of dropouts and patients lost to follow-up, a group dreaded by investigators because it is so difficult to know how they fared after participating in a trial, said Gibson.

Ray Dorsey, a University of Rochester neurology professor involved with the Parkinson’s app, also says researchers will have to weigh the benefit of getting more participants and more data against not being able to see participants in person. 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.

And Asthma Health, devised by LifeMap Solutions, a firm in New York, tracks an asthmatic’s symptoms and lets him avoid places with poor air quality. Although mPower, GlucoSuccess and AsthmaHealth are not yet intended for use by doctors, patients will probably soon be rolling up in surgeries with their iPhone data.

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