Keep it private
Regarding such personal data, there have been concerns about privacy, but Apple’s stance is clear: share data (if you choose to), but retain your privacy.
According to Bloomfield, Apple’s long demonstrated a commitment to privacy, now re-emphasised on entering the healthcare space; he adds: “Apple’s income primarily comes from hardware sales anyway, not monetising data,” which puts the company “in a unique position to guarantee your privacy”.
By contrast, Dr. Schadt explains traditional research studies are “basically ‘owned’ by the investigator, who decides who can see data and who can’t, rather than the contributor having that power”.
He dismisses concerns about people providing inaccurate information, to get into a study or even derail it: “It’s important to note you can provide misleading information to the clinical coordinator enrolling you in a traditional study, too.”
Although it’s perhaps easier to do this online than in person, Dr. Schadt says ResearchKit apps can weed out misleading information by asking questions in multiple different ways or flagging inconsistencies in answers, and take in objective information that does not depend on user input (such as health-tracking and local environmental data).
He adds you’d need to be very determined to mess around with a study anyway: “We’re seeing retention rates of over 60 per cent, weeks after launch. Those who trick the system to sign-up are unlikely to stick with a study over the long haul, given that there is an investment of time.”
A question of bias
With ResearchKit launching only on iPhone in the USA, there has been understandable unease regarding bias, with claims results may be skewed by the limited range of people who can take part. Bridges agrees that “clearly not everyone on the planet can enter a ResearchKit-enabled study”, but counters that traditional studies have been far more limited, in terms of geography, availability and accessibility.
More importantly, the two biggest issues will be dealt with in time: ResearchKit’s US-only nature is down to “regulatory hurdles”, and there’s nothing stopping the framework going beyond iPhone, since it’s open source.
In fact, Bridges appears surprised no-one’s yet adapted ResearchKit for Android, but then mulls it has only been in the wild for a few months: “And what’s happened so far has been pretty darn speedy — the rate of people knowing about it, taking action, and building on it.” He expects to see ResearchKit — or something similar — on Android soon, which will have to be open-source as well; interoperability, he reckons, will be inevitable.
Apple’s announcement ResearchKit would be open source got a cheer on March 9. It was an atypically Apple decision (if less so of late — programming language Swift subsequently followed suit), but essential. “It means someone can take the Parkinson’s work we’ve done and rapidly create an app for Huntington’s disease, without negotiations,” explains Wilbanks. “On another level, it increases the odds we get good, secure code, as the foundation for these apps.”
Moreover, he calls it a commitment to a “certain level of community”, where people aren’t suing over core functionality or ports to other systems — vital when it comes to furthering research.
Gossen adds open source is also a differentiator in a world where most available clinical research technologies are expensive closed solutions. “Research is relatively opaque to most people, in terms of technology and process.
Open up the technology and you open up the process. Open up the process, more people understand it, ultimately contribute and improve it. If ResearchKit can gain traction, it could make research much more transparent and democratic.”
She warns there are concerns with the type of studies ResearchKit is currently suited to — ‘minimal risk studies’, where the regulatory bar is low. But she nonetheless believes “regardless of whether ResearchKit ultimately gains mass adoption, Apple will speed innovation in research because it has chosen to enter the space”.
Industry insiders and outsiders will take note and “be encouraged to engage in activity that pushes the boundaries of the traditional clinical research model”. This may lead to major efficiency improvements in how research is conducted, resulting in rapid advances in medicine that will benefit everyone.
Others foresee a similarly positive future. Wilbanks hopes ResearchKit is “part of a transformation to studies that are fully powered, that create reproducible results, that feed future research, and that put participants in their rightful place as full partners in the research enterprise — because the way we’ve been doing it doesn’t achieve any of those things very well”. And Bridges has no doubt this will all happen.
He speaks of lots of synergy already coming from ResearchKit, influencing best practice across mobile health. This will “accelerate a generation of new scientific insight and population insight,” potentially a virtue for all as the quantity and granularity of global and individual data increases.
This, says Bridges, combined with the increasing ubiquity of technology for gathering biometric data and a “cultural readiness — even eagerness” for new solutions, means ResearchKit will be a spearhead for a “radically different way for people to own and manage their own health through devices, sharing data where they will, under their own control”.
In only a few years, he believes we’ll “look back at the day ResearchKit was announced and say that was the inflection point when scientific medical knowledge — the learning thereof — accelerated”.