In March, Apple announced the ResearchKit along with the highly anticipated Apple Watch. Positioned around the iPhone, ResearchKit is described as “a software framework that makes it easy for researchers and developers to create apps that could revolutionize medical studies.”
Patient confidentiality aside, we feel that Apple is onto something big—not only having an impact on the medical research community, but also making a strategic move to differentiate their products in a competitive industry. Here, we teamed up to explain why.
Let us introduce ourselves:
Interactive team lead
Rajneesh Uzgare, PhD
Medical research specialist in immunology
Medical team member
Mobile app and web performance analyst
Strategy team member
There are challenges
Thousands of participants enrolled in five initial ResearchKit studies within days of the announcement—but we suspect they are young, tech-savvy, educated individuals. They can afford an iPhone and its data plan. ResearchKit is trying to improve the number and availability of study subjects to generate statistically robust clinical data—but that might come at the expense of diversity in the subject population and could lead to skewed data.
Addressing this issue will take time and investments by other technology and medical organizations. Apple is leading the charge, but they have committed to open-sourcing the framework. Bringing ResearchKit to other platforms like Android, which has a larger and more financially diverse user population, may be a step in the right direction. The greatest gains might come from the development of sensors that don’t rely on a phone at all. These cheaper and more focused devices could be distributed to participants in lower-income areas—further expanding the variety of the research pool.
While there are limits to the kind of data that ResearchKit can capture right now, this may change in the future with advances in sensor technology. This in turn may require new FDA regulatory guidance.
Regulations aren’t clear
Today, iPhone and Apple Watch (together with other fitness bands like Fitbit or Jawbone) are not categorized as medical devices, so they aren’t FDA regulated. These devices currently collect and display information and prompt an action (“Get up and walk,” in case of the Watch). Future advancements in algorithms may mean that the iPhone and Watch will become your health coach and help you make better decisions, thus requiring FDA regulation.
This is uncharted territory for all parties: Apple, the FDA, app developers and patients. As the process evolves, so might the FDA’s view on the regulation needed. In fact, Apple met with the FDA almost a year ago to discuss just this. Any further software refinements that involve collecting data from numerous advanced sensors, integrating it with environmental data, analyzing it and providing recommendations are likely to be regulated by FDA.
We think the benefits of having an FDA-approved (and by extension, doctor-recommended) app in a device like the Apple Watch could be huge. It could be an advanced fitness tracker that acts as coach, or highly specialized asthma app that uses geolocation to prompt you to avoid triggers.
There is limited impact today
The proverbial genie is out of the bottle, if Apple didn’t do it somebody else would. The medical community is always struggling to find study subjects and Apple solves this problem beautifully, all you need is an iPhone and the time to contribute.
The five planned studies that launched with the ResearchKit announcement are in the data collection stage. The sponsoring organizations haven’t provided hypotheses, nor information about study design. The data and the conclusions will need to be fully validated.
There are possibilities to collect significant amounts of data first and use it as a baseline for formal studies. In this case, the cost to researchers is virtually zero, yet the opportunity to improve future research studies (and their design) is significant. The impact is even greater when multiple organizations can access the baseline data.
Regardless of use, data concerns can be addressed if appropriate patients are recruited and large amounts of good data are collected frequently. The data from ResearchKit could be collected every few seconds, if needed, compared to every week/month/quarter. Having this tool is of enormous benefit in advancing medical research, and taking data collection out of the conventional clinic setting has the potential to reduce the time and cost of patient visits.
Stay tuned for huge possibilities
We imagined what could happen if ResearchKit becomes a standard in medical research. In 2012, for example, US medical researchers spent $119 billion. Apple’s ResearchKit would potentially improve efficiency by streamlining and simultaneously globalizing the most expensive component in this process—the clinical trial. The fact that several high profile medical institutions have partnered with Apple in this endeavor is a testament to the enthusiasm of the medical community for this potentially game-changing technology.
We might see researchers subsidizing phones or devices in exchange for data. Built-in sensors in these devices might go beyond the individual’s vitals and measures—collecting data on a person’s surroundings at a precise time and location, and studying the effects on disease progression. Mount Sinai Health System, the organization behind the asthma ResearchKit study, has done some of this already. They’ve distributed Bluetooth inhalers and spirometers to tie individuals’ data to environmental data and known pathogens.
Healthcare professionals may have a better opportunity to study and track mental health and social anxiety. The possibility of having a continuous record of a person’s mood, social life or stress levels—all supplemented by sensory data—is huge. Doctors could set up alerts and interact with patients more frequently, allowing for faster, more accurate diagnosis, more informed decisions and better overall outcomes.
It could even be possible to assess the impact of environmental changes on a patient’s mental state. This type of data correlation could provide insights not possible today. Kathryn Schmitz, PhD, at Penn Medicine alluded to this in the official video, “The concept that I can kick out a survey to patients… that would actually improve their health and our ability to care for them… that’s a game-changer.”
Ultimately, patients benefit
Apple isn’t just like any other corporation. They seem to care about social responsibility. Whether it’s (PRODUCT)RED, environmental impact reports or the extensive use of renewable energy, Apple’s actions speak for themselves.
While ResearchKit will take years to reach critical mass, it’s about putting technology where it can solve an existing problem. It might benefit Apple in the future, but it can also benefit any of their competitors. We believe that innovation beyond the tech field is crucial. Any opportunity to find new treatments or gain further insights into diseases should be taken—after all, you can’t put a price on improving patient outcomes all over the world.