Klick Health

Apple’s ResearchKit – can more data mean better science?

Group Account Director

Read More

Yesterday, during Apple’s “Spring Forward” event, a small announcement was somewhat unceremoniously dropped into the presentation between a thinner MacBook and details about the Apple watch. Apple announced their entry into a space that has the potential to be a game changer for health care: a toolkit for developing medical research apps. ResearchKit is Apple’s attempt to empower medical researchers with a platform to develop standardized apps for iOS. This platform will allow for the collection of exponentially more health data than most researchers can currently collect today.

The majority of clinical trials and longitudinal medical research studies are conducted the same way they have been run for decades. Participants meet at scheduled intervals with researchers to receive treatments or medical tests to monitor their health and progress. The large gap between the points of data collection is simply par for the course. Many trials use paper-based self-reported tools to track and monitor changes in symptoms or overall health between visits. These tools, while helpful in increasing the rate of collection, are often intertwined with perception issues, consistency difficulties, adherence problems and human nature-driven biases.

So what’s changed? Millions of people now carry an Apple-built phone in their pockets (Apple has sold over 700MM of them). These iPhones are jam-packed with sensors and nearly constantly connected to the internet. When combined with intelligently designed research protocols, they make the possibility for real-time or near real-time data collection and reporting a reality. Bridging the gaps between the trial participant meetings with researchers, these new apps will start to standardize the mechanisms for real-time research-driven medical data collection.

This, platform has the potential to upend an outdated, outmoded research model. At the very least, it could augment existing research models with a significant increases in data collection frequency and volume. For researchers who spend years trying to collect enough data to analyze, report and ultimately bring new interventions or treatments to patients, this could improve the speed at which research is completed.

What do we know about ResearchKit so far?

At the moment, there has not been a tremendous amount shared. Apple SVP of Operations, Jeff Williams, presented a vision for what ResearchKit could become, but very little else has was revealed. Even the released technical overview (see the technical overview below) is somewhat limited in its explanation of how Apple intends to achieve its long term vision to improve medical research. Here’s what we do know:

  1. ResearchKit will be released to developers next month. It is likely that some of the components of the toolkit have not yet been worked out which is why it’s not quite ready for prime time. It will be interesting to see how, if at all, Apple adjusts its plans based on feedback from scientists and developers alike between now and April.
  2. ResearchKit will be Open Source This means Apple will give free access to the underlying blueprint for ResearchKit to anyone who wants it. They will rely on a broader community of developers and researchers to help evolve the platform to make it better over time. Apple has made Open Source development a part of their software strategy for years and this is precisely the kind of program that will benefit from the crowd sourced evolution.
  3. ResearchKit will not rely on Apple servers for data storage. This means that developers will likely have to solve the concerns around compliant data storage and transmission themselves. Companies that are considered Covered Entities or Business Associates under HIPAA (hospitals, insurers, etc.) will have to pay special attention to this consideration as Apple is not offering solutions as part of ResearchKit (so far). On the other hand, this also means that concerns about Apple knowing more than they should about our health can be mitigated by closed-loop data collection outside of their control.
  4. ResearchKit will integrate with external data too. This means that Apple’s toolkit will allow for 3rd party integration. This opens up opportunities for research using the hundreds of health and fitness accessories that connect through Bluetooth to your iPhone. The expansion of the sensors to additional monitors allows for opportunities like an asthma monitoring app that can study a participant’s breathing with a Bluetooth enabled inhaler (see What’s been done with research kit already?)
  5. ResearchKit has global potential. This means that research can be conducted virtually through apps where historically participants needed to be in close proximity to researchers. Not only does this improve the rate of recruitment for research, but it opens up the range of participants to include anywhere a person can use an iPhone. Current research can be biased by the participants lacking racial or geographic diversity. ResearchKit has the potential to improve that significantly.
  6. ResearchKit has the potential to standardize. This means that Apple is considering the user experience of app-based research as being fundamental to its adoption. Normalizing the way people collect data for scientific research can improve consistency and IRB review of the protocols.

What’s been done with ResearchKit already?

Apple included in its announcement, five apps developed in partnership with early testers of ResearchKit. These apps, which are available on iTunes (only available in the US) showcase the potential power of the toolkit in a variety of condition categories. From neurology to oncology, these apps provide insight into how ResearchKit could be implemented in a number of intelligent ways.

Technical overview – how might it work?

Apple has already released a technical overview for ResearchKit in advance of the actual kit becoming available to developers. It’s only version 1.0 but here’s what it tells us: ResearchKit will likely be released with only three modules but that number will grow as the Open Source community contributes to future releases.

Surveys Module

The ResearchKit survey module will give developers a pre-built front-end user experience to create surveys for research participants. The module will have a series of preset survey instruments from which researchers can choose. The survey module is localized to allow for customization of question and answer sets at the geographic level.

Informed Consent Module

This is a flexible module to allow for multiple types of opt-in to participation in research and data sharing. These visual workflow templates provide opportunities to customize language and authorization mechanisms. Pre-approved IRB consent templates can be integrated easily into apps.

Active Tasks

This is the actual collection of health data from the iPhone’s sensors. Currently the types of active tasks are limited to:

Many of these tasks are aligned to standardized and validated tools or measures to make them more easily integrated into research protocols.

Current limitations – get your hopes up, but not too high

What could this mean for pharmaceutical companies and clinical trials?

ResearchKit is not even born yet, let alone in its infancy. A few companies have already made strides in the use of smartphones for clinical trial data collection (e.g., Vertex Pharmaceuticals conducted research as early as 2011 on the use of smartphones to monitor the progression of Multiple Sclerosis There is a lot of room to grow and experiment using this platform but it will take time to iron out the details.

In conclusion (but reserving judgment)

Even though ResearchKit as a technology on its own may not change research as we know it, when Apple does something, people take notice. These sorts of real-time data collection programs have been possible for years but Apple might be able to make them ubiquitous.

ResearchKit is not (yet) a panacea for helping researchers get over the hurdles of privacy and security inherent in apps. What it does do, is start to get researchers thinking about standards for protocol development that include app-based data collection. These standards may help IRBs (and potentially the FDA) review research more easily knowing that the collection mechanisms (surveys and actions) are based on the same underlying repeatable frameworks.

When the first version of ResearchKit is released to the developer community next month, we will provide additional guidance and analysis of the toolkit. Stay tuned.


If you have any questions about these developments, reach out to your account representative or contact:

More About the Author

Ari Schaefer

Ari is passionate about using data and research to help understand not just what is happening but why it is happening and leveraging those insights to drive impact for the clients with whom he works. Ari specializes in the development of data-driven cross-channel marketing strategies for sites, services and products.

More from this author

Go from news to action. Klick Wire

Weekly Digital Health Newsletter

Klick Health will NEVER spam you. Read our privacy policy

Thank you! You're now signed up to get the Klick Wire every week - news from the world of digital health marketing.

Sorry there seems to be a problem. Please try again later.