How does Apple ResearchKit collect health data?

Announced in March 2015, ResearchKit is an open-source software framework developed by Apple to aid medical researchers and healthcare organizations in collecting medical information on patients and participants straight from their iPhone or Apple watch.

ResearchKit apps created by developers could change the way in which medical research and health monitoring is conducted forever. 1 billion smartphones and 70 million wearable health trackers are purchased every year, and these devices have the capability to monitor how much we exercise and sleep, monitor pulse rates and track what we eat.

While this information is useful to the user, this gold mine of medical information is currently inaccessible to researchers and healthcare professionals that could use this data to make better informed decisions on how they treat medical conditions.

Finding participants to take part in medical studies to collect data is a laborious process, often with very low response rates. If users can contribute to medical studies via a tech device that is almost always with them, the data researchers have access to could advance medical breakthroughs.

To give an idea of how just important these apps could be, in Apple’s ResearchKit promotional video Kathryn Schmitz, PhD, of the University of Pennsylvania Health System states: “We have sent out over 60,000 letters. Those 60,000 letters have netted 305 participants.”

There are endless possibilities for healthcare professionals too. Apple also created HealthKit – a similar framework that can be used to collect a user’s health and fitness information. If healthcare professionals can monitor their patients from the data sent from their smartphones or wearable tech rather than having to visit them, or have them attend an appointment, the time and cost savings for organizations have the potential to be huge.

The data collected from ResearchKit and HealthKit apps is not available to Apple. Although any developer or researcher can create an app, it needs to be IRB or ethics approved before it can be available for download in the app store.

What happens after the participant or patient provides this data is the responsibility of the party that publishes the app – and this means adhering to HIPAA rules.

An app used to collect data on people with asthma developed by the Icahn School of Medicine at Mount Sinai has confirmed the process that they are working to ensure HIPAA compliance once the data is collected:

“The data’s collected in the app, and the data goes to what we call a bridge server. It’s maintained by Sage Bionetworks, a nonprofit medical research institute in Seattle. It’s all encrypted and very secure, meets all the industry standards for shipping sensitive data, HIPAA compliant.”

Any medical researcher or developer that creates an app on the ResearchKit framework will need to bear in mind that HIPAA compliance will be their sole responsibility once the data has been collected.

There have been concerns around data security, as laws and rules governing the medical community’s privacy policies do not always apply to data shared in an app.

The healthcare industry has been targeted more aggressively by hackers, garnering up to 10 times the dollar amount of financial data. It’s an unsettling fact that could result in apps being targeted, and although 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, there is no guarantee that the data collected is safe when being shared within an app.

The ResearchKit and HealthKit software frameworks have created opportunities to make huge changes in the way that health information is collected and managed; however, until the risk of leaks, security breaches and hacks ceases to exist, consumers may never be put at ease with how secure their information is.

Despite these concerns, ResearchKit will change the way in which clinical research is conducted forever, and we can’t wait to see how this shapes the future of medical studies.