Apple is working closely with the FDA to develop an FDA-regulated app for diagnosing Parkinson’s disease, MobiHealthNews has learned. The insight comes from a batch of emails MobiHealthNews obtained from a Freedom of Information Act request to the FDA.
The tech giant held a meeting about Parkinson's at its headquarters in Cupertino in September 2015 attended by a number of neurologists and Parkinson’s experts, as well as Bakul Patel, Associate Director of Digital Health at the FDA and another unnamed FDA representative. Divya Nag, a special projects lead at Apple, organized the meeting, telling Patel in an email that the plan was to “discuss early results from the ResearchKit PD app and ideate on steps moving forward for the app.”
“We’re thinking of breaking the meeting up into two sections, one to discuss the telehealth/remote monitoring use case for Parkinson’s and the second to discuss the diagnostic app,” Nag wrote in an email to Patel on September 2, 2015. “On the telehealth side (where physicians get data updates from their patient between visits) we’d love for you to lead a discussion around whether you think there are any FDA considerations to understand before implementing. We don’t believe there will be, but always good to double check!”
Given the timing of the meeting, references to the telehealth application could refer to the launch, in March of this year, of the Parkinson’s CareKit app, which used learnings from the mPower ResearchKit app to help patients at The University of Rochester Medical Center, UCSF, Parkinson's Disease Care New York, Stanford Medicine, Johns Hopkins Medicine, and Emory Healthcare. But at the time the diagnostic app was (and remains) an unannounced work in progress.
“For the diagnostic side (where an app would diagnose PD) we’d love for you to lead a discussion on what would be required for such an app to be FDA approved,” Nag continued in the email to Patel. “Metrics that need to be accomplished, data requirements, testing protocols, etc. We’d like to use that as a starting point to kickoff our discussions on what needs to be built for such an app and how the folks in the room can work together to make sure we set up the right trials.”
Just a few weeks prior to the meeting invitation, Apple VP of Medical Technology Mike O’Reilly reached out to Patel with a question about “FDA approval for apps that provide a diagnosis”. In a follow-up to the phone conversation that followed, Patel wrote that “I talked to Jeff and he is fully on board with trying to figure this out.. but he also said that we should get a good understanding on what data the researcher has and we can get a sense of the test and applicability of the diagnosis.”
That “Jeff” likely refers to Jeffrey Shuren, Director of the Center for Radiological Devices at the FDA.
Fast Company reported earlier this month that three unidentified Apple sources told the publication that the company is working on using Apple devices to passively monitor Parkinson’s. But monitoring is a far cry from diagnosis, especially from a regulatory perspective.
Maureen Phillips, global clinical trials manager at Great Lakes NeuroTechnologies, which makes wearable devices for Parkinson’s management, told MobiHealthNews that she doesn’t know of any companies using mobile devices for Parkinson’s diagnosis, though the Parkinson’s monitoring space is quickly growing.
“I think it’s because there’s a lot of facets to Parkinson’s disease and Parkinson’s disease is truly a different disease for every patient that it affects,” she said. “So the diagnosis for one patient might be relevant to a motor symptom he or she is experiencing, whereas the diagnosis for another patient could be for a completely different reason. I think the diagnosis of Parkinson’s is relatively complex because it can come down to several factors where just wearable sensors would not be able to capture all of that information.”
Roche Pharmaceuticals, which is working on its own app for Parkinson’s similar in many ways to the emPower ResearchKit app, didn’t rule out the possibility of diagnostic applications for similar apps.
“The technology is currently being developed at Roche as a clinical research tool,” Dr. Ulrike Engels-Lange, the spokesperson for the project, told MobiHealthNews in an email. “In general, technology such as this could have multiple potential applications beyond this.”
Right now, Apple’s Parkinson’s CareKit app monitors the patient’s movement with the gyroscope and accelerometer in the phone and can also measure manual dexterity with a tap test and fluctuations in the patient’s voice using the phone’s microphone.
The emails don’t give much information on the nuts and bolts of the diagnostic app, but an October email from O’Reilly to Patel suggests that Apple’s core motion team is involved either in the diagnostic app or a related technology.
“We are moving full speed ahead,” O’Reilly wrote in an email following the Parkinson’s meeting. “We are working with our core motion team to develop the other [redacted] discussed at the meeting. We’ll get back to you the week after next with an anticipated timeline. We’ve got several projects that will be of interest and we are very grateful for your enthusiastic help! So stay tuned.”
The emails show that getting the Parkinson’s diagnostic app through FDA approval was handed off to Stephen Friend when Apple hired him at the end of June. Friend was the president and cofounder of Sage Bionetworks, which powered a number of ResearchKit apps including emPower, the Parkinson’s study. Robin Goldstein, an attorney at Apple whose roles have included “principal counsel” and “special projects -- health” according to her LinkedIn account, was assigned to help Friend out with legal and regulatory aspects.
An email from Goldstein, dated September 8, 2016, suggests that Apple how data collected by ResearchKit and CareKit apps might speed up the clearance process for regulated products based on them. In it, she asks Patel what the “bare minimum” for a quality system might look like, as well as “how ‘real world evidence’ would apply or impact the kinds of efforts we might get into (back load the process so we can get to market faster) etc.”
This aligns with comments Bud Tribble, Vice President of Software Technology at Apple, made to MobiHealthNews in an interview last fall.
“One way to think about ResearchKit is as the beginning of a pipeline that will lead to more apps that are screening, diagnostic, management and treatment apps,” Tribble said at the time. "In fact, it is a necessary, essential first step to figure out what is needed to develop these apps -- what works and what doesn’t -- before you move into, ultimately, clinical study apps and clearance to use them for diagnosis and treatment.”
Asked about the hypothetical of Apple entering the market with an FDA-regulated device, Phillips from GLNT said she wouldn’t be shocked, because there is a growing awareness that Parkinson’s treatment and diagnosis is ripe for innovation.
“We started in the wearables field eight years ago and we’ve had products in the market for that period of time,” she said. “It seems like the market is finally starting to grow a lot and people are starting to realize that wearables and [mobile health] apps really to have a place in clinical care. We’re going to continue to see more and more companies pop up with potential resources or apps that can be used in that application. So it’s just a part of this technology being on the market and people realizing the importance of it.”