Since its well-publicized meeting with the FDA in 2013, Apple has continued to meet with the agency regularly as well as to correspond by phone and email, according to emails obtained by Babyforyou.net.ua via a Freedom of Information Act request to the FDA.
These emails show that Apple and the FDA have discussed the App Store review process, the 510(k) process, ResearchKit apps, diagnostic apps, working with the FDA in an “unregulated” way and more. The FDA even invited Apple to participate in regular briefings designed to help guide an international effort to harmonize medical software regulation. Though much of the sensitive information is redacted, the emails also point to three regulated medical devices that Apple is seriously pursuing: an app for diagnosing Parkinson’s disease and two separate but related cardiac devices.
Finally, the emails also suggest that, after Apple received a good deal of press for its 2013 FDA meeting, the agency worked with Apple to keep future meetings under the radar. The record shows meeting names and locations were changed, and great consideration was given to when to include top officials, like FDA Commissioner Dr. Robert Califf and Dr. Jeffrey Shuren, director for the agency’s Center for Devices and Radiological Health, whose calendars are public and might have exposed the company to more media scrutiny.
The emails obtained by Babyforyou.net.ua start in December 2013, shortly after Apple’s well-known FDA meeting. We guessed, as did many others, that the content of that meeting was about keeping Apple in unregulated territory for at-the-time upcoming projects like ResearchKit and CareKit. A memo obtained in 2014 by Apple Toolbox, via its own FOIA request, confirmed that hunch.
But now we know that meeting -- and a few scattered meetings that preceded it -- were just the beginning of a long relationship. Almost all of the emails involve Bakul Patel, the FDA’s Associate Center Director for Digital Health. In an email sent shortly after the 2013 meeting, Patel reached out to Apple, asking for further discussion on “a) Expanding our initial discussion on - commercial platforms with sensors; and (b) an overview of the process Apple is currently using to review apps made by developers.”
“With the goal to enhance our approach to promote innovative medical technologies and protect public health, I believe FDA can benefit tremendously from industry leaders like Apple,” Patel writes.
Meetings about Apple’s review process and FDA’s regulatory guidelines
At a January 29, 2014 meeting, Apple gave FDA an overview of how it reviews the third party apps it sells in its App Store. After the meeting, Apple emailed Patel a copy of their app store guidelines as requested.
A follow-up meeting occurred on February 20, 2014 at FDA headquarters in Maryland, to discuss “an update on mobile medical apps” (per an email from Apple Director of Federal Government Affairs Tim Powderly to Patel). Notably, the emails show that Shuren was confirmed to attend the meeting, and that the meeting was scheduled specifically to accommodate his schedule. However, it doesn’t appear on his public calendar for that day. Also notably, the emails show a last minute room change before the meeting.
Another meeting apparently attended by Dr. Shuren occurred on September 15, 2014, again in Maryland, again absent from his public calendar.
“Yes - we are confirmed for Monday. It will just be Dr. Shuren and Bakul Patel from our end,” an executive assistant at the FDA wrote in an email about the meeting.
It’s not clear from the emails what was discussed at this meeting, but they do contain a complete attendee list. From the FDA, Patel and Shuren were the only attendees. From Apple, the list included Powderly; Bud Tribble, a medical doctor and VP of Software Technology at Apple who was involved with Apple Health and ResearchKit; Afshad Mistri, a healthcare marketing manager for Apple whom “Apple’s secret weapon in a stealth campaign to get the iPad into the hands of doctors” in 2011; Vice President of Medical Technology Mike O’Reilly; and Amber Cottle, who at the time was VP of government affairs and public policy for the United States and the Americas at Apple. Marcy Wilder, a partner at Hogan Lovells who specializes in healthcare privacy and digital health, also attended.
The outcome of all these meetings can only be guessed at: A major overhaul of Apple’s App Store guidelines, cracking down more on health apps that the FDA might find objectionable, didn’t take place until September 2016, nearly two years after the last known meeting focused specifically on that topic.
“Adapting regulatory paradigms to enable the kind of solutions we all want to see”
In October 2014, however, Patel reached out to Apple to get an Apple representative onto a working group under the International Medical Device Regulators Forum (IMDRF), a group of regulators, scientists, legal experts, and physicians from the US, Canada, the European Union, Australia, China, Russia and Brazil that originally convened in 2013 to pursue harmonization of the regulatory approach to standalone medical software. Read more about that here.
In general, discussions between Apple and the FDA held in 2016 focused on IMDRF and about working with the FDA on the regulation of new Apple products -- the Parkinson’s diagnosis app and the cardiac devices. This includes the one meeting we know of between Apple and current FDA commissioner Dr. Robert Califf (the 2013 meeting happened under Margaret Hamburg’s tenure).
Discussion of this meeting starts in October 2015, with Patel emailing O’Reilly and Powderly.
“We can have this visit in two phases,” he writes. “(1) We all meet with Dr. Califf, get our principles and intent grounded (2) follow up to work on strategizing/determining concrete next steps and how we best engage with each other.”
The meeting — which doesn’t appear on the public calendars for either Califf or Shuren — took place February 22, 2016. An email from Powderly to Patel on that day reads "took us to Rob's office." In a later email to Goldstein, O’Reilly described the proceedings.
“Bakul, Jeff [Williams] and I met recently with Jeff Shuren and Rob Califf,” he wrote. “[T]hey are keen to work with us as they develop a new framework for regulating SaMD (software as a medical device).”
During the preamble to the meeting, Powderly asked Patel about the “scope of disclosure” regarding Califf’s schedule, noting that “when we met Dr. Hamburg a few years ago it was just the attendees and general topics."
It’s only after the February 2016 meeting that Williams and O’Reilly hand off some of the regulatory work to Robin Goldstein, an attorney at Apple whose current title is Special Projects -- Health. An email from Goldstein to Patel gives the most insight on the contents of these meetings.
“As Mike [O’Reilly] mentioned, Jeff [Williams] has asked me to lead the thinking (or at least the conversation) on the intersection of the regulatory landscape (as it currently exists and where we hope we might be able to influence its movement) and our products and platforms,” she wrote in an email to Patel in March 2016. “I think we all see an opportunity for innovation, building new models of engagement, and adapting regulatory paradigms to enable the kind of solutions we all want to see. I know you have been leading the charge within FDA on this front and would love to get your thinking and begin what I hope is an extended conversation.”
Later, in describing a June meeting, she writes to a colleague in an email CC’d to Patel “the purpose is to talk with Bakul about their (and our) thinking about the process and how it can be re-engineered going forward."
“I have a question about FDA approval for apps that provide a diagnosis”
In between the 2014 meetings and a series of meetings in 2015 dealing with Apple’s efforts around Parkinson’s disease, Powderly sent a handful of emails to Patel asking for his opinion on various things. In April 2015 he checked in about ResearchKit just prior to its launch. In May, he sought Patel’s opinion on the 21st Century Cures bill. But if Patel responded to these queries, he did so by phone or his responses weren't included in the emails the FDA provided Babyforyou.net.ua.
Then, in August 2015, Mike O’Reilly sent the following email to Pa “I have a question about FDA approval for apps that provide a diagnosis. Do you have time for a brief call today or tomorrow?”
That’s when the discussions begin of the Parkinson’s diagnostic app and the two cardiac devices. The Parkinson’s device is described multiple times as a diagnostic app and heavily implied to be separate from Apple’s current ResearchKit and CareKit Parkinson’s apps. It was a key topic at a large meeting in Cupertino with top neurologists, FDA officials, and Apple personnel in September 2015. You can read more about that effort here.
The cardiac devices were to be the focus of a meeting between Apple and the FDA in July 2016, but that meeting was cancelled (after being renamed from “Intro - Cardiac devices” to “Mobile Medical Apps”). You can read more about the cardiac devices here.
So far Apple has slowly but methodically moved into healthcare, first getting the iPhone and iPad into doctors’ hands, then introducing HealthKit and Apple Health, then leveraging those technologies in ResearchKit, and finally leveraging ResearchKit technology in CareKit. Apple's plans for two cardiac devices and a Parkinson’s diagnostic app are a glimpse at what's next for the company's steady move into the medical world.
In , around the time many of these emails were being sent, Apple CEO Tim Cook said as much.
“We’ve gotten into the health arena and we started looking at wellness, that took us to pulling a string to thinking about research, pulling that string a little further took us to some patient-care stuff, and that pulled a string that’s taking us into some other stuff," he said at the time. "When you look at most of the solutions, whether it’s devices, or things coming up out of Big Pharma, first and foremost, they are done to get the reimbursement [from an insurance provider]. Not thinking about what helps the patient. So if you don’t care about reimbursement, which we have the privilege of doing, that may even make the smartphone market look small.”
The difference now is these incremental moves deeper into healthcare will soon take Apple over the FDA’s regulatory line. The emails tell us that Apple won’t be crossing that line unprepared — that in fact, the company has been steadily laying the groundwork for three years.