Apple's Strategic Focus on Cardiac Devices and Parkinson's Diagnostic App Revealed in First-Ever FDA Email Disclosures

As is well known, Apple aims to enter the healthcare sector, particularly in hardware, but FDA review remains an insurmountable hurdle. Since holding extensive public collaboration meetings with the FDA in 2013, Apple has regularly met with the agency and engaged in dialogue via phone and email under the Freedom of Information Act. Foreign media outlet mobihealthnews first disclosed these emails, and VCBeat (WeChat: vcbeat) has compiled them for you.

These emails, dating back to December 2013, reveal what aspects of review Apple and the FDA have discussed. According to data from MobiHealthNews, topics included the App Store review process, the 510(k) clearance pathway, ResearchKit applications, and diagnostic applications. This indicates that Apple has engaged with the FDA in a passive, “unregulated” manner. The FDA even invited Apple to participate in regular briefings aimed at helping guide and tailor internationally harmonized regulatory frameworks for medical software.

Although most sensitive information in the emails has been redacted, a glimpse from the available correspondence suggests that Apple places significant emphasis on the regulatory review of three medical devices: an application for diagnosing Parkinson’s disease and two separate but related cardiac devices. This may also indicate Apple’s future focus in the healthcare sector, potentially involving the development of related devices.

An interesting detail is that, following extensive media coverage of the 2013 meetings between Apple and the FDA, both parties implemented stricter confidentiality measures for their subsequent meetings and collaboration. For instance, email records indicate that meeting titles and locations were altered. Particular care was taken to safeguard the confidentiality of schedules for senior officials, such as FDA Commissioner Dr. Robert Califf and Dr. Jeffrey Shuren, Director of the FDA’s Center for Devices and Radiological Health, whose calendars were more susceptible to public scrutiny and could potentially expose the company to heightened media examination.

In light of heightened confidentiality measures, media reports in December 2013 revealed that Apple executives met with FDA officials, although details of the meeting remained unclear. Apple was represented by Jeff Williams, Senior Vice President of Operations; Bud Tribble, Vice President of Software Technology; Tim Powderly, Government Affairs Advisor; and newly recruited top medical expert O’Reilly. The FDA attendees included Jeff Shuren, Director of the Center for Devices and Radiological Health, and Bakul Patel, who drafted the agency’s “Guidance on Mobile Medical Applications.”

At the time, there were two main conjectures. One was that Apple might have been inquiring about clear regulatory hurdles for launching medical devices or applications with the FDA, or attempting to determine whether its iWatch project—a device capable of reading users’ pulse rates—would encounter setbacks following discussions with the FDA. This speculation arose because, prior to being recruited by Apple, O’Reilly had served as Chief Medical Officer and Executive Vice President of Medical Affairs at Masimo Corporation, a pulse oximetry company.

Another hypothesis is that the meeting discussed granting Apple greater flexibility in upcoming healthcare initiatives such as ResearchKit and CareKit (a memo obtained by Apple Toolbox in 2014 through its own Freedom of Information Act request confirmed this speculation).

But now we know that this meeting, along with several scattered meetings held beforehand, was merely the beginning of a long-term relationship. Nearly all of the emails involved Bakul Patel, who drafted the FDA’s “Guidance on Mobile Medical Applications.” Shortly after the December 2013 meeting was made public, in subsequent email exchanges between the two parties, Patel contacted Apple solely to request a broader initial discussion on the FDA’s perspective regarding sensor-based commercial platforms, as well as an overview of Apple’s current process for reviewing apps developed by third-party developers.

In an email, Patel wrote, “To strengthen our approach to promoting innovative medical technologies and protecting public health, I believe the FDA can benefit from collaborating with industry leaders such as Apple.” Clearly, the FDA holds an optimistic and positive outlook on Apple’s entry.

At a meeting on January 29, 2014, Apple outlined to the FDA how it reviews third-party applications in its App Store. Following the meeting, Apple provided Patel with a copy of its App Store Guidelines, as requested.

On February 20, 2014, a follow-up meeting was held at the FDA headquarters in Maryland to discuss “Updates on Mobile Medical Applications” (according to an email sent by Apple’s government advisor, Tim Powderly, to Patel). Notably, the email indicated that Dr. Jeffrey Shuren, Director of the FDA’s Center for Devices and Radiological Health mentioned earlier, had confirmed his attendance, and the meeting was specifically scheduled on his public calendar. However, Dr. Shuren did not attend the meeting on the day it appeared on his public calendar, as the email showed that the meeting room was changed at the last minute before the meeting.

The same situation occurred on September 15, 2014, when Dr. Shuren again failed to appear on the public schedule. It is unclear from the emails what was discussed at this meeting, but they include a complete list of attendees, many of whom were familiar faces. The FDA had only two participants: Patel and Shuren. On Apple’s side, the list included Powderly; Bud Tribble, Apple’s Vice President of Software Technology (who was involved in the Apple Health and ResearchKit projects and was formerly a physician); Afshad Mistri, Healthcare Marketing Manager (described by Wired magazine in 2011 as the “secret weapon in the secret campaign to get iPads into doctors’ hands”); Mike O’Reilly, Vice President of Medical Technologies (a top medical expert); and Amber Cottle, Vice President of Government Affairs and Public Policy. Also listed among the attendees was Marcy Wilder, a partner at Hogan Lovells specializing in healthcare privacy and digital health.

All these conferences revolved around a single theme: significant improvements to the Apple App Store Guidelines. The FDA might strengthen its review of health applications, and it was not until September 2016 that Apple finally implemented its latest review guidelines.

However, there have been some changes. In October 2014, Patel reached out to Apple Inc., bringing Apple representatives into a working group under the International Medical Device Regulators Forum (IMDRF). This group, composed of regulators, scientists, legal experts, and physicians from the United States, Canada, the European Union, Australia, China, Russia, and Brazil, was initially convened in 2013 with the aim of harmonizing regulatory approaches for standalone medical software.

Generally, the discussions at the meeting held between Apple and the FDA in 2016 focused on regulatory efforts related to the IMDRF and new Apple products—specifically, the Parkinson’s disease diagnosis application and cardiac devices. This includes a meeting held on February 22, 2016, between Apple and the then-current FDA Commissioner, Dr. Robert Califf (the 2013 meeting took place during Margaret Hamburg’s tenure).

In fact, discussions with Dr. Robert Califf began as early as October 2015. Patel sent emails to Apple’s Vice President of Medical Technology, O’Reilly, and Government Affairs Advisor, Powderly, stating, “We can proceed in two phases,” he wrote. “First, we all meet with Dr. Califf to establish a baseline for our principles and intentions. Second, we follow up to develop a strategy, define specific next steps, and determine how we can best engage.”

To maintain confidentiality, the meeting did not appear on the calendars of Califf or Shuren. An email sent that day from Powderly (Apple) to Patel (FDA) read, “Take us to Rob Califf’s office.” In a subsequent email to Goldstein (legal counsel for Apple Health), O’Reilly described the situation at the time.

“Bakul Patel, Jeff Williams, and I recently met with Jeff Shuren and Rob Califf,” he wrote. “They are eager to collaborate with us as they develop a new framework for regulating Software as a Medical Device (SaMD).” In the meeting’s opening remarks, Powderly asked Patel about the “scope of disclosure” in Califf’s plan, emphasizing that “when we met Dr. Hamburg (the then-FDA Commissioner) a few years ago, it involved only participants and general topics.”

It was only after the February 2016 meeting that Jeff Williams and O’Reilly handed over certain regulatory responsibilities to Robin Goldstein, Apple’s attorney in charge of special health projects. Emails from Goldstein to Patel provide the most in-depth insight into the contents of these meetings.

“As O’Reilly noted, Jeff Williams (Apple’s Senior Vice President of Operations) asked me to share our candid views on regulation, products, and platforms,” she wrote in a March 2016 letter to Bakul Patel. “I believe we all see opportunities for innovation to establish new engagement models and adapt regulatory paradigms, thereby achieving the kinds of solutions we all wish to see. I recognize your leadership at the FDA in this area, and I hope to hear your thoughts so we can initiate an in-depth dialogue, including on process redesign.”

Between a series of conferences on Parkinson’s disease in 2014 and 2015, Powderly sent several emails to Patel, requesting the FDA’s views on various matters. Thus, as early as April 2015—before the launch of ResearchKit—Patel had already taken an interest in ResearchKit. In May, he also sought Patel’s input on the 21st Century Cures Act. However, when Patel responded to these inquiries, he did so primarily by phone.

Then, in August 2015, Mike O'Reilly sent the following email to Patel: “I have a question about an FDA-approved application for diagnostic purposes. Do you have time for a brief call today or tomorrow?”

At that time, discussions regarding a Parkinson’s disease diagnostic application and two cardiac devices were just beginning. The Parkinson’s device has been described on multiple occasions as a standalone diagnostic application, distinct from Apple’s existing ResearchKit and CareKit applications for Parkinson’s disease. In September 2015, a major symposium on this topic was held in Cupertino, bringing together leading neurologists, FDA officials, and Apple representatives.

Cardiac devices were the focus of a meeting between Apple and the FDA scheduled for July 2016, but unfortunately, the meeting was canceled and replaced with discussions on mobile medical applications.

To date, Apple has made a slow yet methodical entry into the healthcare sector, first by placing iPhones and iPads in the hands of physicians, followed by the introduction of HealthKit and Apple Health, then leveraging these technologies in ResearchKit, and finally building upon ResearchKit’s framework with CareKit. It is foreseeable that Apple’s next strategic focus will center on two cardiac devices and Parkinson’s disease diagnostic applications.

As early as August 2016, in an interview with Fast Company, Apple CEO Tim Cook’s remarks on healthcare corroborated the information disclosed in this email. “We have entered the healthcare sector and have begun conducting related research aimed at treating patients’ diseases. The future market for healthcare will be even larger than that for smartphones,” he said at the time. “Yet if you look at most current solutions, whether from device manufacturers or large pharmaceutical companies, their primary consideration is surprisingly how to secure reimbursement from insurance providers. We aim to change this status quo.”

While it is possible that Apple’s incremental healthcare research will soon cross the FDA’s regulatory threshold as it deepens, these emails indicate that Apple will not cross this line lightly. Having steadily laid its healthcare foundation over the past three years, is the harvest season far off?