Scoop: Emails between Apple and FDA hint at future plans

By Jonah Comstock

November 28, 2016

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

MobiHealthNews 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 MobiHealthNews 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 Wired

Magazine called “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 MobiHealthNews.

Then, in August 2015, Mike O’Reilly sent the following email to Patel: “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 an interview with Fast Company in August 2016, 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.

Scoop: Apple emails show plans for two FDA-regulated cardiac devices

By Jonah Comstock

November 28, 2016

Since July 2016, Apple has been in discussions with the FDA about two FDA-regulated products in the

cardiac monitoring space, MobiHealthNews has learned. The revelation comes from a collection of

emails MobiHealthNews obtained via a Freedom of Information Act request to the FDA.

On July 14, 2016, Robin Goldstein, at the time Principal Counsel for Apple, sent an email to FDA

Associate Center Director for Digital Health Bakul Patel. According to her LinkedIn, Goldstein’s title

changed shortly thereafter to “Special Projects -- Health.”

“As we discussed, I think this will be an introductory meeting where we will want to talk about two

possible (and related) products in the cardiac space, as well as the associated regulatory and quality

systems and requirements,” Goldstein wrote.

Patel invited three other FDA officials to the introductory meeting: William Maisel, deputy director of

science and chief scientist; Linda J Ricci, branch chief for cardiac diagnostic devices at the FDA; and

Carlos Peña, director of the division of neurological and physical medicine devices. Goldstein also

wanted Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, to attend

but Goldstein left him out of the email citing a “concern”, the exact nature of which was redacted by the

FDA.

Patel sent another invitation a few days later, changed the meeting title from “Apple introductory

meeting - cardiac space” to “Mobile medical apps”. This time he included Shuren in the invitation, as

well as Bram Zuckerman, director of the FDA’s Division of Cardiovascular Devices. The change seems to

have been related to a need for discretion in light of Shuren’s calendar being public.

“Hi Bakul. Got approval from Jeff Williams to have Jeff Shuren join us next week if we’re able to title the

meeting Mobile Medical Applications (which I think you said would be okay),” Goldstein wrote to Patel.

“Just wanted to confirm.”

Patel replied: “So the meeting I sent yesterday has the title Mobile medical app discussion -- that should

work.”

Although the attendee roster of that proposed meeting is interesting, in fact it never seems to have

taken place. Even after the reschedule, Goldstein sent Patel another email saying, “we agree it makes

sense to cancel the planned Monday meeting and reschedule a smaller meeting to discuss how Apple

may engage with the FDA in a way that’s ‘non-regulatory’ so we can learn about your processes and

thinking, and vice versa.”

The emails don’t contain many details about the two devices Goldstein alluded to, but a wearable ECG

device of some kind is one possibility. The form factor could be a combination of the Apple Watch and a

modular strap for the Watch. Apple CEO Tim Cook hinted that a regulated medical device from Apple

would be something along those lines in an interview with the Telegraph last fall.

“We don’t want to put the Watch through the Food and Drug Administration (FDA) process,” he said at

the time. “I wouldn’t mind putting something adjacent to the watch through it, but not the watch,

because it would hold us back from innovating too much, the cycles are too long. But you can begin to

envision other things that might be adjacent to it -- maybe an app, maybe something else.”

According to the Telegraph, Cook was bullish on health prospects for the Apple Watch after hearing the

story of a teenager whose life was saved by his Apple Watch data. We also know that Apple is thinking

about ECG technology at least on some level. In August, Patently Apple spotted an Apple patent for a

wearable ECG device. The device could read ECG from the wrist and fingertip once the user calibrated it

by taking readings on various parts of their body. Obviously many Apple patents never see the light of

day, but it does suggest some level of investment in the space.

It’s worth noting also that at least one startup believes the Apple Watch’s off-the-shelf hardware is

already capable of delivering actionable clinical information, and has put that theory to the test in

partnership. Cardiogram has been working with UCSF since March to collect user data in a study called

mRhythm and use it to develop an app for detecting atrial fibrillation based on on Apple Watch data.

"If you own an Apple Watch, its native software already measures your heart rate once every five

minutes, or continuously if you're working out," Cardiogram CEO Brandon Ballinger said in a recent

statement. "That data does get stored in your Health app, but it's just raw data, and not easily

understandable. What Cardiogram does is organize this info in graphs both real-time short-term graphs,

like your heart rate over the course of a stressful meeting, and long-term trend graphs, like resting heart

rate over time. Plus, we give you full access to the underlying metrics."

Of course, there are a few iPhone connected third party ECG devices already in existence, the best

known is made by AliveCor (which is also working on Kardia Band, an ECG built into a strap for the Apple

Watch). Asked about a hypothetical device from Apple, AliveCor inventor Dr. Dave Albert told

MobiHealthNews he was skeptical, but that it would actually be great for the incumbent players.

“Nothing would be better for AliveCor than Apple introducing an ECG device but I am very skeptical,” he

told MobiHealthNews in an email. “The market is small in Apple terms. Most iPhone customers don't

need an ECG. However, were they to introduce something, I suspect AliveCor would be acquired in a

nanosecond. Alphabet, Microsoft, Fitbit, Medtronic, GE, Philips, Samsung, Huawei, Xiaomi, etc. would

need a solution fast and getting into the highly regulated medical field would not be fast for any of the

nonmedical companies and the medical companies take years to develop products.”

On the other hand, Vital Connect CEO Nersi Nazari has a different opinion. His company makes a

smartphone-connected, peel-and-stick sensor for home and hospital monitoring that can read ECG as

well as other vital signs. In an interview with MobiHealthNews, he noted that if Apple were to get into

patient monitoring on the medical side, it wouldn’t just be competing with small startups but with large

players like Philips and GE.

“If any major company gets into it, it probably would have some effect,” he said. “But as you know there

are already major medical companies that are in the market such as GE [and] Philips. There’s no

shortage of large companies with very good technology in the medical side. It’s not like Apple is getting

into a small market that didn’t have big players to begin with.”

Scoop: Apple is working on a diagnostic app for Parkinson's disease

By Jonah Comstock

November 28, 2016

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.”

Scoop: Emails show FDA asked Apple to advise on Software as a Medical Device

By Heather Mack

November 28, 2016

As the world’s medical device regulators work to harmonize how best to regulate software as a medical

device (SaMD), MobiHealthNews has learned via a Freedom of Information Act request that the FDA

invited Apple to join an international task force focused on shaping this future regulatory framework.

Apple executives quietly joined a working group within 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 to pursue harmonization of the regulatory approach

to standalone medical software.

The agency shed light on its current position on establishing clinical guidelines pertaining to SaMD last

month when it entered into the federal register draft guidance it devised with the IMDRF working group.

While the proposed guidance is officially written by the IMDRF, it is considered to closely represent the

FDA’s thinking on how it will regulate medical software in the future.

The proposed guidance seeks to articulate what's new and different about SaMD (a category that

includes mobile medical apps) and provide a stratified guidance on how to regulate different kinds of

software and what kind of evidence is needed for each regulatory category. The guidance stratifies

devices on two axes: whether the device informs care, drives care, or treats/diagnoses and whether the

condition in question is non-serious, serious, or critical. So software that treats or diagnoses a critical

condition is in the highest risk category, while software that informs care about a non-serious condition

is in the lowest.

The proposed guidelines also call out and address the fact that software development tends to move

faster than traditional medical device development and can more easily be influenced by post-market

data.

While it was widely reported that the FDA met with Apple to discuss “Mobile Medical Apps” in 2013,

emails obtained by MobiHealthNews via a Freedom of Information Act request show the agency was

also eager to solicit Apple’s input on regulation of SaMD, and Apple was in turn eager to join. The

company took part in the global working group, but the Apple representative asked to be left off of the

group’s official list, a request the FDA obliged.

According to the emails, the agency first approached Apple about joining the IMDRF working group in

October 2014. Bakul Patel, the FDA’s associate director for digital health at the agency’s Center for

Devices and Radiological Health, sent an email to Tim Powderly, Apple’s Director of Federal Government

Affairs:

“Can we talk briefly in the next day or so – I am looking to see if there is a senior person at Apple who

would be interested in participating in an international effort that is driving towards clarifying how

current good software development practices can be used and continue to comply with medical device

quality management systems,” he wrote.

That email came shortly after the IMDRF published a consensus document entitled Software as a

Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations. Bradley

Merrill Thompson, a partner at Epstein Becker Green who specializes in the FDA and digital health,

wrote a post for MobiHealthNews in February 2015 in which he wrote, “The document is instructive for

our purposes because FDA was heavily involved in drafting it. To be sure, it is also the product of

compromise among international regulators. But I also can’t see FDA ignoring the document when the

agency’s fingerprints are all over it.”

We don’t know whether Powderly and Patel discussed the IMDRF working group following that email as

our FOIA request yielded no additional 2014 or 2015 emails relevant to the IMDRF discussion. The

IMDRF discussion picks up again in January of this year, and between February and August of 2016,

Apple representatives had in-person and teleconference meetings with the FDA and other members of

the IMDRF SaMD group.

On January 30, 2016, Patel thanked Mike O’Reilly, Apple’s VP of Medical Technology, for agreeing to join

the working group and help on clinical evaluation for software that is a medical device.

“I think that with all the work that Apple is doing – there will be a great advantage on having your

perspective as we are building this,” Patel wrote.

Patel then went on to describe the background of the SaMD working group of the IMDRF and gave an

estimated publish date of early 2017 to look at a few key aspects: what clinical methods and processes

SaMD manufacturers should have regardless of type; when and which clinical methods and processes

are important and should be independently verified; and how much and what type of clinical evidence is

adequate for that independent verification.

A few days later on February 2, 2016, O’Reilly wrote back, “Will have an official response later today.

Thanks. What an honor!”

Later that day, O’Reilly wrote he “got the ok!” but was checking with Bud Tribble, Apple’s VP of

Software, who is also an MD, to make sure there wasn’t someone better suited for the task. Patel wrote

they needed someone who “can bring the clinical research/evaluation perspective,” and said he thought

O’Reilly would be “perfect.”

On February 4, O’Reilly then requested to not be listed on the meeting schedule, writing, “It would

greatly simplify my life to just not list me there. Really appreciate your flexibility there.”

Within 20 minutes, Patel wrote back, “Done. I will not include you.”

Over the next few weeks, O’Reilly’s assistant accepted invitations to meet at the FDA headquarters on

February 16th through 19th, and a couple of teleconferences in March. While O’Reilly is listed on a

March 2 email with every other member of the SaMD working group, his name does not appear in the

list on the group’s official page.

On March 9, 2016, O’Reilly looped in Robin Goldstein, an attorney with Apple whose roles have included

“principal counsel” and “special projects -- health” according to her LinkedIn account. In his email

O’Reilly introduced Goldstein to Patel and explained for Goldstein’s benefit that Jeff Shuren, the FDA’s

Director of the Center for Devices and Radiological Health, and Rob Califf, who had just been confirmed

as the new FDA Commissioner, were “keen to work with us as they develop a new framework for

regulating SaMD (Software as a Medical Device).”

“Bakul, we are very grateful for your collaboration as we work through the issues,” O’Reilly wrote in the

email.

Further emails in March indicate the close ties the company was forming with the FDA as they worked

together, with Goldstein writing to say how much she “enjoyed (seems like an unusual word) our

discussion yesterday…” and also indicating an open availability to speak further “…in the interim, please

feel free to reach out if there’s any way I can be of help (I answer my [texts] pretty much 24/7).”

Apple continued to attend meetings and have conversations with the FDA in March and April. In May,

O’Reilly wrote to Patel about the company’s work on a Parkinson’s diagnostic app, before handing off

the SaMD project to a new Apple hire: Stephen Friend, the co-founder and chairman of Sage

Bionetworks. Sage worked with Apple on one of the first ResearchKit apps at launch that later became

one of the first CareKit-enabled apps. In June,Sage announced that Friend would be stepping away from

day-to-day responsibilities as he had taken a position at Apple to work on “health related projects.”

Friend’s name also does not appear on the SaMD working group’s page, but is included on the March 2,

2016 email to the rest of the working group, along with O’Reilly’s. On June 21, 2016, Friend wrote to

Patel: “I am so eager to join in on these projects!!” and was welcomed to the team in response.

As pointed out in an article by partners at Washington, D.C. law firm Morgan Lewis, published in the

National Law Review, the draft IMDRF guidelines document is important because it’s the first time the

FDA has proposed issuing an IMDRF document as an official FDA guidance document. While the agency

has worked to clarify its position on software products with other documents (like the 2015 Mobile

Medical Applications guidelines) there is no clear overarching policy on when software used for any

health or medical purpose would be considered a medical device and thus under the purview of the

FDA.

In the article – which Morgan Lewis partners Michele L. Buenafe and M. Elizabeth Bierman wrote as

general commentary on the IMDRF guidelines and not Apple specifically – the authors point out that the

guidelines may be coming too soon.

“In this context, issuing guidance on FDA’s expectations for the clinical evaluation of SaMD seems

premature,” the partners wrote on the firm's blog. “Software developers need to first understand where

that proverbial line is before investing in clinical evaluation activities.”

Apple representatives continued to join in meetings on SaMD throughout the summer, with the latest

known discussion taking place on August 2. It isn't clear from the emails what input, if any, Apple

contributed toward the draft document. What we know is that Apple has been part of the discussions of

the SaMD guidelines since January, that they joined the task force at the FDA’s invitation, and that, for

whatever reason, they asked that their involvement -- in shaping a guidance that could have a major

effect on how their products are regulated and sold -- not be disclosed.