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position on establishing clinical guidelines pertaining to SaMD last month when it entered into the federal register draft guidance it devised with the IMDRF working group.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.