Like a lot of people, we are really excited about the advances in mobile technology and how they can be applied in the healthcare environment to facilitate health and wellness in general, and more specifically, drive greater patient engagement and more efficient delivery of patient care. Mobile health, or mHealth as it is frequently called, is an area that is rapidly evolving, as more and more established tech companies seek to expand their portfolios with, among other things, wearable sensor products, diagnostic tools and other monitoring products and accessories.
As the field becomes more crowded each day with companies and developers introducing new and more robust mHealth products, the odds of implicating FDA’s regulatory authority over mobile medical apps becomes a more pressing issue.
As many of our readers may know, FDA’s authority to regulate mobile medical apps stems from what device classification (i.e., I, II or III) the mobile app falls into depending upon the potential risk to the user. As many industry watchers also are aware, FDA will from time to time exercise its enforcement authority against unapproved medical devices, sometimes with drastic consequences. The background of FDA’s enforcement action last November against 23andMe should be required reading for anyone seeking to develop and introduce an mHealth product in the US, as it provides a highly visible cautionary tale about the importance of working within FDA’s regulatory framework applicable to medical devices.
In short, although 23andMe’s product was not a mobile medical app, FDA’s issuance of a warning letter to the company for marketing an unapproved medical device forced the company to suspend a significant part of its business – conducting health-related genetic tests.
To head off similar misfortunes, many mobile medical app developers are learning that engaging FDA in a dialogue about possible regulatory hurdles in the approval process is a path well worth taking. In fact, the chief architect of FDA’s mobile medical app policy, Bakul Patel, endorsed such a path, especially for new developers:
Which is why we are so interested to see two of the most dominant companies in the tech space – Google and Apple – recently engaging FDA on mHealth issues.
There’s already been a lot of coverage of Google’s foray into the mHealth arena with possible medical uses for Google Glass, as well as its efforts to develop a smart contact lens to measure glucose levels in the tears of diabetics.
As the members of the Google X team noted in their blog post, they have already begun discussions with FDA, even though possible approval and commercialization may take up to five years. These meetings between Google X staffers with FDA, further detailed in other press reports based upon FDA’s public calendars, suggest that Google is cognizant of potential regulatory hurdles for mobile medical apps and is taking a proactive approach to working with FDA.
What has been less well-publicized (silent, in fact!) is that Apple appears to have made engaging with FDA on mHealth issues a critical priority. Whether Apple’s outreach corresponds to rumored plans to unveil an iWatch containing medical sensors is unclear, but there is no question that Apple views a dialogue with FDA as a key piece of its mHealth strategy.
For example, last month several senior level executives who seem to have been enlisted in the effort and met with senior FDA officials to discuss mobile medical apps, according to FDA’s public calendar. And this was no ordinary “meet and greet” like the Google meeting with FDA (again, according to the FDA calendar).
Among the Apple attendees:
- Jeff Williams, SVP, Operations and a member of Apple’s executive leadership team
- Bud Tribble, VP Software Technology (How close is Bud Tribble to Tim Cook? Oh look, here he is with Tim Cook on ABC’s 20/20 last week discussing the introduction of the Mac)
- Michael O’Reilly (the former Chief Medical Officer at Masimo Corporation, a manufacturer of pulse oximetry and other monitoring devices, who was hired by Apple sometime last year according to the folks at Mobihealthnews)
- Cathy Novelli and Tim Powderly, both in Apple’s government affairs department
The lineup from FDA? Again, another group of senior level staff, including Jeff Shuren, the director of FDA’s Center for Devices and Radiological Health (CDRH), Bakul Patel, who drafted FDA’s mobile medical app guidance, and two senior legal advisors.
Oh, to have been a fly on the wall in that meeting. While it’s impossible to know whether this meeting occurred as the opening of Apple’s dialogue with FDA, or rather as part of an ongoing dialogue with FDA that began long ago, one thing is clear: the senior level nature of the meeting appears to demonstrate Apple’s extremely strong commitment to the mHealth space and foreshadows a major product announcement or initiative in the mobile medical industry (fully loaded iWatch?)
Again, while we don’t have any knowledge of either Google’s or Apple’s discussions, we view these meetings as extremely encouraging signs that these tech powerhouses are sensitive to FDA’s regulatory framework and appear to be taking steps to work with the agency to bring new mobile health care tools and products to market quickly.
We can’t wait to see what they both come up with.