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When Does a Smartphone Become a Medical Device?

Posted by | 3:05pm on Wednesday, January 26, 2011
iphone displaying mobile health application

The issue of regulation has huge implications for innovation in this space. 

Part of the transformation of health care is the new technology that allows smartphones to be used for diagnosis and tracking medical concerns. These mobile apps do everything from monitoring heart beats to managing glucose levels. There were more than 7,000 health-related apps for the iPhone in September 2010 according to a MobiHealthNews study. With the popularity of the iPad these numbers are sure to grow.

However, it’s important to realize that any programmer can develop a health app. Apple puts the responsibility of following regulatory guidance on developers. So when do these apps (and the smartphone or tablet itself) become considered medical devices requiring monitoring by the U.S. Food and Drug Administration (FDA)?

The FDA defines a medical device broadly on their website and have a variety of classifications: “Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers with micro-chip technology and laser surgical devices.” As we’ve seen with pharmaceutical advertising and promotion, the existing FDA guidelines fail to address the unique issues that arise with new technology. The issue of regulation has huge implications for innovation in this space.

Essential Reading
In December 2010, the mHealth Regulatory Coalition issued a whitepaper, which is essential reading for anyone interested in this topic. The authors discuss what mobile health hardware and software will the FDA regulate and, if they are regulated, in what device classification will the FDA place them?  They don’t come up with any answers, but they do illustrate the complexity of these questions.

The authors identify three areas for review:

  1. Intended use: “To what extent can mHealth‐related products be excluded from FDA regulation by focusing their marketing campaigns on general improvements to consumer wellness, as opposed to focusing on the management or treatment of diseases such as diabetes and hypertension?”
  2. Connected hardware: “To what extent do mobile phones and other generic communication hardware become FDA regulated medical devices simply because they are promoted for connection to a medical device?”
  3. Software functionality: “To what extent does the FDA regulate software apps that are intended to reside on mobile phones, ordinary PCs, servers or perhaps in the cloud if they function to provide connections between communication hardware and medical devices or as repositories for health data?”

With the 54-page whitepaper, the Coalition has identified key topics for discussion and hopes to open a dialogue with the FDA.

How Will the FDA Cope?
With the volume of mobile health apps predicted to grow significantly, how would the FDA handle an increased regulatory workload? And if a pharma brand wants to create an app for patients, will they need to get it approved as a device first and then messaging reviewed by the Division of Drug Marketing, Advertising and Communications (DDMAC)? It will be interesting to see how this all plays out in the years to come.

What do you think?

(Image courtesy of Juhan Sonin on Flickr.)

About Eileen O'Brien

Eileen has more than 16 years of digital healthcare marketing experience. She is an opinion leader on social media and biopharma, and has been invited to speak at industry conferences and quoted in publications.

View other posts from Eileen

13 Pingbacks/Trackbacks

  • http://twitter.com/Haydn_S Haydn Sweterlitsch

    Great post.

    Fact is, very few (if any) regulatory bodies can keep pace with the innovations of consumer technology for any industry, let alone healthcare.

    If the backlog and delays witnessed by the industry for FDA approval in traditional pharma marketing—and their track record of reactionary policy/guidelines rather than proactively foreseeing and scripting policy around new developments—is any indication, the development and deployment of healthcare apps will be a dimly lit labyrinth with plenty of potential landmines around every turn.

    This isn’t necessarily an indictment of the regulators—there simply aren’t the resources (or expedience) for them to get in front with policy for every ripple (that may or may not become a wave).

    But as with every new development in how healthcare brands engage with patients and customers, it’s not a question of “if” or “whether”, it’s “when” and “how”.

    • http://twitter.com/eileenobrien Eileen O’Brien


      Thanks for your thoughtful comment. I agree that there will be innovative organizations and brands that will lead the way and the FDA will probably end up responding to particular cases. We saw this in the pharmaceutical promotional sector when the FDA sent the 14 letters on PPC years after brands had started paid search campaigns.


      • http://twitter.com/Haydn_S Haydn Sweterlitsch


        I suppose the heart of the original question posed in your post comes down to information vs. treatment.

        The FDA regulates information published/distibuted by healthcare brands (obviously), and they regulate devices created to aid in the treatment of conditions (obviously).

        For instance, there are different levels of approval and/or scrutiny involved with a website or TV spot about an injectable drug vs a new device created to make injecting that dug easier for the patient.

        And while I don’t claim to have an answer, I would imagine that if a mobile app could reasonably be seen as aiding in the administering of a specific drug or treatment, it could be classified as a medical device. However, where does that line get drawn? Is an automated phone or text service that reminds you when its time to take your drug a medical device? Clearly not.

        Information created for patients of a particular drug about treatment with that drug clearly are an aide in treatment—think of every retention, persistency/compliance stream ever created—but they are not essential or integral to the administering of that drug (and so are not viewed that way by the FDA).

        So for now, that would be the way I framed it for my clients: If the app is central and essential to administering the treatment, it may be viewed as a medical device. If the app houses, tracks or offers patient/drug information about the treatment or condition, it can’t be reasonably viewed as a medical device.

  • http://twitter.com/Hall_MediaMaven Maureen Hall

    According to a recent article in MobiHealthNews, http://bit.ly/eAeh4X former FDA Director Dr. Dan Schultz opined that “…it is unlikely, again depending on the particulars, that the FDA is going to want to get into regulating these general use products as medical devices”.
    I hope that he is right.

  • http://twitter.com/eileenobrien Eileen O’Brien

    Maureen — thanks for the link to that relevant article. I hope Dr. Schultz is right too!

  • http://twitter.com/SarahBethRN Sarah Beth Cowherd

    Interesting Post.

    This is where technology in health care is heading (whether we are prepared for it or not).

    I think the FDA must incorporate medical apps into their regulatory workload. These apps provide consumers with new tools to engage and stay connected. With FDA approvals, we have the potential to see not only a rise in sales, but *gasp* better patient outcomes.

    These are exciting times.

    • http://twitter.com/eileenobrien Eileen O’Brien


      The FDA has the responsibility to safeguard consumers and as apps get more sophisticated the possibility to do harm will exist. Just like on the internet with advice, anyone can play at being a healthcare professional and create a medical app!

      I agree, these are very exciting times.

  • http://twitter.com/donnawray Donna Wray

    Here’s a question that should help to answer this — how has the FDA ever regulated information systems that hold or process health data? I would think that this is too big a beat for them to patrol, but devices are out of my expertise. On the other hand, if there is hardware that starts to adapt a phone to monitor health info, it would be just as regulated as the average blood pressure monitor or glucose meter.

    My point – this is not a new question. Anyone have an example of the FDA looking at a specific app intended for consumers before the rise of the ‘smart phone’?

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