My thoughts on Waiting for the app-ocalypse: Will toughening FDA regulations disconnect the medical smartphone app industry?

I recently read Waiting for the app-ocalypse: Will toughening FDA regulations disconnect the medical smartphone app industry? [July 22, 2010 by Brendon Nafziger, DOTmed] and found it an informative read.  I'd like to add a few of my own thoughts.

The way this space is evolving is very interesting to me.  Whether you are in the industry or not, it should be to you as well.  Mobile engagement is the future.  Regarding the use of mobile devices in healthcare, while I can understand the FDA’s concern about medical devices and being sure that they follow the correct path to approval, I have to be concerned about the effects to both the industry and the patient (aka consumer) about the potential for overreaching by the FDA regarding what is or is not under their purview.  These comments do not even take into account the potential for the FCC to be involved as well since we are talking about mobile (ie wireless) devices.  Apple may play a role too, but that conversation is for another blog entry.

The future of successful medicine will rely on patients and caregivers being more engaged in their own therapy.  That is not rhetorical, it is fact.  For this to happen, the future is going to rely on mobile computing.

For this to work, from an informational standpoint (messaging, data capture, tracking, reporting), there will be little to no compliance if a patient has to carry around a bag of devices.  Many of these ‘tools’ are going to have to be in the form of software (web or application based) accessible from as few devices as necessary to tote around.   Think about today’s diabetic teenager carrying around a glucose meter, a pump and their cell phone.  Some companies have taken the step to integrate (or facilitate communication between) the meter and the pump and in fact, connect them as one and consolidate reporting from the device(s); a great step forward.  But here is the key compliance question:  When a device on his or her body buzzes or chimes, what do you think he reaches for first? That’s right, the cell phone.  What’s the logical next step to successful engagement with this patient?  Three devices with disparate function and reporting turned into two devices with consolidated function and reporting becoming one device with near time reporting employing the Smartphone for communication and analysis acting as one.

As you can see from my example, Smartphones should offer a solution for better management of healthcare costs for chronic conditions.  The way to manage the costs of caring for these patients is to enable them to self-manage their health. For that to happen, it must be reasonable and easy and fit the right tool (aka device used) to the patient.  By example

• Smartphones make it easy for patients to track important health information
• Smartphones make the technology convenient
• They are mobile; patients can use them at any time or any place.
• If apps are written to support it, they can alert and/or capture data even if no network infrastructure is in place.
• When connectivity is restored, Smartphones make it seamless for patients to share health information with their providers, caregivers and others within their care network.
• Finally, Smartphones used by the individual are selected by the individual.  That is the first step of engagement – a self-selected fit to their personality if you will.

Also, because there are so many mobile phones, Smartphones, etc. out there, it makes sense to extend into this diverse installed base for the benefit of the patient.  Forcing patients to change their provider or equipment is not cost effective or realistic, a fact that has already shown itself in the corporate environment where personal use of Smartphones has driven Enterprise to find ways to accommodate their employee’s facility for increased productivity for the same reasons it will in the case of patient care.  While adapting the technology is feasible for patients, providers, labs and hospitals – the potential costs to develop and go for approval on all of the platforms for the many potential uses of the empowered patient may have the downside of limiting the community of possible developers to the biggest companies with the biggest budgets.  These choices we make regarding regulation and process may, in effect, sideline the creative ideas of startups and small companies.  How realistic is it to test every version of each device in use with every potential device?  I think we have figured at least some of this out with diabetes as an example, each meter is not tested with every computer running every operating system; just the platforms themselves to be sure connectivity worked.  We need to consider this as we decide where the FDA and FCC belong when considering the evolution of mobile and its use in the space.

I think who the user is is another issue we have to consider as well and will go into this further in a later blog.

A few related links:

Smartphone apps make healthcare splash

The Future of Connected Health, Chapter 1

Participatory Health: Online and Mobile Tools Help Chronically Ill Manage Their Care

How Smartphones Are Changing Health Care for Consumers and Providers

http://www.chcf.org/publications/2009/09/participatory-health-online-and-mobile-tools-help-chronically-ill-manage-their-care

Health industry wants 'clarity' on m-health regulation (recently tweeted)

FDA, FCC discuss medical smartphone apps as industry adjusts to regulatory culture

Wireless-Life Sciences Alliance meeting highlights fast-evolving field

And a final note:

As I was reading various articles in preparing my thoughts on this, I came across something that tells me that mobile in healthcare is on the right track.  It’s from Stanford’s Dr. BJ Fogg: To change behaviors we need to “Put hot triggers in the path of motivated people.”

-hb