A few days after the start of the new year, and looking at what has 2013 brought us, I would like to consider the perspective of #mHealth and its evolution over the next few months .
We are facing a clearly asymmetric panorama between the future and the present, but also very promising. Our industry needs to reinvent itself or as some say, Creative Destruction is required to establish the foundations for a new one.
While the FDA is willing to achieve a regulatory process, it looks like it’s going to be long and complex, though the positivething for 2014 is that the starting point is not more complicated than in 2013.
However, in its draft guidance for the regulation of #mHealth the FDA made it clear that supervision will focus on mobile medical applications that meet two requirements:
1. They are intended for use as an accessory to a regulated medical device.
- For example, an application that enables a healthcare professional to make a specific diagnosis by viewing a medical image of a picture archiving and communication system (PACS) on a Smartphone or a mobile tablet.
2. That transforms a mobile platform into a regulated medical device.
- For example, an application that turns a Smartphone into an electrocardiograph (ECG) to detect abnormal heart rhythms or determine if a patient is suffering a heart attack.
Analyzing these two requirements, the first thing that comes to mind is that they are very similar and difficult to differentiate what makes them different. So I wonder what is the FDA referring with these two requirements?
From my point of view, the FDA wants to limit its regulatory process to those Apps that according to a Smartphone’s functionalities or those achieved by connecting devices which transform it in an accessory or pseudo – medical device that helps professionals taking some type clinical decision.
That is, if I send data by Smartphone about my weight or diet to my GP… FDA won’t regulate it. Whereas if I send recordsabout my level of blood glucose, or my blood pressure, or an EKG or a photograph of a rash on my skin, and this information can help the doctor to take any related decision about my health, then the FDA will regulate it.
The great difficulty with regulating #mHealth, is its exponential growth, and while no American lawmaker — of any political party – thinks innovation should be stifled, which seems obvious, they do not seem to have a clear idea how to address such regulation.
But technology continues its evolution and medicine is constantly shaping and leading to important innovations, it has in the past and will continue in the future.
Now add to this evolutionary maelstrom, the emergence of mobile devices (Smartphone , glucometers , blood pressure …) that have led to an emerging branch of technology known as healthcare #mHealth, a broad term that involves any aspect within the health system, and it opens up a range of impressive possibilities.
For example companies like Verizon and Qualcomm are taking steps in this direction with products that make devices that can be used by both patients and healthcare providers, with all that this implies.
But not only companies within the telecommunications world are moving towards #mHealth, also companies like Google with its Google Glass, are incorporating medical applications in this new Gadget.
Also pharmaceutical companies like Sanofi and Merck are starting to use the concept of Gamification to involve more patients in the care, prevention and management of their diseases, as noted in my post THE CHALLENGES OF #MHEALTH FOR 2014.
Sooner or later, something will happen and I guess we’re getting closer to the moment when things will begin to change and reinvent our industry to give a new and more balanced panorama.
In this sense, I point to what Steven Krein said, co-founder and CEO of the company in the past StartUp Health Summit in Washington in December.
Steven believes that the health sector is beginning a process of ” Creative Destruction“, a concept coined by Joseph Schumpeter in the mid- twentieth century, to describe the process in revolutionary innovation that replaces the old industry with a new one.
In fact other industries have been destroyed creatively before, media , entertainment , music , travel and small businesses, health being one of the few that still stand .
According to Krein, the confluence of four factors are helping this transformation occurs:
- Health reform (Obama care) .
- The increasing costs of chronic diseases
- Digital technologies
- The golden age of the entrepreneurship
This view is also shared Eric Topol , MD , director of the Scripps Translational Science Institute and author of “The Creative Destruction of Medicine : How the Digital Revolution Will Create Better Healthcare ” .
Topol writes in his book that “we desperately need medicine to be Schumpetered” and that a “propitious convergence of a maturing Internet, ever-increasing bandwidth, near-ubiquitous connectivity and remarkable miniature pocket computers in the form of mobile phones” are taking doctors and patients places they’ve never been before.”
So 2014 starts where 2013 left us with the #mHealth community, the U.S. Congress and government regulators in continuous discussion about the appropriate balance between promoting innovation and protecting patient safety .
Apparently, the debate is stuck in deciding whether the Software alone can or cannot be considered a medical device. But I think the key debate issue isn’t exactly this.
I agree with Topol and Krein, and advocate to begin to break old patterns and create new ones, because we need to “creatively destroy” the health sector… but how?
Well, I agree with what the FDA proposes as a criterion to filter which Apps should be regulated and which not, but it has to be developed a little further.
From my point of view, what it should really be changed is the regulatory process itself, and I consider that the validation of Apps should not be performed by agencies such as the FDA.
In my opinion, these Apps should be validated by the health centers that use them (hospitals, primary care centers, diagnostic centers …). An application must be tested by doctors and patients, providing everything you need for a full-scale validation, getting real data as the result of the relationship between them, based on clinical evidence.
The aim is to demonstrate that this new technology works as well as, or even better, than the existing conventional technology in healthcare facilities today.
And what about the agencies such as the FDA or similar?
Well, it seems to me that what should be regulated is the study, the requirements to be demonstrated empirically for this technology (glucometer, blood pressure monitor, ECG… ) to receive the “Seal of Validation ” by the medical center that made the study (#HospitalAppValidation).
Thereby, it would be possible to define a universal validation process applicable anywhere in the world where health centers demonstrate, according to their respective administration’s regulated studies, whether or not an App adds value to potential users.