mHealth Monthly Mashup: Release 18.0 – mobile health snapshot: tapping into 2013 and beyond

Michael Spitz


In his 18th article, Michael Spitz looks at the current mobile health landscape and offers up his mhealth trends for 2013.

Please note this article has been slightly amended since it was first published on 5th February 2013, specifically with regards to the content of the Personalized World Medicine Conference.

Like Alice grabbed by the Red Queen in Through the Looking-Glass, healthcare players from professionals to patients have to run just to keep up with mobile health. Transformative change throughout this channel is so rapid and revolutionary, in fact, that the current mhealth landscape is nearly impossible to pin down and evaluate, let alone prognosticate from. Millions of lives and billions of dollars hang in the balance between hype and household application, so let’s take a quick snapshot of the major trends lying before us at the opening salvos of 2013, and see if we can draw any conclusions for the months and years ahead…


The new face of regulation: crowdsourcing, cooperation, and focus

This column has been tracking mobile health regulation since 2011 when the American Food and Drug Administration first proposed draft guidance. Since then the FDA and other governmental organizations including the Federal Trade Commission (FTC) and Federal Communications Commission (FCC) have reached out to individuals, institutions, and entrepreneurs for feedback regarding regulation, the goal to strike a realistic and effective balance between innovation and safety. Along the way the US Congress has proposed a new FDA division called the Office of Wireless Health, while the FCC has even approved a designated frequency range for mobile health called the Medical Body Area Network.


“Millions of lives and billions of dollars hang in the balance between hype and household application…”


The opportune convergence of these sympathetic forces was shared at the recent Personalized World Medicine Conference in Silicon Valley, where it was suggested that most of the more than 40,000 mobile health apps already launched would evade regulatory rigor. Instead, the FDA would reserve its scrutiny to companies building wireless peripherals for existing and already regulated medical devices, and those being developed that turn a smartphone or tablet into what is formally considered a clinical medical device. More conventional, low-risk, and non-diagnostic health and wellness apps such as trackers and diets aids would therefore fall outside this regulatory umbrella, cutting unnecessary interference and red tape — but placing the onus of accuracy and safety on the end user, necessitating improved education.

Although formal guidance has yet to be signed in the States, the current trajectory bodes well for innovators and entrepreneurs, a feeling shared by the venture capitalists, who in 2012 invested nearly a billion dollars into mobile health. Such optimism reverberates throughout the many impacted healthcare sectors, a perfect storm brewing of ever-increasing and confident business investment, governmental cooperation, professional adoption, and patient engagement. A recent PwC report comparing US to EU mobile health regulation shows similar enthusiasm across the pond, qualified by regional differences, a slightly more conservative early approach, and other distinctions — but the winds of change blow so strongly that the global community is poised for sweeping mobile health transformation for the benefit of patients worldwide.

The innovation juggernaut: blowing minds while winning hearts

On a daily, even hourly, basis we’re bombarded by the latest mhealth case study featuring astonishing progress in functionality, platform integration, and utility. Smartphones and tablets, more powerful than the desktop computers of only a few years ago, enable a level of technology application that continues to surprise and enthrall healthcare professionals, patients, and technologists alike. Not surprisingly, pundits have weighed-in on the power of mhealth for redefining public health, EHR integration, and cloud-based platforms, while innovators talk voice activation, seamless monitoring, and the quantified self. Apps now seemingly do everything from store and manage DNA data to conduct laboratory-grade testing of HIV, and even pharma and device manufacturers, historically years behind most other industry verticals, have dipped their toes into mobile health in an admirable and often bold way, with surprising results.


“The global community is poised for sweeping mobile health transformation for the benefit of patients worldwide.”


Despite all the mhealth hype and hope in pharma, device, and beyond however, study after study throughout 2012 revealed that audience engagement remained relatively low for both healthcare professional and patient segments, with disparities between each, and plenty of room for improvement across the board. Many specialists continue to stress that if an app is potentially helpful but nobody uses it, no patient will benefit. Even more importantly, if an app no matter how advanced or sophisticated under-performs or even causes harm, then the healthcare field has actually taken several steps backwards. So just as a balance must be found between innovation and risk, another must be drawn between technology and engagement, ensuring that mobile health apps are not only effective and regulated, but also designed to be utilized and improved, always with end user needs and expectations in mind.

In an earlier column, I shared a few mobile design and development best practices shown to overcome many of these challenges, such as clearly defining goals, understanding audience needs and digital behaviors, and only considering the mobile channel as one qualified tactic among many. Effective behavioral modification (and not mere fascination with gimmickry and gadgetry), bolstered through real-world reinforcement, must remain top of mind. Evidence-based methodology is the foundation of science, but getting human beings to use and benefit from tech can require as much art as logic. As mobile health continues to expand and evolve in 2013 and beyond, these two inversely proportional pressure points—increasing technical sophistication and diminishing usability — will continue to dance around and taunt each other. The key is to not consider them mutually exclusive, but instead build medical and health apps in a manner that makes their form and function complementary.

Redefining privacy and re-engineering security

While the FDA seems to be laying the foundation for collaborative mobile health growth and success, the US Department of Health and Human Services (HHS) is getting tougher on privacy, recently issuing a HIPAA omnibus final rule that makes providers and organizations more accountable for breaches of personal health data. On a similar front, a Congressman has drafted an “AppsRights Privacy Bill”, one that requires mobile app developers to disclose exactly how they collect personal data and which third parties would have access to that data. The privacy noose clearly seems to be getting tighter, justifiably protecting patients but potentially derailing efforts to increase mobile health adoption, a technology and communications channel that requires the wireless transmission of personal health information in greater and greater quantities and depth.


“Many specialists continue to stress that if an app is potentially helpful but nobody uses it, no patient will benefit.”


On the flipside, organizations like HIMSS and the HHS have organized tool kits and roundtables to improve mobile health security, while the FTC has outlined fresh approaches. Meanwhile major device and platform manufacturers including Apple, Android, Blackberry, and Samsung continuously lock their gadgets down, as networks from Verizon to AT&amp,T pursue the latest in encryption and security protocols. While providers tirelessly work to protect data, interestingly enough consumers and even healthcare audiences continue to redefine their own levels of tolerance, akin to what has already happened in the finance and eCommerce industries, where personal financial information is routinely shared through wireless devices and across channels in a manner inconceivable only a few years ago.

The upshot is a complicated data privacy playing field, one where providers have become more accountable, technology continues to fight breaches, and healthcare audience redefine what is and isn’t acceptable, with a general shift toward less stringency, not more. As the pressure to embrace Big Data mounts, will privacy as we now know it cease to exist?

Shaking the Polaroid: mobile health snapshot summary

Let’s shake the few observations shared above, and see if some mobile health trends for 2013 come into focus:

Business, government, and the private sector are progressively working together to stimulate investment, foster innovation, protect the patient, and heighten adoption. The landscape remains uncertain and fragmented, complete integration a long, long way off, but a tipping point will be reached this year or next where mobile health becomes embedded and even essential to point of care experiences worldwide.


“The future picture is focused and looking good for mobile health!”


Increasingly sophisticated mobile med and health apps are improving both user engagement and behavioral modification. As regulators focus on “high risk” apps that fall under the definition of medical devices, the industry will be given plenty of room to innovate and concentrate on improvements to usability and access. Despite ongoing bumps in the road, current disparities between tech innovation and practical application will dissipate.

Improved security and shifting attitudes regarding personal healthcare information actually facilitate and encourage mobile health engagement. For every advancement in security a new breach will be discovered, but patients and even institutions will continue to redefine what they consider acceptable and, much like the finance and eCommerce sector, increasingly embrace wireless data channels for the exchange of personal data, further driving the channel to new heights.

The future picture is focused and looking good for mobile health! What do you think? Share you opinions below.


About the author:

Michael Spitz is SVP, Managing Director of the Healthcare and LifeSciences division of ZEMOGA. Spitz combines his passion for technology with more than 15 years of clinical content expertise to help engineer digital healthcare solutions. Follow @SpitzStrategy on Twitter for his daily – often hourly – updates on all things digital for the ultimate benefit of patients worldwide.

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