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September 24, 2012

Not All Apps Are Created Equal
By Demir Bingol
For The Record
Vol. 24 No. 17 P. 6

“Mobile health” (mHealth) is a term used for the practice of medicine and public health supported by mobile devices and the Internet. As an emerging science, mHealth offers the hope of reducing healthcare costs while improving outcomes and care quality associated with the management of chronic disease.

In the last two years, the mHealth market has exploded as software developers and hardware manufacturers aim to manage and deliver healthcare more effectively using novel technology. According to a recent study by Research2Guidance, the global smartphone app segment of the mHealth market is projected to reach $1.3 billion in 2012, nearly doubling its 2011 revenue.

However, not all mHealth apps are created equal. With more than 6,000 health and wellness apps available to consumers at Apple’s App Store, there are significant degrees of differentiation among mHealth products. These differences range from basic patient logbooks and the lifestyle guidance of simple health and wellness apps to the clinical and behavioral sophistication of mobile integrated therapies.

As software and device manufacturers develop more elaborate and invasive approaches to managing health, questions of both efficacy and safety arise, particularly when dealing with chronic disease. Consequently, the FDA has taken notice.

In July, the FDA released its draft guidance for mobile medical applications to address the proliferation of health-related apps. The guidance states, “When the intended use of a mobile app is for the diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body of man, the mobile app is a device.”

This new guidance provides a regulatory framework that differentiates common health and wellness apps from more sophisticated mobile medical systems, such as mobile integrated therapies, which are designed to meet FDA standards for efficacy and safety.

The Right Approach
App developers almost always approach the development of their products from a technology perspective rather than from a medical perspective. What most app developers don’t understand is that chronic disease management is a patient-centric activity that requires the coordination of many stakeholders and clinical and behavioral expertise to deliver a relevant and credible patient experience. It is the ability to deliver such an experience that engages patients over the long haul.

Health and wellness apps generally lack one or more key elements that constitute a meaningful patient health experience. Usually focused on simple tasks (eg, logbooks for tracking blood glucose readings) and a creative user interface, these apps forsake the bigger picture of clinical credibility, patient/clinician connectivity, and data analytics. These three elements must seamlessly work together to create a solution that is fully rooted in good clinical practice and driven by individualized behavioral messaging. A mobile integrated therapy can and should be enhanced by other elements, such as a stellar user interface and EMR integration, to further enhance the patient experience. Finally, patient engagement is maximized when mobile integrated therapies can provide clinicians with timely and relevant patient information through clinical decision-support systems.

Must-Have Features
Although the mHealth market is rapidly evolving, the following three best-of-breed features have emerged for a sustainable and clinically meaningful mobile integrated therapy: an integrated care platform, a robust behavioral support system, and FDA clearance.

An integrated care platform is the basic building block of any effective mobile integrated therapy. To support both patients and clinicians, a mobile integrated therapy must integrate the following three elements:

Real-time feedback and coaching: Via patient-reported data, this feature allows patients to make timely decisions regarding their health. The system provides patient feedback that includes the right information at the right time and in the right context.

Expert analytic system: This uses artificial intelligence to longitudinally analyze patient data and provides coaching to both patients and clinicians based on robust clinical algorithms.

Clinical decision support: This feature provides guidance to healthcare providers for patient and population decisions based on the aggregation of clinical knowledge and patient information.

Understanding patient behavior and how best to communicate clinical and lifestyle recommendations in a motivating and supportive manner is critical. Behavioral algorithms need to be empathetic and adapt to the patient’s dynamic condition, mood, and general well-being on an ongoing basis rather than simply providing cookbook responses to patient input. A one-size-fits-all approach will not resonate with diverse patients or address their individual needs.

The young life cycle of the mHealth market has reached an inflexion point regarding the issue of FDA clearance. With an increasing number of mHealth products being classified as medical devices, manufacturers must meet FDA standards for the quality of their systems, manufacturing procedures, and postlaunch monitoring. Furthermore, elements such as clinical decision support are also under the regulatory purview of the FDA. As a result, FDA influence on the market will continue to grow, sorting out the common health and wellness apps from mobile integration technologies.

Proof Is in the Pudding
Building a mobile integrated technology is one thing. Being able to demonstrate the quality of a product via proven clinical outcomes is another.

To further advance the merits of mHealth, studies are being conducted to prove its merit. For example, in September 2011, Diabetes Care, the American Diabetes Association’s scientific journal, published the results of a cluster-randomized study of a mobile phone-based diabetes coaching intervention conducted over a one-year treatment period. The mean declines in hemoglobin A1c (the gold-standard measure for diabetes control) were 1.9% in the primary intervention group (usual care plus the mHealth platform) and 0.7% points in the control group (usual care alone), a difference of 1.2%. By comparison, several pharmacologic agents can claim an A1c reduction of between 0.6%and 1.5%.

As the mHealth market continues to mature, the scientific rigor and regulatory oversight applied to these solutions will continue to rise, especially as the products become more sophisticated and intrusive. Device manufacturers that can deliver an mHealth product that is safe and effective by FDA standards will need to take the extra step of incorporating a robust behavioral design that can demonstrate reproducible patient outcomes in clinical trials.

— Demir Bingol is vice president of commercial marketing at WellDoc.