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Barriers to the mHealth Revolution

by Ashley A. Van Zeeland, Ph.D.

More than 100 million Americans are living with at least one chronic disease and if current trends continue, as many as one in three U.S. adults will have diabetes by 2050. In 2009, the U.S. spent more than $1.7 trillion on chronic disease care and by 2010 health care accounted for 17 percent of the U.S. GDP, rising at a rate 2 percent above the overall economy’s growth rate.

Faced with these numbers, it is clear that the public health burden of chronic disease will cripple the health care system unless drastic changes are made. According to Dr. Eric Topol, chief academic officer for the Scripps Translational Science Institute and co-founder of the West Wireless Health Institute, “If there ever was a perfect storm – in a good way – for medicine, this is it, because we’re desperately needing innovation and cost-saving approaches.”

What is the answer to this health care crisis? One solution is wireless or mobile health devices — and San Diego is virtually at the epicenter of the wireless health revolution. Home to 600 life science companies, 1,900 wireless/IT companies and 75 research institutes, San Diego is becoming the preeminent location for wireless and mobile health.

Cementing this reputation was the establishment of the West Wireless Health Institute (WWHI) in La Jolla, one of only a handful of nonprofit institutes around the world specifically created to advance wireless health. The mission of the WWHI is clear: lower health care costs by accelerating the availability of wireless health solutions. Although the public appears poised and ready for these solutions – it is estimated that the market for wireless health devices and services in the U.S. will reach almost $10 billion by 2012 – there is reticence on the part of some physicians, patients and the government that must be addressed before mass adoption of mobile health becomes a reality.

What is mHealth?

Wireless or mobile health (mHealth) is broadly defined as the use of mobile devices for health or wellness purposes. It encompasses the physical devices used to collect or manage health data, the wireless technology used to transmit the data (e.g., Bluetooth, WiFi or 3G) and the associated software applications that support health care. Ranging from large coordinated health care systems such as Kaiser Permanente down to health-conscious consumers, mHealth solutions are present at every level.

While 2009 was considered the breakout year for mHealth, 2010 saw an explosive growth of mHealth technologies and companies, many of which are located in San Diego. From this, it appears the technological hurdles associated with the collection and transmission of mHealth data are being cleared. However, before the mHealth revolution can get underway, there remain a significant number of social and regulatory barriers.

Within mHealth, there are two principal divisions, those devices prescribed or used by doctors in the care of patients and those marketed directly to consumers. Clinical mHealth encompasses the lion’s share of wireless health and includes devices and applications to monitor or treat chronic conditions, such as diabetes, and devices used in hospitals to monitor patients and equipment. These devices must pass federal Food and Drug Administration (FDA) safety standards and demonstrate clinical utility though large clinical trials before being used routinely in medical practice. Currently, there are only a handful of FDA approved wireless medical devices, such as the CardioNet continuous ECG monitor and the myGlucoHealth blood glucose monitor, but many more are positioned to seek approval in the near future.

The other division is consumer mHealth, which is primarily focused on preventative wellness monitoring and not subject to FDA review. Compared to the small number of FDA approved wireless medical devices, there are more than 200 million mHealth applications currently in use and that number is expected to top 600 million by 2012. In addition to smartphone applications, there are standalone devices that consumers can buy directly. Examples include the BodyMedia FIT or FitBit – devices worn on the body to track caloric burn during the day – and such products as the Wii-fit and Nike+, a running shoe that wirelessly shares exercise data.

Regulatory Hurdles

If wireless health technology is here, why is there the sense we are still awaiting the full revolution? To begin, the nascent industry faces a number of uncertainties that make entrepreneurs, developers and investors wary of committing the necessary capital to spur significant growth. One of the most important factors driving uncertainty is the degree to which mHealth devices, transmissions and applications will be regulated by the federal government.

Last year, in a bold and forward-thinking move, the FDA and Federal Communications Commission (FCC) announced a partnership and subsequent public meeting to streamline regulatory processes and clarify the agencies’ jurisdiction over wireless devices. “The joint FCC-FDA public meeting is a vital first step in providing the regulatory clarity that is needed to spur investment and innovation in health care delivery,” said Dr. Joseph Smith, WWHI’s chief medical and science officer. “The relationship between FDA approval and FCC certification of wireless-enabled medical devices must be further delineated and expedited to overcome hurdles to innovation identified by both agencies.”

To accelerate this process and provide a policy perspective, a private sector short-term industry coalition was formed in May 2010. The mHealth regulatory coalition (MRC) includes members ranging from device manufacturers to clinicians and researchers. In August 2010, the MRC submitted a guidance letter to the FDA and FCC outlining three primary considerations to reduce the regulatory burden facing mHealth.

First, the MRC called for clarity in defining the regulatory boundary between medical and wellness uses of mHealth technology. It is clear that the FDA must approve high-risk and medically critical technologies, however it is less clear for devices that are low risk and could be used in medical treatment or for general wellness (e.g., wireless scales for post-bariatric surgery monitoring versus general fitness use).

Second, the MRC urged a review of the medical device accessory rule, arguing that current regulations may “unnecessarily limit the advancements in health care delivery offered by mHealth technologies.” The strict interpretation of this rule requires FDA approval across the myriad of connections necessary for functioning mHealth solutions – from the Bluetooth or cellular network used to initially transmit the data to the broadband Internet connection used to access and manage the data. The MRC argues that these connections are precisely what make mobile health possible and drive much of the value. Requiring individual FDA clearance for each of the multitude of connections would likely inhibit the growth of mHealth.

Finally, the MRC highlights the importance of separating physical mHealth medical devices from supporting software systems that are frequently used by physicians to help diagnose or treat a patient, with the aim of leaving software systems relatively unregulated. They argue that the current rules for regulating software are inadequate because they “cannot cover the complexity of the software architectures and the variety of mHealth systems” and the resulting regulatory uncertainty impedes innovation and development.

In another series of recommendations to the FCC and FDA, the Wireless Life Science Alliance (WLSA) offered a solution to these hurdles, recommending post-market surveillance of some products rather than full pre-market approval.

The Tipping Point

According to a recent report from Pyramid Research, as many as 70 percent of people worldwide are interested in having access to mHealth applications. Notably, countries with large populations and limited health care options, such as South African nations and India, are the most interested in mHealth solutions given the ubiquity of mobile phones even in the most remote regions of these countries. However, even given the significant market size, much of the resistance to adoption of mHealth centers around cost. It is unclear who will pay for these solutions – insurance reimbursements or consumers – and how the development costs will be recouped. Compounding this hesitation is the fact that the health care industry is traditionally a slow adopter of change.

How then will mHealth become the new norm? Many are now looking to the end users, the consumers, to drive the market. As seen in genomic medicine with the popularity of direct-to-consumer genotyping driving genomic education for physicians, if patients begin to demand wireless health solutions, providers will have to listen. “It’s a consumer-driven revolution,” said Topol. “It’s using the smartphone as a mediator of this information.”

Recent research by the Deloitte Center for Health Solutions supports this sentiment. They found that the younger generation will likely drive clinical mHealth, with as many as twice the number of Generation X and Y patients wanting access to their personal health records via a mobile device than baby boomers or seniors.

Paul Sonnier, wireless health industry catalyst and vice president of partner development for the WLSA, envisions a process analogous to the consumer demand for organic foods. “The parallel model demonstrated by the organic movement is that availability of products was not immediate,” said Sonnier. “Of course, neither was demand. There’s a feedback loop that we need to initiate, wherein consumers become aware, products are available, demand increases, solutions evolve and so on in a mutually reinforcing way.”

Although organic foods began as a small niche market, producers were attracted by the demand for organic products and now quality organic produce and meats are everyday items in large supermarket chains. Perhaps one day soon you will find an equal variety of mHealth options at your local drugstore.

 

Ashley A. Van Zeeland, Ph.D. (Rady FlexMBA ’13) received her doctorate in neuroscience from UCLA, specializing in the neurobiology and genetics of autism spectrum disorders. She has been published in Science Translational Medicine, Autism Research and Biological Psychiatry. Dr. Van Zeeland is currently the Dickinson Research Fellow in Genomic Medicine at the Scripps Translational Science Institute. She has an interest in combining genomic medicine with wireless health technologies, especially in early interventions for neurodevelopmental disorders like autism.