TTAC

mHealth – Technology Overview

Even the most cursory review of mHealth literature found online and in print media will result in a wide range of mHealth definitions. Competing interests provide different, sometimes contradictory, views of what constitutes mHealth. Manufacturers, clinicians, service providers, and consumers appear to understand the world of mHealth differently.

Regardless of how diverse the definitions for mHealth have become, one thing is certain – mHealth is a rapidly growing market.  This infographic, created by Float Learning (www.floatlearning.com), very succinctly lays out relevant numbers pertaining to the rise of mobile techology in the healthcare industry.

mHealth - Infographic - Float (Partial)

“Is mHealth Poised to Explode?” – ©2012 Float Learning – (click image for full graphic)

 

The following section of the toolkit provides some information on what mHealth is, how it is being used, and where we see mHealth moving in the future.

Why is mHealth so hard to define?

mHealth is a relative newcomer to the telehealth field.  While some of the well-defined technologies in the telehealth industry have been around long enough to have a common definition, mobile platforms, devices, and services are still in an explosive growth stage.  Existing powerhouses in the telehealth industry have been working towards mobile solutions, as have countless small development firms and product manufacturers, each focusing on what appears to be a very lucrative industry.  In their efforts to provide unique services and leverage existing technologies into the mHealth world, some manufacturers are making the definition a little less than clear.

Compounding the definition problem is the fact that mHealth technologies represent a commoditization of healthcare technology.  Whereas previous telehealth systems were frequently cost-prohibitive for consumers, perhaps best exemplified by videoconferencing or store-and-forward carts that can cost into the tens of thousands of dollars, the new mHealth products are affordable for small businesses and individuals.  Doctors and patients alike are using personal mobile devices as consumers, and are increasingly looking to the mobile market to assist in the delivery of healthcare.

This development leads mHealth systems into the constant-upgrade and frequent innovation cycle of consumer products, resulting in rapidly-changing definitions of what mobile healthcare is and is not.

What is “mobile”? What is “health”?

Organizations within government and industry have been working to determine where mHealth falls in regards to regulation. Because mHealth represents a convergence of mobile and healthcare technologies, questions arise about which products should fall within the realm of FCC regulation and which are in need of FDA oversight.

Some organizations see mHealth as the technology behind mobile data transmission – wireless infrastructure, cellular connectivity, and the individual devices and peripherals – and feel that every component qualifies as mHealth if they are used to send medical information.  The implication of this, when taken to the extreme, is that wireless routers need to be considered medical devices, and cellular service providers should be liable for network outages that impact the delivery of healthcare data from a patient’s phone.

Other groups argue for a decrease in regulation, fearing that an increase in regulatory oversight would serve to hinder innovation and development of mHealth solutions.  Such manufacturers and organizations argue that additional regulations should only apply to those devices intended for clinical diagnostic purposes.

Working committees have been established within the various governmental and industrial groups, all aiming to strike a balance between the need for safe products and the need for an environment conducive to innovation.  These groups have shown progress in many areas.  The FDA published guidelines for products classified as Medical Device Data Systems, and has a Medical Device Innovation Pathway program for fast-tracking the review of cutting-edge products.

In all of this, patients and physicians are still faced with an ever-expanding pool of software, hardware, and peripheral devices that make it possible to send and receive healthcare information from mobile devices.  With this in mind, our toolkit focuses on the definitions of mobile, health, and of mHealth that appeal to a broader consumer base rather than a highly technical audience. This helps to both reduce the complexity of what can seem a convoluted topic, and keeps the toolkit from being made irrelevant, as technology changes so rapidly in the this sector.

Mobile, in the context of this toolkit, refers to multi-function devices that have access to cellular or wireless networks.  Health refers to software, services, and devices that promote wellness by helping patients and providers better manage, triage, and treat physiological and psychological conditions.

Such a definition excludes some products from this toolkit, and may not fit all definitions of mHealth.  The focus of this toolkit is to provide consumers – the doctors and patients who will use the devices – with the necessary information they need to understand the field.  Just as we have not focused exclusively on various issues of network design in previous toolkits, we won’t evaluate wireless routers or network management tools that are used in the course of providing mHealth services.

What are the basics of mHealth technology?

Mobile technology has been expanding over the past decade to encompass a wide range of devices.  At one point, “mobile” referred specifically to mobile phones.  Since the turn of the 21st century, these mobile devices have been expanding beyond simple phones and into full-blown computers that provide a range of features and services.  This expanded array of products makes up the heart of the mobile market.  Additional details about mHealth hardware and software can be found in the Product Information section of this toolkit.

The technology driving the mobile market is in wireless systems, with both Wi-Fi and cellular connectivity providing mHealth infrastructure. Mobile devices all contain a built-in antenna to receive and transmit data from a wireless signal source. The signals come from transmitters that may broadcast radio signals in the 700 MHz to 3 GHz range of the electromagnetic spectrum. These transmitters and receivers are very similar to other devices that utilize radio signals, such as FM radio and walkie-talkies.

Wi-Fi “hotspots”, or access points, provide signals that can be accessed by mobile devices within a 150-foot radius if located indoors or 300-foot radius if placed outdoors, though real life applications rarely see such high levels of performance.  In a home or small office setting, these devices will generally serve as single access points to a wired connection.  Larger Wi-Fi installations a grid of wireless routers that allow a mobile device to switch between access points, allowing for a theoretically seamless transfer from one signal source to another.

These handoffs between transmission points are critical to the operation of cellular networks.  Whereas Wi-Fi networks are often limited in scope and size, and may not be required to support handoffs from one access point to another, cellular networks can span cities, with individual transmission towers providing coverage to a geographical area called a cell. Passing a call from one cell area to another is an intrinsic design feature of a cellular network.

On a smaller scale, devices that utilize Bluetooth wireless signals to send data may connect to a cellphone within an even more limited range. The same principle of data transmission via radio signal applies.

The concept of data being transmitted across wide distances is key to mHealth.  Just as a radio tower can send your favorite songs to your home radio and to your office radio, these systems wirelessly send data from the transmission point – Wi-Fi hotspot, cellular tower, or mobile device – to the receiver.  This has been a cause for concern in the healthcare world, as it means that patient data will be broadcast “over the air”, with the possibility that a third party might intercept and read those exchanges.  Fortunately, Wi-Fi and cellular devices can send encrypted communications so that no one else can intercept what is being sent or discussed.

All of this transmitted data is gathered through various devices, such as blood pressure or glucose monitors, wireless scales, or through software interfaces, such as health record systems and patient wellness applications.  This software, installed onto mobile devices, can enable patients and providers to communicate without being physically present in the same location.

What services are delivered with mHealth technologies?

There are no firm limits to what services can be delivered via mobile platforms, though some specialties are better suited to mHealth than others.  A partial list of categories includes personal health, cardiology, dermatology, epidemiology, chronic and infectious disease management, diabetic care, physical therapy, otolaryngology, pediatrics, data entry, and patient and provider education.

Where is mHealth going?

The field of mHealth is still in an early stage of development, which leaves a lot of potential for growth and maturation within the market.  Major manufacturers are entering into the field as they see the potential to tap into an increasingly lucrative market.  The following trends are likely to develop over the next several years.

Increased Regulatory Clarity

Some of the manufacturers have hesitated to enter into the mHealth market due to concerns that the FDA was not clear about the scope of their oversight.  The US government has further clarified what category of federal oversight some products will fall into.  As a better understanding of which devices will be regulated as Class I, II, or III medical devices is developed, we expect that more manufacturers will establish themselves in the market.

Increased Standardization

Groups such as the Continua Alliance are working to develop and promote standards for mobile and home health products. While many manufacturers will have their own unique understanding and implementation of these standards, a push towards a more consistent plug-and-play experience will develop in the years ahead.  Additionally, existing standards for low-power wireless data transfer will be adopted with greater regularity, allowing for the development of mobile peripherals that can be used without the need for regular docking or recharging.

Improved “Signal-to-Noise Ratio” in the Market

Signal-to-noise ratio is a measure comparing the level of a desired signal to that of the level of background noise. Here, we use the term to refer to the ratio of clinically relevant mHealth technology to the level of irrelevant or substandard products marketed as ‘mHealth’. Some smaller developers and review sites are stepping up to fill voids in the mHealth market. Many of these developers build applications that are not as polished as consumers demand. As developers establish themselves as reliable and mature, the consumer market will gravitate toward them. Large manufacturers will also become a powerful presence in the market, lending the credibility of name recognition in immerging areas presently filled by little-known developers. That said, some great innovations will likely continue to come from the small developers as they work to meet the needs of a rapidly-changing market.

Improved Performance

The power of modern smartphones is increasing, with the speed of the CPU and the number of cores allowing for the development of quality video applications. At the same time, networks are rolling out the latest in high-speed cellular towers, allowing 4G connectivity in many different markets.  The combined speed of the processors and networks will drastically improve the performance of some applications.  Manufacturers are also learning which interfaces work well for consumers, so the usability of applications will also increase over time. The mobile modality is still relatively young, but is maturing with each product release.

Decreased Costs

The very factors that have created the current signal-to-noise problem within the application and peripheral market will also drive down prices.  The creation of a market within health care that serves individual consumers and is grown by small developers will continue a push toward the commoditization of health care.  As more major manufacturers enter the market, the ability of these companies to build and sell products in bulk will further drive prices lower.  Mobile solutions may become a marketing tool to draw people in to larger services and product packages, with free mobile applications being offset by profit from enterprise systems and other services.