Mobile Is the Name of the Game (But Can the FDA Keep Up?)

Mobile Is the Name of the Game (But Can the FDA Keep Up?)

Mark Crawford

According to the PricewaterhouseCoopers and the mobile operator industry association GSMA report Touching Lives through Mobile Health: Assessment of the Global Market Opportunity, global mobile health revenues could reach US$23 billion by 2017, driven by rapid growth in Europe and Asia. Monitoring services, such as those for chronic disease management, will account for 65 percent of the market, followed by diagnostic services.

Increased use of smartphones and other wireless devices, as well as the proliferation of mobile broadband networks and services worldwide, makes the mobile industry a major player in the future of health care. High-demand applications include interoperability with other systems like electronic medical records and laboratory information systems and real-time monitoring of patient conditions and vital signs.

“By 2017, mobile technology will be a key enabler of health-care delivery reaching every corner of the globe,” says Jeanine Vos, executive director of m-health at GSMA. “With developed countries needing to reduce the cost of universal health care, and developing countries looking to roll out life-saving services to in-need communities, mobile technology can deliver highly effective, scalable and affordable health care beyond the confines of a hospital or doctor’s surgery.”

In terms of market opportunity, GSMA indicates the provision of pervasive m-health services and applications worldwide could provide mobile operators with revenues worth approximately $11.5 billion by 2017. Device vendors could benefit from a revenue opportunity of $6.6 billion, content and application providers $2.6 billion, and health-care providers $2.4 billion by 2017.

However, to make this happen, warns the GSMA, governments, regulators, health-care providers, and device makers must collaborate to support the roll-out and adoption of new m-health services—a task much easier said than done.

“There’s no doubt that collaboration is critical,” says Eleanor Chye, executive director of mobility health care and pharma for AT&T Business Solutions. “Leading carriers, device manufacturers, health plans, and providers all need to come together to help transform m-health from a niche play into wide-scale implementation as a standard of care.”

In the murky regulatory realm, regulators need to proactively address the top issues that currently limit the growth of m-health services, such as certification, interoperability, and standardization. The FDA once again finds itself in the middle, wanting to proceed with care but also feeling the pressure to keep up with the quickly evolving wireless medical market and the benefits it can provide, including lowering the overall cost of health care.

Organizations like the American Medical Informatics Association (AMIA) have suggested holding clinical decision support (CDS) information delivery channels and mechanisms, devices, and applications intended primarily for use by clinicians and other providers to a different regulatory standard compared to those intended for patients, consumers, and their caregivers. The AMIA also questioned the singling out of “stand-alone” CDS delivered via “mobile medical devices” as being suitable for FDA oversight, more than other kinds of clinical software environments, such as desktop computers.

Other key issues raised by the AMIA include:

  • The need for the FDA to articulate how it characterizes and defines CDS
  • The need to coordinate efforts among federal agencies and public- and private-sector research and practice communities
  • The potential limitations if FDA focuses too narrowly on CDS, and considers CDS on mobile devices as somehow separate from CDS based on other delivery methods or contexts
  • The importance of addressing rapidly emerging and converging technologies and devices along with new and evolving forms of patient care delivery (such as medical homes and accountable care organizations) and payment methods

“The health sector is exploding with an array of clinical information systems for potential use in a broad range of settings,” says AMIA president and CEO Edward H. Shortliffe. “It is important to have regulations that keep pace with clinicians, many of whom are becoming quite expert at using technology to access pertinent information, thereby streamlining health-care delivery and improving overall health.”

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