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Report: Burgeoning Field of Mobile Health Raises Questions on Regulation, Privacy, and More

From sensors that count footsteps during exercise, to devices that record and transmit measures of heart function, to future implants that might someday detect bacteria and viruses in the body, the use of wireless and mobile technology to enhance health care is growing rapidly and poses challenges for device makers, regulators, doctors and consumers alike, according to a new AAAS report.

The new era of mobile health technologies, or mHealth as it is called, may promote wellness and make it easier for doctors to monitor their patients as they go about their daily lives rather than having to rely on diagnostic "snapshots" during occasional office visits.

"Mobile health needs to prove that it is not just “cool” but also that it has advantages over today’s methods of delivering health care...."

AAAS Report on mHealth

But the report says mHealth also raises important questions, including how health care providers will extract meaningful information from the data deluge generated by devices that do continuous monitoring. Will software associated with a mobile device be able to sort out false positives — an elevated heart rate while climbing a steep hill, for example — and prevent false alarms? Just as importantly, will an electrocardiogram from a mobile device meet the same standard of reliability as one from a stationary machine in a clinic or hospital?

Such questions were discussed during the first of three workshops on mHealth organized by the AAAS Scientific Responsibility, Human Rights and Law Program, with the support of the Robert Wood Johnson Foundation. The new report grew out of that first workshop, in June 2014 at AAAS, which focused on regulation of mHealth devices and technology. Attorneys, regulators, policy makers, patient advocates, health care providers, industry representatives, and information technology specialists attended. Participants agreed that regulations should protect the public's health and safety, without creating barriers to innovation.

Upcoming reports will focus on mHealth privacy/security and liability issues.

On the regulatory front, the report says, it is essential that use of mobile health technologies for diagnosis and treatment of illness meet the same standards of care as traditional approaches, with potential risks carefully evaluated.

"The harms that may accompany mobile health can be much more serious than under- or over-counting calories," the report says. "The analytic and decision-making software needs to be highly reliable and the signals need to be authenticated, so that inferences derived from wireless signals are accurate and the messages back to the body are appropriate. Mobile health needs to prove that it is not just 'cool' but also that it has advantages over today's methods of delivering health care" by improving outcomes and reducing costs. "As of today, mHealth has yet to meet these benchmarks," it adds.

"The harms that may accompany mobile health can be much more serious than under- or over-counting calories."

AAAS Report on mHealth

Still, the ability to measure physiological functions remotely and potentially deliver doses of medication via implants as needed does have promise, the report says, particularly for treating chronic health conditions in the elderly. But, the report asks, will the elderly want to be continuously monitored or will they see it as an infringement on their autonomy?

One of the biggest challenges to wide adoption of mobile health is privacy, the report says. "Although privacy has always been a concern with paper records, mHealth is able to capture much more information about a person, including behavioral and locational data, and is capable of disseminating it to a larger group of people," it says.

The report notes that regulatory agencies often lag behind the pace of innovation in rapidly developing fields such as mHealth and discusses the roles of an alphabet soup of agencies concerned with aspects of mHealth, including:

  • The Food and Drug Administration (FDA), which regulates devices or drugs that prevent, cure or treat disease, but not those that address wellness. It must sort out which mHealth mobile apps require agency pre-market approval and which do not.
  • The Federal Communications Commission (FCC), which regulates use of radio frequency bands of the electromagnetic spectrum by mobile health devices.
  • The Federal Trade Commission (FTC), which can bring enforcement actions against a company that makes a deceptive claim regarding its protection of consumer privacy.
  • The Office of the National Coordinator for Health Information Technology (ONC), an arm of the Department of Health and Human Services (HHS), which sets standards for health information technology.
  • The Centers for Medicare and Medicaid Services (CMS), also an arm of HHS, which determines what devices or procedures will be covered by Medicare and Medicaid and also provides incentives to hospitals and other health care providers to adopt electronic health records. (The report notes that CMS already does approve reimbursement for some remote monitoring, such as diagnosis of skin conditions via cell phone photos by a dermatologist.)

The National Institutes of Health (NIH), while not a regulatory body, funds research to ensure safe and effective medical treatments. In addition, state agencies license and regulate health care providers.

Among the report's recommendations:

  • HHS should launch a national initiative to advance the use and implementation of mobile health.
  • Congress should not attempt to define where FDA should exercise enforcement discretion. Mobile health technology is moving at such a rapid pace that the agency should be allowed flexibility in where it sets the dividing line between devices that merit regulatory oversight and those that do not.
  • As an incentive to innovation, Congress should consider a tax credit for investors in mHealth.
  • FDA should have specially trained reviewers for mHealth, and it should coordinate internal policies so that misinformation is not inadvertently provided to developers, possibly leading to inconsistent agency reviews.
  • In order for physicians to continue to treat patients using mobile medical devices while in another state, interstate licensing of physicians, with an easier path to reciprocity, should be adopted.
  • NIH must develop methods to assess the effectiveness of mobile applications, with a goal of defining standards of reliable and valid clinical research. The agency should consider convening periodic consensus conferences - with clinicians, academic researchers, and developers - to develop best research practices.
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[Photo credit for associated teaser image: Nicola/CC BY 2.0]