- The American Medical Association has signaled its support for mHealth with new policies designed to support physicians adopting mobile health apps and devices.
While approving an eight-part set of mHealth principles at its mid-year meeting this past week, the AMA also called for better regulation of apps – especially those which don’t fall under federal review – and told doctors to seek a legal opinion if an app’s security is questionable.
“While some mobile apps and devices are subject to FDA regulation, others are not, and do not undergo rigorous evaluation before deployment for general use, which raises quality and patient safety concerns,” the AMA’s Council on Medical Service said in a report adopted at last year’s interim meeting. “Without ensuring that there is strong and sufficient evidence that provides clinical validation to mHealth apps and associated devices, trackers and sensors, physicians will not fully integrate mHealth apps into their practices. More investment is needed in expanding the evidence base necessary to show the accuracy, effectiveness, safety and security of mHealth apps.”
As reported in AMA News, the organization approved a set of principles dictating that mHealth technology should:
- Support the establishment or continuation of a valid patient-physician relationship;
- Have a high-quality clinical evidence base to support its use and ensure mHealth app safety and effectiveness;
- Follow evidence-based practice guidelines, especially those developed and produced by national medical specialty societies and based on systematic reviews, to ensure patient safety, quality of care and positive health outcomes;
- Support care delivery that is patient-centered, promotes care coordination and facilitates team-based communication;
- Support data portability and interoperability to promote care coordination through medical home and accountable care models;
- Abide by state licensure laws and state medical practice laws and requirements in the state in which the patient receives services facilitated by the app;
- Require that physicians and other health professionals delivering services through the app be licensed in the state where the patient receives services or be providing these services as otherwise authorized by that state’s medical board; and
- Ensure that the delivery of any services via the app be consistent with state scope of practice laws.
The AMA’s efforts follow a similar track taken for telehealth tools and platforms, which have been slowly working their way into the healthcare ecosystem. Roughly a year ago, the Agency for Healthcare Research and Quality issued a 52-page report calling for more research on telehealth and an exploration of new organizational and payment models.
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“The request for a systematic review of ‘the growing body of evidence demonstrating the value of telehealth technologies’ is rooted in a belief that telehealth has the potential to produce positive benefits, a desire to promote the effective use of telehealth, and motivation to remove barriers to its use,” the AHRQ said. “Telehealth has been described as having great promise in the sense that it could leverage the $30 billion investment in electronic health records that ONC has made in the last half-decade through the Health Information Technology for Economic and Clinical Health (HITECH) Act. While the potential benefits and possible uses have been extensively enumerated and described (e.g., improving quality, promoting safety, and expanding access), there is also a body of literature that outlines barriers as well as challenges to implementation and widespread adoption of telehealth.”
The challenge facing mHealth apps is closely linked to the popularity of the consumer-facing app market. While the U.S. Food and Drug Administration has established a framework for reviewing clinical apps and the Federal Trade Commission has gone after several apps that falsely advertised what they could do, the market is flooded with apps – almost 260,000, up 57 percent from 2015, according to Research2Guidance – making oversight difficult.
To that end, the AMA was directed by its delegates to “assess the feasibility of state and federal legislation (to) mitigate the physicians’ potential risk of liability from the use or recommendation of mHealth apps.” The organization will also reportedly “examine the potential liability risks to physicians for using, recommending or prescribing mHealth apps, including risk under federal and state medical liability, privacy and security laws.”
Even within the industry, security is fleeting. Earlier this year, Arxan Technologies, a global developer of application protection services, surveyed healthcare executives and found that almost 90 percent felt their organization’s apps were “adequately secure;” a separate review, however, found that 86 percent of those apps aren’t safe.
That’s a concern of AMA Executive Vice President and CEO James L. Madara, who earlier this year drew fire for calling mHealth the “digital snake oil of the 21st Century.”
“Physicians celebrate progress in digital health that produces great tools,” he told delegates at the AMA meeting. “At the same time, we don’t hesitate to call out those products that are unhelpful and may even do harm – for example, a blood pressure app which actually failed at high rates in detecting high blood pressure … yet for two years, this was one of the most frequently downloaded health apps. A regulatory framework for this digital field is needed … and we hope to work with stakeholders to make that happen.”