In June of this year, American Medical Association President James Madara pronounced much of digital health technology to be snake oil. He didn’t dismiss all digital health tools out of hand, saying that physicians want “digital tools that would simplify and better organize our lives, and also adapt to variations in our practices, …free[ing] more time for patient interactions.” This fall, Madara said at the annual Health 2.0 conference that, in effect, digital health entrepreneurs need the AMA to provide a framework for self-regulation in order to protect patients and forestall government regulation.
Tha AMA has now made good on that promise, and has announced a set of principles concerning what it calls “mHealth apps” — designed to ensure that they are accurate, effective, safe and secure, in order to protect patients and satisfy providers and payors. The full policy is not yet available on the AMA website, but is summarized in an AMA news item — mHealth apps should:
- Support the establishment or continuation of a valid patient-physician relationship
- Have a high-quality clinical evidence base to support their use in order to 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 in order 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
- Ensure that the delivery of any services via the app be consistent with state scope of practice laws
On the privacy and security front, the AMA calls on industry to be more transparent abut how pateint data is used, and encourages the development of a standard privacy policy for mHealth apps that collect, store and/or transmit PHI.
It appears to me that of the 165,000 or so health apps that are said to be available in the app stores, those that are downloaded and used most often are those that are found to be accurate, effective, safe and secure by the general public through first-hand experience, peer recommendations and clinician and payor recommendations. However, even the best of the lot are often abandoned within a matter of months because they are not compelling enough to hold patients’ interest.
The AMA recommendations are on the whole unobjectionable, but it is not clear to me what they add to the discussion, unless the organization is committing to review the 165,000 apps out there (more coming every day). If it is, no doubt some app developers will cry foul as their apps do not gain the seal of approval.
The app stores have been called upon to keep questionable health apps “off of the shelves,” but it is unclear what criteria might be applied to make such decisions.
Health app curation efforts have failed spectacularly in the past (see, e.g.: Happtique).
While on the whole the AMA guidelines may be unobjectionable, they come with a certain perspective, and some — digital health entrepreneurs, patient advocates, others — may not be willing to cede the field to guidelines which express a bias in favor of viewing health apps only as an adjunct to a physician-patient relationship.
This is certainly not the last we will hear from either side in the digital snake oil debates.
David Harlow
The Harlow Group LLC
Health Care Law and Consulting
