New AMA Guidelines for Health Apps and Digital Health Tools
Health- and medical-related apps have proliferated over the past several years. While many apps are developed and distributed by reputable organizations, not all of them are. And even when the intent for the app is good, the app may not be very useful or effective.
There has not been much official oversight of apps, from a regulatory perspective. The FDA has been mostly hands-off with medical apps except for those related to high-risk conditions. Some professional societies (e.g., the American Academy of Pediatrics) have developed their own apps, and some have developed standards for evaluating the scientific evidence for digital interventions in their specific area of specialty.
But now, the American Medical Association (AMA) has released guidelines that speak to selection, use, coverage, and payment policies of mobile health apps. These guidelines have been vetted by physicians. As the AMA appears to focus efforts on integrating apps into clinical workflows, patient-physician relationships and reimbursement models, these new guidelines are poised to provide guidance to future advocacy and promotion of health app use, as well as use of other digital health tools.
The AMA aims to support health apps and digital health tools that:
- Support the establishment or continuation of a valid patient-physician relationship
- Have a clinical evidence base to support their use in order to ensure mHealth app safety and effectiveness
- Follow evidence-based practice guidelines, to the degree they are available, 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 practitioners 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.