With thousands of medical apps available, many health care organizations are taking a active steps to create guidelines, suggestions and rules for the creation and usage of such technology.
By some estimates, there are around 200,000 health & medical apps available. For clinicians & patients, finding the hidden gems, the health apps that could actually help improve care, is a real challenge.
Part of that challenge comes from the relatively hands-off approach of the Food and Drug Administration (FDA), focused primarily on high risk health apps.
Therefore, it’s important for medical professionals to set standards for this technology. Some professional societies have jumped into this space by developing health apps themselves like the American Academy of Pediatrics. The American Heart Association recently published a Scientific Statement reviewing the evidence for digital health interventions in cardiovascular disease. And most recently, the American Medical Association (AMA) recently approved a physician-adjudicated principles to guide selection, use, coverage, and payment policies of mobile health apps during the AMA Interim Meeting.
According to the AMA statement, these principles will guide future advocacy and efforts in promoting the use of health apps and other digital health tools. In addition to supporting development, a unique focus of the AMA’s efforts seems to be on integration of these tools into clinical workflows, patient-physician relationships, and reimbursement models. Specifically, they will aim to support health apps & 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.
Many of these principles line up nicely with what clinicians and other professional societies are increasingly demanding of health apps, particularly around validation, interoperability, and usability. The latter principles seem more oriented towards getting the digital health industry to play by the existing rules of the road in healthcare, specifically those principles addressing licensure and scope of practice. While those are certainly realistic considerations, it will be interesting to see how they are received by the “disruption” oriented digital health industry.
These guidelines were released with the knowledge that more research must be done to show the “accuracy, effectiveness, safety and security” of health apps. It will be interesting to see what specific actions the AMA takes going forward to push the digital health industry towards these principles.