AMA Adopts Principles to Promote Safe & Effective Mobile Health Apps

During a recent meeting of the American Medical Association (AMA), physicians voted to approve a list of principles to guide coverage and payment policies supporting the use of mobile health (mHealth) apps and associated devices that are accurate, effective, safe, and secure.

Mobile health apps and associated digital health devices, trackers, and sensors can vary greatly in functionality, accuracy, safety, and effectiveness. While physicians are optimistic about digital health innovation and its potential medical benefits, mHealth apps and devices that are not safe can pose threats to the health and safety of patients, officials said. AMA policy acknowledges the need to expand the evidence base necessary to show the accuracy, effectiveness, safety, and security of mHealth apps.

“The new AMA principles aim to foster the integration of digital health innovations into clinical practice by promoting coverage and payment policies that are contingent upon whether mHealth apps and related devices are evidence-based, validated, interoperable, and actionable,” said AMA immediate past president Steven J. Stack, MD. “It is essential for mHealth apps support care delivery that is patient-centered, promotes care coordination, and facilitates team-based communication.”

The AMA’s advocacy promoting coverage, payment, and financial incentive mechanisms will be guided by the following principles to support the use of mHealth apps and associated devices, trackers, and sensors by patients, physicians, and others 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 as well as state medical practice laws and requirements in which the patient receives services facilitated by the app;
• Require 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; and
• Ensure the delivery of any services via the app be consistent with state scope-of-practice laws.

Patient privacy and data security in digital health are also key AMA concerns since mHealth apps and devices can be subject to data breaches that disclose personal health information, officials said. The new AMA policy encourages physicians and the mobile app industry to promote patient awareness of the varying levels of data privacy and security afforded by mHealth apps. To best secure patients’ personal health information, mHealth apps and associated devices, trackers, and sensors must abide by applicable laws addressing privacy and security. According to the new AMA policy, clinicians should consult with qualified legal counsel if they are unsure of whether mHealth apps meet standards required by federal or state privacy and security laws.

Given the lack of regulation of mHealth apps, regardless of whether the apps related device is encrypted, the AMA advises clinicians to alert patients of the potential privacy and security risks for any mHealth apps that they prescribe or recommend, and document the patient’s understanding of such risks. Questions remain regarding liability risks to physicians who use, recommend, or prescribe mHealth apps. Accordingly, the AMA will assess 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, officials said.