ORLANDO, Fla. — The American Medical Association (AMA) believes mobile health applications (mHealth apps) and devices that promote safe and effective patient care have the potential to be integrated into everyday practice. During the AMA Interim Meeting, physicians voted to approve a list of principles to guide coverage and payment policies supporting the use of 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 and can pose threats to the health and safety of patients. 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, M.D. “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 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; and
• Ensure that 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. The new AMA policy encourages physicians and the mobile app industry to promote patient awareness of the varying levels data privacy and security afforded by mHealth apps.

To best secure patients’ personal health information, mHealth apps and associated devices, trackers and sensors need to abide by applicable laws addressing the privacy and security. According to the new AMA policy, physicians 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 physicians 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.

The AMA is partnering with leaders across health care who are keenly focused on technologies that work better for patients and physicians and seeking ways to bring the physician voice into the innovation space. Recent AMA efforts to advance digital health innovation that is patient-centered, evidence based, interoperable and outcomes focused, include:

• The founding partner to Health2047, a San Francisco-based health care innovation company that combines strategy, design and venture disciplines, working in partnership with leading companies, physicians and entrepreneurs to improve health care.
• An expanded partnership with MATTER, Chicago's health care technology incubator, to allow entrepreneurs and physicians to collaborate on the development of new technologies, services and products in a simulated health care environment.
• A collaboration with IDEA Labs, a student-run biotechnology incubator, that helps inspire and support the next generation of young entrepreneurs to tackle unmet needs in healthcare delivery and clinical medicine.
• An advisory role to the SMART project, which was created to ensure EHR systems work better for physicians and patients. A key component of this effort is the development of a flexible information infrastructure that allows for free, open development of plug and play apps to increase interoperability among health care technologies, including EHRs, in a more cost-effective way.
• A partnership with Omada Health and Intermountain Healthcare that has introduced evidence-based, technology-enabled care models that are key to addressing the more than 86 million Americans who currently have prediabetes.

Through its ongoing work to shape and support digital health innovation, the AMA is providing opportunities for physicians to engage in innovation and share their ideas, expertise and real-world perspective on the effectiveness of technology in medical practice settings. From revitalizing medical practices to ensuring that digital health helps provide high-quality patient care, the AMA is striving to help physicians navigate and succeed in a continually evolving health care environment.