Proving the Business Case for the Internet of Things

AMA approves principles for use of mhealth apps

Steve Rogerson
November 22, 2016
The American Medical Association (AMA) has approved 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.
The AMA believes mhealth apps and devices that promote safe and effective patient care have the potential to be integrated into everyday practice.
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. 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 Stack. “It is essential for mhealth apps support care delivery that is patient-centred, promotes care coordination and facilitates team-based communications.”
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 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-centred, promotes care coordination and facilitates team-based communications;
  • Support data portability and interoperability 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 authorised 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 latest 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 secure patients’ personal health information, mhealth apps and associated devices, trackers and sensors need to abide by applicable laws addressing privacy and security. According to the new 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.