MOBILE HEALTH TOOLS, CLINICAL APPS, AND ASSOCIATED DEVICES

To advocate that patients, pharmacists, and other healthcare professionals be involved in the selection, approval, and management of patient-centered mobile health tools, clinical software applications ("clinical apps"), and associated devices used by clinicians and patients for patient care; further,

To foster development of tools and resources to assist pharmacists in designing and assessing processes to ensure safe, accurate, supported, and secure use of mobile health tools, clinical apps, and associated devices; further,

To advocate that decisions regarding the selection, approval, and management of mobile health tools, clinical apps, and associated devices consider patient usability, acceptability, and usefulness and should further the goal of delivering safe and effective patient care that optimizes outcomes; further,

To advocate that mobile health tools, clinical apps, and associated devices that contain health information be interoperable and, if applicable, be structured to allow incorporation of health information into the patient's electronic health record and other essential clinical systems to facilitate optimal health outcomes; further,

To advocate that pharmacists be included in regulatory and other evaluation and approval of mobile health tools, clinical apps, and associated devices that involve medications or medication management; further,

To encourage patient education and assessment of competency in the use of mobile health technologies; further,

To enhance patient awareness on how to access and use validated sources of health information integrated with mobile health tools, clinical apps, and associated devices.

Rationale

Digital health technologies, including mobile health (mHealth) applications (apps), hold great potential to improve health and healthcare. There is nearly ubiquitous use of smartphones and an ever-growing and increasingly sophisticated suite of health apps. These apps are providing a wide range of medical functions that span the care continuum from prevention to diagnosis to care management. The adoption of these digital solutions is further amplified by their accessibility, low cost, and personalized features. In addition, their ability to provide practical functions such as health education, tracking of symptoms and side effects, appointment management, and social support make them compelling healthcare tools. With the proliferation of mHealth tools, clinical apps, and associated devices, healthcare organizations need to address the potential barriers and risks of application use. Particular concerns include (1) assessing the quality of mHealth tools, clinical apps, and associated devices; (2) standardizing choices and use across the organization; (3) ensuring the security of data and data storage; and (4) patient usability, acceptability, and usefulness (e.g., generational differences in acceptance of technology). To maximize the effectiveness of mHealth tools, clinical apps, and associated devices, they must be selected, approved, and managed with the goal of improving care and with input from representatives of all affected parties, including patients, physicians, pharmacists, and other healthcare professionals. In addition, their effectiveness is enhanced when they are interoperable (as described in ASHP policy 1302, Interoperability of Patient-Care Technologies) and the data stored within them can be incorporated into the patient’s electronic health record (EHR) and other essential clinical systems.

Providers and patients currently have little guidance regarding use of these resources or the management of the data they provide. The Food and Drug Administration and other regulatory agencies are just beginning to determine the scope of their oversight regarding standardized evaluation and validation processes. As medication-use experts, pharmacists can contribute to the regulatory evaluation and approval of mHealth tools, clinical apps, and associated devices that involve medications or medication management. For example, pharmacists can help assess the quality of information presented (e.g., incorrect or incomplete information, variation in content, incorrect or inappropriate response to patient needs) and mitigate inconsistencies with patient education resources provided by an organization (e.g., discharge education). ASHP is committed to fostering development of resources to help pharmacists ensure safe, accurate, supported, and secure use of mHealth tools, clinical apps, and associated devices. Patient engagement strategies include patient education and competency assessment and enhanced patient awareness of how to access and use validated sources of health information integrated with mHealth tools, clinical apps, and associated devices. Product customer assistance teams for mHealth tools, clinical apps, and associated devices should be leveraged to provide direct support to sustain these efforts. Patient engagement with these tools will: (1) increase communication between patient and providers, leading to increased patient satisfaction; (2) enhance sharing of health information using EHRs; and (3) enable patients to have access to their health data, which empowers them with the knowledge of their health conditions and helps them make informed treatment choices.