Update on Guidelines for Mobile Health Applications
Event Type
Oral Presentations
TimeFriday, April 162:20pm - 2:40pm EDT
LocationDigital Health

Mobile health (mHealth) applications play a critical role in patient care, whether utilized to improve medication adherence or provide health guidance, to store databases of medical information, for reference by healthcare professionals, or to accomplish any number of wide-ranging medical goals. mHealth needs to be well-designed to achieve the desired outcomes and provide a satisfying experience for users, but this is often left to the discretion of developers when apps fall outside of regulatory oversight.

In February 2019, a set of mHealth guidelines was released by Xcertia, an mHealth collaborative founded by partners representing the American Medical Association, DHX Group, the American Heart Association, and the Healthcare Information and Management System Society. The Guidelines covered five major topics: security, privacy, content, operability, and usability. The Guidelines content comprising each category was generated through individual working groups of industry experts. At the 2019 HFES Healthcare Symposium, several members of the usability working group delivered a presentation focused on the development process for the usability section, which attracted a large number of session attendees and substantial interest in the foreseeable application of the Guidelines and plans for future updates.

In 2020, the Healthcare Information and Management Systems Society, Inc. (HIMSS) elected to continue the work initiated by Xcertia in efforts to further update and improve the Guidelines. A working group has convened to collaborate on decision-making relevant to the overall Guidelines, and individual groups will take on refinement of the information in the major topic categories. This session, which will be presented by two working group members and human factors professionals, will provide an overview of the group’s progress, updates on key decision-making impacting the evolution of Guidelines development, and discussion of practical application of the guidelines.

Guidelines Overview

The first draft of the Guidelines was created to establish safer and more effective development structure for mHealth. Though many informal sources are available for reference, one key benefit of the Guidelines in the consolidating information from these topics into one document. Developers can reference one or more sections based on their need to:

• Assess whether a health app protects the user’s information in full compliance with all applicable laws, rules and regulations (privacy)
• Assess if a health app is protected from external threats and maintain the integrity, availability, confidentiality and resilience of the data (security)
• Assess whether a health app installs, loads, runs and operates in a manner that provides a reasonable user experience on mobile and web platforms while also integrating with existing health IT (operability)
• Assess how a health app is designed to be safe and easy to use (usability)
• Assess whether the information provided in the health app is current and accurate (content)

The Guidelines were released for a public comment from February 2019 to May 2019. The final 2019 version of the Xcertia Guidelines are available on the HIMSS website (

Guidelines Updates

The working group is currently meeting and will continue to meet regularly over the next few months to assess the current Guidelines, determine necessary updates and additions, and update and promote the Guidelines. Currently, the working group is conducting the following activities:

• Assessing the 2019 Guidelines for accuracy and relevance
• As needed, providing input on policy responses that relate to mHealth issues
• Promoting the value and use of the guidelines for the health community

To date, working group discussions and updates include the scope of apps covered in the Guidelines, potential new Guideline sections or topics to include in the next version, and consideration of framework that provides applicable guidance across the health ecosystem. The working group is also aware of related industry activity (e.g., FDA Mobile Medical App Guidance, Germany’s Digital Healthcare Act, American Telemedicine Association resource to ensure mHealth apps are safe and effective for U.S. patients, etc.), and intends to refine the Guidelines to complement, not compete, with these other sources. Additionally, a critically important role for the working group is to ensure the Guidelines are practically applicable, and upcoming efforts will include further consideration of the end users, use environments, and use cases within each section. The presenters for this session will cover updates on decisions made and future direction of the Guidelines based on continuing discussions over the next few months.

Application of Usability Guidelines

Though the Guidelines will provide developers with information on considerations for app design, developers and practitioners will need to determine how and when during development to apply the Guidelines to gain the most benefit. The usability Guidelines should be used as a resource early in the development process and referenced, at minimum, with each major design modification and when the product is finalized. Some ways to tangibly incorporate the information in the usability Guidelines include:

• Creating a checklist of Guidelines requirements that can be referenced and updated throughout development
• Conducting heuristic evaluations early in development that incorporate Guideline-specific heuristics
• Collecting quantitative or qualitative data during human factors evaluations that directly address Guideline requirements
• Incorporating surveys into user studies that can be used to measure Guideline adherence from the user perspective

The presenters will discuss details of these activities and how they can be incorporated without increasing workload or impacting timeline.
Head of Human Factors Engineering