HIMSS Continues Improving Health App Effectiveness and Safety

HIMSS has elected to continue developing mobile health application guidelines published in 2019 by Xcertia, Inc.—focused on topics such as privacy, security, content, usability and operability—for use across the healthcare ecosystem. Xcertia’s founders, including HIMSS, the American Medical Association (AMA), the American Heart Association and DHX Group, have decided to dissolve the Xcertia initiative, and HIMSS is working closely with the founding partners to ensure a smooth transition.

Xcertia was created in December 2016. Working with other high-profile member organizations, it aimed to develop a framework of principles or guidelines to promote safe and effective health apps and to positively influence their use and adoption in healthcare.

A New HIMSS Guidelines Initiative

While the formal collaboration under Xcertia has come to a close, HIMSS and the initiative’s founding members recognize that strong guidance around app development and usage in healthcare remains critical. Under the leadership of HIMSS, Xcertia will continue as a new Health App Guidelines Work Group, which will inform and evolve the Xcertia Guidelines.

This group will convene in late summer 2020 to assess the current guidelines and to determine necessary updates or additions. HIMSS aims to develop a comprehensive framework to guide healthcare organizations, clinicians, consumers and developers on what is needed to create health apps that improve health and the delivery of care.

“The AMA is delighted that HIMSS, a co-founder, has agreed to advance the work begun by Xcertia to further develop this critical guidance for the healthcare industry,” said Michael Hodgkins, MD, Senior Advisor for Digital Medicine, American Medical Association. “The AMA is committed to collaborating with HIMSS in this effort.”

“The American Heart Association is pleased to see HIMSS continue the important work of Xcertia and we look forward to working with HIMSS, the AMA and other industry leaders and experts to evolve and enhance the Xcertia Guidelines,” said Patrick Wayte, SVP Center for Health Technology & Innovation, American Heart Association.

Apps: An Evolving Player in the Health Ecosystem

Health apps have become an integral part of the health ecosystem. They provide support to clinicians during an encounter, they place health information in the hands of providers, they enable remote monitoring via devices, and they even integrate into treatment plans. Government agencies in multiple countries recognize the growing influence of health apps, including the U.S. Food and Drug Administration (FDA) issuing regulatory guidelines for mobile apps, and in Germany where the new Digital Healthcare Act outlines eligible mobile apps doctors can prescribe to patients and receive reimbursement. Both the FDA and the U.S. Department of Health and Human Services provided ex-officio members to the Xcertia Board of Directors, emphasizing the importance of apps to these agencies.

As health apps become more prevalent resources for informing, monitoring and treating health needs, the apps must be safe, effective and evidence-based. App end-users, such as clinicians and consumers, need to have confidence that the app they are integrating into their care strategies will be safe, provide a benefit, be easy to use and will guard privacy. With the large number of apps continuously entering the space, it can be challenging for an individual provider or patient to make decisions.

Defining Components of Effective Apps

Xcertia’s 2019 Guidelines establish safe and effective development structures for health apps. Furthermore, these guidelines give developers straightforward information and resources to ensure they develop apps that can meaningfully contribute to health and healthcare, and they break down the components on which to assess an app’s efficacy and safety.

• Privacy: assess whether a health app protects the user’s information in full compliance with all applicable laws, rules and regulations
• Security: assess if the application is protected from external threats and maintain the integrity, availability, confidentiality and resilience of the data
• Operability: assess whether a mobile health app installs, loads, runs and interoperates in a manner that provides a reasonable user experience on mobile and web platforms while also integrating with existing health IT
• Usability: assess how a health app is designed to be safe and easy to use
• Content: assess whether the information provided in the application is current and accurate