Updated mobile health-application guidelines concerning privacy, security, operability, usability and content have been released for public comment by Xcertia, a nonprofit founded by the AMA and other major players in health care and technology.
The release was made at the Health Information Management Systems Society (HIMSS) annual Global Conference and Exhibition being held this year in Orlando, Florida, with about 45,000 people in attendance.
The AMA’s involvement with the Xcertia effort is an outgrowth of policy adopted in 2016 by the AMA House of Delegates on the integration of mHealth apps and devices into medical practice.
HIMSS is one of the AMA’s partners in Xcertia’s effort to collaboratively develop mHealth-industry guidelines. The American Heart Association and digital health nonprofit DHX Group are also partners. The updated privacy and security guidelines are now open for comment until May 15 at Xcertia’s website.
Drafts of the privacy and security sections of the guidelines were released in October for comment. The latest release incorporates updates from those comments plus new guidelines for operability, usability and content.
"Our guidelines development is an iterative process and our goal is to include input and comment from key stakeholders at every step along the way,” said AMA Chief Medical Information Officer and Xcertia Board Chair Michael L. Hodgkins, MD, MPH.
Members of the Xcertia work groups included subject-matter experts from Partners Connected Health, HIMSS, the Personal Connected Health Alliance, Consumer Technology Association, Medstar, Duke, the Mayo Clinic, the American Academy of Diabetes Education and others.
Steve Ommen, MD, from the Mayo Clinic is also on the Xcertia board. Other organizations represented on the board include Accenture, ACT | The App Association, the Alliance for Nursing Informatics, the American Telemedicine Association, IBM Watson, the IQVIA Institute for Human Data Science, and Partners Healthcare.
The guidelines are intended to address concerns about quality and safety that may be discouraging physicians from integrating mHealth apps into their practice. These concerns were originally raised in a 2016 AMA Council on Medical Services (CMS) report.
“While some mobile apps and devices are subject to FDA regulation, others are not, and do not undergo rigorous evaluation before deployment for general use, which raises quality and patient safety concerns,” said the report that was adopted by the AMA House of Delegates.
“Without ensuring that there is strong and sufficient evidence that provides clinical validation to mHealth apps and associated devices, trackers and sensors,” the CMS report added, “physicians will not fully integrate mHealth apps into their practices.”
The report called for more investment in expanding the evidence base that shows the accuracy, effectiveness, safety and security of mHealth apps.
“Recognizing that privacy and security are paramount to overcoming concerns that are hindering the adoption and use of mHealth apps, we accelerated the release of the privacy and security guidelines in October, to gain the endorsement of our board and other key partners,” Dr. Hodgkins said. “There is a pressing need in the market to establish a framework to evaluate mobile health apps and build confidence among physicians and consumers that apps are safe, trustworthy and important tools to help people achieve their health and wellness goals.”
Interested parties are encouraged to review the guidelines and comment on all or any of the five guideline sections and have until May 15 to do so.