The Consumer Technology Association and Xcertia, a mobile health app collaborative, are working together to develop guidelines for the market. They will consider topics such as accuracy, transparency, privacy, security, regulatory compliance, interoperability, and user experience.
The American Medical Association, American Heart Association, DHX Group, and HIMSS initiated the project.
Xcertia was created in 2016 by the American Medical Association, The American Heart Association, HIMSS, and DHX Group as a collaborative to work toward improved safety and efficacy mobile health apps.
CTA brings to the table expertise on mobile technology, while Xcertia adds industry-developed clinical and design guidelines for health apps. The goal is to create a blueprint for developing and evaluating effective mobile solutions.
Brian Markwalter, senior vice president of research and standards at CTA, said he sees the collaboration as an opportunity to grow the association's portfolio of health, fitness and wellness standards and also to address specific challenges for mobile health solutions.
Representatives from both CTA and Xcertia discussed the issues May 6 during a session at the HLTH conference in Las Vegas.
"Do you want to wait for regulation? Or do you want to self-regulate, come together and do the right thing?" Dr. Michael Hodgkins, president of Xcertia and chief medical information officer at AMA, asked. "We want to move in the right direction that creates a discipline that avoids this Wild West that any app is equal."
Hodgkins sees the agreement with CTA as an important step in finally bringing some order to the mobile health app market of more than 350,000 — and-growing — apps and the relationship between them and the devices with which they interface. He expects the collaboration will result in better digital solutions creating trust and confidence for consumers and healthcare professionals.
Dr. James Mault, chief medical officer at Qualcomm Life and chairman of the CTA Health and Fitness Board, focused on trust.
"It's imperative for the organizations and tech vendors to proactively develop a trust relationship between consumer and clinical communities," he said.
Markwalter noted that U.S. sale of health and fitness devices — including wearables, hearables, and sports tech — is expected to approach 50 million units this year, increasing the patient-generated health data that's available.
As he sees it, CTA's work with Xcertia is critical to addressing the availability, transparency, and reliability of that data.
CTA has published a set of Health, Fitness, and Wellness Standards, developing industry testing protocols, accuracy thresholds, and data availability minimums for biometric conditions such as step counting, heart rate and sleep monitoring.
Xcertia publishes annually the Xcertia Guidelines, a set of app design guidelines that help ensure accuracy, content, security, and privacy within a context of appropriate user experience for application programmers and organizations looking to validate applications for use.
Dr. David Rhew, chief medical officer of Samsung, said the industry is starting to recognize that virtual and digital tools can be effective.
"When you get to the point where an app is tying into the care of a condition and looped into clinical team, the hospital, it's a team approach," he said, "so you want to adopt technologies that have greater transparency."