How will Xcertia affect the future of digital health products?

On December 12, 2016, four organizations announced the beginning of a collaboration intended to develop and promote best practices for digital health apps. The nonprofit corporation, called Xcertia, was officially unveiled at the Connected Health Conference held at the Gaylord National Resort and Conference Center in the Washington, D.C. area. Participants in this venture include the American Heart Association, American Medical Association, the Healthcare Information and Management Systems Society and the DHX Group – a digital health nonprofit.

Xcertia will establish guidelines for safety and effectiveness in mobile health products. These efforts are meant to encourage improved accountability and outcomes as medical professionals make greater use of these devices and applications in clinical practice. It remains to be seen how the corporation will affect the medical device development process, but some signs are beginning to emerge.

Collaborating for better health outcomes
As MedCity News noted, the creation of Xcertia was not an entirely new event. A previous version of the organization was announced a year earlier as a collaboration between two labs: SocialWellth and HITLAB. That incarnation was meant to evaluate specific apps based on quality standards and conduct a certification process.

The new version of Xcertia has a similar mission to drive improvements in the creation and use of mobile devices in healthcare. However, the organizations involved in the corporation plan a different approach, concentrating on setting broad principles for developers to follow rather than judging individual apps. The next steps will include setting board members, electing a chairman of the board and deciding the areas of focus for the first round of workgroups.

Xcertia will work with app marketplaces, healthcare providers and retail pharmacies to improve the options available to doctors and patients. By offering recommendations for how to make apps and devices more useful and transparent, the participants hope to influence future development and consumer choices. The issues the group plans to address early on include what evidence should be used to prove the effectiveness of an app and what criteria should be used to judge that evidence.

Xcertia guidelines and the future of mobile health
Xcertia has not yet provided any specific guidelines, but the organization plans to cover four major areas: content, security, privacy and operability. The group will back apps centered on evidence-based practice, encourage patient-centered care delivery and coordination, and support data practices promoting security, portability and interoperability. In order to define best practices in those categories, the corporation will draw on input from software developers, insurance payers, clinicians, academics and consumers.

In a joint press release, HIMSS Executive Vice President Carla Smith explained the reasoning behind the new group's strategy.

"Secure, real-time access to accurate electronic health information gives consumers, patients, and clinicians the knowledge needed to make informed health-related decisions," she said. "As a founding organization of Xcertia, HIMSS extends its commitment to improving health and healthcare through the best use of IT by championing the creation of guidelines for mobile health apps. With safe, effective, and reputable mobile health apps, clinicians, caregivers, consumers, and patients can better manage care, and maintain their wellness."

Efforts like the Xcertia guidelines could point the way forward for new medical products. By bringing greater attention to the efficacy of digital health apps, the corporation may have an important role to play in making these programs a more widely accepted part of everyday clinical practice.