Toward the end of last year, four key mhealth stakeholders joined forces to launch Xcertia, a collaborative whose mission is to drive the mobile health field forward with established quality, safety, and security best practices at the forefront. The group, which formed in December 2016, is composed of four organizations: the American Medical Association (AMA), the American Heart Association (AHA), the Healthcare Information and Management Systems Society (HIMSS), and mHeatlh app curation company DHX Group. What has happened since then?
In a meeting at HIMSS, Xcertia members set out a plan for a multi-stage initial course of action:
- Put out a call for a range of stakeholders in the mHealth space to join the founding organizations as Xcertia members.
- Assemble working groups to develop mHealth industry standards in a set of key categories including efficacy, usability, interoperability, safety, and data privacy and security.
- Promote new standards among the mHealth application development community and mHealth users themselves.
The central philosophy is to forge a process with a bottom-up, rather than a top-down, approach. Standards will be based on stakeholders’ industry experience and the regulations that are already out there — currently mHealth is governed by a disparate set of rules and guidelines from the Federal Trade Commission (FTC), the Food and Drug Administration (FDA), the HIPAA law, and others.
Consolidating mHealth standards and regulations is an important step that will help mobile health application development companies and their clients. The reason is that the current void of clear guidance is causing problems for the industry. Last month, for instance, New York’s attorney general announced that three heart health apps will face settlements for promoting misleading claims about the apps’ biometric abilities and concerns about data privacy practices. While the FTC governs claims, the FDA governs medical devices — and because mobile phones are not considered medical devices yet can be used to measure health data, the lines are extremely blurred. In an industry that has great potential for improving healthcare and outcomes, lawsuits like these are setbacks.
Together, the organizations forming Xcertia — which should soon number many more — will work to find solutions that will move HIPAA compliant mHealth app development forward to fulfill its potential. And right now, this organization is a key player to watch.
