When you do a web search on articles about mobile health apps and regulation, the term that pops up most often is “Wild West.” That’s because devices such as exercise trackers fall between the cracks of regulatory oversight of federal government agencies. The recently passed 21st Century Cures Act clarifies that the U.S. Food & Drug Administration is not responsible for overseeing consumer-facing health apps.
To help fill that gap of assuring quality and safety of mobile health apps, four organizations have announced the formation of a new, multi-stakeholder collaboration called Xcertia, The initial supporters include the American Heart Association (AHA), the American Medical Association (AMA), the Healthcare Information and Management Systems Society (HIMSS) and the DHX Group, a not-for-profit organization whose mission is to accelerate the development and market implementation of digital health innovations.
As a nonprofit corporation, Xcertia will establish and promote best practices for mobile health apps. Xcertia’s membership and governing board will be open to consumers, developers, payers, clinicians, academia and others with an interest in the development of guidelines for mobile health apps.
“The collaboration builds on each organization’s ongoing efforts to foster safe, effective, and reputable health technologies, while complementing our mutual commitment to advancing innovation in medicine, and improving the health of the nation,” said Xcertia’s four founders. “Our combined expertise, along with a diverse membership, will leverage the insights of clinicians, patients and industry experts to help improve patient care and increase access to data,” they said in a statement.
Xcertia will respond to the need for a comprehensive effort to develop a framework of principles that will impact the trajectory of the mobile health app industry. Xcertia’s guidelines will also be a resource to support consumer and clinician choice of mobile health apps. While Xcertia said it would not engage in certifying mHealth apps, it will encourage others to apply its principles and guidelines in the development and curation of mobile health apps.
Xcertia invites other organizations in the patient, technology and other healthcare communities to join the collaboration and add their expertise to the development of guidelines for mobile health apps. To join in this collaborative effort, go to the Xcertia website at www.xcertia.org for more details.