Reviewing media coverage of the U.S. Food and Drug Administration’s recent announcement that it will recognize standards for medical device interoperability could give a misleading impression that the measure is of little importance. In truth, federal actions to acknowledge interoperability standards in healthcare are among the more sweeping changes we have seen during the time since the Continua Health Alliance was founded in 2006, including activity in the United States, UK, Denmark, Singapore, Japan and the United Arab Emirates.
The FDA’s formal inclusion of these standards on their list of consensus standards helps establish a common framework that adds a measure of predictability for manufacturers that are developing interoperable products. These newly added standards offer approaches and concepts that the FDA recognizes as reasonable to support assessment of product safety. Fulfillment of market standardization is now closer to realizing the axiom “supply creates demand” – manufacturers may be more willing to use FDA-recognized standards as purchasers become aware of product choice. As we have witnessed in other nations, specifying standards at the federal level provides a boost to market adoption.
Among the 25 standards listed are 12 ISO/IEEE or IEEE (Institute of Electrical and Electronic Engineers) standards for interoperability that cover general nomenclature and protocols for personal health device communication as well as profiles for seven personal health devices (i.e., blood pressure monitor and glucose meter). The Association for Advancement of Medical Instrumentation (AAMI), MI, UL, MD PDP, West Health and others have worked with IEEE to help drive these initiatives. An example of how this collaboration works is how Continua helped drive the underlying IEEE 11073-20601 standards to completion. Staff and members of the Continua Health Alliance have been especially active in this process, as these are the standards that underpin Continua’s device certification models.
In a blog post about the new measure, Bakul Patel, senior policy advisor to the director of the FDA’s Center for Devices and Radiological Health (CDRH), talks about improvements in care quality, reduction in errors and lower costs that can come about as a result of interoperability. A tangible and practical illustration of improving care through rapid deployment was demonstrated when previously certified Continua products were implemented to support the Disaster Cardiovascular Prevention Network following the Great East Japan earthquake of 2011.
FDA recognition of interoperability standards is a giant step in the right direction. However, an effective means to ensure interoperability is a certification program, a mechanism with success in other fields. Continua offers a certification program for personal connected health devices, systems and services that incorporates the same standards recently recognized by the FDA, as well as others. Certifying is a practical investment that provides a measure of assurance that products will interoperate with any other certified product, eliminating the need to work directly with each manufacturer to achieve interoperability and facilitating end-to-end solutions in the market. To encourage program participation, Continua’s Design Guidelines are available for free (contact admin@continuaalliance.org).
The FDA nod gives interoperability new momentum that builds upon the work done to date. We are one step closer to an interoperable ecosystem in personal connected health and there are plenty of thanks to go around.
Chuck Parker is executive director of the Continua Health Alliance, based in Beaverton, OR.
