As a healthcare CIO, interoperability is probably on your radar when it comes to the thousands of devices in your organization. With more of these devices connecting to the internet, it’s important to know which vendors and products will help you coordinate your strategy. In August 2013, the United States Food and Drug Administration (FDA) updated its list of Recognized Standards that can be used for premarket reviews. In this update, several of the IEEE 11073 Personal Health Device (PHD) standards are now recognized for increasing the opportunity to produce interoperable health care solutions.
Two of the eight standards that were adopted were 1) a base standard defining common data formats and the exchange protocol and 2) an update to the base standard. The remaining six standards are “specializations” that define how to utilize the base standard to implement specific device types. The supported device types include: thermometers, weighing scales, pulse oximeters, peak flow meters, glucose meters, and basic electrocardiograph (1 to 3 lead ECG) devices.
These standards were created through the consensus driven processes of the Institute of Electrical and Electronics Engineers (IEEE) and are also recognized by the International Organization for Standardization (ISO). With dual recognition from ISO/IEEE, the standards have applicability worldwide.
Further, the Continua Health Alliance references these standards in their Interoperability Guidelines and has a rigorous test and certification process to ensure interoperability between these devices and a receiving device (i.e., PC, tablet, phone). Continua has certified 77 devices that comply with the newly recognized standards.
The IEEE 11073 PHD team continues to generate standards for additional personal health device types such as INR, insulin pump, and body composition analyzer. In addition, there are standards for the health & fitness space (e.g., cardiovascular fitness and activity monitoring) and independent living categories (e.g., medication monitoring).
For device manufacturers interested in creating any of the above mentioned six device types or receiving data from such devices in a standardized fashion, reviewing the FDA Procedures for the Use of Consensus Standards in the Premarket Application Review Process, would be useful. Utilizing these standards may help simplify and streamline the premarket review process and minimize the amount of data and documentation needed in a 510(k) submission.
For healthcare providers planning to purchase personal health devices, these standards, and the IEEE/ISO/Continua/FDA acceptance of them, means it is possible to require interoperable devices utilizing open standards so the best-of-breed devices can be selected from any number of vendors and integrated into the infrastructure.
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