Will Medical Device Makers Get Interoperability Done?

Most of the time, when I think about interoperability, I visualize communication between various database-driven applications, such as EMRs, laboratory information systems and claims records. The truth is, however, that this is a rather narrow definition of interoperability. It’s time we take medical device data into account, the FDA reminds us. In early September, the FDA released its final guidance on how healthcare organizations can share data between medical devices and other information systems. In the guidance, the agency asserts that the time has come to foster data sharing between medical devices, as well as data exchange between devices and information systems like the ones I’ve listed above. Specifically, the agency is offering guidelines to medical device manufacturers, recommending that they: Design devices with interoperability in mind Conduct appropriate verification, validation and risk management to ensure interoperability Make sure users clearly understand the device’s relevant functional, performance and interface characteristics Though these recommendations are interesting, I don’t have much context on their importance. Luckily, Bakul Patel has come to the rescue. Patel, who is associate director for digital health the FDA‘s Center for Devices and Radiological Health, offered more background on medical device interoperability in a recent blog entry. As the article points out, the stakes here are high. “Errors and inadequate interoperabili...
Source: EMR and HIPAA - Category: Information Technology Authors: Tags: Digital Health EHR Electronic Health Record Electronic Medical Record EMR Healthcare Healthcare Devices Healthcare Interoperability HealthCare IT Interfaces Bakul Patel FDA Health Data Exchange Standards Internet of Things Labo Source Type: blogs