The Basics of EMR Integration

With the introduction in 2009 of the Health Information Technology for Economic and Clinical Health (HITECH) Act, which incentivized the adoption and meaningful use of electronic health records (EHRs), healthcare facilities across the United States have been focusing on installing and implementing electronic medical records (EMRs).1 However, the program is not only driving the adoption of EMRs, but also motivating advancements in other related areas, one of which is medical device connectivity.

Although no formal definition has been proposed for “medical device connectivity,” the term generally refers to the integration of medical devices with hospital information systems, which can facilitate a multitude of functions, including automated clinical documentation, alarm management and notification, remote surveillance, and data aggregation for retrospective review and analysis. Medical device connectivity is not part of the current HITECH meaningful use criteria that healthcare facilities must meet to qualify for incentive payments. However, medical device connectivity (and especially automated clinical documentation) can facilitate meaningful use by reducing errors associated with manual documentation and ensuring timely data transfer. We refer to systems that connect medical devices with hospital information systems as medical device connectivity solutions.

An important aspect of medical device connectivity is the integration of medical devices with hospital EMRs for the purpose of automating clinical documentation. This process enables data to flow directly from the medical device at the point of care (POC) into the patient’s medical record, meaning that the clinician will not need to manually enter patient data into the EMR.

Systems that facilitate automated clinical documentation are typically referred to as medical device data systems (MDDSs) and are regulated as Class I medical devices by FDA (based on a 2011 ruling). However, not all systems that integrate medical devices with EMRs fall under the MDDS classification. Some integration solutions, primarily those that have been on the market since before the MDDS rule was finalized, have been cleared by FDA as Class II medical devices (and may have functionality beyond automated documentation, like alarm integration). The term medical device connectivity solution encompasses MDDSs as well as systems that facilitate other functionality (e.g., alarm integration). See our full MDDS...