Patent No. US11177026 (titled "Medical Device Data Back-Association System, Apparatuses, And Methods") was filed by Baxter Healthcare Sa on May 10, 2019.
’026 is related to the field of electronic medical record (EMR) systems and, more specifically, to the automated documentation of medical device data within a patient's EMR. Current systems require an association between a medical device (like an infusion pump) and a patient's record *before* treatment begins. If this association is missed, data from the device is either discarded or stored in a temporary location, requiring manual transfer to the EMR later, a process prone to errors and omissions.
The underlying idea behind ’026 is to enable back-association of medical device data with a patient's EMR, even *after* treatment has started. This is achieved by receiving an 'identifier message' containing the device identifier, patient identifier, and/or medication order identifier while the device is actively administering medication. The system then uses this information to link the device data to the correct patient record, ensuring complete and accurate documentation.
The claims of ’026 focus on a system and method where a server receives medical device data, determines that it's initially unassociated with any patient or medication order, and stores it in a temporary record. Crucially, while the device is still administering medication, the server receives an 'identifier message' containing at least two of: the device identifier, the patient identifier, and the medication order identifier. The server then creates an association and subsequently stores further device data directly to the patient's EMR.
In practice, the system works by first receiving medical device data, such as infusion rates from an infusion pump, and temporarily storing it because the pump isn't yet linked to a specific patient in the EMR. A clinician then uses a barcode scanner to capture the pump's identifier (perhaps displayed as a QR code on the pump's screen) along with the patient's identifier (from their wristband). This information is sent to the server, which then links the pump to the patient's EMR. From that point on, all data from that pump is automatically stored in the correct patient's record.
This approach differs significantly from prior solutions that require pre-treatment association. By allowing on-the-fly association , the invention addresses situations where initial setup is missed or delayed. Furthermore, the system can optionally retrieve the previously unassociated data from the temporary record and add it to the patient's EMR, ensuring a complete medical record. The use of standard identifiers and message formats (like HL7) facilitates integration with existing hospital systems.
In the late 2010s when ’026 was filed, electronic medical records were becoming increasingly prevalent, at a time when medical devices were often integrated with EMR systems using standardized communication protocols. However, associating device data with the correct patient record, especially when the association was not established before treatment began, was typically implemented using manual processes or temporary data storage solutions, when hardware or software constraints made robust, automated back-association non-trivial.
The examiner approved the application because the prior art, specifically Vik et al., failed to teach or suggest an electronic medical record system and method that includes a database storing medication orders linked to patient EMRs, and a server that can receive medical device data, determine if an association exists, store unassociated data temporarily, and then create an association later to properly store the data in the patient's EMR. The examiner stated that it would not have been obvious to combine the missing elements from Vik with other references to achieve the claimed invention.
There are 17 claims in total. Claims 1 and 10 are independent. The independent claims are directed to an electronic medical record system and method for associating medical device data with a patient's electronic medical record. The dependent claims generally elaborate on the features and steps of the independent claims, providing more specific details and implementations.
Definitions of key terms used in the patent claims.
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