Medical Device Data Back-Association System, Apparatuses, And Methods

Patent No. US11177026 (titled "Medical Device Data Back-Association System, Apparatuses, And Methods") was filed by Baxter Healthcare Sa on May 10, 2019.

What is this patent about?

’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.

How does this patent fit in bigger picture?

Technical landscape at the time

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.

Novelty and Inventive Step

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.

Claims

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.

Key Claim Terms New

Definitions of key terms used in the patent claims.

Term (Source)Support for SpecificationInterpretation
Device identifier
(Claim 1, Claim 10)
“The operations include receiving first medical device data from a medical device via a network, the first medical device data including a device identifier of the medical device.”A unique identifier associated with a medical device.
First medical device data
(Claim 1, Claim 10)
“The operations include receiving first medical device data from a medical device via a network, the first medical device data including a device identifier of the medical device, determining, at a first time, there is no association between the device identifier and any patient identifier or medication order identifier and storing the first medical device data to an unassociated record in the database.”The initial data received from a medical device before an association with a patient's EMR is established.
Identifier message
(Claim 1, Claim 10)
“The operations further include receiving, while the medical device is administering the medication to the patient, an identifier message including at least two of the device identifier, the patient identifier, and the medication order identifier, and creating an association between the EMR of the patient and the medical device by matching the patient identifier or the medication order identifier of the identifier message to the medication order identifier or the patient identifier of the medication order.”A message containing at least two of the device identifier, patient identifier, and medication order identifier, used to create an association between the medical device and the patient's EMR.
Medication order identifier
(Claim 1, Claim 10)
“The medication order includes a medication order identifier and a patient identifier of the patient. The EMR of the patient includes the patient identifier.”A unique identifier associated with a medication order stored in the electronic medical record (EMR).
Unassociated record
(Claim 1, Claim 10)
“The operations also include determining, at a first time, there is no association between the device identifier and any patient identifier or medication order identifier and storing the first medical device data to an unassociated record in the database.”A temporary storage location in the database for medical device data when there is no initial association with a patient or medication order.

Litigation Cases New

US Latest litigation cases involving this patent.

Case NumberFiling DateTitle
1:25-cv-00591May 12, 2025Becton, Dickinson And Company V. Baxter International Inc.

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US11177026

BAXTER HEALTHCARE SA
Application Number
US16408978
Filing Date
May 10, 2019
Status
Granted
Expiry Date
May 19, 2040
External Links
Slate, USPTO, Google Patents