System and method for physiological data processing and delivery

• US 9,955,885 B2
• Filed: 03/28/2017
• Issued: 05/01/2018
• Est. Priority Date: 09/25/2013
• Status: Active Grant

• Current Assignee: Bardy Diagnostics, Inc. (Baxter International Inc.)
• Original Assignee: Bardy Diagnostics, Inc. (Baxter International Inc.)
• Inventors: Felix, Jason, Dreisbach, Ezra M., Bishay, Jon Mikalson, Williamson, Corey Bailey, Bardy, Gust H.
• Primary Examiner(s): Cohen, Lee S
• Assistant Examiner(s): Cardinal, Erin M
• Application Number:
  US15/472,183
• Publication Number:
  US 20170196472A1
• Time in Patent Office: 399 Days
• CPC Class Codes: A61B 2560/0487 Special user inputs or interfaces
• CPC Class Codes: A61B 2562/08 Sensors provided with means for identification, e.g. barcodes or memory chips
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/259 using conductive adhesive means, e.g. gels
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/333 Recording apparatus specially adapted therefor
• CPC Class Codes: A61B 5/339 Displays specially adapted therefor
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/361 Detecting fibrillation
• CPC Class Codes: A61B 5/363 Detecting tachycardia or bradycardia
• CPC Class Codes: A61B 5/366 Detecting abnormal QRS complex, e.g. widening
• CPC Class Codes: A61B 5/6823 Trunk, e.g., chest, back, abdomen, hip
• CPC Class Codes: A61B 5/6832 using adhesives A61B5/259 takes precedence
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61B 5/7203 for noise prevention, reduction or removal
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/748 Selection of a region of interest, e.g. using a graphics tablet
• CPC Class Codes: A61B 90/90 : Identification means for patients or instruments, e.g. tags
• CPC Class Codes: A61B 90/96 : using barcodes
• CPC Class Codes: G06F 21/604 : Tools and structures for managing or administering access control systems
• CPC Class Codes: G06F 21/6218 : to a system of files or objects, e.g. local or distributed file system or database
• CPC Class Codes: G16H 40/63 : for local operation

Abstract

A system and method for secure physiological data processing and delivery are provided. A log of identifiers of physiological monitoring patches and of passwords is maintained in a secure database. Physiological monitoring data obtained using one of the patches is received by at least one server together with the identifier and the password associated with that patch. The received identifier and password are compared with the identifiers and passwords stored in the log. The received physiological monitoring data is stored in electronic medical records associated with the matching identifier. The password and the identifier associated with the physiological monitoring data are received from a user device over the data communications network. The received password and identifier are compared to the password and the identifier associated with the electrical medical records. The electronic medical records are provided by to the user device over the data communication network based on the comparison.

Claims

1. A system for secure physiological data processing and delivery, comprising:

a secure database operable to maintain a log of identifiers of physiological monitoring patches and of passwords, each of the passwords associated with one of the identifiers and the patch identified by the associated identifier, wherein each of the identifiers and the password associated with that identifier are loaded into the patch identified by that identifier and wherein the password is necessary to access physiological monitoring data obtained using the patch identified by that identifier;

at least one server interconnected to a data communications network and coupled to the database, the at least one server configured to;

receive the physiological monitoring data obtained using one of the patches together with the identifier and the password loaded into that patch;

compare the received identifier and password with the identifiers and passwords stored in the log;

upon the received identifier and password matching one of the stored identifiers and one of the stored passwords, store the received physiological monitoring data in electronic medical records associated with the matching identifier to associate the identifier, password, physiological monitoring data and electronic medical records together;

receive from a user device over the data communications network a user password and a user identifier;

compare the user password and the user identifier received from the user device to the password and the identifier associated with the electronic medical records in which the physiological monitoring data is stored; and

provide to the user device the electronic medical records over the data communication network upon the user identifier matching the identifier associated with the electronic medical records in which the received physiological monitoring data is stored and the user password matching the password associated with the identifier associated with the electronic medical records in which the received physiological data is stored.

2. A system according to claim 1, further comprising:

a programming wand interfaceable with the patches and configured to load the identifier and the password associated with one of the patches into that patch.

3. A system according to claim 2, wherein the programming wand is wirelessly interfaced to the server and is further configured to report the loaded identifier and the password to the server.

4. A system according to claim 2, wherein the programming wand is further configured to:

generate the password and the identifier loaded into the patch, wherein the password is encoded using a secret key prior to being loaded into the patch; and

load the secret key into a monitor recorder that interfaces with the patch during physiological monitoring, wherein the monitor recorder decodes the encoded password using the secret key and stores the decoded password with the physiological monitoring data.

5. A system according to claim 4, further comprising:

the patch, comprising;

a flexible backing comprising stretchable material defined as an elongated strip with a narrow longitudinal midsection, each end of the flexible backing comprising an adhesive contact surface adapted to serve as a crimp relief;

a pair of electrocardiographic electrodes comprised on the contact surface of each end of the flexible backing, each electrocardiographic electrode conductively exposed for dermal adhesion and adapted to be positioned axially along a midline of a sternum for capturing action potential propagation;

a non-conductive receptacle affixed to a non-contacting surface of the flexible backing and comprising an electro mechanical docking interface;

a pair of flexible circuit traces affixed at each end of the flexible backing with each circuit trace connecting one of the electrocardiographic electrodes to the docking interface, at least one of the circuit traces adapted to extend along the narrow longitudinal midsection to serve as a strain relief; and

a circuit operable to store the identifier associated with the patch and the encoded password associated with the patch.

6. A system according to claim 4, the system further comprising:

a download station configured to interface to the monitor recorder, to receive from the monitor recorder a data stream comprising the password, the identifier, and the physiological monitoring data, and to transmit the password, the identifier, and the physiological monitoring data to the server.

7. A system according to claim 6, wherein the password and the identifier are comprised in a beginning of the data stream.

8. A system according to claim 1, wherein the server is further configured to:

obtain an ECG trace generated based on the physiological monitoring data; and

perform an automated over-read of the ECG trace; and

provide a recommendation based on the automated over-read.

9. A system according to claim 8, wherein the server is further configured to:

identify one or more features of the ECG trace;

compare the identified features to known ECG trace features indicative of one or more conditions; and

generate the recommendation based on the comparison.

10. A system according to claim 1, wherein the server is further configured to:

maintain a website on the data communications network, wherein the server receives from the user device the password and the identifier associated with the physiological monitoring data via the website and the server provides the electronic medical records to the user device via the website.

11. A method for secure physiological data processing and delivery, comprising:

maintaining in a secure database a log of identifiers of physiological monitoring patches and of passwords, each of the passwords associated with one of the identifiers and the patch identified by the associated identifier, wherein each of the identifiers and the password associated with that identifier are loaded into the patch identified by that identifier and wherein the password is necessary to access physiological monitoring data obtained using the patch identified by that identifier;

receiving by at least one server, the at least one server interconnected to a data communications network and coupled to the database, the physiological monitoring data obtained using one of the patches together with the identifier and the password loaded into that patch;

comparing by the at least one server the received identifier and password with the identifiers and passwords stored in the log;

upon the received identifier and password matching one of the identifiers and one of the stored passwords, storing by the at least one server the received physiological monitoring data in electronic medical records associated with the matching identifier to associate the identifier, password, physiological monitoring data and electronic medical records together;

receiving by the at least one server from a user device over the data communications network a user password and a user identifier;

comparing by the at least one server the user password and the user identifier received from the user device to the password and the identifier associated with the electronic medical records in which the physiological monitoring data is stored; and

providing by the at least one server to the user device the electronic medical records over the data communication network upon the user identifier matching the identifier associated with the electronic medical records in which the received physiological monitoring data is stored and the user password matching the password associated with the identifier associated with the electronic medical records in which the received physiological data is stored.

12. A method according to claim 11, further comprising:

loading by a programming wand interfaceable with the patches the identifier and the password associated with one of the patches into that patch.

13. A method according to claim 12, wherein the programming wand is wirelessly interfaced to the server, further comprising:

reporting by the programming wand the loaded identifier and the password to the server.

14. A method according to claim 12, further comprising:

generating by the programming wand the password and the identifier loaded into the patch, wherein the password is encoded using a secret key prior to being loaded into the patch; and

loading by the programming wand the secret key into a monitor recorder that interfaces with the patch during physiological monitoring, wherein the monitor recorder decodes the encoded password using the secret key and stores the decoded password with the physiological monitoring data.

15. A method according to claim 14, further comprising:

interfacing by a download station with the monitor recorder;

receiving by the download station from the monitor recorder a data stream comprising the password, the identifier, and the physiological monitoring data; and

transmitting by the download station the password, the identifier, and the physiological monitoring data to the server.

16. A method according to claim 15, wherein the password and the identifier are comprised in a beginning of the data stream.

17. A method according to claim 11, further comprising:

obtaining by the server an ECG trace generated based on the physiological monitoring data; and

performing by the server an automated over-read of the ECG trace; and

providing by the server a recommendation based on the automated over-read.

18. A method according to claim 17, further comprising:

identifying by the server one or more features of the ECG trace;

comparing by the server the identified features to known ECG trace features indicative of one or more conditions; and

generating by the server the recommendation based on the comparison.

19. A method according to claim 17, further comprising:

obtaining by a further user device an ECG trace corrupted with noise;

applying by the further user device one or more filters based on user input to the corrupted ECG trace to obtain the ECG trace; and

providing by the further user device the ECG trace to the server.

20. A method according to claim 11, further comprising:

maintaining by the server a website on the data communications network, wherein the server receives from the user device the password and the identifier associated with the physiological monitoring data via the website and the server provides the electronic medical records to the user device via the website.