Computer-implemented system for secure physiological data collection and processing

• US 9,619,660 B1
• Filed: 03/12/2015
• Issued: 04/11/2017
• 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: Williamson, Corey Bailey, Felix, Jason, Dreisbach, Ezra M., Bishay, Jon Mikalson, Bardy, Gust H.
• Primary Examiner(s): Dvorak, Linda
• Assistant Examiner(s): Cardinal, Erin M
• Application Number:
  US14/656,661
• Time in Patent Office: 761 Days
• Field of Search: 600382, 600391-393, 600509
• 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

The electrode patch can store an identifier, such as a serial number, and a password associated with the identifier. The password can include a cryptographic hash of the identifier. The password and the identifier are coupled to the data collected using the patch and the data can be stored as electronic medical records (EMR) in a database based on the identifier. A patient or another authorized party can access the data using the identifier and the password. The EMRs can also include results of analysis of data received from the monitor, such as an automated over-read of an ECG trace based on the received data.

Claims

1. A computer-implemented system for secure physiological data collection and processing, comprising:

an extended wear electrocardiography and physiological sensor monitor recorder, comprising;

a sealed housing adapted to be removably secured into a non-conductive receptacle on a disposable extended wear electrode patch, wherein an identifier associated with the patch and a password for accessing results of a physiological monitoring conducted using the patch are stored on the patch; and

an electronic circuitry comprised within the sealed housing, comprising;

an electrocardiographic front end circuit electrically interfaced to an externally-powered micro-controller and operable to sense electrocardiographic signals through electrocardiographic electrodes provided on the disposable extended wear electrode patch when the sealed housing is secured within the non-conductive receptacle of the patch, wherein each of the electrocardiographic electrodes are adapted to be positioned axially along the midline of a sternum for capturing action potential propagation;

the externally-powered micro-controller electrically interfaced to the front end and operable to execute under micro programmable control through firmware that is stored in a program memory unit of the micro-controller, the micro-controller operable to retrieve the password and the identifier from the patch when the sealed housing is secured within the non-conductive receptacle of the patch; and

an externally-powered flash memory electrically interfaced with the micro-controller and operable to store together the password, the identifier, and samples of the electrocardiographic signals, the micro-controller further configured to offload the stored samples of the electrocardiographic signals from the memory together with the stored password and identifier.

2. A system according to claim 1, wherein the password stored on the patch is encoded using a secret key and the micro-controller decodes the password using the secret key.

3. A system according to claim 1, wherein one or more of:

the identifier comprises a serial number; and

the password comprises a hash of the serial number or a part thereof.

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

a secure database interconnected to a data communications network and operable to maintain data collected using the patch associated with the identifier, the data comprising the samples of the electrocardiographic signals received from the monitor recorder;

a server coupled to the database and configured to maintain a webpage on the data communications network, the webpage comprising the data;

a barcode comprising an encoding of the address of the webpage, the password, and the identifier; and

a user device comprising a scanner operable to scan the barcode, the user device operable to access the webpage using the scan.

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

one or more labels on which the barcode is comprised, the label further comprising one or more of the identifier and the password.

6. A system according to claim 4, wherein the data displayed on the webpage comprises a report generated based on the samples of the electrocardiographic signals.

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

a download station configured to receive the offloaded password, identifier, and samples of the electrocardiographic signals from the memory and to provide the received password, identifier, and samples to the server, wherein the server stores the samples in the database based on the provided password and identifier.

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

a log of issued identifiers and issued passwords associated with the issued identifiers, the log stored in the database;

a receipt module comprised in the server and configured to receive the password and the identifier scanned using the scanner from the barcode and to compare the received password and the identifier to one or more of the issued passwords and the issued identifiers in the log;

a webpage module comprised in the server configured to provide the webpage to the user device based on the comparison.

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

an over-read module comprised in the server and configured to perform an automated over-read of an ECG trace generated based on the samples of the electrocardiographic signals; and

a recommendation module comprised in the server and configured to generate a recommendation based on the over-read.

10. A system according to claim 4, wherein the user device is associated with a patient whose electrocardiographic signals were sensed and the user device is operable to present the webpage to the patient.

11. A computer-implemented system for secure low amplitude cardiac action potential data collection and processing, comprising:

a disposable extended wear electrode 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 the 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 an identifier associated with the patch and a password for accessing results of a physiological monitoring conducted using the patch; and

an ambulatory electrocardiography monitor comprising;

a wearable housing adapted to securely fit into the receptacle; and

electronic circuitry provided within the wearable housing and comprising an external interface configured to be removably connected to the electrocardiographic electrodes via the docking interface, further comprising;

a low power microcontroller operable to execute over an extended period under modular micro program control as specified in firmware and further operable to retrieve the identifier and the password from the circuit when the wearable housing is secured within the non-conductive receptacle of the patch;

an electrocardiographic front end circuit under the control of the microcontroller adapted to sense cardiac electrical potential differentials through the electrocardiographic electrodes, which are provided to the microcontroller as electrocardiographic signals representative of amplitudes of the action potential propagation; and

a non-volatile memory electrically interfaced with the microcontroller and operable to continuously store samples of the electrocardiographic signals collected throughout the extended period together with the retrieved password and identifier, the micro-controller is further configured to offload the stored samples of the electrocardiographic signals from the memory together with the stored password and identifier.

12. A system according to claim 11, wherein the password stored on the patch is encoded using a secret key and the micro-controller decodes the password using the secret key.

13. A system according to claim 11, wherein one or more of:

the identifier comprises a serial number; and

the password comprises a hash of the serial number.

14. A system according to claim 11, further comprising:

a secure database interconnected to a data communications network and operable to maintain data collected using the patch associated with the identifier, the data comprising the samples of the electrocardiographic signals received from the monitor recorder;

a server coupled to the database and configured to maintain a webpage on the data communications network, the webpage comprising the data;

a barcode comprising an encoding of the address of the webpage, the password, and the identifier; and

a user device comprising a scanner operable to scan the barcode, the user device operable to access the webpage using the scan.

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

one or more labels on which the barcode is comprised, the label further comprising one or more of the identifier and the password.

16. A system according to claim 14, wherein the data displayed on the webpage comprises a report generated based on the samples of the electrocardiographic signals.

17. A system according to claim 14, further comprising:

a download station configured to receive the offloaded password, identifier, and samples of the electrocardiographic signals from the memory and to provide the received password, identifier, and samples to the server wherein the server stores the samples in the database based on the provided password and identifier.

18. A system according to claim 14, further comprising:

a log of issued identifiers and issued passwords associated with the issued identifiers, the log stored in the database; and

a receipt module comprised in the server and configured to receive the password and the identifier scanned using the scanner from the barcode and to compare the received password and identifier to one or more of the issued passwords and the issued identifiers in the log;

a webpage module comprised in the server configured to provide the webpage to the user device based on the comparison.

19. A system according to claim 14, further comprising:

an over-read module comprised in the server and configured to perform an automated over-read of an ECG trace generated based on the samples of the electrocardiographic signals; and

a recommendation module comprised in the server and configured to generate a recommendation based on the over-read.

20. A system according to claim 19, wherein the ECG trace is filtered prior to the over-read being performed.