METHOD FOR SECURE PHYSIOLOGICAL DATA ACQUISITION AND STORAGE

• US 20190290150A1
• Filed: 05/06/2019
• Published: 09/26/2019
• 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.
• Granted Patent: US 10,433,743 B1
• Time in Patent Office: 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 method for secure physiological data acquisition and storage is provided. An identifier of a physiological monitoring device that is configured to store the identifier within a cryptographic circuit is obtained by a programming wand. A password for accessing physiological monitoring data collected using that device is generated based on at least a portion of the identifier. The password is encrypted using a secret key, and password is loaded into the cryptographic circuit. The secret key is loaded into a monitor recorder, wherein the monitor recorder retrieves the identifier and the password from the device, decodes the password, and offloads the physiological monitoring data together with the identifier and the decoded password. The identifier and the password are reported to at least one server. The offloaded physiological monitoring data is stored using the identifier. Access to the data is granted upon receipt of the decoded password from a user.

Claims

1. A method for secure physiological data acquisition and storage, comprising:

obtaining by a programming wand an identifier of a physiological monitoring device that is configured to store the identifier within a cryptographic circuit on that device;

generating by the programming wand a password for accessing physiological monitoring data collected using that device based on at least a portion of the identifier, encrypting the password using a secret key, and loading the encrypted password into the cryptographic circuit;

loading by the programming wand the secret key into a monitor recorder configured to couple with the device and to obtain the physiological monitoring data using the device, wherein the monitor recorder retrieves the identifier and the password from the device, decodes the password, and offloads the physiological monitoring data together with the identifier and the decoded password; and

reporting by the programming wand the identifier and the password within the cryptographic circuit to at least one server;

storing by the at least one server the offloaded physiological monitoring data using the identifier within a secure database; and

granting by the at least one server access to the physiological monitoring data upon receipt of the decoded password from a user.

2. A method according to claim 1, wherein the programming wand is calibrated after a preset number of times of password generation.

3. A method according to claim 1, wherein at least one of the identifier is pre-loaded into the wand and the programming wand generates the identifier and loads the identifier into the cryptographic circuit.

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

tracking by the at least one server whether the offloaded physiological monitoring data has been received based on the report.

5. A method according to claim 1, wherein the programming wand wirelessly interfaces with the at least one server, the physiological monitoring device and the monitor recorder.

6. A method according to claim 1, wherein the password comprises a cryptographic hash of a portion of the identifier, the password further comprising additional data.

7. A method according to claim 1, wherein the additional data comprises pseudorandomly generated numbers.

8. A method according to claim 1, further comprising:

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

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

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

9. A method according to claim 8, further comprising:

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

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

generating by the at least one server the recommendation based on the comparison.

10. A method according to claim 1, further comprising:

maintaining by the at least one server a website on a data communication network, wherein the at least one server receives from a user device associated with the user the password and the identifier via the website and the at least one server provides the password and the identifier to the user device via the website.

11. A method for secure physiological monitoring result acquisition and storage, comprising:

obtaining by a programming wand an identifier associated with an electrocardiography monitor that is configured to store the identifier within a cryptographic circuit within the monitor;

generating by the programming wand a password for accessing physiological monitoring data collected using the monitor based on at least a portion of the identifier, encrypting the password using a secret key, and loading the encrypted password into the cryptographic circuit;

loading by the programming wand the secret key into a portion of the monitor other than the cryptographic circuit, wherein the portion retrieves the identifier and the password from the cryptographic circuit, decodes the password, and offloads the physiological monitoring data together with the identifier and the decoded password; and

reporting by the programming wand the identifier and the password within the cryptographic circuit to an at least one server;

storing by the at least one server the offloaded physiological monitoring data using the identifier within a secure database; and

granting by the at least one server access to the physiological monitoring data upon receipt of the decoded password from a user.

12. A method according to claim 11, wherein the programming wand is calibrated after a preset number of times of password generation.

13. A method according to claim 11, wherein at least one of the identifier is pre-loaded into the wand and the programming wand generates the identifier and loads the identifier into the cryptographic circuit.

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

tracking by the at least one server whether the offloaded physiological monitoring data has been received based on the report.

15. A method according to claim 11, wherein the programming wand wirelessly interfaces with the at least one server and the monitor.

16. A method according to claim 11, wherein the password comprises a cryptographic hash of a portion of the identifier, the password further comprising additional data.

17. A method according to claim 11, wherein the additional data comprises pseudorandomly generated numbers.

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

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

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

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

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

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

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

generating by the at least one server the recommendation based on the comparison.

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

maintaining by the at least one server a website on a data communication network, wherein the at least one server receives from a user device associated with the user the password and the identifier via the website and the at least one server provides the password and the identifier to the user device via the website.