System and method for secure physiological data acquisition and storage

• US 10,278,603 B2
• Filed: 04/30/2018
• Issued: 05/07/2019
• 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.
• Primary Examiner(s): Cohen, Lee S
• Assistant Examiner(s): Cardinal, Erin M
• Application Number:
  US15/966,896
• Publication Number:
  US 20180242867A1
• Time in Patent Office: 372 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 acquisition and storage. An identifier of a physiological monitoring patch is obtained by a programming wand, the patch configured to store the identifier within a cryptographic circuit. A password for accessing physiological monitoring data collected using that patch is generated based on at least a portion of the identifier, the password is encrypted using a secret key, and the encrypted password is loaded into the cryptographic circuit. The key is loaded onto a monitor recorder that couples with the patch and obtains the physiological monitoring data using the patch, wherein the monitor recorder offloads the data together with the identifier and the decoded password. The identifier and the password are reported to a server that stores the offloaded physiological monitoring data using the identifier within a secure database and grants access to the data upon receipt of the decoded password.

Claims

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

a programming wand configured to;

obtain an identifier of a physiological monitoring patch that is configured to store the identifier within a cryptographic circuit on that patch;

generate a password for accessing physiological monitoring data collected using that patch from an at least one server based on at least a portion of the identifier, to encrypt the password using a secret key, and to load the encrypted password into the cryptographic circuit;

load the secret key onto a monitor recorder that is configured to couple with the patch and that is configured to obtain the physiological monitoring data using the patch, wherein the monitor recorder retrieves the identifier and the password from the patch, decodes the password, and offloads the physiological monitoring data together with the identifier and the decoded password; and

report the identifier and the password within the cryptographic circuit to the at least one server; and

the at least one server, wherein the server is configured to store the offloaded physiological monitoring data using the identifier within a secure database and to grant access to the physiological monitoring data upon receipt of the decoded password from a user.

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

the programming wand further configured to require a calibration after a preset number of times of password generation prior to performing further password generation.

3. A system according to claim 1, wherein the identifier is pre-loaded into the cryptographic circuit or the programming wand generates the identifier and loads the identifier into the cryptographic circuit.

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

the at least one server further configured to track whether the offloaded physiological monitoring data has been received based on the report.

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

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

a hashing function stored within the programming wand, wherein the programming wand encrypts at least a portion of the identifier using the hashing function to generate the password and further generates additional data for inclusion into the password.

7. A system according to claim 6, wherein the additional data comprises pseudorandomly generated numbers.

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

the at least one server 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 at least one 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, further comprising:

the at least one server further configured to maintain 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.