Secure communication architecture for medical devices

• US 9,980,140 B1
• Filed: 02/13/2017
• Issued: 05/22/2018
• Est. Priority Date: 02/11/2016
• Status: Active Grant

• Current Assignee: Insulet Corporation
• Original Assignee: Bigfoot Biomedical, Inc.
• Inventors: Spencer, Gil, Lee, Kevin S., Hinkel, Cameron
• Primary Examiner(s): Le, Thien M
• Application Number:
  US15/431,452
• Time in Patent Office: 463 Days
• Field of Search: 235380
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/6072 Bar codes
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61M 5/20 Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically A61M5/142 , A61M5/46 take precedence; hypodermic projectiles F42B12/54
• CPC Class Codes: G06F 21/44 Program or device authentication
• CPC Class Codes: G06F 21/602 Providing cryptographic facilities or services
• CPC Class Codes: G06F 21/629 to features or functions of an application
• CPC Class Codes: G06K 19/06028 using bar codes
• CPC Class Codes: G06K 7/10722 Photodetector array or CCD scanning
• CPC Class Codes: G06K 7/1413 1D bar codes
• CPC Class Codes: H04L 2209/80 Wireless network architectures or network communication protocols for wireless network security H04W12/00
• CPC Class Codes: H04L 2209/88 Medical equipments
• CPC Class Codes: H04L 63/0435 wherein the sending and receiving network entities apply symmetric encryption, i.e. same key used for encryption and decryption cryptographic mechanisms or cryptographic arrangements for symmetric key encryption H04L9/06
• CPC Class Codes: H04L 63/0823 using certificates cryptographic mechanisms or cryptographic arrangements for entity authentication involving certificates H04L9/3263
• CPC Class Codes: H04L 63/18 using different networks or channels, e.g. using out of band channels cryptographic mechanisms or cryptographic arrangements for key distribution involving distinctive intermediate devices or communication paths H04L9/0827; cryptographic mechanisms or cryptographic arrangements for authentication using a plurality of channels H04L9/3215
• CPC Class Codes: H04L 9/0631 : Substitution permutation network [SPN], i.e. cipher composed of a number of stages or rounds each involving linear and nonlinear transformations, e.g. AES algorithms
• CPC Class Codes: H04L 9/0637 : Modes of operation, e.g. cipher block chaining [CBC], electronic codebook [ECB] or Galois/counter mode [GCM]
• CPC Class Codes: H04L 9/0825 : using asymmetric-key encryption or public key infrastructure [PKI], e.g. key signature or public key certificates
• CPC Class Codes: H04L 9/3236 : using cryptographic hash functions
• CPC Class Codes: H04L 9/3271 : using challenge-response
• CPC Class Codes: H04W 12/02 : Protecting privacy or anonymity, e.g. protecting personally identifiable information [PII]
• CPC Class Codes: H04W 12/06 : Authentication
• CPC Class Codes: H04W 12/50 : Secure pairing of devices
• CPC Class Codes: H04W 12/71 : Hardware identity
• CPC Class Codes: H04W 12/77 : Graphical identity
• CPC Class Codes: H04W 84/18 : Self-organising networks, e.g. ad-hoc networks or sensor networks

Abstract

In one implementation, a computer-implemented method of establishing a secure wireless communication connection between an insulin pump device and a mobile computing device includes receiving, at a mobile computing device, a device identifier for the insulin pump device; obtaining, by the mobile computing device, device information for the insulin pump device from a remote server system using the device identifier; establishing, by the mobile computing device, a secure wireless connection with the insulin pump device using, at least in part, the device information; authenticating, by the mobile computing device, the insulin pump device based on asymmetric key verification using the public key for the insulin pump; and securely communicating, by the mobile computing device and in response to authenticating the insulin pump device, information with the insulin pump device.

Claims

1. A computer-implemented method of establishing a secure wireless communication connection between an insulin pump device and a mobile computing device, the method comprising:

receiving, at a mobile computing device, a device identifier for the insulin pump device, wherein the insulin pump device includes an insulin reservoir to store insulin to be administered to a user, a pump assembly to delivery insulin from insulin reservoir to the user, and a controller to control operation of the pump assembly according, at least in part, to commands provided to the insulin pump by the mobile computing device;

obtaining, by the mobile computing device, device information for the insulin pump device from a remote server system using the device identifier, wherein the device information includes, at least, a public key for the insulin pump device, wherein the insulin pump device has a corresponding private key that is stored locally by the insulin pump device;

establishing, by the mobile computing device, a secure wireless connection with the insulin pump device using, at least in part, the device information;

authenticating, by the mobile computing device, the insulin pump device based on asymmetric key verification using the public key for the insulin pump;

permitting, by the mobile computing device, pass-through encryption between the insulin pump device and the remote server system in response to authenticating the insulin pump device, wherein the insulin pump device is programmed to obtain, at least, a public key for the mobile computing device the from the remote server system;

communicating with the insulin pump device to authenticate the mobile computing device with the insulin pump device, wherein the communicating with the insulin pump device to authenticate the mobile computing device with the insulin pump device comprises;

receiving, at the mobile computing device, a challenge message from the insulin pump device;

generating, by the mobile computing device, a response message and a hash of the response message;

encrypting, by the mobile computing device, the hash using a private key that corresponds to the public keys, and appending the encrypted hash to the response message; and

transmitting, by the mobile computing device, the response message with encrypted hash to the insulin pump device.

2. The computer-implemented method of claim 1, wherein receiving the device identifier comprises:

optically scanning, using a digital camera that is embedded within or otherwise in communication with the mobile computing device, a barcode on one or more surfaces of the insulin pump device; and

identifying the device identifier based on the optical scanning of the barcode.

3. The computer-implemented method of claim 1, wherein receiving the device identifier comprises:

receiving, through a user interface of the mobile computing device, user input that identifies at least a portion of the device identifier.

4. The computer-implemented method of claim 1, wherein the device identifier comprises a serial number for the insulin pump device.

5. The computer-implemented method of claim 1, wherein the secure wireless connection comprises a BLUETOOTH connection.

6. The computer-implemented method of claim 1, wherein the insulin pump further includes a crypto processor that is configured to encrypt and decrypt information securely communicated with the mobile computing device.

7. The computer-implemented method of claim 1, wherein the communication between the mobile computing device and the insulin pump device is encrypted using symmetric key encryption.

8. The computer-implemented method of claim 7, wherein the symmetric key encryption comprises AES-CBC symmetric key encryption.

9. The computer-implemented method of claim 1, wherein the mobile computing device comprises a smartphone.

10. A computer-implemented method of establishing a secure wireless communication connection between an medical device and a mobile computing device, the method comprising:

receiving, at a mobile computing device, a device identifier for the medical device;

obtaining, by the mobile computing device, device information for the medical device from a remote server system using the device identifier;

wherein the device information includes, at least, a public key for the medical device, wherein the medical device has a corresponding private key that is stored locally by the medical device;

establishing, by the mobile computing device, a secure wireless connection with the medical device using, at least in part, the device information;

authenticating, by the mobile computing device, the medical device based on the device information, wherein the authenticating comprises;

transmitting, by the mobile computing device, a challenge message to the medical device;

receiving;

at the mobile computing device and in response to the challenge message, a signed message from the medical device, wherein the signed message includes a message and an encrypted hash appended to the message;

decrypting, by the mobile computing device, the encrypted hash with the public key for the medical device to generate a decrypted hash;

independently generating, by the mobile computing device, a hash of the message;

comparing, by the mobile computing device, the decrypted hash with the independently generated hash of the message; and

determining, by the mobile computing device, that the medical device is authentic based on the decrypted hash matching the independently generated hash; and

securely communicating, by the mobile computing device and in response to authenticating the medical device, information with the medical device.

11. The computer-implemented method of claim 10, wherein receiving the device identifier comprises:

optically scanning, using a digital camera that is embedded within or otherwise in communication with the mobile computing device, a barcode on one or more surfaces of the medical device; and

identifying the device identifier based on the optical scanning of the barcode.

12. The computer-implemented method of claim 10, wherein receiving the device identifier comprises:

receiving, through a user interface of the mobile computing device, user input that identifies at least a portion of the device identifier.

13. The computer-implemented method of claim 10, wherein the device identifier comprises a serial number for the medical device.

14. The computer-implemented method of claim 10;

wherein the secure wireless connection comprises a BLUETOOTH connection.

15. The computer-implemented method of claim 10, further comprising:

permitting, by the mobile computing device, pass-through encryption between the medical device and the remote server system in response to authenticating the medical device, wherein the medical device is programmed to obtain, at least, a public key for the mobile computing device the from the remote server system;

communicating with the medical device to authenticate the mobile computing device with e medical device, wherein the communicating comprises;

receiving, at the mobile computing device, a challenge message from the medical device;

generating, by the mobile computing device, a response message and a hash of the response message;

encrypting, by the mobile computing device, the hash using a private key that corresponds to the public key, and appending the encrypted hash to the response message; and

transmitting, by the mobile computing device;

the response message with encrypted hash to the medical device.

16. The computer-implemented method of claim 10, wherein the medical further includes a crypto processor that is configured to encrypt and decrypt information securely communicated with the mobile computing device.

17. A method for authenticating a mobile application installed on a diabetes management controller, the method comprising:

generating, by a diabetes management computer system;

a secret value to be used to verify authenticity of the mobile application installed on the diabetes management controller, wherein the diabetes management controller comprises a mobile computing device that interfaces with an insulin pump and the diabetes management computer system over in-band communication channels to control operation of the insulin pump;

transmitting, by the diabetes management computer system, a request to an out-of-band service to provide the secret value to the mobile application via an out-of-band communication channel that is different from the in-band communication channels, wherein the transmitting causes;

(i) the secret value to be transmitted to the diabetes management controller via the out-of-band communication channel, wherein the secret value is transmitted to the diabetes controller as a push notification with an application identifier that is correlated to an application keychain to ensure that the secret value is provided to the authentic instance of the mobile application,

(ii) the diabetes management controller to provide the secret value to an authentic instance of the mobile application installed on the diabetes management controller, and

(iii) the authentic instance of the mobile application on the diabetes management controller to automatically retransmit the secret value to the diabetes management computer system;

receiving, at the diabetes management computer system, verification value from the diabetes management controller;

comparing, by the diabetes management computer system, the verification value to the secret value; and

determining, by the diabetes management computer system, that the instance of the mobile application installed on the diabetes management controller is authentic based, at least in part, on the comparison of the verification value with the secret value.

18. The method of claim 17, further comprising:

automatically initiating a timer on the diabetes management computer system after transmitting the request to the out-of-band service, the timer being programmed to expire if the verification value is not received within a threshold period of time since initiating the timer, wherein expiration of the timer indicates that the mobile application installed on the diabetes management controller is not authentic.