Wireless patient communicator employing security information management

• US 8,395,498 B2
• Filed: 05/09/2008
• Issued: 03/12/2013
• Est. Priority Date: 08/31/2007
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Gaskill, Robert, Gryzwa, Mark, LaLonde, John, Hoyme, Kenneth, Mass, William, Johnson, David C., Barton, Mike
• Primary Examiner(s): Wong, Albert
• Assistant Examiner(s): MEHRAVARI, PETER CYRUS
• Application Number:
  US12/151,910
• Publication Number:
  US 20090058636A1
• Time in Patent Office: 1,768 Days
• Field of Search: 340/539.11, 340/539.1, 340/539.12, 340/669, 340/5.74, 340/573.1, 340/5.61, 600/300, 600/513, 600/518, 600/301, 607/59, 607/60, 607/32, 607/15
• US Class Current: 340/539.12
• CPC Class Codes: A61B 5/0026 characterised by the transmission medium
• CPC Class Codes: A61B 5/747 in case of emergency, i.e. alerting emergency services
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: A61N 1/37282 characterised by communication with experts in remote locations using a network
• CPC Class Codes: G08B 21/02 Alarms for ensuring the safety of persons
• CPC Class Codes: G08C 17/02 using a radio link
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 40/20 for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
• CPC Class Codes: G16H 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: H04L 67/12 specially adapted for proprietary or special-purpose networking environments, e.g. medical networks, sensor networks, networks in vehicles or remote metering networks
• CPC Class Codes: H04W 12/04 Key management, e.g. using generic bootstrapping architecture [GBA]
• CPC Class Codes: H04W 12/06 Authentication
• CPC Class Codes: H04W 12/50 Secure pairing of devices

Abstract

A portable patient communicator (PPC) includes a portable housing supporting a processor, memory for storing medical and wireless radio firmware, first and second radios, a processor, an identity module, and a power source. The PPC and a patient implantable medical device (PIMD) communicate via the first radio in accordance with the medical firmware. The PPC communicates with a wireless network via the second radio in accordance with the wireless radio firmware. Data stored in the identity module is used to authenticate the PPC by the remote server prior to permitting PPC access to the remote server, and may also be used to authenticate the remote server by the PPC prior to permitting access to the PPC or the PIMD by the remote server or other device communicatively coupled to the wireless network, after which PIMD and other medical data is exchanged between the PPC and remote server.

Claims

1. A portable patient communicator (PPC) for communicating with a patient implantable medical device (PIMD) and facilitating communications with a remote server via a wireless network, the portable patient communicator comprising:

a housing configured for portability by an ambulatory patient;

an identity module provided in the housing and configured to store at least identity data that

     1) uniquely identifies the patient or

     2) uniquely identifies the PPC as being associated with the patient, wherein the identity data comprises physiologic data obtained from the patient;

a processor coupled to memory and the identity module, the processor and the memory provided in the housing, the memory storing wireless radio firmware and medical firmware, the medical firmware executable by the processor to facilitate interaction between the PPC and the PIMD in accordance with predetermined medical device guidelines, the processor configured to prevent data exchange between the PPC and the PIMD unless the identity module of the PPC is designated only for use with the PPC;

a first radio provided in the housing and configured to effect communications with the PIMD in accordance with program instructions of the medical firmware executable by the processor;

a second radio provided in the housing and configured to effect communications via a channel of the wireless network other than a voice channel in accordance with program instructions of the wireless radio firmware executable by the processor; and

a power source provided in the housing and configured to supply power for components of the PPC;

the processor configured to use at least the identity data stored in the identity module and execute program instructions for one or both of (a) facilitating authentication of the PPC by the remote server prior to permitting PPC access to the remote server, and (b) facilitating authentication of the remote server by the PPC prior to permitting access to the PPC or the PIMD by the remote server or other device communicatively coupled to the wireless network.

2. The communicator of claim 1, wherein the channel of the wireless network comprises a data channel.

3. The communicator of claim 1, wherein the channel of the wireless network comprises a signaling channel.

4. The communicator of claim 1, wherein the identity module is configured to store identity data that uniquely identifies the PPC and the patient.

5. The communicator of claim 1, wherein the processor is configured to use the identity data stored in the identity module for facilitating authentication of the PPC by the remote server and authentication of the remote server by the PPC.

6. The communicator of claim 1, wherein the identity data stored in the identity module comprises PIMD data obtained from the patient.

7. The communicator of claim 1, wherein the physiologic data is obtained from the patient at a time during or after initial pairing of the PPC and the PIMD.

8. The communicator of claim 1, wherein the identity data stored in the identity module comprises at least some PIMD programmer data.

9. The communicator of claim 1, wherein the identity data stored in the identity module comprises one or more of PIMD calibration data, PIMD manufacturing data, and PIMD parameter data.

10. The communicator of claim 1, wherein the identity data stored in the identity module comprises decoder logic for facilitating communication between the PPC and the PIMD.

11. The communicator of claim 1, wherein configuration data is stored in the identity module, the configuration data comprising configuration parameters that are selectably enabled and disabled by the processor to enable and disable selected PPC functions.

12. The communicator of claim 1, wherein software code is stored in the identity module, the software code executable by the processor during PPC initialization or reset processes.

13. The communicator of claim 1, wherein software code is stored in the identity module, the software code executable by the processor to perform PPC diagnostics.

14. The communicator of claim 1, wherein the processor uses the identity data stored in the identity module to facilitate data exchange only with the PIMD to which the PPC is paired.

15. A portable patient communicator (PPC) for communicating with a patient implantable medical device (PIMD) and facilitating communications with a remote server via a wireless network, the portable patient communicator comprising:

a housing configured for portability by an ambulatory patient;

an identity module provided in the housing and configured to store at least identity data that

     1) uniquely identifies the patient or

     2) uniquely identifies the PPC as being associated with the patient, wherein the identity data comprises physiologic data obtained from the patient;

a processor coupled to memory and the identity module, the processor and the memory provided in the housing, the memory storing wireless radio firmware and medical firmware, the medical firmware executable by the processor to facilitate interaction between the PPC and the PIMD in accordance with predetermined medical device guidelines, the processor configured to prevent data exchange between the PPC and the PIMD unless the identity module of the PPC is designated for use only with the PPC;

a first radio provided in the housing and configured to effect communications with the PIMD in accordance with program instructions of the medical firmware executable by the processor;

a second radio provided in the housing and configured to effect communications via the wireless network in accordance with program instructions of the wireless radio firmware executable by the processor; and

a power source provided in the housing and configured to supply power for components of the PPC;

the processor configured to use at least the identity data stored in the identity module and execute program instructions for (a) facilitating authentication of the PPC by the remote server prior to permitting PPC access to the remote server and (b) facilitating authentication of the remote server by the PPC prior to permitting access to the PPC or the PIMD by the remote server or other device communicatively coupled to the wireless network.

16. The communicator of claim 15, wherein the identity module is configured to store identity data that uniquely identifies the PPC and the patient.

17. The communicator of claim 15, wherein the identity data stored in the identity module comprises an authentication key that is used for one or both of PPC and remote server authentication.

18. The communicator of claim 15, wherein the physiologic data is obtained from the patient at a time after initial pairing of the PPC and the PIMD.

19. The communicator of claim 15, wherein the processor is configured to use the identity data stored in the identity module for pairing the PPC with the PIMD.

20. The communicator of claim 15, wherein the processor is configured to transmit at least some of the identity data and PIMD data to the remote server, the at least some of the identity data useable by the remote server to create or update patient data residing on the remote server.

21. The communicator of claim 15, wherein the identity module is non-detachable with respect to the PPC.

22. The communicator of claim 15, wherein the identity module is detachable with respect to the PPC.

23. The communicator of claim 22, wherein the identity module is encompassed at least partially by a sleeve comprising a grasping feature to facilitate enhanced manipulation of the identity module by the patient.

24. The communicator of claim 15, wherein the identity module is embodied in a semiconductor chip.

25. The communicator of claim 15, wherein the identity data stored in the identity module of the PPC is mappable to the identity module of a second PPC by the remote server.

26. The communicator of claim 15, wherein activation of wireless network services for effecting PPC communications is based on a specified activation date.

27. The communicator of claim 15, wherein activation of wireless network services for effecting PPC communications is based on detection of a wireless network connection by the processor using identity data stored in the identity module.

28. The communicator of claim 15, wherein activation of wireless network services for effecting PPC communications comprises an initial cost-free or reduced cost period prior to subscription-based service.

29. A method for effecting communications between a portable patient communicator (PPC) and a patient implantable medical device (PIMD) and for facilitating communications between the PPC and a remote server via a wireless network, the method comprising:

providing the PPC comprising a housing configured for portability by an ambulatory patient, the housing supporting a processor coupled to memory for storing medical firmware and wireless radio firmware, first and second radios, a processor, an identity module storing identity data that

     1) uniquely identifies the patient or

     2) uniquely identifies the PPC as being associated with the patient and the identity data comprises physiologic data obtained from the patient, and a power source, the processor configured to prevent data exchange between the PPC and the PIMD unless the identity module of the PPC is designated for use only with the PPC;

effecting communications between the PIMD and the first radio of the PPC in accordance with program instructions of the medical firmware;

effecting communications between the second radio of the PPC and the wireless network in accordance with program instructions of the wireless radio firmware;

authenticating, using the identity data stored in the identity module, the PPC by the remote server prior to permitting PPC access to the remote server;

authenticating, using the identity data stored in the identity module, the remote server by the PPC prior to permitting access to the PPC or the PIMD by the remote server or other device communicatively coupled to the wireless network; and

exchanging at least PIMD data between the PPC and the remote server in response to successful authentication.

30. The method of claim 29, comprising exchanging at least the PIMD data between the PPC and the remote server via a channel of the wireless network other than a voice channel.