System and method for providing a secure feature set distribution infrastructure for medical device management

• US 20070136098A1
• Filed: 12/12/2005
• Published: 06/14/2007
• Est. Priority Date: 12/12/2005
• Status: Abandoned Application

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Hoyme, Kenneth, Simms, Howard, Jelatis, George, Smythe, Alan
• Application Number:
  US11/299,980
• Publication Number:
  US 20070136098A1
• Time in Patent Office: Days
• US Class Current: 705/3
• CPC Class Codes: A61N 1/37254 Pacemaker or defibrillator security, e.g. to prevent or inhibit programming alterations by hackers or unauthorised individuals
• CPC Class Codes: A61N 1/37264 Changing the program; Upgrading firmware
• 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 63/123 received data contents, e.g. message integrity
• CPC Class Codes: H04L 63/126 the source of the received data
• 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: H04L 67/34 involving the movement of software or configuration parameters network booting or remote initial program loading [RIPL] G06F9/4416

Abstract

A system and method for providing a secure feature set distribution infrastructure for medical device management is presented. A unique association is mapped for data download between a medical device and a communications device transiently coupleable to the medical device. A configuration catalog is maintained, including operational characteristics of at least one of the medical device and the communications device. The operational characteristics as maintained in the configuration catalog are periodically checked against a database storing downloadable sets of features and one or more feature sets including changed operational characteristics are identified for distribution. The one or more feature sets are digitally signed and the one or more feature sets are provided to the communications device over a plurality of networks. The one or more feature sets are authenticated and their integrity is checked over a chain of trust originating with a trusted source and terminating at the communications device.

Claims

1. A system for providing a secure feature set distribution infrastructure for medical device management, comprising:

a unique association map for data download between a medical device and a communications device transiently coupleable to the medical device;

a configuration catalog comprising operational characteristics of at least one of the medical device and the communications device;

an update checker to periodically check the operational characteristics as maintained in the configuration catalog against a database storing downloadable sets of features and to identify one or more feature sets comprising changed operational characteristics for distribution, wherein the one or more feature sets are digitally signed and the one or more feature sets are provided to the communications device over a plurality of networks; and

an authenticator to authenticate and check the integrity of the one or more feature sets over a chain of trust originating with a trusted source and terminating at the communications device.

2. A system according to claim 1, wherein the trusted source is a secure distribution server.

3. A system according to claim 1, wherein the one or more feature sets are sent to the communications device in response to a download request.

4. A system according to claim 1, wherein the one or more feature sets are sent on-demand or incrementally or are unilaterally broadcast from a secure distribution server to the communications device.

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

an installer to update the at least one of the medical device and the communications device with the one or more feature sets, and to send a notification to the secure distribution server following successful updating.

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

a collector to regularly collect physiological measures from at least one of the medical device into the communications device, and to provide the collected physiological measures in response to an upload request periodically received.

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

a further map to map associations for data upload between at least one further medical device and the communications device transiently coupleable to the at least one further medical device.

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

a further map to map unique associations for data download between a plurality of medical devices and the communications device transiently coupleable to each such medical device.

9. A system according to claim 1, wherein the one or more feature sets comprises program code comprising at least one of a firmware and a software update.

10. A system according to claim 1, wherein the medical device comprises at least one of an implantable medical device and an external medical device.

11. A system according to claim 1, wherein the medical device comprises at least one of a pacemaker, implantable cardioverter-defibrillator, cardiac resynchronization device, neurological implant, heart monitor, respiratory monitor, automated external defibrillator, Holter monitor, pill dispenser, weight scale, and blood pressure monitor.

12. A system according to claim 1, wherein the medical device comprises at least one of a patient communications device, repeater, programmer, and programmer/recorder.

13. A method for providing a secure feature set distribution infrastructure for medical device management, comprising:

mapping a unique association for data download between a medical device and a communications device transiently coupleable to the medical device;

maintaining a configuration catalog comprising operational characteristics of at least one of the medical device and the communications device;

periodically checking the operational characteristics as maintained in the configuration catalog against a database storing downloadable sets of features and identifying one or more feature sets comprising changed operational characteristics for distribution;

digitally signing the one or more feature sets and providing the one or more feature sets to the communications device over a plurality of networks; and

authenticating and checking the integrity of the one or more feature sets over a chain of trust originating with a trusted source and terminating at the communications device.

14. A method according to claim 13, wherein the trusted source is a secure distribution server.

15. A method according to claim 13, further comprising:

sending the one or more feature sets to the communications device in response to a download request.

16. A method according to claim 13, further comprising:

sending the one or more feature sets to the communications device in response to a download request.

17. A method according to claim 13, further comprising:

on-demand or incrementally sending or unilaterally broadcasting the one or more feature sets from a secure distribution server to the communications device.

18. A method according to claim 13, further comprising:

updating the at least one of the medical device and the communications device with the one or more feature sets; and

sending a notification from a secure distribution server following successful updating.

19. A method according to claim 13, further comprising:

regularly collecting physiological measures from at least one of the medical device into the communications device; and

providing the collected physiological measures in response to an upload request periodically received.

20. A method according to claim 13, further comprising:

mapping associations for data upload between at least one further medical device and the communications device transiently coupleable to the at least one further medical device.

21. A method according to claim 13, further comprising:

mapping unique associations for data download between a plurality of medical devices and the communications device transiently coupleable to each such medical device.

22. A method according to claim 13, wherein the one or more feature sets comprises program code comprising at least one of a firmware and a software update.

23. A method according to claim 13, wherein the medical device comprises at least one of an implantable medical device and an external medical device.

24. A method according to claim 13, wherein the medical device comprises at least one of a pacemaker, implantable cardioverter-defibrillator, cardiac resynchronization device, neurological implant, heart monitor, respiratory monitor, automated external defibrillator, Holter monitor, pill dispenser, weight scale, and blood pressure monitor.

25. A method according to claim 13, wherein the medical device comprises at least one of a patient communications device, repeater, programmer, and programmer/recorder.

26. A computer-readable storage medium holding code for performing the method according to claim 13.

27. An apparatus for providing a secure feature set distribution infrastructure for medical device management, comprising:

means for mapping a unique association for data download between a medical device and a communications device transiently coupleable to the medical device;

means for maintaining a configuration catalog comprising operational characteristics of at least one of the medical device and the communications device;

means for periodically checking the operational characteristics as maintained in the configuration catalog against a database storing downloadable sets of features and means for identifying one or more feature sets comprising changed operational characteristics for distribution;

means for digitally signing the one or more feature sets and means for providing the one or more feature sets to the communications device over a plurality of networks; and

means for authenticating and means for checking the integrity of the one or more feature sets over a chain of trust originating with a trusted source and terminating at the communications device.