Regulatory compliant transmission of medical data employing a patient implantable medical device and a generic network access device

• US 8,103,346 B2
• Filed: 05/05/2009
• Issued: 01/24/2012
• Est. Priority Date: 05/22/2008
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Mass, William, Carpenter, Greg P., Kollmann, Daniel, Lai, Arthur, Dion, Philip G., Phillips, Thomas, Eash, Aaron
• Primary Examiner(s): Manuel, George
• Assistant Examiner(s): Wieland, Robert
• Application Number:
  US12/435,866
• Publication Number:
  US 20090292340A1
• Time in Patent Office: 994 Days
• Field of Search: 600/300, 607/30, 607/32, 705/2, 709/205
• US Class Current: 607/32
• CPC Class Codes: A61N 1/37282 characterised by communication with experts in remote locations using a network
• CPC Class Codes: H04L 65/1069 Session establishment or de-establishment

Abstract

Various embodiments concern a method which may include communicating medical information between a PIMD and an interface module via a first channel in compliance with a predetermined medical information regulatory standard, preventing access to the PIMD via the interface module other than through the first channel, detecting a communication protocol used by an available generic network access device, selecting a communication protocol rule set from a plurality of communication protocol rule sets to effect communication between the interface device and an available generic network access device of a plurality of generic network access devices, and transferring at least some of the medical information to the remote network via a second channel established between the interface module and the available generic network access device using the selected communication protocol rule set.

Claims

1. An interface module for facilitating communication and data transmission between a patient implantable medical device (PIMD) and a remote server, the interface module comprising:

first circuitry comprising;

a first communications interface configured for communication with a PIMD; and

a regulatory compliance module having an input coupled to the first communications interface, an output, and a regulatory memory for storing compliance rules consistent with a predetermined medical device regulatory requirements specification which governs at least implantable medical devices including the PIMD, the compliance module configured to moderate communicative interaction between the PIMD and the first circuitry and to process PIMD data in accordance with the compliance rules;

second circuitry having an input coupled to the output of the compliance module and comprising;

a protocol library comprising sets of communication protocol rules, each communication protocol rule set associated with one of a plurality of disparate communication protocols; and

a second communications interface coupled to the protocol library and configurable to implement any one of the communication protocol rule sets, the first communications interface partitioned from the second communications interface such that the PIMD data is communicated to the input of the second circuitry only via the output of the compliance module;

a processor coupled to the first and second circuitry, the processor configured to detect a communication protocol used by an available generic network access device of a plurality of generic network access devices and select a communication protocol rule set from the protocol library for implementation by the second communications interface to effect communication between the interface module and the available generic network access device; and

a housing configured to house the first communication circuitry, the second communication circuitry, and the processor.

2. The interface module of claim 1, further comprising program instructions stored in the protocol memory and executable by the processor to cause the interface module to issue data link layer commands using the second communications interface to the available communications device for controlling a subset of available communications device functions.

3. The interface module of claim 2, wherein execution of stored program instructions further causes the interface device to requisition one or more functions of the subset of available communications device functions to communicate with, and collect data from, a sensor-based patient data collection device.

4. The interface module of claim 1, wherein processing of the PIMD data in accordance with the compliance rules by the regulatory compliance module comprises encrypting, de-identifying, and adding authentication elements to the PIMD data.

5. The interface module of claim 4, further comprising software executable by the remote server to effect de-encryption, re-identification, and authentication of the PIMD data after the PIMD data has passed through the public network.

6. The interface module of claim 1, wherein the interface module is configured to facilitate remote access to the PIMD via the first communications interface, the second communications interface, and the generic network access device, and the regulatory compliance module is further configured to limit non-authenticated remote access to the PIMD.

7. The interface module of claim 1, wherein at least some of the plurality of generic network access devices, including the available generic network access device, comprise off-the-shelf cellular telephones that have not been configured for compliance with the predetermined medical device regulatory requirements specification.

8. The interface device of claim 1, further comprising program instructions stored in the protocol memory and executable by the processor to cause the interface device to send a plurality of stored inquiry commands to the available generic network access device using the second communications interface and monitor for one or more predetermined responses from the generic network access device, the one or more predetermined responses indicating functions that are enabled on the communications device.

9. The interface device of claim 1, wherein at least some of the plurality of generic network access devices, including the available generic network access device, comprise one of a plurality of different cellular telephones each using a different one of the plurality of disparate communication protocols, and the interface device is configured to facilitate transmission of PIMD data in compliance with the predetermined medical device regulatory requirements specification between the PIMD and the remote server via the public network using any one of the plurality of different cellular telephones without being reconfigured to facilitate transmission of PIMD data in compliance with the predetermined medical device regulatory requirements specification when switching use of different ones of the plurality of different cellular telephones.

10. A method, implemented by use of an interface module transportable by an ambulatory patient, for facilitating transfer of medical information between a patient implantable medical device (PIMD) and a remote network server, the method comprising:

communicating medical information between the PIMD and the interface module via a first channel and in compliance with a predetermined medical information regulatory standard governing implantable medical devices including the PIMD;

preventing access to the PIMD via the interface module other than through the first channel;

detecting a communication protocol used by an available generic network access device;

selecting a communication protocol rule set from a plurality of communication protocol rule sets to effect communication between the interface device and an available generic network access device of a plurality of generic network access devices, each of the protocol rule sets associated with one of the disparate communication protocols; and

transferring at least some of the medical information to a remote network via a second channel established between the interface module and the available generic network access device using the selected communication protocol rule set, wherein the at least some of the medical information is transferred between the interface device and the remote network in compliance with the predetermined medical information regulatory standard.

11. The method of claim 10, further comprising controlling a subset of functions of the available generic network access device by data link layer commands sent from the interface module.

12. The method of claim 11, further comprising transferring information between the available generic network access device and a sensor-based patient data collection device, wherein the data link layer commands are used to requisition control of the subset of functions of the available generic network access device to facilitate communication with the sensor-based patient data collection device.

13. The method of claim 10, wherein communicating and transferring at least some of the medical information in compliance with the predetermined medical information regulatory standard comprises encrypting, de-identifying, and adding authentication elements to the at least some medical information.

14. The method of claim 13, further comprising de-encrypting, re-identify, and authenticating the medical information using a server of the remote network after the at least some medical information has been transferred to the remote network.

15. The method of claim 10, further comprising remotely reprogramming the PIMD from the remote network using the first channel and the second channel.

16. The method of claim 10, wherein at least some of the plurality of generic network access devices, including the available generic network access device, comprises off-the-shelf cellular telephones that have not been configured for compliance with the predetermined medical regulatory requirements specification.

17. The method of claim 10, wherein detecting the communication protocol used by the available generic network access device further comprising sending a plurality of stored inquiry commands to the available generic network access device and monitoring for one or more predetermined responses from the available generic network access device, the one or more predetermined responses indicating what functions are enabled on the available generic network access device.

18. The method of claim 10, wherein at least some of the plurality of generic network access devices, including the available generic network access device, are different cellular telephones each using a different one of the plurality of communication protocol types.

19. The method of claim 10, further comprising:

detecting an additional communication protocol used by an additional generic network access device of the plurality of generic network access devices;

selecting an additional communication protocol rule set from the plurality of communication protocol rule sets to effect communication between the interface device and the additional generic network access device; and

transferring at least some of the medical information to the remote network via a third channel established between the interface module and the additional generic network device using the selected additional communication protocol rule set, wherein the at least some of the medical information is transferred between the interface device and the remote network in compliance with the predetermined medical information regulatory standard.

20. An interface device for facilitating transfer of medical information between a patient implantable medical device (PIMD) and a remote network server via a public network using any one of a plurality of generic network access devices having disparate communication protocols, the interface device comprising:

a portable housing configured for transport by an ambulatory patient;

first communication circuitry configured to implement medical firmware to effect communication between a PIMD and the interface device in compliance with a predetermined medical information regulatory standard governing implantable medical devices including the PIMD;

second communication circuitry configured to implement communication firmware to effect communication between the interface device and any one of a plurality of generic network access devices;

memory configured to store a plurality of communication protocol rule sets, each communication protocol rule set associated with a communication protocol of a different one of the plurality of generic network devices;

a processor coupled to the memory and the first and second communication circuitry, the processor configured to detect a communication protocol used by an available generic network access device of the plurality of generic network access devices and select a communication protocol rule set from memory for implementation by the second communication circuitry to effect communication between the interface device and the available generic network device; and

a power source configured to supply power to components of the interface device, the power source, memory, processor, and first and second communication circuitry supported by the housing.

21. The interface device of claim 20, wherein the communication firmware is partitioned from the medical firmware such that each of the plurality of generic network access devices is agnostic with respect to compliance with the predetermined medical information regulatory standard.

22. A system for transferring medical information between a patient implantable medical device (PIMD) and a remote server over a public network using an interface module and any one of a plurality of generic network access devices, comprising:

means for communicating medical information between the PIMD and the interface module via a first channel and in compliance with a predetermined medical information regulatory standard governing implantable medical devices including the PIMD;

means for preventing access to the PIMD via the interface module other than through the first channel;

means for detecting a communication protocol used by an available generic network access device;

means for selecting a communication protocol rule set from a plurality of communication protocol rule sets to effect communication between the interface device and the available generic network access device, each of the protocol rule sets associated with one of the disparate communication protocols; and

means for transferring at least some of the medical information to the remote network via a second channel established between the interface module and the available generic network access device using the selected communication protocol rule set, wherein the at least some of the medical information is transferred between the interface device and the remote network in compliance with the predetermined medical information regulatory standard.