METHODS AND SYSTEMS FOR MANAGING, CONTROLLING AND MONITORING MEDICAL DEVICES VIA ONE OR MORE SOFTWARE APPLICATIONS FUNCTIONING IN A SECURE ENVIRONMENT

• US 20100292556A1
• Filed: 05/12/2010
• Published: 11/18/2010
• Est. Priority Date: 05/12/2009
• Status: Active Grant

• Current Assignee: Chronicmobile Incorporated
• Original Assignee: Chronicmobile Incorporated
• Inventors: Golden, Michael
• Granted Patent: US 9,656,092 B2
• Time in Patent Office: Days
• US Class Current: 600/364
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/7465 Arrangements for interactive communication between patient and care services, e.g. by using a telephone network telemetry of measured physiological signal A61B5/0002
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer
• CPC Class Codes: A61N 1/37282 characterised by communication with experts in remote locations using a network
• CPC Class Codes: G06Q 10/06 Resources, workflows, human or project management; Enterprise or organisation planning; Enterprise or organisation modelling
• CPC Class Codes: G06Q 50/22 Social work or social welfare, e.g. community support activities or counselling services
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• 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

Abstract

Systems and methods that include configurations of a medical device, user device and service platform are described. Embodiments may include a secure network to run medical applications that control and/or monitor the medical device. An online store may be provided for storing and distributing medical applications to the user device and medical device. A secure environment may be provided within the user device and medical device that protects the integrity of medical applications running on those devices. A service platform may provide a service that enables a medical authority to certify and monitor the medical applications. In some implementations, various third parties and the user of the user device may be allowed to manage and monitor the medical device.

Claims

1. A computer-implemented method of interacting with a medical device in conjunction with a user device, comprising:

receiving, at the user device, a certified medical application;

storing the certified medical application in a secure memory segment of the user device, wherein the secure memory segment is configured to be isolated from a nonsecure memory segment of the user device and wherein the nonsecure memory segment is configured to store one or more noncertified applications; and

initiating establishment of a communication link from the user device to the medical device, wherein the communication link is configured to facilitate execution of the certified medical application.

2. The method of claim 1 further comprising sending, to the medical device, one or more instructions for execution on the medical device to implement a medical control or monitoring function.

3. The method of claim 1 further comprising receiving, from the medical device, a set of data associated with a control or monitoring function implemented on the medical device.

4. The method of claim 3 further comprising storing, in the secure memory segment, the set of data.

5. The method of claim 4 wherein the set of data is encrypted prior to storing.

6. The method of claim 4 further comprising sending, from the user device to a service platform, the set of data.

7. The method of claim 6 further comprising encrypting the set of data prior to the sending the set of data.

8. The method of claim 1 further comprising verifying that the certified medical application conforms to one or more regulatory requirements.

9. The method of claim 8 wherein the verifying including validating that the certified medical application conforms to a Food and Drug Administration (FDA) medical device compliance regulation.

10. A computer implemented method of operating a medical device, comprising:

initiating establishment of a communications connection between a user device and the medical device;

sending, from a secure segment of the user device to the medical device, via the communications connection, instructions for controlling or monitoring an operational function of the medical device;

receiving, from the medical device, data associated with operation of the medical device; and

storing the data associated with operation of the medical device in the secure segment.

11. The method of claim 10 wherein the sending is initiated from a certified medical application.

12. The method of claim 10 wherein the data is received by a certified medical application.

13. The method of claim 10 further including sending, from the user device, the data associated with operation of the medical device to a service platform.

14. The method of claim 10 wherein the sending further includes sending a certified medical application to the medical device.

15. The method of claim 14 wherein the certified medical application is received at the user device, from a service platform, in a secure environment of the user device, and stored in the secure segment.

16. An apparatus for a user device, comprising:

one or more processors configured to be coupled to a network communication interface and a medical device communication interface; and

a memory coupled to the one or more processors, said memory configured to include;

an unsecured segment; and

a secure segment logically separated from the unsecured segment, wherein the secured segment is configured to securely store a certified medical application disposed for execution on the processor to facilitate control and/or monitoring of a medical device.

17. The apparatus of claim 16 wherein the secure segment is further configured to securely store a set of data provided from the medical device.

18. The apparatus of claim 16 wherein the memory further includes a secure communication application configured to receive, from a service platform, a certified medical application and store the certified medical application in the secure segment.

19. The apparatus of claim 18 wherein the secure communication application is further configured to verify, in response to receipt of the medical application, that the received medical application has been approved for operation with the medical device by a regulatory authority.

20. The apparatus of claim 19 wherein the regulatory authority is the FDA.

21. The apparatus of claim 19 wherein the one or more processors includes two processor cores and wherein a first of the two processor cores is coupled to the unsecure segment and the second of the two processor cores is coupled to the secure segment.

22. The apparatus of claim 21 wherein the first processor core and the second processor core are isolated from each other.

23. A method of provisioning medical applications to a user device, comprising:

receiving, from a medical application developer, a first medical application, wherein the first medical application is configured to operate a specific medical device subject to a regulatory certification;

storing, in a computer system, the first medical application;

providing the first medical application to a regulatory authority for certification of the first medical application in conjunction with the specific medical device;

receiving, from the regulatory authority, a certified version of the first medical application; and

storing the certified version of the first medical application in a certified medical application repository.

24. The method of claim 23 further including providing the certified version of the first medical application to a user device via an electronic communications interface, wherein the user device is configured to communicate with the medical device to facilitate medical device operation.

25. The method of claim 23, further including testing, prior to the providing the first medical application to a regulatory authority, the first medical application for compliance with one or more statutory or regulatory requirements.

26. The method of claim 23, further including providing the certified first medical application to an online applications store.

27. The method of claim 23 further including receiving, from a second medical application developer, a second medical application, wherein the second medical application is configured to operate a second specific medical device subject to a regulatory certification;

storing, in a computer system, the second medical application;

providing the second medical application to a regulatory authority for certification of the second medical application in conjunction with the second specific medical device;

receiving, from the regulatory authority, a certified version of the second medical application; and

providing the certified version of the second medical application to a second user device via an electronic communications interface, wherein the second user device is configured to communicate with the second medical device to facilitate medical device operation.

28. The method of claim 23 wherein the medical device is an infusion pump.

29. The method of claim 23 wherein the medical device is a pacemaker, defibrillator, heart monitor or heart control device.

30. The method of claim 23 wherein the medical device is a blood glucose monitor.

31. The method of claim 30 wherein the blood glucose monitor is a continuous blood glucose monitor.

32. The method of claim 23 wherein the medical device is a pulse sensor.

33. The method of claim 23 wherein the medical device is an oxygen saturation sensor.

34. The method of claim 23 wherein the medical device includes data defining a collection of reference information associated with a monitoring function, wherein the medical device is further configured to provide the data to a second medical device.

35. A medical device, comprising:

a medical monitoring or control apparatus disposed to monitor or control a patient medical function;

a network communication interface;

one or more processors configured to be coupled to the network communication interface and the medical monitoring or control apparatus; and

a memory coupled to the one or more processors, said memory configured to include;

an unsecured segment; and

a secure segment logically separated from the unsecured segment, wherein the secured segment is configured to securely store a certified medical application disposed for execution on the processor to facilitate control and/or monitoring of the medical monitoring or control apparatus.

36. The device of claim 35 wherein the secure segment is further configured to securely store a set of data provided from the medical monitoring or control apparatus.

37. The device of claim 36 wherein the memory further includes a secure communication application configured to receive, from a service platform, a certified medical application and store the certified medical application in the secure segment.

38. The device of claim 37 wherein the secure communication application is further configured to verify, in response to receipt of the medical application, that the received certified medical application has been approved for operation with the medical device by a regulatory authority.

39. The device of claim 38 wherein the regulatory authority is the FDA and the certified medical application has been certified by the FDA.

40. The device of claim 38 wherein the one or more processors includes two processor cores and wherein a first of the two processor cores is coupled to the unsecure segment and the second of the two processor cores is coupled to the secure segment.

41. The device of claim 40 wherein the first processor core and the second processor core are isolated from each other.