Subscription based monitoring system and method

• US 6,413,213 B1
• Filed: 04/18/2000
• Issued: 07/02/2002
• Est. Priority Date: 04/18/2000
• Status: Expired due to Term

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Corporation (Roche Holding AG)
• Inventors: Gerber, Martin T., Cronrath, Christoph M., Hansen, Michael V., Essenpreis, Matthias
• Primary Examiner(s): Winakur, Eric F.
• Assistant Examiner(s): McCrosky, David J.
• Application Number:
  US09/551,269
• Time in Patent Office: 805 Days
• Field of Search: 600/300, 600/301, 600/331, 128/897-925, 340/501, 340/502, 340/825.28, 713/182, 713/1
• US Class Current: 600/300
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: G07F 7/08 by coded identity card or credit card or other personal identification means without personal verification means G07F7/02

Abstract

A system (10) for subscription monitoring of a medically significant characteristic of a bodily fluid which includes a meter (12), a ROM circuit (36), a test strip (34), and a registry (50). Meter (12) has an identifier corresponding to a subscription user. ROM circuit (36) is provided with test strips (34), and contains calibration data and an identifier. The meter (12) requires an activation code before it may conduct a biosensing test. The meter (12) communicates with registry (50) through communication means (40) and provides the meter identifier and ROM circuit identifier. Registry (50) checks for valid association of the meter identifier, ROM circuit identifier, and user identifier. If a valid association is established, the registry (50) provides an activation code to the meter (12), enabling meter (12) to conduct testing during a subscription period. The meter (12) thereafter validates the ROM circuit (36) association on power up, so that ROM circuit (36) may only be used with meter (12), thereby discouraging fraudulent conveyance of ROM circuit (36) and test strips (34).

Claims

1. A system for monitoring a medically significant characteristic-of a bodily fluid, the system comprising:

a biosensing meter identified as a subscription meter by a first identifier and having a controller being adapted to activate the meter upon receiving an activation code; and

a test media for the biosensing meter, the test media identified as a subscription test media by a second identifier, the test media and biosensing mater having a predetermined association based on the first and second identifiers.

2. The system of claim 1, further comprising a registry, the registry including a user identifier, and associating the user identifier to the first identifier.

3. The system of claim 2, wherein the registry associates the first identifier, the second identifier, and provides the activation code to the controller.

4. The system of claim 2, wherein the test media comprises an electronically readable information carrier.

5. The system of claim 4, wherein the test media further comprises a vial of test strips.

6. The system of claim 5, wherein the electronically readable information carrier includes calibration data associated with the test strips.

7. The system of claim 4, wherein the electronically readable information carrier is a read only memory (ROM) circuit.

8. The system of claim 7, wherein the controller activates the meter for a subscription period.

9. The system of claim 8, wherein the controller renders the ROM circuit inoperable after expiration of the subscription period.

10. The system of claim 9, wherein the controller includes an override code to activate the meter after a subscription period has expired.

11. The system of claim 4, wherein the electronically readable information carrier includes a meter activation code.

12. The system of claim 1, further comprising a registry, the registry associating the first identifier to the second identifier, and providing the activation code to the controller.

13. The system of claim 12, wherein the controller activates the meter for a specified time period.

14. The system of claim 13, wherein the specified time period is a subscription period.

15. The system of claim 1, wherein the controller activates the meter for a specified number of tests.

16. The system of claim 15, wherein the specified number of tests is equal to the quantity of test strips provided in a vial of test strips.

17. The system of claim 1, wherein the first identifier is a unique identifier.

18. The system of claim 17, wherein the second identifier is a unique identifier.

19. The system of claim 18, further comprising a registry, the registry including a user identifier, and associating the user identifier to the first identifier.

20. The system of claim 19, wherein the registry associates the first identifier to the second identifier.

21. The system of claim 20, wherein the registry provides the activation code to the controller.

22. The system of claim 21, wherein the controller activates the meter for a subscription period.

23. A method for subscription monitoring of a medically significant characteristic of a bodily fluid, the method comprising the steps of:

identifying a biosensing meter as a subscription meter;

identifying a test media;

determining whether the identified biosensing meter is associated with the identified test media; and

selectively activating the identified biosensing meter based on the results of the determining step.

24. The method of claim 23, further comprising the step of associating the identified biosensing meter with a unique subscriber.

25. The method of claim 23, wherein the identified biosensing meter is activated for a specified time period.

26. The method of claim 23, wherein the step of identifying a test media comprises the steps of:

providing a vial of test strips;

providing an electronically readable information carrier readable by the biosensing meter; and

encoding onto the electronically readable information carrier an identifier.

27. The method of claim 26, wherein the step of identifying a test media further comprises the steps of:

determining calibration data for the vial of test strips; and

encoding onto the electronically readable information carrier the calibration data.

28. The method of claim 27, wherein the identified biosensing meter is uniquely identified.

29. The method of claim 28, wherein the identified test media is uniquely identified.

30. The method of claim 29, wherein the association between the uniquely identified biosensing meter and the uniquely identified test media is exclusive.

31. The method of claim 28, wherein the uniquely identified biosensing meter is activated for a specified time period.

32. The method of claim 26, wherein the step of identifying a test media further comprises the step of encoding onto the electronically readable information carrier a meter activation code.

33. The method of claim 23, wherein the identified biosensing meter is uniquely identified.

34. The method of claim 33, wherein the identified test media is uniquely identified.

35. The method of claim 34, wherein the association between the uniquely identified biosensing meter and the uniquely identified test media is exclusive.

36. The method of claim 35, wherein the step of activating the uniquely identified biosensing meter comprises the steps of:

exchanging information between the biosensing meter and a registry; and

retrieving an activation code from the registry.

37. The method of claim 36, wherein the step of identifying a unique test media comprises the steps of:

providing a vial of test strips;

providing an electronically readable information carrier readable by the biosensing meter; and

encoding onto the electronically readable information carrier a unique identifier.

38. The method of claim 37, wherein the step of identifying a unique test-media further comprises the steps of:

determining calibration data for the vial of test strips; and

encoding onto the electronically readable information carrier the calibration data.

39. The method of claim 38, wherein the uniquely identified biosensing meter is activated for a specified time period.

40. The method of claim 39, further comprising the step of providing an override signal to activate the meter for an override period after the specified time period has expired.

41. The method of claim 40, further comprising the step of rendering the test media inoperative after the override period has expired.

42. A method for subscription monitoring of a medically significant characteristic of a bodily fluid, the method comprising the steps of:

uniquely identifying a biosensing meter;

associating the uniquely identified biosensing meter to a particular user;

uniquely identifying a set of test media;

associating the uniquely identified biosensing meter to the uniquely identified set of test media;

determining whether the particular user is an authorized subscriber;

when the particular user is an authorized subscriber, activating the uniquely identified biosensing meter for use with the uniquely identified set of test media; and

when the particular user is an authorized subscriber, monitoring the use of the uniquely identified set of test media with the uniquely identified biosensing meter by the particular user.

43. The method of claim 42, wherein the step of uniquely identifying a set of test media comprises the steps of:

providing an information carrier readable by the uniquely identified biosensing meter;

associating the information carrier with the uniquely identified set of test media; and

encoding a unique identifier onto the information carrier.

44. The method of claim 42, wherein a registry associates the uniquely identified biosensing meter with the particular user and with the uniquely identified set of test media.

45. The method of claim 44, wherein the step of activating the uniquely identified biosensing meter for use with the uniquely identified set of test media when the particular user is an authorized subscriber, comprises the steps of:

establishing bidirectional communication between the uniquely identified biosensing meter and the registry;

identifying the uniquely identified biosensing meter to the registry;

determining whether the particular user associated with the uniquely identified biosensing meter is an authorized subscriber;

identifying the uniquely identified set of test media to the registry; and

pairing the uniquely identified biosensing meter with the uniquely identified set of test media.

46. The method of claim 44, wherein the step of monitoring the use of the uniquely identified set of test media with the uniquely identified biosensing meter by the particular user when the particular user is an authorized subscriber, comprises the steps of:

collecting information to be monitored using one of the uniquely identified set of test media and the uniquely identified biosensing meter;

establishing bidirectional communication between the uniquely identified biosensing meter and the registry;

identifying the uniquely identified biosensing meter to the registry;

determining whether the particular user associated with the uniquely identified biosensing meter is an authorized subscriber;

identifying the uniquely identified set of test media to the registry;

determining whether the uniquely identified biosensing meter is associated with the uniquely identified set of test media; and

when the particular user is an authorized subscriber and the uniquely identified biosensing meter is associated with the uniquely identified set of test media, reading and storing the collected information to be monitored at the registry.

47. The method of claim 46, further comprising the steps of:

establishing bidirectional communication between the registry and a data inquirer;

receiving a data request from the data inquirer to access requested registry data;

verifying the data inquirer'"'"'s authorization to access the requested registry data;

when the data inquirer is authorized, communicating the requested registry data from the registry to the data inquirer.

48. A method monitoring a medically significant characteristic of a bodily fluid, the method comprising the steps of:

identifying a biosensing meter;

entering into a subscription agreement defining a subscription period; and

providing a test media for the identified biosensing meter during the subscription period.

49. The method of claim 48, wherein the biosensing meter is identified as a subscription biosensing meter.

50. The method of claim 49, wherein the test media is identified as subscription test media.

51. The method of claim 49, further comprising the steps of:

conducting biosensing tests during the subscription period; and

storing data from the biosensing tests in the biosensing meter.

52. The method of claim 51, further comprising the steps of:

establishing communication between the meter and a registry; and

providing an activation code from the registry to the biosensing meter.

53. The method of claim 52, further comprising the step of monitoring the stored biosensing test data.

54. The method of claim 53, wherein the biosensing test data is monitored by providing the biosensing test data to the registry.

55. The method of claims 53, wherein the biosensing test data is monitored by providing the biosensing test data to a health care provider.

56. The method of claim 48, further comprising the steps of:

establishing communication between the meter and a registry; and

providing an activation code from the registry to the biosensing meter.

57. A system for monitoring, a medically significant characteristic of a bodily fluid, the system comprising a biosensing meter including a controller configured to activate the biosensing meter upon receipt of an activation code during a subscription period defined by a subscription agreement.

58. The system of claim 57, wherein the controller includes a first identifier identifying the biosensing meter as a subscription meter.

59. The system of claim 58, further comprising a registry, the registry providing the activation code to the biosensing meter after receiving the first identifier from the biosensing meter.

60. The system of claim 58, further comprising a test media identified as subscription test media by a second identifier.

61. The system of claim 60, wherein the test media includes the meter activation code.

62. The system of claim 60, wherein the test media comprises a ROM circuit coupled to the controller.

63. The system of claim 62, wherein the test media further comprises a test strip.

64. The system of claim 63, further comprising an optical reader coupled to the controller.

65. The system of claim 64, wherein the test strip includes an optical identifying code, and wherein the ROM circuit includes an electronic identifying code.

66. The system of claim 65, wherein the optical reader is configured to read the optical identifying code.

67. The system of claim 66, wherein the controller is further configured to compare the optical identifying code to the electronic identifying code, and activate the biosensing meter based on the results of the comparison.

68. The system of claim 57, further comprising a registry, the registry providing the activation code to the biosensing meter.