Medical data management system and process

• US 20060031094A1
• Filed: 08/06/2004
• Published: 02/09/2006
• Est. Priority Date: 08/06/2004
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Van Antwerp, William P., Cohen, Gary, Goldsmith, Joel, Widran, Sanford, Daugherty, James R., Roller, Pam S., Patterson, George W.
• Granted Patent: US 8,313,433 B2
• Time in Patent Office: Days
• US Class Current: 705/2
• CPC Class Codes: A61B 2560/0271 using a remote monitoring unit
• 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 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61M 2205/3553 remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G06F 2221/2113 Multi-level security, e.g. mandatory access control
• CPC Class Codes: G06F 2221/2141 Access rights, e.g. capability lists, access control lists, access tables, access matrices
• CPC Class Codes: G06Q 10/10 Office automation; Time management
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 15/00 ICT specially adapted for medical reports, e.g. generation or transmission thereof
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 20/30 relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
• 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 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/70 for mining of medical data, e.g. analysing previous cases of other patients
• CPC Class Codes: G16H 70/20 relating to practices or guidelines

Abstract

Systems and processes for managing data relating to one or more medical or biological conditions of a plurality of subjects (such as patients) over a wide area network, such as the Internet, may be employed for diabetes subjects or subjects with other medical conditions requiring monitoring and/or treatment over time. Such systems and processes provide various functions for several types of users, including patients or subject-users, healthcare provider-users and payor entity-users and combinations thereof, which allow for improved treatment and medical data management of individual subjects and groups of subjects and which allow collection and analysis of aggregate data from many subject sources, for improving overall healthcare practices of providers and subjects (e.g., patients).

Claims

1. A system for managing medical data on an electronic communication network, the system comprising

at least one sensor or meter, each sensor or meter for sensing or monitoring a biological condition of a respective subject user;

at least one infusion device, each infusion device for infusing an infusion medium to a respective subject user,

a first interface associated with each infusion device for allowing the infusion device to receive information regarding a detected biological condition from at least one respective sensor or meter and a memory for storing received information;

a second interface associated with each infusion device, for allowing the infusion device to be connectable, directly or indirectly, to the communication network, for communicating information stored in the memory of the infusion device over the communication network.

2. A system as recited in claim 1, further comprising:

at least one server connectable for communication on the communication network, the at least one server being configured for;

receiving from a plurality of infusion devices, at least some information stored in the memory of the infusion devices;

storing received medical data; and

providing controlled access to stored medical data for authorized users over the communication network.

3. A system as recited in claim 2, wherein the at least one server is programmed to interface with a plurality of different types of infusion devices.

4. A system as recited in claim 3, wherein the plurality of different types of infusion devices include infusion devices manufactured by plural different manufacturers.

5. A system as recited in claim 3, wherein the plurality of different types of infusion devices include different models of infusion devices manufactured by the same manufacturer.

6. A system as recited in claim 3, wherein the at least one sensor or meter comprises a plurality of different types of sensors or meters.

7. A system as recited in claim 2, wherein receiving at least some information comprises receiving data over the communication network from a plurality of users.

8. A system as recited in claim 2, wherein receiving at least some information comprises:

providing a network site accessible to users that have user computers connected to the communication network,

providing instructions to a user on the network site, the instructions for connecting an infusion device to the user'"'"'s computer;

receiving-infusion device data through the user'"'"'s computer, once a user has connected the infusion device to the user'"'"'s computer in accordance with the instructions.

9. A system as recited in claim 8, wherein receiving infusion device data through the user'"'"'s computer comprises retrieving infusion device data that had been stored in a memory associated with the user'"'"'s computer previously in accordance with the user'"'"'s previous connection of an infusion device to the user'"'"'s computer.

10. A system as recited in claim 8, wherein receiving infusion device data through the user'"'"'s computer comprises retrieving infusion device data stored in the memory associated with the infusion device, the data being retrieved from the infusion device memory and received by the system during a time period in which the infusion device is connected to the user'"'"'s computer.

11. A system as recited in claim 1, wherein the second interface comprises:

a cradle for supporting each infusion device and electrically coupling to the infusion device; and

a computer electrically coupled to the cradle;

wherein information stored by the memory of the infusion device may be communicated, through the cradle, to the computer, upon the cradle supporting and electrically coupling to the infusion device.

12. A process for managing medical data on an electronic communication network, the process comprising

sensing or monitoring a biological condition of a plurality of subjects with an associated plurality of sensors or meters;

infusing an infusion medium to a plurality of subjects with an associated plurality of infusion devices,

receiving, by an infusion device associated with a subject, information regarding a detected biological condition of the subject from at least one respective sensor or meter that senses or monitors the biological condition of the subject;

storing the received information in a memory associated with the infusion device;

connecting the infusion device, directly or indirectly, to the communication network; and

communicating information stored in the memory of the infusion device over the communication network.

13. A process as recited in claim 12, the process comprising:

connecting at least one server for communication on the communication network;

receiving at least some information stored in the memories of a plurality of different types of infusion devices over the communication network by the at least one server;

storing information received over the network in at least one electronic storage device associated with the at least one server; and

providing controlled access to stored information for authorized users over the wide area network.

14. A process as recited in claim 13, wherein the at least one server is programmed to interface with a plurality of different types of infusion devices.

15. A process as recited in claim 14, wherein the plurality of different types of infusion devices include infusion devices manufactured by plural different manufacturers.

16. A process as recited in claim 14, wherein the plurality of different types of infusion devices include different models of infusion devices manufactured by the same manufacturer.

17. A process as recited in claim 12, wherein receiving at least some information comprises receiving data over the communication network from a plurality of users.

18. A process as recited in claim 12, wherein receiving at least some information comprises:

providing a network site accessible to users that have user computers connected to the communication network,

providing instructions to a user on the network site, the instructions for connecting an infusion device to the user'"'"'s computer;

receiving infusion device data through the user'"'"'s computer, once a user has connected the infusion device to the user'"'"'s computer in accordance with the instructions.

19. A process as recited in claim 18, wherein receiving infusion device data through the user'"'"'s computer comprises retrieving information that had been stored in a memory associated with the user'"'"'s computer previously in accordance with the user'"'"'s previous connection of a infusion device to the user'"'"'s computer.

20. A process as recited in claim 18, wherein receiving infusion device data through the user'"'"'s computer comprises retrieving information stored in a memory associated with the infusion device, the data being retrieved from the infusion device memory and received by the system during a time period in which the infusion device is connected to the user'"'"'s computer.

21. A system for managing medical data on a wide area communication network, the system comprising at least one server connectable for communication on the wide area communication network, the at least one server being configured for:

receiving medical data from at least one subject support device;

storing received medical data;

providing controlled access to stored medical data for authorized users;

receiving treatment recommendations from authorized users, wherein treatment recommendations may be based, at least in part, on the authorized user'"'"'s review of stored medical data;

storing received treatment recommendations; and

providing controlled access to stored treatment recommendations for authorized users.

22. A system as recited in claim 21, wherein the at least one server is configured to communicate with subject-users, healthcare provider-users and system personnel-users, wherein each subject-user may designate at least one healthcare provider-user, wherein each system personnel-user is associated with an entity operating the system, and wherein:

providing controlled access to stored medical data comprises providing a system personnel-user with access to medical data associated with a given subject-user;

receiving treatment recommendations comprises receiving a communication from the system personnel-user over the wide area network, the communication including recommendations for treating the given subject-user;

providing controlled access to stored treatment recommendations comprises providing the given subject-user'"'"'s designated healthcare provider-user with access to stored treatment recommendations for treating the given subject-user.

23. A system as recited in claim 21, wherein the at least one server is configured to communicate with subject-users, healthcare provider-users and system personnel-users, wherein each subject-user may designate at least one healthcare provider-user, wherein each system personnel-user is associated with an entity operating the system, and wherein:

providing controlled access to stored medical data comprises providing a system personnel-user with access to medical data associated with a given group of subject-users;

receiving treatment recommendations comprises receiving a communication from the system personnel-user over the wide area network, the communication including recommendations for treating a particular subject-user, wherein the recommendation is based at least in part on medical data associated with the given group of subject-users;

providing controlled access to stored treatment recommendations comprises providing at least one of the subject-user'"'"'s designated healthcare provider-users with access to stored treatment recommendations for treating the particular subject-user.

24. A system as recited in claim 21, wherein the at least one server is configured to communicate with subject-users, healthcare provider-users and system personnel-users, wherein each subject-user may designate at least one healthcare provider-user and wherein:

providing controlled access to stored medical data comprises providing a system personnel-user with access to medical data associated with subject-users;

receiving treatment recommendations comprises receiving a communication from the system personnel-user over the wide area network, the communication including recommendations for treating each subject within a particular group of subject-user, wherein the recommendation is based at least in part on medical data accessible to the system personnel-user;

providing controlled access to stored treatment recommendations comprises providing at least one healthcare provider who is designated for at least one of the subject-user'"'"'s in the group with access to stored treatment recommendations for treating the particular subject-user.

25. A system as recited in claim 21, wherein providing controlled access to stored medical data comprises providing access to medical data that is free of individual identifiers that identify a subject or subjects for which the medical data relates.

26. A system as recited in claim 21, wherein storing received medical data comprises storing data having individual identifiers that identify a subject or subjects in a first storage area and storing data that is free of individual identifiers in a second storage area, the second storage area being separate from the first storage area.

27. A system as recited in claim 26, wherein users authorized to have controlled access to stored medical data include first users authorized to access data in the first storage area or the second storage area and second users authorized to access data in the second storage area but not in the first storage area.

28. A system as recited in claim 21, wherein each treatment recommendation is associated with at least one subject-user and wherein providing controlled access to stored treatment recommendations for authorized users comprises providing a subject-user with access to treatment recommendations associated with that subject-user and inhibiting that subject'"'"'s access to treatment recommendations associated with other subject-users.

29. A system as recited in claim 21, wherein each treatment recommendation is associated with at least one subject-user and wherein providing controlled access to stored treatment recommendations for authorized users comprises providing a healthcare provider-user with access to treatment recommendations associated with a subject-user who designated that healthcare provider-user, and inhibiting that healthcare provider-user'"'"'s access to treatment recommendations associated with other subject-users.

30. A system as recited in claim 21, wherein receiving medical data from at least one subject support device comprises receiving data over the wide area communication network from a plurality of users.

31. A process for managing medical data on a wide area communication network, comprising:

connecting at least one server for communication on a wide area communication network; and

configuring the at least one server for;

receiving medical data from at least one subject support device;

storing received medical data;

providing controlled access to stored medical data for authorized users;

receiving treatment recommendations from authorized users, wherein treatment recommendations may be based, at least in part, on the authorized user'"'"'s review of stored medical data;

storing received treatment recommendations; and

providing controlled access to stored treatment recommendations for authorized users.

32. A process as recited in claim 31, wherein the at least one server is configured to communicate with subject-users, healthcare provider-users and system personnel-users, wherein each subject-user may designate at least one healthcare provider-user, wherein each system personnel-user is associated with an entity operating the system, and wherein:

providing controlled access to stored medical data comprises providing a system personnel-user with access to medical data associated with a given subject-user;

receiving treatment recommendations comprises receiving a communication from the system personnel-user over the wide area network, the communication including recommendations for treating the given subject-user;

providing controlled access to stored treatment recommendations comprises providing the given subject-user'"'"'s designated healthcare provider-user with access to stored treatment recommendations for treating the given subject-user.

33. A process as recited in claim 31, wherein the at least one server is configured to communicate with subject-users, healthcare provider-users and system personnel-users, wherein each subject-user may designate at least one healthcare provider-user, wherein each system personnel-user is associated with an entity operating the system, and wherein:

providing controlled access to stored medical data comprises providing a system personnel-user with access to medical data associated with a given group of subject-users;

receiving treatment recommendations comprises receiving a communication from the system personnel-user over the wide area network, the communication including recommendations for treating a particular subject-user, wherein the recommendation is based at least in part on medical data associated with the given group of subject-users;

providing controlled access to stored treatment recommendations comprises providing at least one of the subject-user'"'"'s designated healthcare provider-users with access to stored treatment recommendations for treating the particular subject-user.

34. A process as recited in claim 31, wherein the at least one server is configured to communicate with subject-users, healthcare provider-users and system personnel-users, wherein each subject-user may designate at least one healthcare provider-user and wherein:

providing controlled access to stored medical data comprises providing a system personnel-user with access to medical data associated with subject-users;

receiving treatment recommendations comprises receiving a communication from the system personnel-user over the wide area network, the communication including recommendations for treating each subject within a particular group of subject-user, wherein the recommendation is based at least in part on medical data accessible to the system personnel-user;

providing controlled access to stored treatment recommendations comprises providing at least one healthcare provider who is designated for at least one of the subject-user'"'"'s in the group with access to stored treatment recommendations for treating the particular subject-user.

35. A process as recited in claim 31, wherein providing controlled access to stored medical data comprises providing access to medical data that is free of individual identifiers that identify a subject or subjects for which the medical data relates.

36. A process as recited in claim 31, wherein storing received medical data comprises storing data having individual identifiers that identify a subject or subjects in a first storage area and storing data that is free of individual identifiers in a second storage area, the second storage area being separate from the first storage area.

37. A process as recited in claim 31, wherein users authorized to have controlled access to stored medical data include first users authorized to access data in the first storage area or the second storage area and second users authorized to access data in the second storage area but not in the first storage area.

38. A process as recited in claim 31, wherein each treatment recommendation is associated with at least one subject-user and wherein providing controlled access to stored treatment recommendations for authorized users comprises providing a subject-user with access to treatment recommendations associated with that subject-user and inhibiting that subject'"'"'s access to treatment recommendations associated with other subject-users.

39. A process as recited in claim 31, wherein each treatment recommendation is associated with at least one subject-user and wherein providing controlled access to stored treatment recommendations for authorized users comprises providing a healthcare provider-user with access to treatment recommendations associated with a subject-user who designated that healthcare provider-user, and inhibiting that healthcare provider-user'"'"'s access to treatment recommendations associated with other subject-users.

40. A process as recited in claim 31, wherein receiving medical data from at least one subject support device comprises receiving data over the wide area communication network from a plurality of users.

41. A system for managing medical data on a wide area communication network, the system comprising at least one server connectable for communication on the wide area communication network, the at least one server being configured for:

receiving, over the wide area communication network, at least one treatment plan from an authorized healthcare provider-user, wherein each received treatment plan relates to a medical treatment of at least one subject-user, at least one of the received treatment plans including at least one treatment modification that is implemented upon the occurrence of at least one specified event according to the treatment plan;

storing each received treatment plan;

determining whether or not the at least one specified event in a stored treatment plan has occurred; and

causing a treatment modification to be implemented, if it is determined that the at least one specified event has occurred.

42. A system as recited in claim 41, wherein determining whether or not the at least one specified event has occurred comprises:

receiving medical data from at least one subject support device; and

applying the received medical data to an algorithm included in at least one received treatment plan.

43. A system as recited in claim 42, wherein the at least one subject support device comprises at least one insulin infusion device, blood glucose meter and continuous glucose monitoring system.

44. A system as recited in claim 41, wherein determining whether or not the at least one specified event has occurred comprises:

receiving medical data from at least one subject support device, the medical data including data representing a value of a detected parameter;

determining whether or not the value of the detected parameter crosses a defined threshold value.

45. A system as recited in claim 44, wherein the value of the detected parameter represents a number of times that a subject-user has changed an infusion needle set for a medical infusion device.

46. A system as recited in claim 44, wherein the value of the detected parameter represents a quantity of infusion medium remaining in a reservoir of a medical infusion device or a quantity of power remaining in a depletable power source.

47. A system as recited in claim 41, wherein causing a treatment modification to be implemented comprises transmitting parameters for setting a subject support device to a user over the wide area network.

48. A system as recited in claim 41, wherein causing a treatment modification to be implemented comprises providing a network site location for access by a user and posting the parameters on the network site location.

49. A system as recited in claim 41, wherein causing a treatment modification to be implemented comprises:

providing a network site location for access by the subject-user related to the treatment plan that specifies the treatment modification; and

posting the parameters on the network site location.

50. A system as recited in claim 41, wherein causing a treatment modification to be implemented comprises transmitting a message to a user over the wide area network, the message including a warning or instructions regarding the use or operation of a subject support device.

52. A process as recited in claim 41, wherein determining whether or not the at least one specified event has occurred comprises:

receiving medical data from at least one subject support device; and

applying the received medical data to an algorithm included in at least one received treatment plan.

53. A process as recited in claim 52, wherein the at least one subject support device comprises at least one insulin infusion device, blood glucose meter and continuous glucose monitoring system.

51. A process for managing medical data on a wide area communication network, comprising:

connecting at least one server for communication on the wide area communication network; and

configuring the at least one server for;

receiving, over the wide area communication network, at least one treatment plan from an authorized healthcare provider-user, wherein each received treatment plan relates to a medical treatment of at least one subject-user, at least one of the received treatment plans including at least one treatment modification that is implemented upon the occurrence of at least one specified event according to the treatment plan;

storing each received treatment plan;

determining whether or not the at least one specified event in a stored treatment plan has occurred; and

causing a treatment modification to be implemented, if it is determined that the at least one specified event has occurred.

54. A process as recited in claim 51, wherein determining whether or not the at least one specified event has occurred comprises:

receiving-medical data from at least one subject support device, the medical data including data representing a value of a detected parameter;

determining whether or not the value of the detected parameter crosses a defined threshold value.

55. A process as recited in claim 54, wherein the value of the detected parameter represents a number of times that a subject-user has changed an infusion needle set for a medical infusion device.

56. A process as recited in claim 55, wherein the detected parameter comprises a parameter indicating the occurrence of a priming event carried out by an infusion pump after an infusion needle change operation.

57. A process as recited in claim 54, wherein the value of the detected parameter represents a quantity of infusion medium remaining in a reservoir of a medical infusion device or a quantity of power remaining in a depletable power source.

58. A process as recited in claim 51, wherein causing a treatment modification to be implemented comprises transmitting parameters for setting a subject support device to a user over the wide area network.

59. A process as recited in claim 51, wherein causing a treatment modification to be implemented comprises providing a network site location for access by a user and posting the parameters on the network site location.

60. A process as recited in claim 51, wherein causing a treatment modification to be implemented comprises:

providing a network site location for access by the subject-user related to the treatment plan that specifies the treatment modification; and

posting the parameters on the network site location.

61. A process as recited in claim 51, wherein causing a treatment modification to be implemented comprises transmitting a message to a user over the wide area network, the message including a warning or instructions regarding the use or operation of a subject support device.

62. A process for managing medical data on a wide area communication network in which at least one server is connected for communication, the process comprising:

accessing stored medical data from the at least one server over the wide area network, the stored medical data comprising data obtained from a plurality of subject support devices;

determining at least one starting setting or operating parameter for a given subject support device, based at least in part on stored medical data accessed from the at least one server;

providing the at least one starting setting or operating parameter to a given subject support device, to set the given subject support device for its first use by a subject.

63. A process as recited in claim 62, wherein accessing stored medical data comprises accessing a website location and selecting optional information available on the website.

64. A process as recited in claim 62, wherein providing the at least one starting setting or operating parameter comprises sending information over the wide area network, the information corresponding to a starting setting or operating parameter to subject support device connected to a user'"'"'s computer that is connected to the wide area network.

65. A process as recited in claim 62, wherein each subject support device includes an input interface and wherein providing the at least one starting setting or operating parameter comprises inputting a setting or operating parameter through an input interface of the subject support device

66. A process as recited in claim 62, wherein determining at least one starting setting or operating parameter comprises

providing the subject with a controlled intake having a pre-known amount of a defined substance;

evaluating the subject'"'"'s response to the pre-known amount of the defined substance upon the subject taking in the pre-known amount of the defined substance;

evaluating the responses of other subjects to a treatment, the evaluation based on stored medical data accessed from the at least one server, the treatment for treating subject responses to the defined substance.

determining a starting setting or operating parameter based at least in part on the subject'"'"'s response to the pre-known amount of the defined substance and from other subject'"'"'s response to a treatment,

67. A process as recited in claim 66, wherein determining a starting setting or operating parameter comprises applying values to an algorithm, the values being associated with the subject'"'"'s response to the pre-known amount of the defined substance and other subject'"'"'s response to a treatment

68. A process as recited in claim 66, wherein providing the subject with a controlled intake comprises providing the subject with food or other eatable material having a predefined amount of the defined substance.

69. A process as recited in claim 66, wherein providing the subject with a controlled intake comprises providing the subject with food or other eatable material having a predefined amount carbohydrates.

70. A process as recited in claim 69, wherein evaluating the responses of other subjects to a treatment comprises evaluating insulin responses of other subjects.

71. A process as recited in claim 70, wherein determining a starting setting or operational parameter comprises determining a starting setting or operational parameter for an insulin infusion pump.