Medical data management system and process

• US 8,313,433 B2
• Filed: 08/06/2004
• Issued: 11/20/2012
• Est. Priority Date: 08/06/2004
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Cohen, Gary, Goldsmith, Joel, Roller, Pam S., Widran, Sanford, Patterson, George W., Daugherty, James R., Van Antwerp, William P.
• Primary Examiner(s): Morse, Gregory A
• Assistant Examiner(s): SORIANO, BOBBY GILES
• Application Number:
  US10/913,149
• Publication Number:
  US 20060031094A1
• Time in Patent Office: 3,028 Days
• Field of Search: 600300-301, 705 2- 5, 34053912-53914
• US Class Current: 600/301
• 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 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 a plurality of subject support devices including a first subject support device associated with a first subject;

storing the received medical data;

providing controlled access over the wide area communication network to the stored medical data for authorized users, wherein providing controlled access to the stored medical data comprises providing access to medical data that is free of individual identifiers that identify the first subject or any other subjects for which the medical data relates;

receiving a plurality of treatment recommendations for the first subject from a plurality of authorized users over the wide area communication network, wherein the treatment recommendations are based, at least in part, on the authorized user'"'"'s review of the stored medical data that is free of individual identifiers;

storing the received treatment recommendations; and

providing controlled access to the stored treatment recommendations for authorized users over the wide area communication network,

wherein the medical data includes information gathered from the first subject support device and information regarding a medical condition of the subject for which the first subject support device is associated and a reaction of that subject to the treatment.

2. A system as recited in claim 1, 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.

3. A system as recited in claim 1, 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.

4. A system as recited in claim 1, 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.

5. A system as recited in claim 1, 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.

6. A system as recited in claim 5, 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.

7. A system as recited in claim 1, 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.

8. A system as recited in claim 1, 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.

9. A system as recited in claim 1, 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.

45. The system as recited in claim 1, wherein the at least one subject support device comprises at least one insulin infusion device, blood glucose meter and continuous glucose monitoring system.

10. 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;

configuring the at least one server for;

receiving medical data from a plurality of subject support devices including a first subject support device associated with a first subject;

storing the received medical data;

providing controlled access over the wide area communication network to the stored medical data for authorized users, wherein providing controlled access to the stored medical data comprises providing access to medical data that is free of individual identifiers that identify the first subject or any other subjects for which the medical data relates;

receiving a plurality of treatment recommendations for the first subject from a plurality of authorized users over the wide area communication network, wherein the treatment recommendations are based, at least in part, on the authorized user'"'"'s review of the stored medical data that is free of individual identifiers;

storing the received treatment recommendations; and

providing controlled access to the stored treatment recommendations for authorized users over the wide area communication network,

wherein the medical data includes information gathered from the first subject support device and information regarding a medical condition of the subject for which the first subject support device is associated and a reaction of that subject to the treatment.

11. A process as recited in claim 10, 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.

12. A process as recited in claim 10, 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.

13. A process as recited in claim 10, 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.

14. A process as recited in claim 10, 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.

15. A process as recited in claim 10, 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.

16. A process as recited in claim 10, 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.

17. A process as recited in claim 10, 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.

18. A process as recited in claim 10, 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.

46. The system as recited in claim 10, wherein the at least one subject support device comprises at least one insulin infusion device, blood glucose meter and continuous glucose monitoring system.

19. 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, wherein the treatment modification includes adjusting an amount of infusion medium to be infused from a reservoir of a medial infusion device;

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; and

determining whether or not the value of the detected parameter crosses a defined threshold value such that upon reaching the threshold value continuing to provide a different treatment amount to the at least one subject-user according to the treatment modification, and

wherein the value of the detected parameter represents a quantity of infusion medium remaining in the reservoir of the medical infusion device.

20. A system as recited in claim 19, 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.

21. A system as recited in claim 20, wherein the at least one subject support device comprises at least one insulin infusion device, blood glucose meter and continuous glucose monitoring system.

22. A system as recited in claim 19, 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.

23. A system as recited in claim 19, 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.

24. A system as recited in claim 19, 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.

25. A system as recited in claim 19, 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.

26. A system as recited in claim 19, 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.

27. 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, wherein the treatment modification includes adjusting an amount of infusion medium to be infused from a reservoir of a medial infusion device;

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; and

determining whether or not the value of the detected parameter crosses a defined threshold value such that upon reaching the threshold value continuing to provide a different treatment amount to the at least one subject-user according to the treatment modification, and

wherein the value of the detected parameter represents a quantity of infusion medium remaining in the reservoir of the medical infusion device.

28. A process as recited in claim 27, 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.

29. A process as recited in claim 28, wherein the at least one subject support device comprises at least one insulin infusion device, blood glucose meter and continuous glucose monitoring system.

30. A process as recited in claim 27, 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.

31. A process as recited in claim 30, 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.

32. A process as recited in claim 27, 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.

33. A process as recited in claim 27, 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.

34. A process as recited in claim 27, 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.

35. A process as recited in claim 27, 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.

36. 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 starting operating parameter for a given subject support device, based on the stored medical data obtained from at least one other of the plurality of subject support devices and accessed from the at least one server;

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

wherein determining at least one starting setting or starting operating parameter comprises providing the subject with a controlled intake having a pre-known amount of a 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; and

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

37. A process as recited in claim 36, wherein accessing stored medical data comprises accessing a website location and selecting optional information available on the website.

38. A process as recited in claim 36, wherein providing the at least one starting setting or starting operating parameter comprises sending information over the wide area network, the information corresponding to a starting setting or starting operating parameter to subject support device connected to a user'"'"'s computer that is connected to the wide area network.

39. A process as recited in claim 36, wherein each subject support device includes an input interface and wherein providing the at least one starting setting or starting operating parameter comprises inputting a setting or operating parameter through an input interface of the subject support device.

40. A process as recited in claim 36, wherein determining a starting setting or starting 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.

41. A process as recited in claim 36, 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.

42. A process as recited in claim 36, wherein providing the subject with a controlled intake comprises providing the subject with food or other eatable material having a predefined amount carbohydrates.

43. A process as recited in claim 42, wherein evaluating the responses of other subjects to a treatment comprises evaluating insulin responses of other subjects.

44. A process as recited in claim 43, wherein determining a starting setting or starting operational parameter comprises determining a starting setting or operational parameter for an insulin infusion pump.