System and method for managing health data

• US 9,618,967 B2
• Filed: 05/29/2008
• Issued: 04/11/2017
• Est. Priority Date: 05/30/2007
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Inventors: Yao, Simin, Brown, Darren, Chen, Jun, Gofman, Igor, Harris, Steven B., Inman, Paul L., Kates, Richard, Li, Qiong, Lieber, Harris, Ripley, Paul M., Stefkovic, Gregory, Sun, Hoi-Cheong Steve, Wu, Mu, Yao, Raymond
• Primary Examiner(s): Patel, Neha
• Assistant Examiner(s): TIEDEMAN, JASON S
• Application Number:
  US12/129,547
• Publication Number:
  US 20080301158A1
• Time in Patent Office: 3,239 Days
• Field of Search: 705 2, 705 3
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: G06F 1/16 Constructional details or arrangements
• CPC Class Codes: G06F 1/1605 Multimedia displays, e.g. with integrated or attached speakers, cameras, microphones
• CPC Class Codes: G06F 1/266 Arrangements to supply power to external peripherals either directly from the computer or under computer control, e.g. supply of power through the communication port, computer controlled power-strips
• CPC Class Codes: G06F 13/385 for adaptation of a particular data processing system to different peripheral devices
• CPC Class Codes: G06F 13/4081 Live connection to bus, e.g. hot-plugging current or voltage limitation during live insertion H02H9/004
• CPC Class Codes: G06F 16/182 Distributed file systems
• CPC Class Codes: G06F 16/22 Indexing; Data structures therefor; Storage structures
• CPC Class Codes: G06F 8/61 Installation
• CPC Class Codes: G06F 8/65 Updates security arrangements therefor G06F21/57
• CPC Class Codes: G06F 8/71 Version control security arrangements therefor G06F21/57; Configuration management
• CPC Class Codes: G06Q 30/02 Marketing; Price estimation or determination; Fundraising
• 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 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: H04L 69/329 in the application layer [OSI layer 7]
• CPC Class Codes: H04L 9/40 Network security protocols

Abstract

A portable data-management system may be easily employed with multiple processing devices by eliminating the need to pre-install additional programs, agents, device drivers, or other software components on the hosts. A portable storage device contains software for a data-management application, which receives and processes test data from a meter that measures an analyte. The portable device may employ an interface protocol that makes the portable device immediately compatible with different operating systems and hardware configurations. Once the portable device is connected to the host, the data-management application can be automatically launched. The convenience and portability of a data-management system may be enhanced by integrating advanced data processing and display features with the portable device. The users may access some advanced presentations of health data without having to launch the data-management application on a separate host.

Claims

1. A system for securing health data, comprising:

a blood glucose meter including;

a housing having a port configured to receive a test sensor therein;

a measurement system disposed within the housing, the measurement system being configured to be coupled with the test sensor received in the port of the housing, the measurement system including at least one processor that executes program instructions to determine a glucose concentration measurement of a blood sample received by the test sensor;

a data storage system disposed within the housing, the data storage system including a first memory device storing a data-management application and a second memory device storing health data, the health data including glucose concentration measurements determined by the at least one processor of the measurement system, the second memory device being separate from the first memory device;

a data communications interface; and

a user interface operable to display at least a portion of the stored glucose concentration measurements; and

a processing device configured to establish data communications with the blood glucose meter via the data communications interface; and

wherein, in response to establishment of the data communications between the blood glucose meter and the processing device, the processing device (i) reads the data-management application from the first memory device and the health data from the second memory device, (ii) processes the health data by executing the data-management application, and (iii) displays the processed health data on a display of the processing device, the displayed processed health data being different than the glucose concentration measurements displayed on the user interface of the blood glucose meter,

wherein the processing device is configured to execute one or more other applications, and wherein the blood glucose meter is configured to prevent the one or more other applications executing on the processing device from accessing the health data,

wherein the processing device does not store any component of the data-management application before data communications are established between the blood glucose meter and the processing device,

wherein the processing device processes the health data from the second memory without permanently storing the health data on the processing device, and

wherein the data-management application includes a termination component configured to delete any of the health data transferred to the processing device.

2. The system of claim 1, wherein the second memory device is at least one of a universal serial bus (USB) flash drive and a memory card.

3. The system of claim 1, wherein the data storage system is configured according to a memory map indicating security levels for areas of memory in the data storage system, the security levels determining access to data stored in the areas of memory.

4. The system of claim 1, wherein the first memory device is an EEPROM and the second memory device is a flash memory.

5. The system of claim 1, wherein the blood glucose meter includes a data-check system configured to validate the data-management application stored in the data storage system.

6. The system of claim 1, wherein the processing device removes any data associated with the data-management application from a memory of the processing device before ending execution of the data-management application.

7. The system of claim 1, wherein the processing device ends the processing and display of the health data on the display of the processing device when the data communications between the data storage system and the processing device are terminated.

8. The system of claim 1, wherein the processing device is compatible with an interface protocol configuration of the blood glucose meter, the interface protocol configuration allowing data communication to be established between the blood glucose meter and the processing device, and in response to establishment of the data communications between the blood glucose meter and the processing device, the blood glucose meter is reconfigured from the interface protocol configuration to a software configuration allowing the processing device to read the data-management application and the health data from the data storage system, the software configuration being different from the interface protocol configuration.

9. The system of claim 8, wherein the interface protocol configuration is a universal serial bus (USB) mass portable device (MSD) configuration.

10. The system of claim 1, wherein the data communications interface includes at least one of a universal serial bus (USB) interface, a secure digital (SD) interface, and a radio frequency (RF) link.

11. The system of claim 1, wherein the processing device is a personal computer, a personal digital assistant, or a smart cellular phone.

12. The system of claim 1, wherein the data communications interface further provides data communications between the blood glucose meter and a printer, and wherein (i) the blood glucose meter provides a ready-to-print file from the health data and sends the ready to print file to the printer, or (ii) the printer receives, formats, and prints the health data from the data storage system.

13. The system of claim 1, wherein the health data further includes temperature data, blood pressure data, heart rate data, breathing data or weight data.

14. The system of claim 1, wherein the processing device is one of a plurality of types of processing devices that are compatible with the data communications interface.

15. The system of claim 1, further comprising a second processing device, wherein additional features of the data-management application are enabled when the blood glucose meter detects it is connected to the second processing device as compared to the processing device.

16. The system of claim 15, wherein the additional features include a download of all health data in the data storage system to the second processing device or a launching of a master version of the data-management application.

17. The system of claim 1, wherein a security component controls access by the processing device to the health data in the data storage system.

18. The system of claim 17, wherein the security component prompts a user for authentication information and validates the authentication information when the processing device attempts to access the health data.

19. The system of claim 17, wherein the security component establishes a trusted system by requiring the processing device to be registered with the blood glucose meter.

20. The system of claim 19, wherein the processing device requires the blood glucose meter to be registered and a two-way authentication is established.

21. The system of claim 17, wherein the security component encrypts the health data on the data storage system.

22. The system of claim 17, wherein the security component only permits the data-management application access to the health data.

23. The system of claim 17, wherein the health data is encrypted and the data-management application is required to decrypt the data.

45. The system of claim 1, wherein the displayed processed health data includes:

(i) customizable averages based on the health data;

(ii) health data in relation to a user-specified target range;

(iii) feedback and predictive analysis related to the health data;

or (iv) any combination of (i), (ii), and (iii).

46. The system of claim 1, wherein the blood glucose meter is configured to prevent the one or more other applications executing on the processing device from accessing the health data by being reconfigured from an interface protocol configuration to a software configuration.

24. A system for securing health data, comprising:

a blood glucose meter including;

a housing having a port configured to receive a test sensor therein;

a measurement system disposed within the housing, the measurement system being configured to be coupled with the test sensor received in the port of the housing, the measurement system including at least one processor that executes program instructions to determine a glucose concentration measurement of a blood sample received by the test sensor;

a data storage system disposed within the housing, the data storage system including a first memory device storing a data-management application and a second memory device storing health data, the second memory device being separate from the first memory device, the stored health data including the glucose concentration measurements determined by the at least one processor of the measurement system;

a data-check system configured to validate the data-management application stored in the data storage system, and

a user interface operable to display at least a portion of the stored glucose concentration measurements; and

a processing device configured to be connected to the blood glucose meter; and

a display configured to be communicatively coupled to the processing device,

wherein the blood glucose meter has a first software configuration corresponding to an interface protocol and a second software configuration specific to the data-management application, the second software configuration permitting the data-management application to be executed from the blood glucose meter,

wherein upon connection between the blood glucose meter and the processing device, the processing device communicates with the blood glucose meter according to the interface protocol, and thereafter the blood glucose meter is reconfigured from the first configuration to the second configuration, with the blood glucose meter in the second configuration, the processing device (i) reads the data-management application from the first memory device and the health data from the second memory device, (ii) processes the health data by executing the data-management application, and (iii) displays the processed health data on the display, the displayed processed health data being different than the glucose concentration measurements displayed on the user interface of the blood glucose meter,

wherein the processing device is configured to execute one or more other applications, and wherein the blood glucose meter is configured to prevent the one or more other applications executing on the processing device from accessing the health data,

wherein the processing device does not store any component of the data-management application before the connection is established between the blood glucose meter and the processing device, and

wherein the processing device processes the health data from the second memory without permanently storing the health data on the processing device, and

wherein the data-management application includes a termination component configured to delete any of the health data transferred to the processing device.

25. The system according to claim 24, wherein the data storage system includes an initialization program, and upon connection between the blood glucose meter and the processing device, the initialization program is executed and causes the blood glucose meter to be reconfigured from the first configuration to the second configuration.

26. The system of claim 24, wherein the interface protocol corresponds to a universal serial bus (USB) and the first configuration is a USB mass portable device (MSD) configuration.

27. The system according to claim 24, wherein the blood glucose meter and the processing device are connected via a universal serial bus (USB) interface, a secure digital interface, or a radio frequency (RF) link.

28. The system of claim 24, wherein the processing device is a personal computer, a personal digital assistant, or a smart cellular phone.

29. The system of claim 24, wherein the processing device removes any data on the processing device associated with the data-management application before ending execution of the data-management application.

30. The system according to claim 24, wherein the data-management application closes when the data communications between the blood glucose meter and the processing device is terminated.

31. A method for securing health data, comprising:

receiving a test sensor in a port of a housing of a blood glucose meter such that the test sensor is coupled with a measurement system of the blood glucose meter;

receiving a blood sample via the test sensor;

in response to the receiving the blood sample, executing program instructions, via at least one processor of the blood glucose meter, to determine a first glucose concentration measurement of the received blood sample;

storing the determined first glucose concentration measurement in a data storage system of the blood glucose meter, the data storage system including a first memory device storing a data-management application and a second memory device storing glucose concentration measurements including the determined first glucose concentration measurement, the second memory device being separate from the first memory device;

displaying, on a user interface of the blood glucose meter, the first stored glucose concentration measurement;

establishing, for a first time, data communications between the blood glucose meter and a processing device via a data communications interface of the blood glucose meter, the processing device does not store any component of the data-management application before data communications are established between the blood glucose meter and the processing device for the first time;

in response to the establishing of the data communications between the blood glucose meter and the processing device, reading, with the processing device, the data-management application from the first memory device and the glucose concentration measurements from the second memory device;

in response to the establishing of the data communications between the blood glucose meter and the processing device, preventing one or more other applications executing on the processing device from accessing the stored glucose concentration measurements;

processing, with the processing device, the glucose concentration measurements from the second memory by executing the data-management application without permanently storing the glucose concentration measurements on the processing device;

displaying, with the processing device, the processed glucose concentration measurements on a display coupled to the processing device, the displayed processed glucose concentration measurements being different than the first glucose concentration measurement displayed on the user interface of the blood glucose meter; and

deleting from a memory of the processing device, using a termination component of the data-management application, the glucose concentration measurements read by the processing device.

32. The method of claim 31, further comprising removing any data on the processing device associated with the data-management application before termination of the act of processing the glucose concentration measurements.

33. The method according to claim 31, further comprising terminating the act of processing the glucose concentration measurements when the data communications between the blood glucose meter and the processing device is terminated.

34. The method of claim 31, wherein the processing device is compatible with an interface protocol configuration of the blood glucose meter, the interface protocol configuration allowing data communication to be established between the blood glucose meter and the processing device, and in response to the establishing of the data communications between the blood glucose meter and the processing device, the method further comprising reconfiguring the blood glucose meter from the interface protocol configuration to a software configuration specific to the data-management application, the software configuration being different from the interface protocol configuration.

35. The method of claim 34, wherein the interface protocol configuration is a universal serial bus (USB) mass portable device (MSD) configuration.

36. The method of claim 31, wherein the data communications interface includes at least one of a universal serial bus (USB) interface, a secure digital (SD) interface, and a radio frequency (RF) link.

37. The method of claim 31, wherein the processing device is a personal computer, a personal digital assistant, or a smart cellular phone.

38. The method of claim 31, further comprising controlling access by the processing device to the glucose concentration measurements in the data storage system.

39. The method of claim 38, wherein controlling access comprises prompting a user for authentication information and validating the authentication information when the processing device attempts to access the glucose concentration measurements.

40. The method of claim 38, wherein controlling access comprises restricting access to the glucose concentration measurements to the data-management application.

41. The method of claim 38, further comprising encrypting the glucose concentration measurements and the controlling access comprises requiring the data-management application to decrypt the glucose concentration measurements.

47. The method of claim 31, further comprising validating, using a data-check system, the glucose concentration measurement stored in the data storage system.

48. The method of claim 31, further comprising validating, using a data-check system, the glucose concentration measurement and the data-management application stored in the data storage system.

42. A method for securing health data, comprising:

receiving a test sensor in a port of a housing of a blood glucose meter such that the test sensor is coupled with a measurement system of the blood glucose meter;

receiving a blood sample via the test sensor;

in response to the receiving the blood sample, executing program instructions, via at least one processor of the blood glucose meter, to determine a first glucose concentration measurement of the received blood sample;

storing the determined first glucose concentration measurement in a data storage system of the blood glucose meter, the data storage system including a first memory device storing data-management application and a second memory device storing health data including glucose concentration measurements, the second memory device being separate from the first memory device;

validating, using a data-check system, the first glucose concentration measurement stored in the data storage system;

displaying, on a user interface of the blood glucose meter, at least a portion of the stored glucose concentration measurements;

detecting a connection between the blood glucose meter and a processing device, the processing device does not store any component of the data-management application before the connection is detected between the blood glucose meter and the processing device, the blood glucose meter having a first software configuration corresponding to an interface protocol and a second software configuration specific to the data-management application, the second software configuration permitting the data-management application to be executed from the blood glucose meter;

in response to the detecting of the connection between the blood glucose meter and the processing device, reconfiguring the blood glucose meter from the first software configuration to the second software configuration, followed by;

reading, with the processing device, the data-management application from the first memory device and the health data from the second memory device;

preventing one or more other applications executing on the processing device from accessing the health data from the second memory device;

processing, with the processing device, the health data from the second memory device by executing the data-management application without permanently storing the health data on the processing device; and

displaying, with the processing device, the processed health data on a display of the processing device, the displayed processed health data being different than the glucose concentration measurements displayed on the user interface of the blood glucose meter; and

deleting from a memory of the processing device, using a termination component of the data-management application, the health data read by the processing device.

43. The method of claim 42, further comprising launching an initialization program stored in the data storage system upon detection of the connection, wherein the blood glucose meter is reconfigured by the initialization program.

44. The method of claim 42, wherein the interface protocol corresponds to one of a universal serial bus (USB) interface, a secure digital interface, and a radio frequency (RF) link.

49. A system for securing health data, comprising:

a blood glucose meter including;

a housing having a port configured to receive a test sensor therein;

a measurement system disposed within the housing, the measurement system being configured to be coupled with the test sensor received in the port of the housing, the measurement system including at least one processor that executes program instructions to determine a glucose concentration measurement of a blood sample received by the test sensor;

a data storage system disposed within the housing, the data storage system including a first memory device storing data-management application and a second memory device storing health data in an encrypted fashion such that the data-management application is required to decrypt the stored health data, the health data including glucose concentration measurements determined by the at least one processor of the measurement system, the second memory device being separate from the first memory device;

a data communications interface;

a user interface operable to display at least a portion of the stored glucose concentration measurements; and

a data-check system configured to validate the data-management application stored in the data storage system;

a first processing device configured to establish data communications with the blood glucose meter via the data communications interface; and

a second processing device configured to establish data communications with the blood glucose meter via the data communications interface;

wherein, in response to establishment of the data communications between the blood glucose meter and the first processing device, the first processing device (i) reads the data-management application from the first memory device and the health data from the second memory device, (ii) processes the health data by executing the data-management application, and (iii) displays the processed health data on a display of the first processing device, the displayed processed health data being different than the glucose concentration measurements displayed on the user interface of the blood glucose meter, the displayed processed health data including;

(i) customizable averages based on the health data;

(ii) health data in relation to a user-specified target range;

(iii) feedback and predictive analysis related to the health data;

or (iv) any combination of (i), (ii), and (iii),

wherein the first processing device is compatible with an interface protocol configuration of the blood glucose meter allowing data communication to be established between the blood glucose meter and the first processing device, and in response to establishment of the data communications between the blood glucose meter and the first processing device, the blood glucose meter is reconfigured from the interface protocol configuration to a software configuration allowing the first processing device to read the data-management application and the health data from the data storage system, the software configuration being different from the interface protocol configuration, the software configuration including a security component that controls access by the first processing device to the health data in the data storage system such that the security component only permits the data-management application access to the health data, the security component controlling access to the health data based on data type,

wherein the first processing device does not store any component of the data-management application before data communications are established between the blood glucose meter and the first processing device,

wherein the first processing device processes the health data from the second memory without permanently storing the health data on the first processing device,

wherein the first processing device removes any data associated with the data-management application from a memory of the first processing device before ending execution of the data-management application,

wherein the data-management application includes a termination component configured to delete any health data transferred to the first processing device, and

wherein, in response to establishment of the data communications between the blood glucose meter and the second processing device, additional features of the data-management application are enabled on the second processing device as compared with the first processing device, the additional features including a download of all health data in the data storage system to the second processing device.

50. A method for securing health data, comprising:

receiving a test sensor in a port of a housing of a blood glucose meter such that the test sensor is coupled with a measurement system of the blood glucose meter;

receiving a blood sample via the test sensor;

in response to the receiving the blood sample, executing program instructions, via at least one processor of the blood glucose meter, to determine a first glucose concentration measurement of the received blood sample;

storing the determined first glucose concentration measurement in a data storage system of the blood glucose meter in an encrypted fashion, the data storage system including a first memory device storing data-management application and a second memory device storing health data including glucose concentration measurements, the second memory device being separate from the first memory device;

validating, using a data-check system, the first glucose concentration measurement stored in the data storage system;

displaying, on a user interface of the blood glucose meter, at least a portion of the stored glucose concentration measurements;

detecting a connection between the blood glucose meter and a first processing device, the first processing device does not store any component of the data-management application before the connection is detected between the blood glucose meter and the first processing device, the blood glucose meter having a first software configuration corresponding to an interface protocol and a second software configuration specific to the data-management application, the second software configuration permitting the data-management application to be executed from the blood glucose meter;

in response to the detecting of the connection between the blood glucose meter and the first processing device, reconfiguring the blood glucose meter from the first software configuration to the second software configuration, followed by;

controlling access, via a security component of the blood glucose meter, to the health data based on data type;

reading, with the first processing device, the data-management application from the first memory device and the health data from the second memory device;

decrypting, using the data-management application running on the first processing device, the health data read from the second memory device;

preventing one or more other applications executing on the first processing device from accessing the health data from the second memory device such that only the data-management application running on the first processing device is permitted access to the health data;

processing, with the first processing device, the health data from the second memory by executing the data-management application without permanently storing the health data on the first processing device; and

displaying, with the first processing device, the processed health data on a display of the first processing device, the displayed processed health data being different than the glucose concentration measurements displayed on the user interface of the blood glucose meter, the displayed processed health data including;

(i) customizable averages based on the health data;

(ii) health data in relation to a user-specified target range;

(iii) feedback and predictive analysis related to the health data;

or (iv) any combination of (i), (ii), and (iii);

deleting from a memory of the first processing device, using a termination component of the data-management application, the health data read by the first processing device; and

in response to detecting of a connection between the blood glucose meter and a second processing device, enabling additional features of the data-management application on the second processing device as compared with the first processing device, the additional features including a download of all health data in the data storage system to the second processing device.