Method and apparatus for the processing of remotely collected electronic information characterizing properties of biological entities

• US 20020059030A1
• Filed: 07/17/2001
• Published: 05/16/2002
• Est. Priority Date: 07/17/2000
• Status: Abandoned Application

• Current Assignee: Andrew Cole, Enoch Scott Blackwell, Galo F. Acosta, Gregory A. Mullins, John A. Mcmorris III, John S. Scott, Meagan J. Packard, Michael J. Otworth, Richard H. Ferrans
• Original Assignee: Andrew Cole, Enoch Scott Blackwell, Galo F. Acosta, Gregory A. Mullins, John A. Mcmorris III, John S. Scott, Meagan J. Packard, Michael J. Otworth, Richard H. Ferrans
• Inventors: Cole, Andrew, Scott, John S., Acosta, Galo F., Mullins, Gregory A., Packard, Meagan J., Ferrans, Richard H., Blackwell, Enoch Scott, Otworth, Michael J., McMorris, John A. III
• Application Number:
  US09/906,005
• Publication Number:
  US 20020059030A1
• Time in Patent Office: Days
• US Class Current: 702/19
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/1112 Global tracking of patients, e.g. by using GPS
• CPC Class Codes: A61B 5/117 Identification of persons methods or arrangements for recognising patterns, e.g. fingerprints, G06F18/00, G06V40/00; identification of persons by analysing their voice or speech G10L17/00
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: Y02A 90/10 Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

A method and system 1 for processing electronic information associated with pre-determined characteristics of a biological subject 10. A testing kit 100 is provided at a location proximate the subject 10 for obtaining a representative sample 115 of the biological subject 10. The testing kit 100 includes a cartridge 110 which performs a pre-selected test or series of tests and generates electronic information 70 representative of sample characteristics. The electronic information 70 is transmitted to a remote data service 200 to determine pre-selected test results. The data service generates and transmits the test results to a testing kit operator, the subject, a provider, or a pre-selected third party, as may be appropriate and also performs a wide range of attendant administrative functions.

Claims

1. A method for processing electronic information associated with predetermined characteristics of a biological subject, the method comprising:

providing a testing kit to a location proximate the biological subject;

obtaining a representative sample of the biological subject;

introducing the sample to the testing kit;

the testing kit performing a pre-selected test or series of tests;

the testing kit generating electronic information representative of at least one characteristic of the sample;

transmitting the electronic information to a data service that is functionally not proximate the testing kit;

receiving the electronic information at the data service;

the data service processing the electronic information to determine a test result representative of the at least one sample characteristic of the sample;

the data service generating and electronically transmitting the test result to at least one of a testing kit operator, the subject, a provider, and a third party; and

the at least one of the testing kit operator, the subject, the provider, and the third party receiving the test result.

2. The method of claim 1, wherein the electronic information includes descriptive information associated with the at least one of the testing kit operator, the subject, the testing kit, the testing kit location.

3. The method of claim 2, further comprising the testing kit:

generating the electronic information representative of at least one of an acceptable operation of the testing kit and an acceptable introduction of the sample to the testing kit; and

transmitting the electronic information to the data service correlated with the electronic data resulting from the testing.

4. The method of claim 3, wherein determining a test result further comprises analysis of the electronic information to determine at least one of the acceptable operation of the testing kit and the proper introduction of the sample to the testing kit.

5. The method of claim 4, further comprising reporting by the data service to at least one of the subject, the provider and the third party of the results of the electronic information representing at least one of the acceptable operation of the testing kit and of the proper introduction of the sample.

6. The method of claim 2, further comprising communicating testing kit identification information and subject identification information to the data service.

7. The method of claim 6, further comprising associating a testing kit identification with a subject record.

8. The method of claim 2, further comprising communicating testing kit identification information to the data service.

9. The method of claim 2, wherein the testing kit comprises a cartridge for receiving the sample therein, the method comprising:

determining an in-service date associated with the cartridge;

accessing a second set of electronic information comprising expiration information for the cartridge;

determining an expiration status of the cartridge; and

transmitting a notification to at least one of the subject, the testing kit operator, the provider, and the third party as to the status.

10. The method of claim 8, wherein the testing kit comprises a cartridge for receiving the sample therein, the method further comprising:

determining an in-service date associated with the cartridge;

accessing a second set of electronic information comprising expiration information for the cartridge;

determining the expiration status of the cartridge; and

transmitting a notification to at least one of the subject, the testing kit operator, the provider and the third party as to the status.

11. The method of claim 2, wherein the descriptive information associated with the testing kit location is information obtained from a Global Positioning Satellite system.

12. The method of claim 11, wherein equipment for receiving and accessing the Global Positioning Satellite system location information is integral to a reader operable with the testing kit.

13. The method of claim 1, further comprising confirming the test results by one of reusing the testing kit and by using another testing kit.

14. The method of claim 1, further comprising storing the test results such that the results can be retrieved or reviewed at a later time.

15. The method of claim 1, further comprising notifying at least one of the subject and the testing kit operator that the results were transmitted to at least one of the provider and the third party.

16. The method of claim 1, further comprising indicating to at least one of the subject, the provider and the third party that the testing kit performed within allowable accuracy limits.

17. The method of claim 16, wherein the indicating is accomplished within a timeframe so as to avoid delay in providing a conclusion.

18. The method of claim 1, further comprising encrypting of the electronic information prior to transmitting to the data service.

19. The method of claim 18, further comprising decrypting by the data service of the received electronic information.

20. The method of claim 1, further comprising preparing the sample prior to introducing the prepared sample to the testing kit.

21. The method of claim 20, wherein the preparing includes one or more of liquification, addition of reagents, temperature treatment, physical treatment and chemical treatment.

22. The method of claim 1, wherein the test results are available within approximately an hour of the receiving of the electronic information by the data service.

23. The method of claim 1, wherein the testing kit contains at least one of a disposable sample cartridge, a re-useable sample collection cartridge, and a sample transport cartridge.

24. The method of claim 23, wherein the testing kit further includes at least one cartridge reader to be used in conjunction with the cartridge for performing a desired test.

25. The method of claim 1, further comprising storing of the electronic information received by the data service such that it may be used at a later time.

26. The method of claim 1, further comprising evaluating the test results to determine at least one of further testing and treatment requirements.

27. The method of claim 1, further comprising minimizing potential sample contamination through a reduction of at least one of the provider and the third party handling of the sample from the time of collection to the time of introduction to the testing kit.

28. The method of claim 1, where the location of the sample is remote from at least one of the location of a provider and the location of the third party.

29. The method of claim 1, wherein the location of the sample is proximate at least one of the location of the provider and the location of the third party.

30. The method of claim 1, wherein the sample comprises saliva.

31. The method of claim 1, further comprising at least one of allocating a fee and authorizing a disbursement for accomplishing at least a portion of the method for processing the electronic information.

32. The method of claim 31, wherein at least one of the fee allocating and disbursement authorization is initiated by a billing transaction when the electronic information is received at the data service.

33. The method of claim 31, wherein at least one of the fee allocating and disbursement authorization is initiated by a billing transaction from the data service when electronically transmitting test results to at least one of the provider and the third party.

34. The method of claim 31, further comprising selling the testing kit.

35. The method of claim 34, wherein the selling is associated with the cost of the determining the test results by the data service.

36. The method of claim 34, wherein the selling is associated with at least one of the cost of the storage of the electronic information and the determining of test results by the data service.

37. The method of claim 34, wherein the selling is associated with at least one of the cost of transporting the testing kit to the sample location and the amount pre-determined for disbursement to at least one of the provider and third party.

38. The method of claim 34, wherein the selling is associated with the cost of transmitting the test results to at least one of the subject, the provider, and the third party.

39. The method of claim 31, further comprising at the data service, communicating billing information associated with the testing to a compensator.

40. The method of claim 1, further comprising accomplishing all required laboratory certification activities at the data service location.

41. The method of claim 40, wherein the proximate location and the data service are operated such to avoid requirements of CLIA certification at proximate locations and wherein CLIA requirements are met at the data service.

42. The method of claim 1, further comprising:

the testing kit electronically transmitting a test request to the data service;

the data service receiving the test request;

based on the information contained in the test request, the data service accessing existing electronic information and retrieving a pre-defined operation required to perform the requested test for the testing kit transmitting the test request;

the data service generating controlling information representative of the pre-defined operation;

the data service transmitting the controlling information to the testing kit;

the testing kit receiving the controlling information and determining the pre-defined operation; and

the testing kit performing the pre-defined operation.

43. The method of claim 42, wherein the test request is initiated by at least one of the subject, the provider, and the third party located proximate the testing kit.

44. The method of claim 42, wherein the test request is initiated by at least one of the provider and the third party remote from the testing kit.

45. The method of claim 42, wherein the pre-defined operation and the resulting controlling information is under functionally centralized control of at least one individual.

46. The method of claim 1, wherein the biological subject is a human.

47. The method of claim 46, further comprising:

the introducing of the testing kit to the subject at subject initiation;

the receiving of a subject-initiated request for the testing kit to determine at least one subject characteristic by at least one of the provider and the third party;

the providing of the testing kit by at least one of the provider and the third party;

the obtaining of a small amount of the sample from the subject without participation by a licensed laboratory technician;

the interpreting of the received electronic information at the remote diagnostic data service;

the determining of the test result based upon an interpreting of the electronic information; and

the making of the test result available to at least one of the subject and the provider for subject consultation.

48. The method of claim 47, further comprising after receiving the test result, introducing at least one of a drug, medication, and treatment to the subject based at least in part on the test result.

49. The method of claim 1, wherein the biological subject is an animal.

50. The method of claim 49, wherein the animal is at least one animal used for at least one of developing drugs, evaluating drugs, evaluating medications, and evaluating treatments;

the sample is such that the taking of the sample does not jeopardize the animal'"'"'s life or otherwise preclude the taking of samples from the animal; and

the introducing of the sample to the testing kit is performed to a pre-determined schedule.

51. The method of claim 50, further comprising:

interpreting the received information for generating a test result;

electronically storing the test result at the data service; and

correlating the test result to support the evaluating, and developing of a drug, medications, and treatment.

52. The method of claim 1, wherein the biological subject is at least one of one of a plant, a collection of plants, and parts thereof.

53. The method of claim 1, wherein the biological subject is at least one of an environmental ecosystem, and elements thereof.

54. The method of claim 1, further comprising adding at least one of subject biometric, biographical, and demographic data to the electronic information transmitted to the data service.

55. The method of claim 54, further comprising:

the data service incorporating the at least one of the biometric, biographical, and demographic information with the test results;

the data service transmitting the at least one of the biometric, biographical, and demographic information to the subject, a provider or third party along with the test results; and

the subject, a provider or third party verifying that the reported results represent the intended sample from the correct subject.

56. The method of claim 55, wherein said verifying is made by the testing kit at the location of at least one of the subject, the provider, and the third party.

57. The method of claim 1, further comprising:

the provider determining a set of subject characteristics to be determined prior to a scheduled meeting between the subject and a provider;

the provider or a third party defining a testing kit based on the set of characteristics;

the provider or a third party preparing the defined testing kit;

at least one of the provider, and the third party including at least one disposable, reusable sample collection, and sample transport cartridge in the testing kit;

at least one of the provider and the third party introducing the testing kit to the location of the subject and the subject location being other than that of the provider;

at least one of the subject and the testing kit operator introducing the sample to the at least one disposable, reusable sample collection, and transport device;

the subject or testing kit operator introducing the at least one of the disposable and reusable sample collection and sample transport cartridge to a cartridge reader;

the cartridge reader generating electronic information representative of sample characteristics as determined by the cartridge reader;

the cartridge reader generating and transmitting the electronic information to the data service;

the data service interpreting the electronic information to determine a test result representative of the subject characteristics of interest; and

the data service electronically transmitting the test result to at least one of the subject, the provider, and the third party.

58. The method of claim 57, further comprising the data service reporting to at least one of the provider and the third party that the electronic information was received by the data service.

59. The method of claim 57 wherein the determining a set of subject characteristics comprises;

receiving a request for the history of the subject;

accessing at least one record in a database, the at least one record being related to the subject; and

providing the contents of the at least one record to the third party.

60. The method of claim 57, further comprising at the data service, performing an analysis to determine a recommendation for additional testing.

61. The method of claim 60, further comprising at the data service, the performing an analysis to determine a recommendation for additional testing includes comparing present data with prior data for the subject.

62. The method of claim 57, wherein the defined test kit provides for the testing for an allergic or interaction to a particular substance.

63. The method of claim 62, further comprising prior to obtaining the sample by a pre-defined time, introducing a screening-effective quantity of the substance to the subject.

64. The method of claim 57, wherein the testing kit provides for the testing for at least one of a response to a drug and medication based on changing conditions of the subject.

65. The method of claim 1, further comprising using biometrics to associate the sample with the subject.

66. The method of claim 65, wherein the receiving of the electronic information by the data service further comprises verifying the identity of an individual initiating the electronic information transmittal.

67. The method of claim 66, wherein the data service has access to information indicating authorization for at least one individual to transmit the electronic information.

68. The method of claim 66, wherein identification is based upon biometric data transmitted with the electronic information and representative of the individual initiating the transmittal of the electronic information.

69. The method of claim 68, further comprising the generation and transmittal of a notification to the individual initiating the transmittal of the electronic information of the resulting authorization determination.

70. The method of claim 69, further comprising providing a message by the data service to the individual initiating the transmittal of electronic information containing instructions for repeating the transmittal process if authorization is not initially successful.

71. The method of claim 1, further comprising encrypting of the test result by the data service before transmitting to at least one of the subject, the provider, and the third party.

72. The method of claim 71, further comprising decrypting of the transmitted test result at the location of at least one of the subject, the provider, and the third party.

73. The method of claim 72, further comprising determining an authorization of at least one of the subject, the provider, and the third party receiving the encrypted interpreting results to have access to the decrypted test result.

74. The method of claim 73, further comprising preventing decrypting of the received test result if the authorization determination is that the initiating individual does not have approved access to the decrypted test result.

75. The method of claim 1, further comprising correlating the electronic information or test result with at least one of a second set of electronic information, and the test results to generate correlation information.

76. The method of claim 75, wherein the electronic information or test results comprises electronic information about other samples from other subjects.

77. The method of claim 75, wherein the electronic information or test results comprises electronic information from other samples from the same subject.

78. The method of claim 75, wherein the electronic information comprises pre-defined test result standards.

79. The method of claim 78, wherein the correlation information is used for recommending further testing for subject.

80. The method of claim 78, further comprising:

the testing kit electronically transmitting a test request to the data service;

the data service receiving the test request;

based on the information contained in the test request, the data service accessing existing electronic information and retrieving the pre-defined operation or series of operations required to perform the requested test for the testing kit transmitting the test request;

the data service generating controlling information representative of the pre-defined operation or series of operations;

the data service transmitting the controlling information to the testing kit;

the testing kit receiving the controlling information and from it determining the pre-defined operation or series of operations; and

the testing kit performing at least one of the pre-defined operation and the series of operations.

81. The method of claim 80, wherein the test request is initiated by at least one of the subject, the provider, and the third party located proximate the testing kit.

82. The method of claim 80, wherein the test request is initiated by at least one of the provider and the third party while being remotely located from the testing kit.

83. The method of claim 75, further comprising analyzing the correlation information to determine if the test results lie within a pre-determined range of acceptable values.

84. The method of claim 83, further comprising notifying at least one of the subject, the provider, and the third party if the test results lie within a pre-determined range of acceptable values.

85. The method of claim 75, further comprising an electronic transmitting of the correlation information generated to at least one of the subject, the provider, and the third party.

86. The method of claim 75, wherein the correlating comprises comparing at least one of the electronic information and the test results with a second set of electronic information.

87. The method of claim 86, wherein the electronic information comprises a treatment database.

88. The method of claim 87, further comprising presenting treatment options data based on the treatment database and at least one of the test results of the subject, the provider, and the third party.

89. The method of claim 86, wherein the electronic information comprises a set of pre-defined clinical trial recruitment criteria where resulting correlation information is used to determine potential candidates to participate in clinical trials of at least one of medications and treatment.

90. The method of claim 89, further comprising notifying at least one of the subject, the provider, and the third party that the test results indicate the subject to be a potential candidate for inclusion into at least one clinical trial conducted by a fourth party.

91. The method of claim 90, further comprising transmitting at least one of an acceptance and a rejection by at least one of the subject, the provider, and the third party regarding participation in the at least one clinical trial conducted by the fourth party.

92. The method of claim 90, wherein the notifying is transmitted to the testing kit.

93. The method of claim 90, wherein the notifying is provided to at least one of the subject, the provider, and the third party in conjunction with the transmittal of the test results.

94. The method of claim 89, further comprising notifying a fourth party conducting the clinical trials of the identification by the data service of a potential candidate to participate in the at least one clinical trials.

95. The method of claim 94, wherein the notifying is provided to the fourth party conducting the at least one clinical trials without including the identification information of the subject.

96. The method of claim 94, further comprising billing the fourth party conducting the at least one clinical trial for fees associated with determining and reporting the existence of a potential candidate to participate in the at least one clinical trial.

97. The method of claim 86, wherein the electronic information includes side effects data.

98. The method of claim 97, further comprising the data service presenting the side effects data along with the test results to at least one of the subject, the provider, and the third party.

99. The method of claim 75, further comprising generating at least one of referral and advertising revenue from the generating of the correlation information.

100. The method of claim 75, further comprising storing the correlation information such that the correlation information is accessible to a plurality of third parties.

101. The method of claim 100, wherein access is available to the data service for a fee set by the data service to be paid by the third party.

102. The method of claim 1, further comprising:

when introducing a testing kit to a location proximate the sample, determining a schedule for performing the testing based upon subject history or requirements of the testing kit;

at the data service, determining if the testing has been performed by comparing received electronic information from the testing kit to the required schedule; and

at the data service, transmitting a reminder to at least one of the subject, the provider, and the third party if the testing has not been performed

103. The method of claim 102, further comprising:

issuing one or more reminders to at least one of the subject, the provider, and the third party when said electronic information has not been received according to the schedule; and

issuing a notification to at least one of the subject, the provider, and the third party when said test has not been performed within a preset expiration time.

104. The method of claim 1, further comprising:

the subject being evaluated as a possible candidate for quarantine based upon at least one of potential medical, chemical, and biological condition;

a provider determining a set of desired tests based upon the at least one potential medical, chemical, and biological condition;

preparing a testing kit based on the set of desired tests;

introducing the testing kit to the subject at a quarantine facility;

the testing kit comprising at least one of a disposable sample and a reusable sample collection and transport kit;

collecting at least one sample from the subject in such a method as required by the desired tests;

introducing the at least one sample to the at least one of the disposable and reusable sample collection and transport device;

introducing the at least one disposable or reusable sample collection and transport kit to a reusable testing kit;

the reusable testing kit generating electronic information representative of sample parameters of interest as determined by the reusable testing kit;

at a data service, receiving electronic information generated by the testing kit;

at the data service interpreting the received electronic information to determine if the subject should be quarantined; and

providing a notification to at least one of the provider and the third party of such determination.

105. The method of claim 104, wherein a quarantine facility is part of an immigration facility that screens an immigrating person as the quarantine subject.

106. The method of claim 104, further comprising granting the quarantine subject a clearance based upon the granting notification.

107. The method of claim 106, wherein the clearance is a determination that the quarantine subject is not a substantial health threat outside of the quarantine facility.

108. The method of claim 107, further comprising the step of allowing the quarantined subject to leave the quarantine facility.