Computer systems and methods for providing health care

• US 8,135,595 B2
• Filed: 05/14/2004
• Issued: 03/13/2012
• Est. Priority Date: 05/14/2004
• Status: Active Grant

• Current Assignee: H Lee Moffitt Cancer Center & Research Institute (State University System of Florida)
• Original Assignee: H Lee Moffitt Cancer Center & Research Institute (State University System of Florida)
• Inventors: Dalton, William S.
• Primary Examiner(s): Sereboff, Neal
• Application Number:
  US10/846,977
• Publication Number:
  US 20050256745A1
• Time in Patent Office: 2,860 Days
• Field of Search: 705/2, 705/3, 435/6
• US Class Current: 705/2
• CPC Class Codes: G06Q 10/00 Administration; Management
• CPC Class Codes: G06Q 40/08 Insurance
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

The invention provides a computer network comprising a first computer and one or more second computers that are in electronic communication with each other. The first computer is associated with a first health care facility and has instructions for retrieving, over a network, one or more data structures for a patient enrolled in a health care program. The one or more data structures for the patient collectively comprise (i) a patient identifier, (ii) a molecular profile from a biological specimen obtained from the patient at the first health care facility; and (iii) a clinical characterization of the patient that was made at the first health care facility. The first computer has instructions for retrieving, over the network connection, one or a plurality of treatment regimens that are deemed suitable for the patient based upon the molecular profile and the clinical characterization of the patient. The one or more second computers are at one or more locations other than the first health care facility and have one or more data structures for each patient in a plurality of patients enrolled in the health care program.

Claims

1. A computer program product for use in conjunction with a computer system, the computer program product comprising a computer readable storage medium and a computer program mechanism embedded therein, the computer program mechanism comprising:

one or more data structures associated with each patient in a plurality of patients enrolled in a health care program, the one or more data structures associated with each respective patient in the plurality of patients collectively comprising;

a patient identifier for the respective patient;

a molecular profile from one or more biological specimen obtained from the respective patient where the molecular profile comprises a longitudinal molecular profile for the patient, the longitudinal molecular profile being developed over time and being updated in response to one or more treatment regimens that have been provided to the respective patient;

a current clinical characterization of the respective patient including an updated clinical assessment based on treatment of the respective patient by the one or more treatment regimens; and

a plurality of treatment regimens and evidence based data relating to an outcome of treating one or more of the plurality of patients with one of the plurality of treatment regimens, wherein one or more of the plurality of treatment regimens is updated based at least in part on assessments of patients after treatment in accordance with a given treatment regimen; and

a therapeutic determination module comprising;

instructions executable by one or more processors for identifying a treatment regimen, from among the plurality of treatment regimens, for a patient in the plurality of patients based at least in part on the molecular profile, the current clinical characterization and the evidence based data.

2. The computer program product of claim 1 wherein

a data structure in the one or more data structures associated with a patient in the plurality of patients comprises a family medical history, and

the instructions for identifying a treatment regimen for the patient based upon the molecular profile associated with the patient and the clinical characterization associated with the patient further uses the family medical history for the patient to identify the treatment regimen.

3. The computer program product of claim 1, the computer program mechanism further comprising a data processing module, the data processing module comprising:

instructions for enrolling a patient in the health care program.

4. The computer program product of claim 3, wherein the instructions for enrolling the patient in the health care program comprise:

instructions for receiving a patient identifier for the patient.

5. The computer program product of claim 3, the data processing module further comprising:

instructions for inputting a detail of a clinical trial in which the patient is enrolled into a data structure associated with the patient.

6. The computer program product of claim 5, the data processing module further comprising:

instructions for inputting a result of the clinical trial in which the patient is enrolled into the data structure associated with the patient.

7. The computer program product of claim 6, the computer program mechanism further comprising:

instructions for using the result of the clinical trial in which the patient is enrolled to identify one or more treatment regimens in the plurality of treatment regimens.

8. The computer program product of claim 3, wherein the instructions for enrolling the patient in the health care program comprise:

instructions for receiving a molecular profile from a biological specimen obtained from the patient.

9. The computer program product of claim 3, wherein the instructions for enrolling the patient in the health care program comprise:

instructions for receiving a clinical characterization of the patient.

10. The computer program product of claim 1 wherein a data structure associated with a patient in the plurality of patients comprises at least one demographic characteristic for the patient.

11. The computer program product of claim 10 wherein the at least one demographic characteristic comprises at least one of:

a gender of the patient;

a marital status of the patient;

an ethnicity of the patient;

a primary language spoken by the patient;

the color of the eyes of the patient;

the hair color of the patient;

the height of the patient;

the weight of the patient;

the social security number of the patient;

the name of the patient;

the date of birth of the patient;

the education status of the patient;

a name of the primary physician for the patient;

a name of a referring physician for the patient;

a referral source for the patient;

an indication as to whether the patient is disabled;

an indication as to whether the patient is a smoker;

an indication as to whether the patient consumes alcohol;

a residential address of the patient;

a telephone number of the patient;

a name of an insurance carrier for an insurance policy held by the patient; and

a member identifier number for an insurance policy held by the patient.

12. The computer program product of claim 1 wherein the molecular profile in a data structure associated with a patient in the plurality of patients comprises abundance values of a plurality of cellular constituents in the biological specimen obtained from the patient.

13. The computer program product of claim 12 wherein each said abundance value is a normalized abundance level measurement for a cellular constituent in the biological sample.

14. The computer program product of claim 13 wherein each abundance value is an amount of a cellular constituent in the biological specimen, a concentration of a cellular constituent in the biological specimen, a cellular constituent activity level for a cellular constituent in the biological specimen, or a state of modification of a cellular constituent in the biological specimen.

15. The computer program product of claim 12 wherein each normalized abundance level measurement is obtained by a normalization technique selected from the group consisting of Z-score of intensity, median intensity, log median intensity, Z-score standard deviation log of intensity, Z-score mean absolute deviation of log intensity, calibration DNA gene set, user normalization gene set, ratio median intensity correction, and intensity background correction.

16. The computer program product of claim 12 wherein each said abundance value is determined by measuring an amount of a cellular constituent in the biological specimen.

17. The computer program product of claim 16 wherein the amount of the cellular constituent comprises an abundance of an RNA present in the biological specimen.

18. The computer program product of claim 17 wherein the abundance of the RNA is measured by contacting an array with the RNA from the biological specimen, or with nucleic acid derived from the RNA, wherein the array comprises a positionally addressable surface with attached nucleic acids or nucleic acid mimics, wherein the nucleic acids or nucleic acid mimics are capable of hybridizing with the RNA species, or with nucleic acid derived from the RNA species.

19. The computer program product of claim 1 wherein the biological specimen is a solid tumor, a liquid tumor, blood, or a biopsy from the respective patient.

20. The computer program product of claim 1 wherein the biological specimen is a liver biopsy, a breast biopsy, a kidney biopsy, a large intestine biopsy, an endometrial biopsy, a prostate biopsy, a skin biopsy, a bone marrow biopsy, a small intestine biopsy, a muscle biopsy, a thyroid nodule biopsy, a heart biopsy, or a nerve biopsy.

21. The computer program product of claim 1, the computer program mechanism further comprising a relapse module, the relapse module comprising:

instructions for determining whether a patient has relapsed with respect to a disease.

22. The computer program product of claim 1, the computer program mechanism further comprising a relapse module, the relapse module comprising:

instructions for identifying a clinical regimen when the patient has relapsed.

23. The computer program product of claim 1, the computer program mechanism further comprising a patient risk module comprising:

instructions for identifying a patient in the plurality of patients that is at risk for a disease.

24. The computer program product of claim 23 wherein the instructions for identifying the patient at risk for a disease comprises instructions for using at least one of a genetic factor and a predisposing environmental factor associated with the patient.

25. The computer program product of claim 1, the computer program mechanism further comprising a cost analysis module, the cost analysis module comprising:

instructions for computing a cost for treating a patient in the plurality of patients.

26. The computer program product of claim 1, wherein

the one or more data structures associated with a patient in the plurality of patients further comprises a clinical outcome of the patient;

and

the computer program mechanism further comprises a feedback module for receiving the clinical outcome of the patient.

27. The computer program product of claim 26, the computer program mechanism further comprising:

instructions for using the clinical outcome of the patient to identify one or more treatment regimens in the plurality of treatment regimens.

28. The computer program product of claim 1 wherein the clinical characterization in a data structure associated with a patient in the plurality of patients comprises a clinical diagnosis having an ICD-9 code and a date the clinical diagnosis was made by the patient'"'"'s physician.

29. The computer program product of claim 1 wherein a data structure in the one or more data structures associated with a patient in the plurality of patients further comprises at least one of an objective progress assessment for the patient and a subjective progress assessment for the patient.

30. The computer program product of claim 1 wherein a data structure in the one or more data structures associated with a patient in the plurality of patients further comprises a treatment history for the patient.

31. The computer program product of claim 1 wherein a data structure in the one or more data structures associated with the patient further comprises a reference to a clinical trial in which the patient is enrolled.

32. The computer program product of claim 31 wherein a data structure in the one or more data structures associated with a patient in the plurality of patients further comprises a result of the clinical trial.

33. The computer program product of claim 1 wherein a data structure in the one or more data structures associated with a patient in the plurality of patients comprises a Current Procedural Terminology (CPT) code for a procedure performed on the patient and a date the procedure was performed on the patient.

34. The computer program product of claim 1 wherein a data structure in the one or more data structures associated with a patient in the plurality of patients comprises information about a drug prescribed to the patient.

35. The computer program product of claim 34 wherein the information about the drug comprises at least one of a name of the drug prescribed, a strength of the drug prescribed, a quantity of the drug prescribed, and a number of refills of the drug prescribed.

36. The computer program product of claim 1 wherein the instructions for determining a diagnosis for the patient further comprise instructions for determining whether the patient has relapsed based upon a clinical outcome of the patient wherein, when a determination is made that the patient has relapsed, the instructions for identifying a treatment regimen comprise instructions for identifying a different treatment regimen from among the plurality of treatment regimens.

37. The computer program product of claim 1 wherein a diagnosis for a patient in the plurality of patients comprises a type of cancer, a heart disease, an autoimmune disease, a neurodegenerative disorder, or an infectious disease.

38. The computer program product of claim 1 wherein the plurality of patients enrolled in the health care program exceeds 100 patients.

39. The computer program product of claim 1, wherein

the one or more data structures associated with each respective patient in the plurality of patients further collectively comprise a clinical outcome of each respective patient in the plurality of patients;

and

the computer program mechanism further comprises instructions for using the clinical outcome of each respective patient in the plurality of patients to define one or more treatment regimens in the plurality of treatment regimens.