System, method, and business method for storage, search and retrieval of clinical information

• US 20050071189A1
• Filed: 09/25/2003
• Published: 03/31/2005
• Est. Priority Date: 09/25/2003
• Status: Abandoned Application

• Current Assignee: Dstudysite, Inc., Estudysite., Inc. (Velocity Clinical Research, Inc.)
• Original Assignee: Estudysite., Inc. (Velocity Clinical Research, Inc.)
• Inventors: Blake, Richard A., McKewon, Christopher W., Kenney, Stephen W., O'Riordan, William D.
• Application Number:
  US10/670,763
• Publication Number:
  US 20050071189A1
• Time in Patent Office: Days
• US Class Current: 705/2
• 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 70/60 relating to pathologies

Abstract

Patient medical information is processed for storage and retrieval subject to anonymity constraints. The patient medical information is divided into a first information portion including information identifying a patient and information identifying a physician of the patient, and a second information portion including clinical and demographic information for the patient and the information identifying the physician. A unique code associated with the patient, but which does not identify the patient, is obtained when the first and second information portions are processed. The unique code is appended to the first and second information portions. The first information portion is then stored in a first information storage facility with other first information portions for other patients, and the second information portion is stored in a second information storage facility, separate from the first information storage facility, with second information portions for other patients. The anonymity constraints include the ability to mine the second information storage facility for clinical and demographic information useful for evaluating protocols for clinical trials and assembling candidate groups for the clinical trials without revealing the identities of the patients. Search results are made available to physicians who are identified in the results. Those physicians may then recruit their patients for participation in clinical trials.

Claims

1. A computer-implemented method for processing patient medical information for storage, comprising:

separating the patient medical information into a first information portion that includes at least information identifying a patient and information identifying a physician of the patient, and a second information portion that includes clinical and demographic information for the patient, and the information identifying the physician, but that does not include information identifying the patient;

generating a unique code for the patient which does not identify the patient;

placing the unique code into the first and second information portion;

providing the first information portion for storage in a first storage; and

providing the second information portion for storage in a second storage, separate from the first storage.

2. The method of claim 1, wherein the first storage is a first database system and the second storage is a second database system, separate from the first database system, the method further comprising:

placing the first information portion in one or more first database records;

placing the second information portion in one or more second database records;

and wherein, providing the first information portion includes providing the one or more first database records for storage in the first database system, and providing the second information portion includes providing the one or more second database records for storage in the second database system.

3. The method of claim 1, wherein the clinical and demographic information includes at least one ICD (International Classification of Diseases) code.

4. The method of claim 1, wherein the clinical and demographic information includes genetic information.

5. The method of claim 1, further comprising:

providing at least one third party subscription to contents of the second storage;

permitting a third party holding a third party subscription to search the second storage using clinical trial search criteria;

obtaining search results including a count of second information portions in the third party search which satisfy the clinical trial search criteria; and

providing the clinical trial search criteria and the search results to an administrator process.

6. The method of claim 5, further comprising the administrator process searching the second storage using the clinical trial search criteria, obtaining search results including one or more unique codes and information identifying one or more physicians of patients for whom the one or more unique codes were generated.

7. The method of claim 6, further comprising:

associating a physician process with a physician; and

providing the one or more unique codes of the search results to the physician process;

the physician process;

obtaining from the first storage information identifying patients for whom the one or more unique codes of the search results were generated; and

using the information identifying patients for whom the one or more unique codes of the search results were generated, recruiting patients for a clinical trial.

8. An entry processor for processing patient medical information for storage, comprising:

means for separating the patient medical information into a first information portion that includes at least information identifying a patient and information identifying a physician of the patient, and a second information portion that includes clinical and demographic information for the patient, and the information identifying the physician, but that does not include information identifying the patient;

means for placing a unique code for the patient which does not identify the patient into the first and second information portion; and

means for providing the first information portion for storage in a first storage, and for providing the second information portion for storage in a second storage, separate from the first storage.

9. The entry processor of claim 8, in combination with means for generating the unique code.

10. The entry processor of claim 8, wherein the clinical and demographic information includes at least one ICD (International Classification of Diseases) code.

11. The entry processor of claim 8, wherein the clinical and demographic information includes genetic information of the patient.

12. The entry processor of claim 8 further including:

means for placing the first information portion in one or more first database records; and

means for placing the second information portion in one or more second database records;

and wherein, the means for providing includes means for providing the one or more first database records for storage in a first database system, and for providing the one or more second database records for storage in a second database system, separate from the first database system.

13. A processor associated with a physician for retrieving patient medical information from storage, the patient medical information having been separated into first records stored in a first database and second records stored in a second database, separate from the first database, each first record being for a respective patient of the physician and associated with a second record for the same patient by a unique code which is contained in the first and second records and which does not identify the patient, each first record including at least patient identification information identifying a patient and information identifying the physician, each second record including clinical and demographic information for a patient, and information identifying a physician of the patient, but not including information identifying a patient, the physician processor comprising:

means for receiving results of a search conducted on the second database according to clinical trial search criteria, the results including one or more unique codes for patients of the physician;

means for using the one or more unique codes to obtain patient identification information from the first database; and

means for recruiting one or more patients identified by the patient identification information obtained from the first database.

14. The processor of claim 13, wherein the clinical and demographic information includes at least one ICD (International Classification of Diseases) code.

15. The processor of claim 13, wherein the clinical and demographic information includes genetic information of the patient.

16. A processor combination for processing patient medical information for storage and retrieval, comprising:

at least one entry processor with;

means for separating patient medical information into a first information portion that includes at least information identifying a patient and information identifying the patient'"'"'s physician, and a second information portion that includes clinical and demographic information for the patient, and the information identifying the patient'"'"'s physician (PHID), but that does not include information identifying the patient;

means for placing a unique code (PID) which does not identify the patient into the first and second information portion; and

means for providing the first information portion for storage in a first storage, and for providing the second information portion for storage in a second storage, separate from the first storage; and

at least one additional processor, with;

means for searching the second data storage using clinical trial search criteria;

means for receiving search results from the second data storage in response to the clinical trial search criteria.

17. The combination of claim 16, wherein the at least one additional processor is an administrator processor associated with the second storage, and the search results include:

PIDS for patients whose clinical and demographic information satisfies the clinical trial criteria; and

PHIDS for physicians of the patients whose clinical and demographic information satisfies the clinical trial criteria.

18. The combination of claim 16, wherein the at least one additional processor is a third party subscriber processor, and the search results include a number of second information portions satisfying the clinical trial search criteria.

19. A business method for evaluating a clinical trial protocol using patient medical information and one or more processors, comprising:

receiving patient medical information;

the patient medical information including patient identification information and clinical and demographic information;

storing the patient identification information separately from the clinical and demographic information;

subjecting the stored patient identification information and the stored clinical and demographic information to anonymity constraints;

according at least one subscriber a privilege level with respect to the clinical and demographic information denying identification of patients associated with the clinical and demographic information;

permitting the subscriber to search the clinical and demographic information according to search criteria for a clinical trial protocol; and

providing results to the subscriber.

20. The business method of claim 19, wherein the anonymity constraints include:

providing a unique code for a patient which does not include identification of the patient;

appending the unique code for the patient to the patient identification information for that patient and to the clinical and demographic information for the patient; and

storing including storing the patient identification information with appended unique code in a first storage, and storing the clinical and demographic information with appended unique code in a second storage separate from the first storage.

21. The business method of claim 20, wherein the search results provided to the subscriber include a number of hits but do not include unique codes.

22. The business method of claim 20 further including:

according an administrator of the second storage a privilege level with respect to the clinical and demographic information denying identification of patients associated with the clinical and demographic information, but permitting retrieval of unique codes;

permitting the administrator to search the clinical and demographic information according to the search criteria for a clinical trial protocol; and

providing results to the administrator which include unique codes.