ELECTRONIC HEALTH RECORDS IN CLINICAL TRIALS

• US 20110251855A1
• Filed: 04/08/2011
• Published: 10/13/2011
• Est. Priority Date: 04/09/2010
• Status: Active Grant

• Current Assignee: MyMedicalRecords Incorporated
• Original Assignee: MyMedicalRecords Incorporated
• Inventors: Lorsch, Robert H.
• Granted Patent: US 8,775,212 B2
• Time in Patent Office: Days
• US Class Current: 705/3
• 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 80/00 ICT specially adapted for facilitating communication between medical practitioners or patients, e.g. for collaborative diagnosis, therapy or health monitoring
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

A method for collecting self-reported data from an individual for use in a clinical trial is provided. The method includes providing a web site allowing the individual to store, organize, and access personal health records associated with the individual and sharing selected personal health records associated with the individual with a clinical trial sponsor. A system for electronic health records includes a web server programmed to provide a secure web-based interface to the electronic health records, means to collect self-reports from an individual participating in a clinical trial, means to disseminate the self-reports from the individual to a clinical trial sponsor, and means to collect health care records from a health care provider of the individual.

Claims

1. A method for collecting self-reported data from an individual for use in a clinical trial, the method comprising:

providing a web site allowing the individual to store, organize, and access personal health records associated with the individual; and

sharing selected personal health records associated with the individual with a clinical trial sponsor, wherein the selected personal health records are specified by the individual through the web site.

2. The method of claim 1 further comprising receiving self-reports from the individual associated with participation in the clinical trial and storing health records containing the self-reports on a computer readable storage medium accessible by the web site.

3. The method of claim 2 wherein the receiving the self-reports comprises receiving the self-reports at a fax server.

4. The method of claim 3 where the receiving the self-reports comprises receiving the self-reports through an interactive voice response system of a server.

5. The method of claim 2 wherein the receiving the self-reports comprises receiving the self-reports through the web site.

6. The method of claim 2 wherein the self-reports include bar codes.

7. The method of claim 1 wherein the sharing the selected personal health records is performed using a clinical trial portal.

8. The method of claim 1 further comprising receiving medical records for the individual from one or more health care providers and storing the medical records on a computer readable storage medium.

9. The method of claim 1 further comprising providing a wallet card comprising emergency information associated with the individual including an emergency password and a web site identifier associated with the web site.

10. The method of claim 9 wherein the emergency information includes clinical trial participation information.

11. A system for electronic health records, comprising:

a web server programmed to provide a secure web-based interface to the electronic health records through a first web portal;

means to collect self-reports from an individual participating in a clinical trial and communicate the self-reports to the first web portal;

means to disseminate the self-reports from the individual to a clinical trial sponsor; and

means to collect health care records from a health care provider of the individual and communicate the health care records to the first web portal;

wherein the first portal being configured to provide access to both the self-reports and the health care records to the individual to the individual.

12. The system of claim 11 wherein the web server being programmed to provide emergency access to data of the individual through use of an emergency log-on to the first web portal.

13. The system of claim 12 wherein the data of the individual includes clinical trial contact information.

14. The system of claim 12 wherein the data includes self-reports associated with the clinical trial.

15. The system of claim 12 wherein the data includes data selected by the individual for the emergency access.

16. The system of claim 12 wherein emergency log-on instructions being provided on an emergency card.

17. The system of claim 11 wherein the first web portal allows the individual having access through the first web portal to specify health care records to share with the clinical trial sponsor.

18. A method for assisting in conducting a clinical trial, the method comprising:

providing participants in the clinical trial with access to a first web portal;

receiving self-reports from the participants in the clinical trial via at least one of phone, fax, and web and storing the self-reports and making available the self-reports to the participants through the first web portal;

receiving additional medical records associated with the participants from the participants in the clinical trial or health care providers of the participants in the clinical trial and making available the medical records to the participants through the first web portal;

providing a clinical trial sponsor with access to a second web portal, the self-reports from the participants in the clinical trial being made available through the second web portal;

selectively providing the additional medical records to the clinical trial sponsor according to preferences of the participants.