System and method for performing medical research across a vast patient population

• US 8,595,028 B2
• Filed: 04/08/2011
• Issued: 11/26/2013
• Est. Priority Date: 02/25/2009
• Status: Active Grant

• Current Assignee: Greenway Health LLC (Greenway Medical Technologies Incorporated)
• Original Assignee: Greenway Medical Technologies Incorporated
• Inventors: Green, W. Thomas III, Ingram, James T., Samples, Johnathan, Schulenburg, Gregory H., Colquitt, Jason, Felt, Steve
• Primary Examiner(s): Morgan, Robert
• Assistant Examiner(s): KANAAN, MAROUN P
• Application Number:
  US13/082,761
• Publication Number:
  US 20110264466A1
• Time in Patent Office: 963 Days
• Field of Search: 705/2, 705/3
• US Class Current: 705/2
• CPC Class Codes: G06Q 10/06 Resources, workflows, human or project management; Enterprise or organisation planning; Enterprise or organisation modelling
• CPC Class Codes: G06Q 10/10 Office automation; Time management
• CPC Class Codes: G06Q 30/04 Billing or invoicing
• 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 15/00 ICT specially adapted for medical reports, e.g. generation or transmission thereof

Abstract

A system and method for performing medical research over an extended computer network is disclosed. The system and method comprise a plurality of Electronic Health Record (EHR) systems configured to capture patient data for a plurality of general patients at a plurality of corresponding healthcare provider sites during encounters with those patients, a research system configured to generate one or more electronic documents for completion with patient data that is related to the medical research, and an enhanced services server built on the same architecture as the plurality of EHR systems, wherein the one or more electronic documents include one or more first fields and one or more second fields for completion with patient data that is related to the medical research and the enhanced services server is in electronic data communication with the plurality of EHR systems and the one or more research systems via a network connection. Qualifying patients are identified from among the plurality of general patients and the first fields in each of the electronic documents are automatically populated with patient data for a corresponding qualifying patient. The one or more electronic documents that were automatically populated with patient data is electronically transmitted to at least one EHR system via the network connection, and the at least one EHR system is used to complete the second fields in each of the electronic documents during subsequent patient encounters. The completed electronic documents are electronically transmitted from the at least one EHR system to the enhanced services server, which electronically transmits the completed electronic documents back to the research system via the network connection.

Claims

1. A system for performing medical research over an extended computer network, the system comprising:

an enhanced services server built on the same architecture as a plurality of Electronic Health Record (EHR) systems, the plurality of EHR systems being configured to capture patient data for a plurality of general patients at a plurality of corresponding healthcare provider sites during encounters with those patients, said plurality of EHR systems being configured to capture and transmit the patient data in a common data format that specifies information to be collected and a format for the information to be collected, and the enhanced services server being in electronic data communication with the plurality of EHR systems and the one or more research systems via a network connection and being configured to transmit and receive the patient data in the common data format and to perform the steps of;

identifying a plurality of qualifying patients from among the plurality of general patients that qualify for the medical research;

electronically receiving the one or more electronic documents in the common data format from a research system via the network connection, the one or more electronic documents including one or more first fields and one or more second fields for completion with patient data that is related to the medical research;

automatically populating the one or more first fields in each of the one or more electronic documents with patient data in the common data format for a corresponding one of the plurality of qualifying patients, the patient data being related to the medical research and having been captured with at least one of the plurality of EHR systems during previous encounters with the plurality of qualifying patients;

electronically transmitting the one or more electronic documents that were automatically populated with patient data for each of the qualifying patients to at least one EHR system via the network connection, the at least one of the plurality of EHR systems being used to complete the one or more second fields in each of the one or more electronic documents with patient data related to the medical research during subsequent encounters with the plurality of qualifying patients;

electronically receiving the one or more electronic documents from the at least one EHR system via the network connection, the one or more electronic documents electronically received from the at least one of the plurality of EHR systems having the one or more first fields and one or more second fields completed; and

electronically transmitting the one or more electronic documents with the one or more first fields and one or more second fields completed back to the research system via the network connection.

2. The system of claim 1, wherein the at least one of the plurality of EHR systems includes Electronic Data Capture (EDC) software for completing the one or more second fields in each of the one or more electronic documents.

3. The system of claim 1, wherein

the research system is interfaced with the enhanced services server via an interoperability engine at the enhanced services server;

and

the patient data related to the medical research is made available to the research system in real time as it is captured with the at least one of the plurality of EHR systems.

4. The system of claim 1, wherein the one or more electronic documents are electronically transmitted, electronically received, electronically consumed, and automatically populated using the Retrieve Form for Data Capture (RFD) form management standard.

5. The system of claim 4, wherein

the at least one of the plurality of EHR systems performs as a form filler under the RFD form management standard;

the research system performs as a form manager and a form archiver under the RFD form management standard; and

the enhanced services server performs as a form filler and a form receiver under the RFD form management standard.

6. The system of claim 1, wherein the enhanced services server identifies the plurality of qualifying patients based on criteria received from the research system via the network connection.

7. The system of claim 1, wherein the enhanced services server is further configured to perform the steps of:

automatically populating consent forms with language required by the Health Insurance Portability and Accountability Act (HIPAA) regarding patient data that is protected under HIPAA; and

electronically transmitting the populated consent form to the at least one of the plurality of EHR systems for receiving consent from the plurality of qualifying patients to access those patients'"'"' patient-specific information,

wherein at least one of the plurality of qualifying patient'"'"'s patient-specific information will not be automatically populated in the one or more first fields or the one or more second fields if consent is not received from that qualifying patient.

8. The system of claim 1, wherein

the enhanced services server is further configured to perform the step of electronically transmitting the one or more electronic documents that were automatically populated with patient data for each of the qualifying patients back to the research system via the network connection;

and

the research system is configured to electronically transmit the one or more electronic documents that were automatically populated with patient data for each of the qualifying patients to one or more external systems for the one or more second fields to be completed and to receive the one or more electronic documents back from the one or more external systems with the one or more first fields and one or more second fields completed, the one or more external systems having EDC software for capturing patient data related to the medical research during subsequent encounters with the plurality of qualifying patients.

9. The system of claim 1, wherein the at least one of the plurality of EHR systems is further configured to automatically retrieve the one or more electronic documents for at least one of the plurality of qualifying patients at a scheduled time for a subsequent encounter with that qualifying patient, the one or more first fields in the one or more electronic documents retrieved for that qualifying patient being automatically populated with patient data for that at least one qualifying patient that is related to the medical research.

10. The system of claim 1, wherein

the research system includes Clinical Trials Management System (CTMS) software that generates clinical instructions for the medical research;

and

the enhanced services server consumes the clinical instructions and integrates them into tasks performed with the at least one of the plurality of EHR systems to automatically schedule subsequent encounters with the plurality of qualifying patients.

11. The system of claim 10, wherein the Retrieve Protocol for Execution (RPE) integration standard is used to consume the clinical instructions and integrate them into tasks performed with the at least one of the plurality of EHR systems.

12. The system of claim 1, wherein the research system includes template builder and/or form manager software for creating the one or more electronic documents and defining the one of more first fields and one or more second fields in the one or more electronic documents.

13. A method for performing medical research over an extended computer network, the method comprising the steps of:

placing an enhanced services server in electronic data communication with a plurality of Electronic Health Record (EHR) systems and a research system via a network connection, the plurality of EHR systems being configured to capture patient data for a plurality of general patients at a plurality of corresponding healthcare provider sites during encounters with those patients, said plurality of EHR systems being configured to capture and transmit the patient data in a common data format that specifies information to be collected and a format for the information to be collected, and the enhanced services server being built on the same architecture as the plurality of EHR systems and configured to transmit and receive the patient data in the common data format;

using the enhanced service server to identify a plurality of qualifying patients from among the plurality of general patients that qualify for the medical research;

electronically receiving at the enhanced services server one or more electronic documents in the common data format from the research system, the one or more electronic documents including one or more first fields and one or more second fields for completion with patient data that is related to the medical research;

using the enhanced services server to automatically populate the one or more first fields in each of the one or more electronic documents with patient data in the common data format for a corresponding one of the plurality of qualifying patients, the patient data being related to the medical research and having been captured with at least one of the plurality of EHR systems during previous encounters with the plurality of qualifying patients;

electronically transmitting the one or more electronic documents that were automatically populated with patient data for each of the qualifying patients from the enhanced services server to the at least one of the plurality of EHR systems via the network connection;

using the at least one of the plurality of EHR systems to complete the one or more second fields in each of the one or more electronic documents with patient data related to the medical research during subsequent encounters with the plurality of qualifying patients;

electronically transmitting the one or more electronic documents from the at least one EHR system to the enhanced services server via the network connection, the one or more electronic documents electronically received from the at least one of the plurality of EHR systems having the one or more first fields and one or more second fields completed; and

electronically transmitting the one or more electronic documents with the one or more first fields and one or more second fields completed from the enhanced services server back to the research system via the network connection.

14. The method of claim 13, wherein the at least one of the plurality of EHR systems includes Electronic Data Capture (EDC) software for completing the one or more second fields in each of the one or more electronic documents.

15. The method of claim 13, further comprising the step of using the enhanced services server to make the patient data related to the medical research available to the research system in real time as it is captured with the at least one of the plurality of EHR systems, wherein the research system is interfaced with the enhanced services server via an interoperability engine at the enhanced services server.

16. The method of claim 13, wherein the one or more electronic documents are electronically transmitted, electronically consumed, and automatically populated using the Retrieve Form for Data Capture (RFD) form management standard.

17. The method of claim 16, wherein

the at least one of the plurality of EHR systems performs as a form filler under the RFD form management standard;

the research system performs as a form manager and a form archiver under the RFD form management standard; and

the enhanced services server performs as a form filler and a form receiver under the RFD form management standard.

18. The method of claim 13, wherein the enhanced services server identifies the plurality of qualifying patients based on criteria received from the research system via the network connection.

19. The method of claim 13, further comprising the steps of:

automatically populating consent forms with language required by the Health Insurance Portability and Accountability Act (HIPAA) regarding patient data that is protected under HIPAA; and

electronically transmitting the populated consent form to the at least one of the plurality of EHR systems for receiving consent from the plurality of qualifying patients to access those patients'"'"' patient-specific information,

wherein at least one of the plurality of qualifying patient'"'"'s patient-specific information will not be automatically populated in the one or more first fields or the one or more second fields if consent is not received from that qualifying patient.

20. The method of claim 13, further comprising the steps of:

electronically transmitting the one or more electronic documents that were automatically populated with patient data for each of the qualifying patients from the enhanced services server back to the research system via the network connection;

electronically transmitting the one or more electronic documents that were automatically populated patient with data for each of the qualifying patients from the research system to one or more external systems for the one or more second fields to be completed;

completing the one or more fields in the one or more electronic documents with patient data related to the medical research during subsequent encounters with the plurality of qualifying patients, the one or more external systems having EDC software for capturing that patient data; and

transmitting the one or more electronic documents from the one or more external systems back to the research system via the network connection, the one or more electronic documents transmitted back to the research system having the one or more first fields and one or more second fields completed.

21. The method of claim 13, further comprising the step of using the at least one of the plurality of EHR systems to automatically retrieve the one or more electronic documents for one of the plurality of qualifying patients at a scheduled time for a subsequent encounter with that qualifying patient, the one or more first fields in the one or more electronic documents retrieved for that qualifying patient being automatically populated with patient data for that qualifying patient that is related to the medical research.

22. The method of claim 13, further comprising the steps of:

generating clinical instructions for the medical research with Clinical Trials Management System (CTMS) software at the research system; and

using the enhanced services server to consume the clinical instructions and integrate them into tasks performed with the at least one of the plurality of EHR systems to automatically schedule subsequent encounters with the plurality of qualifying patients.

23. The method of claim 22, wherein the Retrieve Protocol for Execution (RPE) integration standard is used to consume the clinical instructions and integrate them into tasks performed with the at least one of the plurality of EHR systems.

24. The method of claim 13, further comprising the step of using template builder and/or form manager software at the research system to create the one or more electronic documents and define the one of more first fields and one or more second fields in the one or more electronic documents.