System and method for tracking and reporting clinical events across a vast patient population

• US 8,438,041 B2
• Filed: 04/08/2011
• Issued: 05/07/2013
• 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:
  US13/082,740
• Publication Number:
  US 20110246236A1
• Time in Patent Office: 760 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 gathering quality data for a plurality of healthcare providers over an extended computer network is disclosed. The system and method comprise an enhanced services server in electronic data communication with a plurality of Electronic Health Record (EHR) systems via a network connection, the plurality of EHR systems being configured to capture patient data for a plurality of patients at the plurality of healthcare providers'"'"' sites during a plurality of encounters with each of the plurality of patients, and the enhanced services server being built on the same architecture as the plurality of EHR systems. Electronic quality of care forms are retrieved from one or more form managers via the network connection and a plurality of fields in each of the electronic quality of care forms are automatically populated using the patient data captured by the plurality of EHR systems. The completed electronic quality of care forms are then automatically transmitted to one or more form receivers via the network connection, the one or more form receivers being one or more organizations that process quality of care data to qualify healthcare providers for at least one of certifications, accreditations, and monetary incentives.

Claims

1. A system for tracking and reporting clinical events over an extended computer network, the system comprising:

a plurality of Electronic Health Record (EHR) systems that are built on the same architecture and configured to capture patient data for a plurality of patients at a plurality of healthcare provider sites during a plurality of 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

an enhanced services server built on the same architecture as the plurality of EHR systems and that is in electronic data communication with the plurality of EHR systems via a network connection and configured to transmit and receive the patient data in the common data format, the enhanced services server including;

clinical event functionality configured to actively track the patient data in real time as it is captured at the plurality of EHR systems and identify any clinical events experienced by any of the plurality of patients, said client event functionality operating in response to triggering events at the plurality of healthcare provider sites that create a need for data to flow among the plurality of EHR systems or one of the plurality of EHR systems and the enhanced services server;

form retrieval functionality configured to retrieve electronic clinical event forms in the common data format from one or more form managers via the network connection, each of the electronic clinical event forms having a plurality of fields to be completed with patient data for the plurality of patients that experience clinical events, and the one or more form managers being one or more organizations responsible for maintaining forms used by healthcare providers to report clinical events; and

form filler functionality configured to fill in the plurality of fields in each of the electronic clinical event forms using the patient data captured in the common data format by the plurality of EHR systems, each of the adverse event forms being completed for a single patient from among the plurality of patients that experience a clinical event,

wherein each of the electronic clinical event forms is automatically transmitted to one or more form receivers via the network connection after its plurality of fields are filled in, the one or more form receivers being one or more organizations that process clinical event data to keep track of clinical events.

2. The system of claim 1, wherein the patient data captured by the plurality of EHR systems and filled in the plurality of fields in each of the electronic clinical event forms corresponds to at least one of:

adverse events being tracked for patients participating in a clinical trial;

efficacy events being tracked for at least one of a drug, a drug combination, and a medical device; and

general health events being tracked across a general patient population.

3. The system of claim 2, wherein the enhanced services server is configured to archive the patient data filled in to the plurality of fields in each of the electronic clinical event forms on a central database, to aggregate the patient data from the electronic clinical event forms based on user-defined criteria, and to identify patterns of adverse events from the clinical event data based on user-defined criteria.

4. The system of claim 3, wherein

each of the plurality of EHR systems includes functionality for capturing patient data corresponding to at least one of a drug and a medical device with which each of the plurality of patients is being treated;

and

the enhanced services server aggregates the patient data from the electronic clinical event forms based on the at least one of a drug and a medical device with which each of the plurality of patients is being treated.

5. The system of claim 4, wherein the enhanced services server is further configured to identify a potential problem with the at least one of a drug and a medical device by identifying a pattern of adverse events from the patient data from the electronic clinical event forms.

6. The system of claim 5, wherein the enhanced services server is further configured to identify a time period over which the pattern of adverse events occurs.

7. The system of claim 2, wherein

the one or more form receivers are at least one of a clinical trial sponsor, a clinical research organization (CRO), and the Food and Drug Administration (FDA) when the patient data in the plurality of fields in each of the electronic clinical event forms corresponds to an adverse event;

the one or more form receivers are at least one of a drug manufacturer, a medical device manufacturer, and the World Health Organization (WHO) when the patient data in the plurality of fields in each of the electronic clinical event forms corresponds to an efficacy event; and

the one or more form receivers are a public health organization when the patient data in the plurality of fields in each of the electronic clinical event forms corresponds to a general health event.

8. The system of claim 7, wherein the one or more form managers and the one or more form receivers are a single entity and the enhanced services server is interfaced with that single entity via an interoperability engine at the enhanced services server.

9. The system of claim 2, wherein the patient data from the electronic clinical event forms is aggregated using a sequential filtering process that implements a plurality of steps corresponding to a plurality user-defined criteria input into the enhanced services server.

10. The system of claim 2, further comprising a research system that is built on the same architecture as the enhanced services server and the plurality of EHR systems and that is in electronic data communication with the enhanced services server and the plurality of EHR systems via the network connection, wherein the enhanced services server is configured to receive input from a researcher at the research system to establish the user-defined criteria on which the identification of adverse events is based.

11. The system of claim 2, further comprising a research system that is maintained by a researcher and built on a different architecture than the enhanced services server and the plurality of the EHR systems, the research system being interfaced with at least the enhanced services server via an interoperability engine at the enhanced services server, and the enhanced services server being configured to receive input from a researcher at the research system to establish the user-defined criteria on which the identification of adverse events is based.

12. A method for gathering quality data for a plurality of healthcare providers 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 via a network connection, the plurality of EHR systems being configured to capture patient data for a plurality of patients at a plurality of healthcare provider sites during a plurality of 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;

actively tracking the patient data in real time in the enhanced services server as it is captured at the plurality of EHR systems and identifying any clinical events experienced by any of the plurality of patients, said operation of actively tracking operating in response to triggering events at the plurality of healthcare provider sites that create a need for data to flow among the plurality of EHR systems or between one of the plurality of EHR systems and the enhanced services server;

retrieving electronic clinical event forms in the enhanced services server in the common data format from one or more form managers via the network connection, each of the electronic clinical event forms having a plurality of fields to be completed with patient data, and the one or more form managers being one or more organizations responsible for maintaining forms used by healthcare providers to report clinical events;

filling in the plurality of fields in each of the electronic clinical event forms in the enhanced services server using the patient data captured in the common data format by the plurality of EHR systems, each of the adverse event forms being completed for a single patient from among the plurality of patients that experience a clinical event; and

automatically transmitting each of the electronic clinical event forms to one or more form receivers via the network connection after its plurality of fields are filled in, the one or more form receivers being one or more organizations that process clinical event data to keep track of clinical events.

13. The method of claim 12, wherein the patient data captured by the plurality of EHR systems and filled in the plurality of fields in each of the electronic clinical event forms corresponds to at least one of:

adverse events being tracked for patients participating in a clinical trial;

efficacy events being tracked for at least one of a drug, a drug combination, and a medical device; and

general health events being tracked across a general patient population.

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

archiving the patient data filled in to the plurality of fields in each of the electronic clinical event forms on a central database;

aggregating the patient data from the electronic clinical event forms based on user-defined criteria; and

identifying patterns of adverse events from the patient data from the electronic clinical event forms based on user-defined criteria.

15. The method of claim 14, further comprising the step of capturing patient data with the plurality of EHR systems that corresponds to at least one of a drug and a medical device with which each of the plurality of patients is being treated, wherein the step of aggregating the patient data from the electronic clinical event forms is based on the at least one of a drug and a medical device with which each of the plurality of patients is being treated.

16. The method of claim 15, further comprising the step of identifying a potential problem with the at least one of a drug and a medical device by identifying a pattern of adverse events from the patient data from the electronic clinical event forms.

17. The method of claim 16, wherein the enhanced services server is further configured to identify a time period over which the pattern of adverse events occurs.

18. The method of claim 13, wherein

the one or more form receivers are at least one of a clinical trial sponsor, a clinical research organization (CRO), and the Food and Drug Administration (FDA) when the patient data in the plurality of fields in each of the electronic clinical event forms corresponds to an adverse event;

the one or more form receivers are at least one of a drug manufacturer, a medical device manufacturer, and the World Health Organization (WHO) when the patient data in the plurality of fields in each of the electronic clinical event forms corresponds to an efficacy event; and

the one or more form receivers are a public health organization when the patient data in the plurality of fields in each of the electronic clinical event forms corresponds to a general health event.

19. The method of claim 18, wherein the one or more form managers and the one or more form receivers are a single entity and the enhanced services server is interfaced with that single entity via an interoperability engine at the enhanced services server.

20. The method of claim 13, wherein the step of aggregating the patient data from the electronic clinical event forms is implemented using a sequential filtering process in a plurality of steps corresponding to a plurality user-defined criteria input into the enhanced services server.

21. The method of claim 13, further comprising the step of placing a research system in electronic data communication with the enhanced services server and the plurality of EHR systems via the network connection, the research system being built on the same architecture as the enhanced services server and the plurality of EHR systems, and the enhanced services server being configured to receive input from a researcher at the research system to establish the user-defined criteria on which the identification of adverse events is based.

22. The method of claim 13, further comprising the step of interfacing a research system with at least the enhanced services server via an interoperability engine at the enhanced services server, the research system being maintained by a researcher and built on a different architecture than the enhanced services server and the plurality of the EHR systems, and the enhanced services server being configured to receive input from a researcher at the research system to establish the user-defined criteria on which the identification of adverse events is based.

23. A system for tracking and reporting clinical events 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 and that is in electronic data communication with the plurality of EHR systems via a network connection, the plurality of EHR systems being configured to capture patient data for a plurality of patients at a plurality of healthcare provider sites during a plurality of 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 configured to transmit and receive the patient data in the common data format and including;

clinical event functionality configured to actively track the patient data in real time as it is captured at the plurality of EHR systems and identify any clinical events experienced by any of the plurality of patients, said client event functionality operating in response to triggering events at the plurality of healthcare provider sites that create a need for data to flow among the plurality of EHR systems or between one of the plurality of EHR systems and the enhanced services server;

form retrieval functionality configured to retrieve electronic clinical event forms in the common data format from one or more form managers via the network connection, each of the electronic clinical event forms having a plurality of fields to be completed with patient data for the plurality of patients that experience clinical events, and the one or more form managers being one or more organizations responsible for maintaining forms used by healthcare providers to report clinical events; and

form filler functionality configured to fill in the plurality of fields in each of the electronic clinical event forms using the patient data captured in the common data format by the plurality of EHR systems, each of the adverse event forms being completed for a single patient from among the plurality of patients that experience a clinical event,

wherein each of the electronic clinical event forms is automatically transmitted to one or more form receivers via the network connection after its plurality of fields are filled in, the one or more form receivers being one or more organizations that process clinical event data to keep track of clinical events.

24. The system of claim 23, wherein the patient data captured by the plurality of EHR systems and filled in the plurality of fields in each of the electronic clinical event forms corresponds to at least one of:

adverse events being tracked for patients participating in a clinical trial;

efficacy events being tracked for at least one of a drug, a drug combination, and a medical device; and

general health events being tracked across a general patient population.

25. The system of claim 24, wherein the enhanced services server is configured to archive the patient data filled in to the plurality of fields in each of the electronic clinical event forms on a central database, to aggregate the patient data from the electronic clinical event forms based on user-defined criteria, and to identify patterns of adverse events from the clinical event data based on user-defined criteria.

26. The system of claim 25, wherein

each of the plurality of EHR systems includes functionality for capturing patient data corresponding to at least one of a drug and a medical device with which each of the plurality of patients is being treated;

and

the enhanced services server aggregates the patient data from the electronic clinical event forms based on the at least one of a drug and a medical device with which each of the plurality of patients is being treated.

27. The system of claim 26, wherein the enhanced services server is further configured to identify a potential problem with the at least one of a drug and a medical device by identifying a pattern of adverse events from the patient data from the electronic clinical event forms.

28. The system of claim 27, wherein the enhanced services server is further configured to identify a time period over which the pattern of adverse events occurs.

29. The system of claim 24, wherein

the one or more form receivers are at least one of a clinical trial sponsor, a clinical research organization (CRO), and the Food and Drug Administration (FDA) when the patient data in the plurality of fields in each of the electronic clinical event forms corresponds to an adverse event;

the one or more form receivers are at least one of a drug manufacturer, a medical device manufacturer, and the World Health Organization (WHO) when the patient data in the plurality of fields in each of the electronic clinical event forms corresponds to an efficacy event; and

the one or more form receivers are a public health organization when the patient data in the plurality of fields in each of the electronic clinical event forms corresponds to a general health event.

30. The system of claim 29, wherein the one or more form managers and the one or more form receivers are a single entity and the enhanced services server is interfaced with that single entity via an interoperability engine at the enhanced services server.

31. The system of claim 24, wherein the patient data from the electronic clinical event forms is aggregated using a sequential filtering process that implements a plurality of steps corresponding to a plurality user-defined criteria input into the enhanced services server.

32. The system of claim 24, further comprising a research system that is built on the same architecture as the enhanced services server and the plurality of EHR systems and that is in electronic data communication with the enhanced services server and the plurality of EHR systems via the network connection, wherein the enhanced services server is configured to receive input from a researcher at the research system to establish the user-defined criteria on which the identification of adverse events is based.

33. The system of claim 24, further comprising a research system that is maintained by a researcher and built on a different architecture than the enhanced services server and the plurality of the EHR systems, the research system being interfaced with at least the enhanced services server via an interoperability engine at the enhanced services server, and the enhanced services server being configured to receive input from a researcher at the research system to establish the user-defined criteria on which the identification of adverse events is based.