Direct reporting of adverse events

• US 8,457,989 B2
• Filed: 01/09/2009
• Issued: 06/04/2013
• Est. Priority Date: 01/09/2009
• Status: Active Grant

• Current Assignee: Cerner Innovation, Inc. (Oracle Corporation)
• Original Assignee: Cerner Innovation, Inc. (Oracle Corporation)
• Inventors: Gedeon, Hanna Mina, Griffin, Sara Jane
• Primary Examiner(s): Lubin, Valerie
• Application Number:
  US12/351,620
• Publication Number:
  US 20100179829A1
• Time in Patent Office: 1,607 Days
• Field of Search: 707/100, 707/636, 705/2, 705/3
• US Class Current: 705/3
• CPC Class Codes: G06Q 10/06 Resources, workflows, human or project management; Enterprise or organisation planning; Enterprise or organisation modelling
• CPC Class Codes: G06Q 50/26 Government or public services business processes related to the transportation industry G06Q50/40
• 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
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 50/70 for mining of medical data, e.g. analysing previous cases of other patients
• CPC Class Codes: G16H 70/40 relating to drugs, e.g. their side effects or intended usage
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

Systems, methods, and computer readable media are described for communicating an adverse event report directly to an end-user receiving party and tracking one or more adverse event reports. An adverse event may be detected manually or automatically by a system and an electronic adverse event reporting form presented to a user with one or more data fields pre-populated with data from a patient'"'"'s electronic health record (EHR). The user may enter and edit data in the electronic form and may submit the data in the electronic form directly to an end-user receiving party such as the U.S. Food and Drug Administration. One or more receipts may be received from the receiving party and indicia from the receipts recorded to one or more records. The submitted adverse event reports may be tracked, accessed, and interacted with through a user interface and additional information may be provided to a user therein.

Claims

1. A method in a medical information computing environment for communicating data in an electronic adverse event reporting form directly to one or more end-user receiving parties, the method comprising:

monitoring, by a computing device having a processor and a memory, an electronic health record of a patient for one or more keywords that indicate the occurrence of an adverse event;

detecting by the computing device the occurrence of the adverse event based on the presence of the keywords in the electronic health record of the patient;

presenting automatically on a display device an electronic adverse event reporting form pre-populated with one or more patient data obtained from the electronic health record of the patient;

receiving one or more additional data from a user; and

electronically communicating, by the computing device having a processor and a memory, the data in the electronic form to the one or more end-user receiving parties, wherein the one or more end-user receiving parties comprise one or more of a government organization, a regulatory agency, a manufacturer, a non-governmental health organization, a research organization, quality control personnel, and an interested party.

2. The method of claim 1, wherein the electronic form is substantially similar in content to an adverse event reporting form provided by one or more of a government organization, a regulatory agency, a non-governmental health organization, and a research organization.

3. The method of claim 2, wherein the content of the electronic form is substantially similar to an adverse event reporting form provided by the United States Food and Drug Administration.

4. The method of claim 1, wherein the one or more data in the electronic form are communicated directly to at least the United States Food and Drug Administration.

5. The method of claim 1, wherein the one or more data in the electronic form are formatted to comply with an industry standard format.

6. The method of claim 5, wherein the one or more data in the electronic form are formatted to comply with at least one of a Health Level Seven, Inc. (HL7) standard and International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines.

7. The method of claim 1, wherein the one or more data in the electronic form are communicated as an electronic mail message.

8. The method of claim 7, wherein one or more of validating, encrypting and signing the message are completed prior to the step of communicating.

9. The method of claim 1, wherein the one or more data in the electronic form are usable by the one or more end-user receiving parties for at least one of viewing the electronic form on a computing device display, printing a copy of the electronic form, and populating one or more databases with the one or more data in the electronic form.

10. The method of claim 1, wherein a user accesses the electronic form from a user interface on a computing device displaying a patient'"'"'s electronic health record.

11. The method of claim 1, wherein the user is automatically prompted with the electronic form at a user interface of a computing device when an adverse event is detected.

12. A system in a medical information computing environment for facilitating the direct communication of one or more data in an electronic adverse event reporting form to one or more end-user receiving parties, the system comprising;

one or more computing devices having a processor and a memory and configured to provide;

an adverse event detection component that detects an adverse event through monitoring and analyzing a patient'"'"'s one or more electronic health records to identify a combination of first data elements in the one or more electronic health records that indicate the occurrence of the adverse event;

an electronic form generation component that generates an electronic form, at least partially pre-populates the form with one or more second data elements from patient'"'"'s one or more electronic health records, the second data elements being the same or different than the first data elements, and presents the at least partially pre-populated form to a user to allow additional input of one or more third data elements; and

a communication component that electronically communicates the one or more second and third data elements in the electronic form directly to the one or more end-user receiving parties.

13. The system of claim 12, wherein the content of the electronic form is substantially similar to an adverse event reporting form provided by the United States Food and Drug Administration.

14. The system of claim 12, wherein the electronic form is formatted to comply with one or more of a Health Level Seven, Inc. (HL7) standard and International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines.

15. The system of claim 12, wherein the one or more data in the electronic form is communicated as an electronic mail message directly to the one or more end-user receiving parties, and wherein the end-user receiving parties comprise one or more of a government organization, a regulatory agency, a non-governmental health organization, a research organization, and an interested party.

16. The system of claim 15 wherein the communication component provides one or more of the functions of validating the structure of the message, validating the one or more data, encrypting the message, encrypting the data, and signing the message prior to communicating the message.

17. A method in a medical information computing environment for communicating one or more data in an electronic adverse event reporting form directly to one or more end-user receiving parties, the method comprising:

monitoring, by a computing device having a processor and a memory, a patient'"'"'s electronic health record for a combination of first data elements that display a relationship between one or more of drugs, symptoms, and devices used in the care of the patient, the relationship indicating the occurrence of an adverse event, the adverse event comprising one or more of a medical error and an adverse reaction to a treatment provided to the patient;

detecting, by the computing device having a processor and a memory, the occurrence of the adverse event based on the combination of first data elements;

pre-populating an electronic adverse event reporting form with one or more second data elements from the patient'"'"'s electronic health record, the first and second data elements being the same or different;

presenting the electronic form to a user on a display device;

receiving one or more additional third data elements from a user to the electronic form;

preparing the one or more second and third data elements in the electronic form for communicating to at least the United States Food and Drug Administration by formatting the electronic form in an electronic messaging format in compliance with at least one of a Health Level Seven, Inc. (HL7) standard and International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines, and providing one or more of validation, encryption and signing of one or more of the message and the one or more second and third data elements in the electronic form; and

communicating the one or more second and third data elements in the electronic form to at least the United States Food and Drug Administration as an electronic mail message.