DIRECT REPORTING OF ADVERSE EVENTS
First Claim
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:
- presenting on a display an electronic adverse event reporting form pre-populated with one or more data;
receiving one or more additional data from a user; and
communicating 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.
1 Assignment
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Accused Products
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.
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Citations
20 Claims
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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:
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presenting on a display an electronic adverse event reporting form pre-populated with one or more data; receiving one or more additional data from a user; and communicating 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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13)
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14. 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:
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an adverse event detection component for detecting an adverse event through monitoring and analyzing a patient'"'"'s one or more electronic health records or by receiving a user input; an electronic form generation component for generating an electronic form, at least partially pre-populating the form with one or more data from one or more electronic records, and presenting the at least partially pre-populated form to a user to allow additional data input; and a communication component for communicating the one or more data in the electronic form directly to the one or more end-user receiving parties. - View Dependent Claims (15, 16, 17, 18, 19)
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20. 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:
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detecting the occurrence of an adverse event, wherein the adverse event is detected automatically by monitoring and analyzing a patient'"'"'s electronic health record, or manually by receiving an input from a user, and wherein a user is prompted to complete an electronic adverse event reporting form when an adverse event is automatically detected; pre-populating an electronic adverse event reporting form with at least one or more data from a patient'"'"'s electronic health record; presenting the electronic form to a user on a display; receiving one or more additional data inputs from a user to the electronic form; preparing the one or more data 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 data in the electronic form; and communicating the one or more data in the electronic form to at least United States Food and Drug Administration as an electronic mail message.
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Specification