Computer algorithms and methods for product safety
DC CAFCFirst Claim
1. A method of generating and commercializing newly-identified proprietary data about a proprietary or nonproprietary product or device, wherein the method comprises the steps of:
- accessing at least one adverse event data source that stores adverse event data associated with the product or device;
analyzing the adverse event data to identify at least one new essential adverse event associated with the product or device, wherein the essential adverse event is one regulated by a regulatory agency requiring disclosure of the event in a package insert or data sheet accompanying the product or device;
creating at least one essential adverse event information database, wherein the creating step comprises analyzing data from the at least one adverse event data source to identify at least one new proprietary characteristic or use for the product or device responsive to identification of the at least one new essential adverse event associated with the product or device, wherein the creating step further comprises storing essential adverse event information, and wherein the essential adverse event information includes the at least one proprietary new use or characteristic and data related thereto; and
commercializing the proprietary essential adverse event information stored at the essential adverse event information database, which step comprises exclusive disclosure of the newly-identified proprietary essential adverse event information which, once identified, must then accompany the product or device.
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Abstract
The invention comprises systems, methods and a computerized data management device for creating and using data relating to a medical or non-medical product or device to enhance the safety of the product or device. A vast amount of data regarding adverse events associated with a particular product or device is analyzed to identify new essential adverse events associated with the product or device. At least one database of new essential adverse event information is created and utilized, and new characteristics of or uses for the product or device related to the new essential adverse event information are determined. Adverse event information is gathered for a large number of population sub-groups. The system may also be programmed to incorporate the information into intellectual property and contract documents. Manufacturers and/or distributors can include the proprietary information in consumer safety information, which accompanies the product or device, or which is provided to patients, users, consumers and the like, or in the case of certain medical products or devices, to prescribers of those products or devices. The system and methods also provide for commercializing the essential adverse event information.
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Citations
65 Claims
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1. A method of generating and commercializing newly-identified proprietary data about a proprietary or nonproprietary product or device, wherein the method comprises the steps of:
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accessing at least one adverse event data source that stores adverse event data associated with the product or device; analyzing the adverse event data to identify at least one new essential adverse event associated with the product or device, wherein the essential adverse event is one regulated by a regulatory agency requiring disclosure of the event in a package insert or data sheet accompanying the product or device; creating at least one essential adverse event information database, wherein the creating step comprises analyzing data from the at least one adverse event data source to identify at least one new proprietary characteristic or use for the product or device responsive to identification of the at least one new essential adverse event associated with the product or device, wherein the creating step further comprises storing essential adverse event information, and wherein the essential adverse event information includes the at least one proprietary new use or characteristic and data related thereto; and commercializing the proprietary essential adverse event information stored at the essential adverse event information database, which step comprises exclusive disclosure of the newly-identified proprietary essential adverse event information which, once identified, must then accompany the product or device. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65)
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Specification