COMPUTER ALGORITHMS AND METHODS FOR PRODUCT SAFETY

摘要

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.

主权项

1. A new use for a product or device, wherein at least one pre-existing or planned use for the product or device risks occurrence of at least one adverse events associated with such use, wherein the risk is as determined from at least one essential adverse event information database, wherein the data therein is derived from an analysis of data from at least one adverse event computerized data source, and identifies at least one new essential adverse event associated with the product or device, based upon essential adverse event information stored in the data source, said new use comprising commercializing at least one use that differs from the pre-existing or planned use by disclosing or avoidance of the at least one identified essential adverse event associated with the product or device where commercialization means creating profit from the exclusive disclosure of said use and or adverse event where an essential adverse event is one that must be disclosed in the information accompanying the product.