Systems and methods for managing regulatory information
First Claim
1. A computer-implemented system for managing and accessing interconnected regulatory data associated with a regulatory status of a healthcare product of an entity, comprising:
- a network interface configured to receive a plurality of types of regulatory data associated with the regulatory status of the healthcare product, wherein the plurality of types of regulatory data reflect interactions by the entity with a regulatory authority with respect to the healthcare product;
a plurality of information memory stores configured to store regulatory data records, each record including one or more of the plurality of types of regulatory data associated with the regulatory status of the healthcare product;
a computer processing module configured to;
establish data relationships between the plurality of types of regulatory data records, wherein the data relationships are used to interconnect the information memory stores;
maintain the interconnected information memory stores based on the data relationships between the plurality of types of regulatory data records associated with the regulatory status of the healthcare product, wherein the processing module is configured to maintain the interconnected information memory stores based on a common data pattern associated with a type of the healthcare product;
identify, in response to a received request, the interconnected regulatory data records associated with the regulatory status of the healthcare product stored in the interconnected information memory stores;
perform a first determination as to whether to generate, based upon the entry of regulatory data into a first regulatory data record stored in at least one of information memory stores, a second regulatory data record for storage in another of the information memory stores;
based on the first determination, generate the second regulatory data record;
perform a second determination as to whether a communication with a regulatory authority, recorded in a contact record, results in a commitment; and
based on the second determination, link the contact record to a commitment record, said commitment record recording the commitment.
1 Assignment
0 Petitions
Accused Products
Abstract
Systems, methods, and articles of manufacture are provided for managing regulatory data pertaining to a healthcare product. For example, the system may include a network interface for receiving, from a client terminal, a request for regulatory data related to regulatory activity about a product as it pertains to a regulatory authority. The system also includes interconnected information stores for storing regulatory data associated with the product, where the information stores may include: contact records associated with respective contacts with the regulatory authority; commitment records associated with respective commitments made to the regulatory authority; and product information records associated with respective documents associated with the product. The system also includes a processing module for identifying, in response to the received request, each contact record, commitment record, product information record, and central files record associated with the product related to the received request.
25 Citations
23 Claims
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1. A computer-implemented system for managing and accessing interconnected regulatory data associated with a regulatory status of a healthcare product of an entity, comprising:
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a network interface configured to receive a plurality of types of regulatory data associated with the regulatory status of the healthcare product, wherein the plurality of types of regulatory data reflect interactions by the entity with a regulatory authority with respect to the healthcare product; a plurality of information memory stores configured to store regulatory data records, each record including one or more of the plurality of types of regulatory data associated with the regulatory status of the healthcare product; a computer processing module configured to; establish data relationships between the plurality of types of regulatory data records, wherein the data relationships are used to interconnect the information memory stores; maintain the interconnected information memory stores based on the data relationships between the plurality of types of regulatory data records associated with the regulatory status of the healthcare product, wherein the processing module is configured to maintain the interconnected information memory stores based on a common data pattern associated with a type of the healthcare product; identify, in response to a received request, the interconnected regulatory data records associated with the regulatory status of the healthcare product stored in the interconnected information memory stores; perform a first determination as to whether to generate, based upon the entry of regulatory data into a first regulatory data record stored in at least one of information memory stores, a second regulatory data record for storage in another of the information memory stores; based on the first determination, generate the second regulatory data record; perform a second determination as to whether a communication with a regulatory authority, recorded in a contact record, results in a commitment; and based on the second determination, link the contact record to a commitment record, said commitment record recording the commitment. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 20)
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13. A computer-implemented method for managing and accessing interconnected regulatory data associated with a regulatory status of a healthcare product of an entity, comprising:
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receiving, at a computer, a plurality of types of regulatory data associated with the regulatory status of the healthcare product, wherein the plurality of types of regulatory data reflect interactions by the entity with a regulatory authority with respect to the healthcare product; storing, in a plurality of information memory stores of the computer, regulatory data records, each record including one or more of the plurality of types of regulatory data associated with the regulatory status of the healthcare product; establishing data relationships between the plurality of types of regulatory data records, wherein the data relationships are used to interconnect the plurality of information memory stores; maintaining, through use of a processor of the computer, the interconnected information memory stores based on the data relationships between the plurality of types of regulatory data records associated with the regulatory status of the healthcare product, including maintaining the interconnected information memory stores based on a common data pattern associated with a type of the healthcare product; identifying, through use of the processor and in response to a received request, the interconnected regulatory data records associated with the regulatory status of the healthcare product stored in the interconnected information memory stores; performing a first determination as to whether to generate, based upon the entry of regulatory data into a first regulatory data record stored in at least one of information memory stores, a second regulatory data record for storage in another of the information memory stores; based on the first determination, automatically generating the second regulatory data record; performing a second determination as to whether a communication with a regulatory authority, recorded in a contact record, results in a commitment; and based on the second determination, linking the contact record to a commitment record, said commitment record recording the commitment. - View Dependent Claims (14, 15, 16, 17, 18, 19, 21)
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22. A non-transitory computer-readable storage medium including instructions for performing, when executed by a processor, a method for managing and accessing interconnected regulatory data associated with a regulatory status of a healthcare product of an entity, the method comprising:
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receiving a plurality of types of regulatory data associated with the regulatory status of the healthcare product, wherein the plurality of types of regulatory data reflect interactions by the entity with a regulatory authority with respect to the healthcare product; storing, in a plurality of information memory stores, regulatory data records, each record including one or more of the plurality of types of regulatory data associated with the regulatory status of the healthcare product; establishing data relationships between the plurality of types of regulatory data records, wherein the data relationships are used to interconnect the information memory stores; maintaining the interconnected information memory stores based on the data relationships between the plurality of types of regulatory data records associated with the regulatory status of the healthcare product, including maintaining the interconnected information memory stores based on a common data pattern associated with a type of the healthcare product; identifying, in response to a received request, the interconnected regulatory data records associated with the regulatory status of the healthcare product stored in the interconnected information memory stores; performing a first determination as to whether to generate, based upon the entry of regulatory data into a first regulatory data record stored in at least one of information memory stores, a second regulatory data record for storage in another of the information memory stores; based on the first determination, automatically generating the second regulatory data record; performing a second determination as to whether a communication with a regulatory authority, recorded in a contact record, results in a commitment; and based on the second determination, linking the contact record to a commitment record, said commitment record recording the commitment. - View Dependent Claims (23)
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Specification