Digital label management
Embodiments of the present disclosure provide a method for monitoring/tracking the lifecycle of a drug from build (e.g., as part of clinical trial development), to approval (e.g., regulatory), to in-market (e.g., distribution and safety information). The use of artificial intelligence (AI) and blockchain technology may enable the system to track the drug down to the prescription level and may support a digital label that can be updated as necessary based on such monitoring (e.g., that can be amended based on safety information detected while the drug is in market and warnings sent out upon amendment).
1. A computer-implemented method comprising:
in response to receiving data representing information about a product, identifying one or more geographic regions where the product is being processed;
in response to identifying the one or more geographic regions where the product is being processed, generating, in a blockchain, one or more blockchain entries storing data representing the processing of the product;
detecting, from one or more external data sources, data indicative of safety information of an application of the product;
generating, in the blockchain, a second blockchain entry that stores the data indicative of the safety information, wherein the second blockchain entry links to the one or more blockchain entries;
storing, in the second blockchain entry, additional data based upon subsequent detections of data indicative of safety information of one or more applications of the product;
providing, for output, the data indicative of the safety information; and
generating a third blockchain entry that stores data indicative of received adjustments to the product according to the data indicative of the safety information, wherein the product is distributable according to the adjustments.
2. The computer-implemented method of claim 1 , further comprising:
prior to identifying the one or more geographic regions where the product is being processed, receiving the data representing the information about the product, wherein the information comprises (i) a particular geographic region where the processing was performed, (ii) a name of an organization that performed the processing, and (iii) an entity type of the organization.
3. The computer-implemented method of claim 1 , further comprising:
generating label information about the product;
generating, in the blockchain, a first blockchain entry that stores the generated label information about the product; and
generating, from the generated label information, a label that is (i) linked to the blockchain and (ii) coupled to the product.
4. The computer-implemented method of claim 3 , further comprising:
providing a label change request for the product;
generating updates to the label information based on a label change process initiated in response to the provided label change request; and
generating, in the blockchain, one or more additional blockchain entries, the one or more additional blockchain entries corresponding to the updates to the label information and the label change process.
5. The computer-implemented method of claim 3 , wherein the label information about the product comprises one or more of product composition, compound components, clinical trial results, efficacy study results, safety test results, data relevant to electronic common technical document regulatory filings, or government entities involved in approval of the product.
6. The computer-implemented method of claim 1 , wherein identifying the one or more geographic regions where the product is being processed comprises:
determining a device that scanned a label coupled to the product, wherein the label directs the device to a uniform resource locator of the blockchain in response to the device scanning the label; and
providing a notification indicating the one or more blockchain entries are generated.
7. The computer-implemented method of claim 1 , wherein identifying the one or more geographic regions where the product is being processed further comprises one or more of:
detecting that the product is being sold in the one or more geographic regions; or
detecting that the product is being shipped from the one or more geographic regions.
8. The computer-implemented method of claim 1 , wherein the product is distributable according to the adjustments comprises wherein the product is distributable according to the adjustments to the product indicated by the data in the third blockchain entry based on approval from a regulatory authority.
9. The computer-implemented method of claim 8 , further comprising distributing the product according to the adjustments to the product indicated by the data in the third blockchain entry based on approval from the regulatory authority.
10. The computer-implemented method of claim 9 , wherein distributing the product according to the adjustments to the product indicated by the data in the third blockchain entry comprises:
enabling one or more users from the regulatory authority to access the data indicative of the received adjustments to the product in the third blockchain entry; and
in response to enabling the one or more users from the regulatory authority to access the data indicative of the received adjustments, receiving approval to distribute the product according to the adjustments to the product indicated by the data in the third blockchain entry.
11. A system comprising:
one or more computers and one or more storage devices storing instructions that are operable, when executed by the one or more computers, to cause the one or more computers to perform operations comprising:
in response to receiving data representing information about a product, identifying one or more geographic regions where the product is being processed;
in response to identifying the one or more geographic regions where the product is being processed, generating, in a blockchain, one or more blockchain entries storing data representing the processing of the product;
detecting, from one or more external data sources, data indicative of safety information of an application of the product;
generating, in the blockchain, a second blockchain entry that stores the data indicative of the safety information, wherein the second blockchain entry links to the one or more blockchain entries;
storing, in the second blockchain entry, additional data based upon subsequent detections of data indicative of safety information of one or more applications of the product;
providing, for output, the data indicative of the safety information; and
generating a third blockchain entry that stores data indicative of received adjustments to the product according to the data indicative of the safety information, wherein the product is distributable according to the adjustments.
12. The system of claim 11 , further comprising:
prior to identifying the one or more geographic regions where the product is being processed, receiving the data representing the information about the product, wherein the information comprises (i) a particular geographic region where the processing was performed, (ii) a name of an organization that performed the processing, and (iii) an entity type of the organization.
13. The system of claim 11 , further comprising:
generating label information about the product;
generating, in the blockchain, a first blockchain entry that stores the generated label information about the product; and
generating, from the generated label information, a label that is (i) linked to the blockchain and (ii) coupled to the product.
14. The system of claim 13 , further comprising:
providing a label change request for the product;
generating updates to the label information based on a label change process initiated in response to the provided label change request; and
generating, in the blockchain, one or more additional blockchain entries, the one or more additional blockchain entries corresponding to the updates to the label information and the label change process.
15. The system of claim 14 , wherein the label information about the product comprises one or more of product composition, compound components, clinical trial results, efficacy study results, safety test results, data relevant to electronic common technical document regulatory filings, or government entities involved in approval of the product.
16. The system of claim 11 , wherein identifying the one or more geographic regions where the product is being processed comprises:
determining a device that scanned a label coupled to the product, wherein the label directs the device to a uniform resource locator of the blockchain in response to the device scanning the label; and
providing a notification indicating the one or more blockchain entries are generated.
17. The system of claim 11 , wherein identifying the one or more geographic regions where the product is being processed further comprises one or more of:
detecting that the product is being sold in the one or more geographic regions; or
detecting that the product is being shipped from the one or more geographic regions.
18. A non-transitory computer-readable medium storing software comprising instructions executable by one or more computers which, upon such execution, cause the one or more computers to perform operations comprising:
in response to receiving data representing information about a product, identifying one or more geographic regions where the product is being processed;
in response to identifying the one or more geographic regions where the product is being processed, generating, in a blockchain, one or more blockchain entries storing data representing the processing of the product;
detecting, from one or more external data sources, data indicative of safety information of an application of the product;
generating, in the blockchain, a second blockchain entry that stores the data indicative of the safety information, wherein the second blockchain entry links to the one or more blockchain entries;
storing, in the second blockchain entry, additional data based upon subsequent detections of data indicative of safety information of one or more applications of the product;
providing, for output, the data indicative of the safety information; and
generating a third blockchain entry that stores data indicative of received adjustments to the product according to the data indicative of the safety information, wherein the product is distributable according to the adjustments.
19. The non-transitory computer-readable medium of claim 18 , further comprising:
prior to identifying the one or more geographic regions where the product is being processed, receiving the data representing the information about the product, wherein the information comprises (i) a particular geographic region where the processing was performed, (ii) a name of an organization that performed the processing, and (iii) an entity type of the organization.