US-20260124380-A1 - BLOCKCHAIN-BASED IMMUTABLE CHAIN OF CUSTODY SYSTEM FOR INJECTABLE MEDICATION MANAGEMENT

US20260124380A1US 20260124380 A1US20260124380 A1US 20260124380A1US-20260124380-A1

Abstract

An immutable chain of custody system for injectable medications utilizes blockchain technology to create tamper-proof records of medication transfers from manufacturers through distributors, delivery contractors, or healthcare providers to patient administration. The system includes a custody tracking module that generates immutable blockchain records, a device integration module that receives custody data from intelligent injection devices including geolocation, temperature monitoring, biometric verification, environmental condition, or administration event data, or a smart contract execution module that automatically updates blockchain records upon custody transfer events. The system features multi-party authentication for supply chain participants, sensor data collection throughout the custody chain, verification modules for tracking location and environmental conditions, immutable audit trails, or automated alert systems for custody violations. This comprehensive approach ensures medication integrity, regulatory compliance, or fraud prevention throughout the pharmaceutical supply chain while maintaining complete transparency and accountability.

Inventors

Jeremy Corbett

Assignees

DATADOSE, LLC

Dates

Publication Date: 20260507
Application Date: 20250829

Claims (20)

1 . An immutable chain of custody system for injectable medications, comprising: a custody tracking module configured to create immutable blockchain records of medication transfers from one or more of manufacturers, distributors, delivery contractors, or healthcare providers to patient administration; a device integration module configured to receive custody data from intelligent injection devices including one or more of geolocation data, temperature monitoring data, biometric verification data, environmental condition data, or administration event data; and a smart contract execution module configured to one or more of: automatically update the blockchain records upon detection of custody transfer events; trigger one or more automated downstream actions based on custody status changes; execute predefined business logic for one or more of insurance workflows, regulatory reporting, or compliance verification; or validate custody handoff requirements for device transfer authorization.
2 . The system of claim 1 , wherein the custody tracking module is further configured to record one or more of timestamps, participant identities, or transfer locations for each custody event.
3 . The system of claim 1 , wherein the device integration module is further configured to receive data from one or more of smart syringes, intelligent injection devices, IoT sensors, or wearable monitoring devices.
4 . The system of claim 1 , wherein the smart contract execution module is further configured to automatically execute payment transactions upon successful custody transfers.
5 . The system of claim 1 , wherein the blockchain records include one or more of medication lot numbers, expiration dates, storage requirements, or chain of custody participants.
6 . The system of claim 1 , wherein the smart contract execution module is configured to automatically lock or disable intelligent injection devices upon detection of custody violations.
7 . The system of claim 1 , wherein the custody tracking module is configured to integrate with one or more of electronic health record systems, pharmacy management systems, or insurance claim processing systems.
8 . The system of claim 1 , further comprising a compliance monitoring module configured to ensure adherence to one or more of FDA regulations, state pharmacy laws, or institutional policies.
9 . The system of claim 1 , wherein the device integration module is configured to receive real-time data streams from intelligent injection devices during medication administration events.
10 . An immutable chain of custody system for an injectable administration compliance management platform, comprising: a custody tracking module configured to create immutable blockchain records of medication transfers from one or more of manufacturers, distributors, delivery contractors, or healthcare providers to patient administration; a device integration module configured to receive custody data from intelligent injection devices including one or more of geolocation data, temperature monitoring data, biometric verification data, environmental condition data, or administration event data; a multi-party authentication module configured to verify identities of one or more supply chain participants including manufacturers, distributors, delivery contractors, or healthcare providers; a sensor data collection module configured to gather one or more of environmental monitoring data, biometric verification data, device status information, or geospatial tracking data throughout the custody chain; a smart contract execution module configured to: automatically update the blockchain records upon detection of custody transfer events; trigger one or more automated downstream actions based on custody status changes; execute predefined business logic for one or more of insurance workflows, regulatory reporting, or compliance verification; and validate custody handoff requirements for device transfer authorization; a verification module configured to track and verify one or more of location data for shipments, administration events, or environmental conditions; an immutable audit trail module configured to maintain tamper-proof records of one or more of custody events, environmental conditions, or participant actions; and an automated alert system configured to generate notifications upon detection of one or more of custody violations, environmental excursions, or unauthorized access attempts.
11 . The system of claim 10 , wherein the multi-party authentication module is configured to use one or more of biometric verification, digital certificates, cryptographic keys, or multi-factor authentication.
12 . The system of claim 10 , wherein the sensor data collection module is configured to monitor one or more of temperature variations, humidity levels, shock events, or light exposure during medication transport.
13 . The system of claim 10 , wherein the verification module is configured to compare actual conditions against predefined acceptable ranges for one or more of temperature, humidity, or transport duration.
14 . The system of claim 10 , wherein the immutable audit trail module is configured to generate cryptographic hashes for each recorded event to ensure data integrity.
15 . The system of claim 10 , wherein the automated alert system is configured to send alerts to one or more of healthcare providers, patients, regulatory authorities, or insurance companies.
16 . The system of claim 10 , wherein the smart contract execution module is further configured to automatically execute financial transactions upon verification of successful custody transfers.
17 . The system of claim 10 , wherein the verification module is configured to validate one or more of medication authenticity, proper storage conditions, or authorized personnel access.
18 . The system of claim 10 , wherein the sensor data collection module is configured to integrate with one or more of RFID tags, GPS tracking devices, or environmental monitoring sensors.
19 . The system of claim 10 , wherein the automated alert system is configured to trigger escalation protocols based on one or more of severity levels, response times, or stakeholder roles.
20 . A computer-implemented method for managing immutable chain of custody of injectable medications using blockchain technology, comprising: receiving, by a blockchain-based custody tracking system, custody data from one or more of manufacturers, distributors, delivery contractors, or healthcare providers; collecting, through a device integration module, custody data from intelligent injection devices including one or more of geolocation data, temperature monitoring data, biometric verification data, environmental condition data, or administration event data; verifying, through a multi-party authentication module, identities of one or more supply chain participants including manufacturers, distributors, delivery contractors, or healthcare providers; gathering, via a sensor data collection module, one or more of environmental monitoring data, biometric verification data, device status information, or geospatial tracking data throughout the custody chain; detecting, by smart contract monitoring modules, custody transfer events between supply chain participants; automatically updating, via smart contract execution, blockchain records upon detection of custody transfer events; triggering, through smart contract automation, one or more automated downstream actions based on custody status changes; executing, by the smart contract execution module, predefined business logic for one or more of insurance workflows, regulatory reporting, or compliance verification; validating, through the smart contract execution module, custody handoff requirements before authorizing transfers; tracking and verifying, through a verification module, one or more of location data for shipments, administration events, or environmental conditions; maintaining, via an immutable audit trail module, tamper-proof records of one or more of custody events, environmental conditions, or participant actions; generating, through an automated alert system, notifications upon detection of one or more of custody violations, environmental excursions, or unauthorized access attempts; and recording, in the immutable blockchain ledger, final administration records with tamper-proof timestamping.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation-in-part of U.S. patent application no. 19/281,005, filed on July 25, 2025, which is a continuation of U.S. patent application no. 19/031,862, filed on January 18, 2025, which is a continuation of U.S. patent application no. 19/030,829, filed on January 17, 2025, which claims the benefit of U.S. provisional application no. 63/715,505, filed on November 1, 2024, which are all hereby incorporated by reference in their entirety. FIELD The present disclosure relates generally to a management platform for injection devices, such as syringes, and, more particularly, to data reporting regarding administration completion of an injectable pharmaceutical. BACKGROUND Understanding administration of drugs and their interaction in the healthcare ecosystem are important in delivering beneficial patient care. Applicant appreciates that regular pharmaceutical therapy and a need for real time data management related to both timing of and compliance in dosing bundled with increased information sharing across the care continuum can provide valuable insight for improving care and, in turn, reducing fraud, waste, and abuse. SUMMARY In some aspects, the techniques described herein relate to an immutable chain of custody system for injectable medications, including: a custody tracking module configured to create immutable blockchain records of medication transfers from one or more of manufacturers, distributors, delivery contractors, or healthcare providers to patient administration; a device integration module configured to receive custody data from intelligent injection devices including one or more of geolocation data, temperature monitoring data, biometric verification data, environmental condition data, or administration event data; and a smart contract execution module configured to one or more of: automatically update the blockchain records upon detection of custody transfer events; trigger one or more automated downstream actions based on custody status changes; execute predefined business logic for one or more of insurance workflows, regulatory reporting, or compliance verification; or validate custody handoff requirements for device transfer authorization. In some aspects, the techniques described herein relate to a system, wherein the custody tracking module is further configured to record one or more of timestamps, participant identities, or transfer locations for each custody event. In some aspects, the techniques described herein relate to a system, wherein the device integration module is further configured to receive data from one or more of smart syringes, intelligent injection devices, IoT sensors, or wearable monitoring devices. In some aspects, the techniques described herein relate to a system, wherein the smart contract execution module is further configured to automatically execute payment transactions upon successful custody transfers. In some aspects, the techniques described herein relate to a system, wherein the blockchain records include one or more of medication lot numbers, expiration dates, storage requirements, or chain of custody participants. In some aspects, the techniques described herein relate to a system, wherein the smart contract execution module is configured to automatically lock or disable intelligent injection devices upon detection of custody violations. In some aspects, the techniques described herein relate to a system, wherein the custody tracking module is configured to integrate with one or more processing systems. In some aspects, the techniques described herein relate to a system, further including a compliance monitoring module configured to ensure adherence to one or more of FDA regulations, state pharmacy laws, or institutional policies. In some aspects, the techniques described herein relate to a system, wherein the device integration module is configured to receive real-time data streams from intelligent injection devices during medication administration events. In some aspects, the techniques described herein relate to an immutable chain of custody system for an injectable administration compliance management platform, including: a custody tracking module configured to create immutable blockchain records of medication transfers from one or more of manufacturers, distributors, delivery contractors, or healthcare providers to patient administration; a device integration module configured to receive custody data from intelligent injection devices including one or more of geolocation data, temperature monitoring data, biometric verification data, environmental condition data, or administration event data; a multi-party authentication module configured to verify identities of one or more supply chain participants including manufacturers, distributors, delivery contractors, or healthcare providers; a sensor data collection module configured to gather one or more of environmental monitoring data, biometric