US-20260124389-A1 - INTELLIGENT DOSING PLATFORM WITH COMPREHENSIVE GOVERNANCE, REGULATORY COMPLIANCE, AND AUDIT TRAIL MANAGEMENT FOR INJECTABLE MEDICATION ADMINISTRATION

US20260124389A1US 20260124389 A1US20260124389 A1US 20260124389A1US-20260124389-A1

Abstract

An intelligent dosing platform incorporating comprehensive governance and regulatory compliance capabilities for injectable medication administration. The platform includes regulatory tracking modules configured to monitor compliance with Merit-based Incentive Payment System (MIPS) requirements, STAR quality metrics for Medicare and Medicaid programs, and federal fraud, waste, and abuse (FWA) program standards. The system features audit trail generation modules that create tamper-proof documentation with cryptographic signatures and immutable timestamping for regulatory reporting and compliance validation activities. Compliance assessment modules evaluate medication administration events against regulatory benchmarks and quality performance indicators, while automated reporting systems generate submissions for oversight bodies and fraud prevention agencies. The platform incorporates fraud detection capabilities, compliance dashboard visualization, risk assessment modules, and real-time alert systems to ensure comprehensive regulatory compliance and audit trail management across healthcare networks and injectable medication administration environments.

Inventors

Jeremy Corbett

Assignees

DATADOSE, LLC

Dates

Publication Date: 20260507
Application Date: 20251029

Claims (20)

1 . A governance and regulatory compliance system for injectable medication administration, comprising: a regulatory tracking module configured to monitor compliance with one or more governance and/or regulatory program standards; an audit trail generation module configured to create comprehensive documentation for one or more of regulatory reporting, quality assurance verification, and compliance validation activities; and a compliance assessment module configured to evaluate injectable medication administration events against one or more of regulatory benchmarks, quality performance indicators, or audit requirements.
2 . The system of claim 1 , wherein the regulatory tracking module is further configured to monitor compliance with one or more of Merit-based Incentive Payment System (MIPS) requirements, STAR quality metrics, and federal fraud, waste, and abuse (FWA) program standards.
3 . The system of claim 1 , wherein the audit trail generation module is further configured to create tamper-proof documentation with one or more of cryptographic signatures, blockchain verification, and immutable timestamping.
4 . The system of claim 1 , wherein the compliance assessment module is further configured to generate automated compliance scores based on one or more of adherence rates, safety indicators, and cost-effectiveness measures.
5 . The system of claim 1 , further comprising a quality metrics calculation module configured to analyze one or more of patient outcomes, treatment effectiveness, and healthcare delivery performance indicators.
6 . The system of claim 1 , further comprising a regulatory reporting module configured to automatically generate reports for one or more of Medicare and Medicaid oversight bodies, quality assurance organizations, and fraud prevention agencies.
7 . The system of claim 1 , further comprising an alert system configured to provide real-time notifications regarding one or more of compliance deviations, regulatory violations, and audit findings.
8 . The system of claim 1 , further comprising a data integration module configured to interface with one or more of electronic health record systems, pharmacy management platforms, and government regulatory databases.
9 . The system of claim 1 , wherein the regulatory tracking module is configured to monitor compliance across one or more of institutional policies, state regulations, and federal oversight requirements.
10 . A comprehensive governance and regulatory audit system for injectable medication compliance management, comprising: a regulatory tracking module configured to monitor compliance with one or more of Merit-based Incentive Payment System (MIPS) requirements, STAR quality metrics for Medicare and Medicaid programs, and federal fraud, waste, and abuse (FWA) program standards; an audit trail generation module configured to create comprehensive documentation for one or more of regulatory reporting, quality assurance verification, and compliance validation activities; a compliance assessment module configured to evaluate injectable medication administration events against one or more of regulatory benchmarks, quality performance indicators, and audit requirements; a quality metrics calculation module configured to generate performance scores based on one or more of patient outcomes, adherence rates, safety indicators, and cost-effectiveness measures; a regulatory reporting module configured to automatically generate reports for one or more of Medicare and Medicaid oversight bodies, quality assurance organizations, and fraud prevention agencies; an alert system configured to notify stakeholders of one or more of compliance deviations, regulatory violations, and audit findings; and a data integration module configured to interface with one or more of electronic health record systems, pharmacy management platforms, and government regulatory databases.
11 . The comprehensive governance and regulatory audit of claim 10 , wherein the quality metrics calculation module is configured to track one or more of clinical quality measures, patient safety indicators, and healthcare utilization metrics for regulatory reporting.
12 . The comprehensive governance and regulatory audit of claim 10 , wherein the regulatory reporting module is configured to generate automated submissions to one or more of CMS quality reporting programs, state Medicaid programs, and federal oversight agencies.
13 . The comprehensive governance and regulatory audit of claim 10 , wherein the alert system is configured to provide escalating notifications based on one or more of violation severity levels, regulatory timeframes, and stakeholder responsibilities.
14 . The comprehensive governance and regulatory audit of claim 10 , wherein the data integration module is configured to perform real-time synchronization with one or more of health information exchanges, pharmacy benefit management systems, and clinical decision support platforms.
15 . The comprehensive governance and regulatory audit of claim 10 , further comprising a fraud detection module configured to identify suspicious patterns in one or more of prescription patterns, administration frequencies, and billing irregularities.
16 . The comprehensive governance and regulatory audit of claim 10 , further comprising a compliance dashboard module configured to provide visualization of one or more of regulatory performance metrics, audit trail summaries, and compliance status indicators.
17 . The comprehensive governance and regulatory audit of claim 10 , wherein the audit trail generation module is configured to maintain records for one or more of regulatory inspection readiness, legal discovery requirements, and institutional quality assurance programs.
18 . The comprehensive governance and regulatory audit of claim 10 , further comprising a risk assessment module configured to evaluate potential compliance risks based on one or more of historical violation patterns, regulatory changes, and institutional practice variations.
19 . The comprehensive governance and regulatory audit of claim 10 , wherein the regulatory tracking module is configured to automatically update compliance parameters based on one or more of regulatory guidance updates, policy changes, and industry best practice modifications.
20 . A computer-implemented method for governance and regulatory compliance management in injectable medication administration, comprising: monitoring, via a regulatory tracking module, compliance with one or more of Merit-based Incentive Payment System (MIPS) requirements, STAR quality metrics for Medicare and Medicaid programs, and federal fraud, waste, and abuse (FWA) program standards; generating, via an audit trail generation module, comprehensive documentation for one or more of regulatory reporting, quality assurance verification, and compliance validation activities; evaluating, via a compliance assessment module, injectable medication administration events against one or more of regulatory benchmarks, quality performance indicators, and audit requirements; calculating, via a quality metrics calculation module, performance scores based on one or more of patient outcomes, adherence rates, safety indicators, and cost-effectiveness measures; generating, via a regulatory reporting module, automated reports for one or more of Medicare and Medicaid oversight bodies, quality assurance organizations, and fraud prevention agencies; providing, via an alert system, stakeholder notifications regarding one or more of compliance deviations, regulatory violations, and audit findings; integrating, via a data integration module, with one or more of electronic health record systems, pharmacy management platforms, and government regulatory databases; detecting, via a fraud detection module, suspicious patterns in one or more of prescription patterns, administration frequencies, and billing irregularities; visualizing, via a compliance dashboard module, one or more of regulatory performance metrics, audit trail summaries, and compliance status indicators; assessing, via a risk assessment module, potential compliance risks based on one or more of historical violation patterns, regulatory changes, and institutional practice variations; and updating, automatically through the regulatory tracking module, compliance parameters based on one or more of regulatory guidance updates, policy changes, and industry best practice modifications.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of International Application No. PCT/US2025/053140, filed on Oct. 29, 2025, which is a continuation of U.S. patent application Ser. No. 19/373,017, filed on Oct. 29, 2025, which is a continuation-in-part of U.S. patent application Ser. No. 19/314,854, filed on Aug. 29, 2025, which is a continuation-in-part of U.S. patent application Ser. No. 19/281,005, filed on Jul. 25, 2025, which is a continuation of U.S. patent application Ser. No. 19/031,862, filed on Jan. 18, 2025, which is a continuation of U.S. patent application Ser. No. 19/030,829, filed on Jan. 17, 2025, which claims the benefit of U.S. provisional application No. 63/715,505, filed on Nov. 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 a governance and regulatory compliance system for injectable medication administration, including: a regulatory tracking module configured to monitor compliance with one or more governance and/or regulatory program standards; an audit trail generation module configured to create comprehensive documentation for one or more of regulatory reporting, quality assurance verification, and compliance validation activities; and a compliance assessment module configured to evaluate injectable medication administration events against one or more of regulatory benchmarks, quality performance indicators, or audit requirements. In some aspects, the techniques described herein relate to a system, wherein the regulatory tracking module is further configured to monitor compliance with one or more of Merit-based Incentive Payment System (MIPS) requirements, STAR quality metrics, and federal fraud, waste, and abuse (FWA) program standards. In some aspects, the techniques described herein relate to a system, wherein the audit trail generation module is further configured to create tamper-proof documentation with one or more of cryptographic signatures, blockchain verification, and immutable timestamping. In some aspects, the techniques described herein relate to a system, wherein the compliance assessment module is further configured to generate automated compliance scores based on one or more of adherence rates, safety indicators, and cost-effectiveness measures. In some aspects, the techniques described herein relate to a system, further including a quality metrics calculation module configured to analyze one or more of patient outcomes, treatment effectiveness, and healthcare delivery performance indicators. In some aspects, the techniques described herein relate to a system, further including a regulatory reporting module configured to automatically generate reports for one or more of Medicare and Medicaid oversight bodies, quality assurance organizations, and fraud prevention agencies. In some aspects, the techniques described herein relate to a system, further including an alert system configured to provide real-time notifications regarding one or more of compliance deviations, regulatory violations, and audit findings. In some aspects, the techniques described herein relate to a system, further including a data integration module configured to interface with one or more of electronic health record systems, pharmacy management platforms, and government regulatory databases. In some aspects, the techniques described herein relate to a system, wherein the regulatory tracking module is configured to monitor compliance across one or more of institutional policies, state regulations, and federal oversight requirements. In some aspects, the techniques described herein relate to a comprehensive governance and regulatory audit system for injectable medication compliance management, including: a regulatory tracking module configured to monitor compliance with one or more of Merit-based Incentive Payment System (MIPS) requirements, STAR quality metrics for Medicare and Medicaid programs, and federal fraud, waste, and abuse (FWA) program standards; an audit trail generation module configured to create comprehensive documentation for one or more of regulatory reporting, quality assurance verification, and compliance validation activities; a compliance assessment module configured to evaluate inje