Development of a Personalized Medication Dosage SaMD for Healthcare Networks

The healthcare organization faces difficulties such as manual and error-prone medication dosage calculations, scattered patient data across multiple systems, and lengthy prescription processing times which hinder optimal patient care and staff efficiency. They seek to reduce medication errors, streamline prescribing workflows, and automate the calculation of personalized drug dosages using advanced software integration.

A mid-sized healthcare provider or pharmacy network operating across multiple regions, aiming to enhance medication safety, automate prescription processes, and improve patient outcomes through innovative software solutions.

• Implement an automated system capable of processing comprehensive patient data including medical histories, lab results, current medications, genetic information, and lifestyle factors to support accurate dosage calculations.
• Integrate the software with existing Electronic Health Records (EHR) systems via a scalable, secure API interface for seamless data aggregation.
• Enable integration with Prescription Drug Monitoring Programs (PDMPs) to efficiently access drug histories and calculate risk scores, such as Narx Scores, to inform dosage decisions.
• Design an intuitive and user-friendly UI/UX that allows prescribers and pharmacists to conduct drug dosage calculations quickly, with minimal training, supporting multiple patient workflows.
• Prepare comprehensive project documentation aligned with regulatory standards to facilitate potential approval or certification processes, such as FDA clearance.
• Reduce prescription processing time significantly and improve medication accuracy to enhance patient safety and operational efficiency.

• Integration with multiple EHR systems for real-time patient data aggregation via APIs.
• Automatic retrieval and analysis of patient medical records, lab results, genetic data, and lifestyle information.
• Connection to PDMPs for quick access to prescription histories and risk scoring (e.g., Narx Score).
• A drug dosage calculator interface optimized for fast calculations across multiple patients with just a few clicks.
• Features to review and compare prescription history over time and generate reports.
• Secure data handling complying with healthcare privacy standards.
• Supporting documentation for regulatory approval processes (e.g., FDA).

• Electronic Health Record (EHR) systems for comprehensive patient data collection.
• Prescription Drug Monitoring Programs (PDMPs) for drug history and risk assessment.
• Regulatory compliance documentation systems as required for approval processes.

• High system reliability and uptime to ensure continuous clinical availability.
• Fast response times to enable drug dosage calculations within seconds for multiple patients.
• Secure handling of sensitive health data in compliance with relevant standards (e.g., HIPAA, FDA regulations).
• Scalability to support increasing patient data volume and user base.
• Intuitive UI/UX designed to minimize training time and reduce user error.

The implementation of this SaMD solution is expected to automate time-consuming prescription tasks, reducing medication calculation errors and decreasing prescription processing time by approximately 10 minutes per patient. Overall, patient processing time could decrease by 30%, leading to increased staff efficiency, enhanced medication safety, and streamlined clinical workflows, ultimately improving patient care quality and operational productivity.