🏥 Medical Device Integrity
PromedAI is designed by prioritizing patient safety, deploying structured medical ontologies (such as RxNorm and NDC codes), and following rigorous software-as-a-service frameworks.
1. Medical Device Classification and Regulatory Exclusions
A. United States (FDA Guidelines)
In accordance with the U.S. Food and Drug Administration (FDA) "General Wellness: Policy for Low Risk Devices" and the "Medical Device Data Systems (MDDS)" guidelines, PromedAI does not diagnose, treat, prevent, or cure any medical disease or health condition. Specifically:
- PromedAI serves solely to log, track, and document medication intake intervals.
- It provides general education, reminders, and database check flags which do not constitute customized medical treatment instructions.
- Therefore, PromedAI qualifies as an exempt digital wellness application and is not classified as Software as a Medical Device (SaMD) under FDA 510(k) review.
B. United Kingdom (MHRA) and European Union (CE Mark)
Under the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the EU Medical Device Regulation (MDR 2017/745) guidelines:
- Software intended purely for tracking, logging, or cataloging medication histories falls outside the scope of Class IIa/IIb medical device classifications.
- Any medication crosscheck remains an automated lookup based on standard medical databases, which users are directed to verify with licensed medical practitioners.
2. Data Security & Information Governance
To ensure high standards of health data custody, PromedAI aligns its development and operational processes with the following compliance targets:
- ISO/IEC 27001: We align our platform deployments with information security management best practices, ensuring strict access audits, continuous threat monitoring, and regular vulnerability scanning.
- SOC 2 Type II: Our server environments leverage SOC 2 validated cloud host providers, including Firebase and Google Cloud, ensuring extreme uptime resilience and encrypted database segregation.
3. Accessibility Compliance
We believe digital health companions must be accessible to everyone. Our design system adheres to the Web Content Accessibility Guidelines (WCAG 2.1 AA) standards:
- High-contrast text scaling compatibility.
- Screen reader descriptive markup (ARIA roles) for critical warning panels.
- Support for alternative navigation states, including full keyboard and voice assist features.
4. Drug Database Integrity
Our AI model checks and automated warning flags are compiled from public, standardized medical databases, including the National Library of Medicine (NLM) and licensed database partners. While we perform daily verification sweeps to ensure our index is correct, new medication adjustments or changes in prescribing advice may take up to 24 hours to replicate. Users are cautioned to confirm contraindications with their direct care provider.
5. Compliance Contact
If you represent a medical institution, research laboratory, or government regulatory body and have compliance inquiries, reach out to our legal counsel at:
Email: support@promedai.xyz