Med About You Smart Reminder AI v3.3
Safety Registry
AI Safety Guide
Med About You Smart Reminder AI
About This Safety Guide
This guide explains how the AI systems in Med About You Smart Reminder have been tested and verified for safety. Just as cars undergo safety testing before hitting the road, AI systems need thorough safety checks before they can help manage your medications.
What is an Independent AI Audit? Independent experts, not connected to MedLee Smart Ace Solutions, thoroughly examined the device's AI systems. These experts checked for problems that could affect your safety, like biases in decision-making, errors in medication timing, or risks to your private health information.
Why This Matters:
- For You: Ensures the device will safely and accurately manage your medications, protect your privacy, and work reliably when you need it 
- For Healthcare Providers: Confirms the device meets medical safety standards and can be trusted as part of patient care 
- For MedLee: Verifies their AI systems work as intended and meet regulatory requirements 
- For Regulators: Provides evidence that the device meets health and safety standards 
About This Product?
Med About You Smart Reminder AI (version 3.3) is a medical device that helps you manage your medications. It was approved for use in January 2025 and will be supported until January 2032. The device is made by MedLee Smart Ace Solutions Inc.
Performance Data (Based on Assurance Testing)
The device operates using AI (artificial intelligence) - computer programs trained to make decisions. These AI programs handle safety features, from checking medications to sending alerts. The audit confirmed the information below:
- Schedule tracking: 99.97% accuracy across trial runs (This means that out of 10,000 medication reminders, only 3 might be incorrectly timed.) 
- Potential drug interaction flags: 99.8% accuracy in test cases (For every 1,000 potential drug interactions, 2 might be missed.) 
- Dosage verification: 99.5% accuracy (Out of 1,000 dosage checks, 5 might need manual verification.) 
- Alert delivery: 99.7% success rate (Out of 1,000 alerts, only 3 might not be delivered immediately.) 
What Makes It Secure?
Your health information is protected by:
- Strong passwords (at least 12 characters with numbers and special characters) 
- Triple-checking with your pharmacy records 
- Secure encryption to protect your data 
- Regular monthly security updates 
- Emergency updates for critical safety issues 
Your Rights
You have control over your data. You can:
- Access your information whenever you want 
- Delete your data if you choose 
- Override AI decisions if you disagree 
- Change your preferences 
- Opt out of certain features 
Getting Help
If you need assistance, you have several options:
- Emergency Support: Call (555) 123-4567 
- Technical Help: Email support@medlee-smart-ace-solutions.com 
- General Questions: Check the user manual (available online) 
Important Safety Features
The device is designed to keep risks low for:
- Missing medications 
- Getting wrong medications 
- Privacy breaches 
- Incorrect timing of doses 
What To Do In An Emergency
If the device stops working:
- Call emergency support immediately: (555) 123-4567 
- Follow your backup medication plan 
- Report any device problems 
- Keep emergency contact information handy 
Key Documents You Can Access
Remember:
Your health and safety come first. If something doesn't seem right, contact support immediately. They're available 24/7 to help you.
More Details
- Product Name: Med About You Smart Reminder AI v3.3 
- Manufacturer: MedLee Smart Ace Solutions Inc. 
- Authorization Date: January 15, 2025 
- Authorization Status: Active 
- Support Period End Date: January 15, 2032 
Certification Details
- Certifying Body: Acme AI Auditors Ltd. 
- Contact: certification@acmeaiauditors.com 
- Phone: (555) 123-4567 
- Certification Number: #12-2024-42001 
User Rights & Controls
Safety Performance Metrics
- Prescription Schedule Accuracy: 99.97% 
- Drug Interaction Detection: 99.8% 
- Dosage Verification: 99.5% 
- Alert Receipt Confirmation: 99.7% 
- Prescription Update Accuracy: 99.6% 
Security & Configuration
Password Management
- Default password: must be changed upon first use 
- Password requirements: Minimum 12 characters, Must include numbers, special characters, and mixed case 
Software Updates
- Update Policy: Automatic updates enabled by default 
- Update Frequency: Monthly security updates 
- Critical Updates: Pushed immediately upon verification 
Device Security
- Triple verification with pharmacy records 
- End-to-end encryption for all data transmission 
- HIPAA compliant data storage 
- Software Bill of Materials (SBOM) Available: Yes (Request here) 
- Hardware Bill of Materials: Yes (Request here) 
Risk Assessment
- Risk of Missing Medications: Low 
- Risk of Dispensing Wrong Medication: Low 
- Privacy Concerns: Low 
- Wrong Timing Risk: Very Low 
Important Links & Policies
- Privacy Policy - How we protect and handle your personal health information 
- Terms of Service - Your rights and obligations when using this device 
- HIPAA Compliance Statement - Our healthcare data protection measures 
- Data Collection & Usage Policy - What data we collect and why 
- AI Ethics Statement - Our commitment to responsible AI use 
- Accessibility Statement - How we ensure our product is accessible to all users 
Data Privacy & Protection
Health Information Privacy
AI Training & Data Usage
Safety & Compliance Documents
United States
- FDA Compliance Documentation - Class II Medical Device certification 
- HIPAA Compliance Certificate - Healthcare data privacy protection requirements 
- ISO/IEC 42001 AI Management Certification - AI system management standards 
- FCC IoT Cybersecurity Label Certification - IoT device cybersecurity compliance 
- Third-Party Security Audit Reports - Independent security assessments 
- UL 2900-2-1 Software Cybersecurity - Medical device software security standard 
- NIST AI Risk Management Framework Documentation - AI system risk assessment 
- SBOM Documentation - Software components and dependencies 
- Incident Response Plan - Required for healthcare devices 
- Post-Market Surveillance Reports - Ongoing safety monitoring 
- PATCH Act Compliance Documentation - Medical device security requirements 
European Union
- EU Declaration of Conformity - Required for CE marking 
- CRA Conformity Assessment Documentation - Product cybersecurity requirements 
- EU Cyber Resilience Act Risk Assessment - Including vulnerability handling process 
- Incident Reporting Procedures (CRA Article 11) 
- Product Security Information Documentation - As required by CRA 
- Critical Software Bill of Materials (SBOM) - Required under CRA 
- Vulnerability Handling & Disclosure Policy - CRA compliance requirement 
- EU Product Digital Security Requirements Checklist 
- Post-Market Surveillance Documentation - Required under CRA 
Emergency Information
- Emergency Support Hotline: (555) 123-4567 
- 24/7 Technical Support: support@medlee-smart-ace-solutions.com 
Support & Documentation
- Technical Support: support@medlee-smart-ace-solutions.com 
Last Updated: January 20, 2025
Registry Information Maintained by MedLee Smart Ace Solutions Inc.
This is version 1.0 of the mockup | Created by Ezra Schwartz 2025
