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