Regulatory Positioning
Last Updated: March 15, 2026
Regulatory Overview
Abgrat is an AI-powered medical intelligence and health education information platform. We are not a regulated medical device and therefore do not require pre-market regulatory approval as a medical device in most jurisdictions.
Abgrat IS
- • AI-powered medical intelligence platform
- • Clinical decision support system (informational)
- • Health education tool
- • Clinical reasoning system (informational)
Abgrat IS NOT
- • Regulated medical device
- • Medical diagnostic tool
- • Medical treatment system
- • In vitro diagnostic device (IVD)
- • Software as a Medical Device (SaMD)
Rationale
Intended Use
Designed for educational and informational purposes, not for diagnosis, treatment, or disease prevention
Operational Context
Operates as an informational support tool requiring professional interpretation
Product Claims
No diagnostic, therapeutic, preventive, or medical outcome claims
Regulatory Classification
Abgrat is classified as an unregulated health information educational system.
Classification
Unregulated Health Information Educational System
Key Characteristics
- • Informational, not diagnostic
- • Educational, not therapeutic
- • Decision support, not decision making
- • Human-augmented, not autonomous
Position by Jurisdiction
🇺🇸 United States - FDA
- • Not regulated by FDA as a medical device
- • Not classified as Software as a Medical Device (SaMD)
- • Complies with FTC advertising standards
- • Voluntarily follows HIPAA best practices
🇪🇺 European Union - MDR
- • Not regulated under MDR 2017/745
- • Does not require CE marking as medical device
- • Fully GDPR compliant
- • Monitoring EU AI Act developments
🇬🇧 United Kingdom - MHRA
- • Not regulated by MHRA as medical device
- • Does not require UKCA marking
- • Fully UK GDPR compliant
- • Follows Consumer Rights Act 2015
Canada
Not regulated by Health Canada as medical device
Australia
Not regulated by TGA as medical device
Global Approach
- • Regulatory research for each jurisdiction
- • Compliance assessment
- • Comprehensive documentation
- • Transparent communication
Classification Rationale
Intended Use Definition
Educational health information platform designed to provide general health information and support clinical understanding
Operational Context
- • Requires human interpretation
- • Does not operate autonomously
- • Does not directly affect patient care
- • Advisory role only
Claims & Representations
- • No diagnostic accuracy claims
- • No therapeutic efficacy claims
- • No preventive benefits
- • No clinical outcomes claims
Risk Assessment
- • Low risk profile
- • Requires professional interpretation
- • Clear disclaimers
- • Multiple safety warnings
Intended Use
Abgrat is designed to provide an AI-powered medical intelligence educational platform that offers:
General Health Information
To enhance health literacy
Educational Content
About medical topics and concepts
Clinical Reasoning Support
To support understanding and conversations with medical professionals
Informational Support
For individuals seeking to better understand health information
Operational Environment
Intended Contexts
- • Personal use at home
- • Education and learning
- • Preparation for medical conversations
- • Health information research
Unintended Contexts
- • Clinical environments (without professional supervision)
- • Medical emergencies
- • Independent medical decision making
- • Replacement of medical consultation
What We Are Not
Not a Medical Diagnostic Device
We do not diagnose diseases, determine specific medical conditions, provide final medical assessments, or replace professional diagnosis
Not a Medical Treatment System
We do not prescribe treatments, recommend specific medications, suggest treatment plans, or replace medical guidance
Not an Autonomous Clinical Decision Tool
We do not make medical decisions, operate independently, replace clinical judgment, or directly affect patient care
Not Software as a Medical Device (SaMD)
We do not meet SaMD definitions, are not intended for medical purposes, do not make independent medical decisions, and require professional interpretation
Voluntary Compliance
Although Abgrat is not regulated as a medical device, we voluntarily follow many best practices from regulatory frameworks.
Standards We Follow
HIPAA Standards (US)
- • Apply technical safeguards
- • Apply administrative safeguards
- • Apply physical safeguards
- • Follow privacy practices
GDPR Standards (EU)
- • Full GDPR compliance
- • Respect all data rights
- • Lawful processing
- • Transparency and accountability
ISO Quality Principles
- • ISO/IEC 25010 (Product Quality)
- • ISO/IEC 25040 (Evaluation Process)
- • ISO/IEC 27001 (Information Security)
Ethical AI Guidelines
- • WHO Ethical AI Principles
- • EU Trustworthy AI Guidelines
- • OECD AI Principles
- • IEEE Ethical AI Standards
Liability Limitations
We do not guarantee medical accuracy, completeness, suitability for specific conditions, or outcomes. Users are responsible for seeking professional medical care, verifying information with professionals, making their own health decisions, and following their doctor's advice.
No Medical Warranties
We provide no guarantees regarding medical accuracy, completeness, or suitability for specific conditions
User Responsibilities
Users must seek professional medical care and verify information with qualified professionals
Liability Limitations
Our liability is limited as per our Terms of Service and to the maximum extent permitted by law
Regulatory Evolution
We actively monitor regulatory developments worldwide and are prepared to adapt as regulations evolve.
Potential Future Scenarios
Scenario A: Required Regulation
If Abgrat becomes regulated, we will seek necessary approvals and maintain full compliance
Scenario B: Voluntary Classification
We may choose to voluntarily seek classification as a medical device to enhance credibility
Scenario C: Continue Unregulated
If we remain unregulated, we will maintain voluntary compliance and best practices
Transparency & Accountability
Regulatory Status
We clearly state we are not a regulated medical device and explain our intended use and limitations
Capabilities & Limitations
We are honest about what we can and cannot do, how we work, and when to seek professional care
Risks & Benefits
We clarify potential benefits, risks, limitations, and appropriate use
Decision Rationale
We explain why we are not regulated, how decisions are made, and standards we follow
For Medical Professionals
Do not use Abgrat for clinical decision-making, patient diagnosis, treatment recommendations, or to replace professional judgment. Abgrat is not an approved clinical tool.
Acceptable Use
- • Personal education
- • Exploring medical topics
- • Informational research
- • Continuing learning
Unacceptable Use
- • Clinical decision making
- • Patient diagnosis
- • Treatment prescriptions
- • Replacing professional judgment
- • Patient care documentation
Frequently Asked Questions
Contact Us
Compliance Team
Regulatory Affairs
General Counsel
Clinical Inquiries
Professional Partnerships
Research Collaboration
This document is for informational purposes only and does not constitute legal or regulatory advice. Regulatory status may change. Check this document regularly for updates.