Regulatory Status
In DevelopmentCurrent Status
- Development Stage: Pre-seed, MVP complete (Q3 2025)
- Device Classification: Class IIb Software as a Medical Device (SaMD)
- Regulatory Pathway: MHRA AIaMD (AI as a Medical Device)
- Approval Status: Not approved for clinical use
- Expected Submission: Q2 2026
- Target Authorization: Q3 2026
What This Means
HeAIth is NOT currently:
- Approved for clinical use in the UK or any jurisdiction
- Available for sale or distribution
- Authorized to diagnose, treat, cure, or prevent any disease
- A replacement for clinical judgment or diagnostic testing
- Validated for use in patient care
HeAIth IS:
- In active development with clinical advisor input
- Designed as a clinical decision support tool (when approved)
- Following established MHRA regulatory pathways
- Intended for use by qualified healthcare professionals (post-approval)
- Building with doctors for doctors
Regulatory Pathway
HeAIth is being developed to comply with:
- MHRA Medical Device Regulations: UK Medical Devices Regulations 2002 (UK MDR 2002)
- Device Classification: Class IIb - Software as a Medical Device (SaMD)
- UKCA Marking: UK Conformity Assessed marking for medical devices
- NHS Clinical Safety Standards: DCB0129 & DCB0160 compliance
- NHS DSPT: Data Security and Protection Toolkit standards
- ISO 13485:2016: Quality Management System for medical devices
- ISO 14971:2019: Risk Management for medical devices
- ISO 62304: Medical device software lifecycle processes
- UK GDPR: Data Protection Act 2018 compliance
Timeline to Market Authorization
Total Duration: 12-18 months (Q4 2025 - Q3 2026)
| Phase | Timeline | Key Activities |
|---|---|---|
| Phase 1: Foundation | Q4 2025 (Months 1-3) |
• Regulatory strategy finalization • Clinical Safety Officer appointment • Data Protection Officer appointment • Documentation framework established |
| Phase 2: Quality & Safety | Q1 2026 (Months 3-6) |
• ISO 13485 QMS implementation • DCB0129 clinical safety compliance • Hazard analysis and risk management • Clinical Safety Case Report |
| Phase 3: Technical Documentation | Q1 2026 (Months 6-9) |
• Technical File preparation • Clinical Evaluation Report • Data Protection Impact Assessment • Clinical validation studies |
| Phase 4: Conformity Assessment | Q2 2026 (Months 9-12) |
• UK Approved Body engagement • QMS audit and technical review • UKCA Certificate of Conformity • MHRA device registration |
| Phase 5: NHS Readiness | Q2 2026 (Months 10-12) |
• NHS DTAC completion • Cyber Essentials certification • HL7 FHIR interoperability • NHS Digital integration testing |
| Phase 6: Market Entry | Q3 2026 (Months 12-15) |
• UKCA marking affixed • Post-market surveillance active • Limited NHS pilot release • Market authorization obtained |
| Phase 7: Post-Market | Ongoing |
• Continuous performance monitoring • MHRA incident reporting (Yellow Card) • Annual management reviews • Clinical evaluation updates |
Key Standards & Compliance
MHRA Regulations
UK Medical Device Regulations 2002, UKCA marking pathway, AIaMD classification under 2025 MHRA AI/ML guidance
Quality Management
ISO 13485:2016 certification for medical device lifecycle quality assurance and continuous improvement
Clinical Safety
DCB0129 compliance with appointed Clinical Safety Officer (CSO) for comprehensive hazard analysis
Risk Management
ISO 14971:2019 framework for systematic risk identification, analysis, and control measures
NHS DTAC
Digital Technology Assessment Criteria for NHS procurement eligibility and clinical safety
Data Protection
UK GDPR compliance, DPIA, ICO registration, NHS DSPT standards for patient data protection
Cybersecurity
Cyber Essentials certification (annual), ISO 27001, regular penetration testing and vulnerability management
Interoperability
HL7 FHIR R4 standards, NHS Digital integration, SNOMED CT clinical terminology support
Investment in Regulatory Compliance
We are committed to the highest standards of regulatory compliance, patient safety, and data protection. Full regulatory authorization requires substantial investment over 12-18 months:
Total Estimated Investment: £250,000 - £500,000
This represents 35% of our seed funding round, demonstrating our commitment to doing this right.
Why this matters: Many health tech startups underestimate regulatory complexity by 6-12 months and 2-3x cost. We've done the homework upfront—our timeline and budget are realistic, not aspirational. This reduces risk for investors and demonstrates our operational maturity.
Website Purpose
This website is intended for:
- Healthcare professionals considering advisory board participation
- Investors evaluating HeAIth for funding opportunities
- Healthcare organizations interested in early pilot programs (post-approval)
- General information about our approach and development progress
Important: Information on this website is not medical advice and should not be used for diagnosis or treatment decisions. Always consult qualified healthcare professionals for medical conditions.
Transparency Commitment
We believe in radical transparency about our regulatory status:
- We will never claim MHRA or FDA approval until we have it
- We clearly state our "in development" status on all materials
- We provide realistic timelines based on research and expert guidance
- We openly share our regulatory roadmap and compliance requirements
- We acknowledge the complexity and investment required
This transparency builds trust with advisors, investors, and future customers.
Contact for Regulatory Inquiries
If you have questions about our regulatory status or compliance approach:
- Email: maximus.smith@heaith.co.uk
- Subject: "Regulatory Status"
- Response time: We aim to respond within 2-3 business days