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Regulatory Status

In Development
IMPORTANT: HeAIth is an investigational clinical decision support software currently in development. This product has NOT been approved, cleared, or authorized by the MHRA, FDA, or any other regulatory authority.

Current 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)
  • Doctors decide, AI assists

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
• Documentation framework established
Phase 2: Quality & Safety Q1 2026
(Months 3-6)		 • ISO 13485 QMS implementation
• DCB0129 clinical safety compliance
• Clinical Safety Case Report
Phase 3: Technical Documentation Q1 2026
(Months 6-9)		 • Technical File preparation
• Clinical Evaluation Report
• 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
Phase 5: NHS Readiness Q2 2026
(Months 10-12)		 • NHS DTAC completion
• Cyber Essentials certification
• NHS Digital integration testing
Phase 6: Market Entry Q3 2026 - Q4 2027 • UKCA marking affixed
• Limited NHS pilot release
• General UK availability
Phase 7: Product Refinement 2028+ • Cost optimisation and accuracy enhancement
• International market preparation (EU, US)
• Multi-country scalability development
Phase 8: Post-Market Surveillance Ongoing • Continuous performance monitoring
• MHRA incident reporting
• Annual clinical evaluation updates

Key Standards & Compliance

MHRA Regulations

UK Medical Device Regulations 2002, UKCA marking pathway

Quality Management

ISO 13485:2016 certification for medical device lifecycle

Clinical Safety

DCB0129 compliance with appointed Clinical Safety Officer

Risk Management

ISO 14971:2019 for risk identification and control

NHS DTAC

Digital Technology Assessment Criteria for NHS procurement

Data Protection

UK GDPR compliance, DPIA, and NHS DSPT standards

Cybersecurity

Cyber Essentials certification and ISO 27001

Interoperability

HL7 FHIR R4 and NHS Digital integration

Investment in Regulatory Compliance

We are committed to the highest standards of regulatory compliance, patient safety, and data protection. Full regulatory authorisation 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.

ISO 13485 QMS Implementation & Certification £20,000 - £50,000
Clinical Safety Officer (DCB0129) £20,000 - £100,000/year
Data Protection Officer (UK GDPR) £15,000 - £80,000/year
UK Approved Body Assessment £15,000 - £40,000
Clinical Evaluation & Validation Studies £10,000 - £25,000
NHS DTAC & Technical Assurance £10,000 - £30,000
NHS Interoperability (FHIR) £20,000 - £50,000
Regulatory Consulting & Support £20,000 - £60,000

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