Frequently Asked Questions

Everything you need to know about HeAIth, our regulatory pathway, and how to get involved

General Information

HeAIth is an AI-powered clinical decision support tool designed to assist healthcare professionals at the critical first moment of patient assessment. Built by doctors for doctors, HeAIth helps clinicians make faster, more informed diagnostic decisions while maintaining the highest standards of patient safety.

Our system is specifically designed for NHS workflows and UK regulatory standards, aiming to help hardworking clinicians see more patients efficiently while providing faster reassurance to those who don't need complex treatment.

HeAIth was founded by Maximus Smith, a software engineer with a BSc in Mathematics. The company was born from a personal experience: Maximus successfully used AI to diagnose his own skin condition, saving over £200 in private dermatology fees and months of NHS waiting time.

Recognizing the NHS's capacity challenges and the potential to help millions, Maximus built a working diagnostic system within a week. HeAIth is now being developed as a more advanced, accurate MVP designed to integrate smoothly into doctor workflows while drastically cutting costs.

HeAIth uses advanced AI algorithms to analyze patient symptoms, medical history, and clinical presentations to provide diagnostic support recommendations. The system is designed to augment—not replace—clinical judgment, offering clinicians evidence-based insights at the point of care.

The platform integrates into existing NHS workflows, providing real-time decision support while maintaining complete clinician oversight. All final diagnostic and treatment decisions remain with qualified healthcare professionals.

Regulatory & Compliance

No. HeAIth is currently in development and has NOT been approved by the MHRA, FDA, or any regulatory authority. It is not available for clinical use.

Information on this website is for healthcare professionals, advisors, and investors only. Do not use this information for medical decisions.

We are pursuing MHRA authorization as a Class IIb Software as a Medical Device (SaMD) in the United Kingdom. Our regulatory pathway includes:

  • Timeline: 12-18 months to MHRA authorization
  • Investment: £250,000-£500,000 in regulatory compliance
  • Standards: ISO 13485, ISO 14971, IEC 62304, DCB0129, DCB0160, DTAC
  • Clinical Validation: Multi-site clinical trials with NHS trusts
  • Quality Management: Full QMS implementation

We are committed to doing this properly, with no shortcuts on patient safety.

Patient safety is our top priority. We ensure this through:

  • Clinical Advisory Board: 3-5 practicing GPs and frontline clinicians guiding all development decisions
  • Regulatory Compliance: Following MHRA, ISO, and UK healthcare standards rigorously
  • Evidence-Based Design: All recommendations based on peer-reviewed clinical evidence
  • Clinical Validation: Extensive testing in real NHS environments before approval
  • Risk Management: Comprehensive risk assessment and mitigation (ISO 14971)
  • Transparency: Clear communication about capabilities, limitations, and development status

We are committed to the highest standards of data protection:

  • UK GDPR Compliance: Full compliance with UK data protection regulations
  • NHS Standards: DCB0129 and DCB0160 compliance for NHS data security
  • Data Minimization: Only collecting data essential for clinical decision support
  • Encryption: End-to-end encryption for all patient data in transit and at rest
  • Access Controls: Strict role-based access controls for healthcare professionals only
  • Audit Trails: Complete audit logging of all system access and decisions

For full details, see our Privacy Policy.

Clinical Advisory Board

Our Clinical Advisory Board is a group of 3-5 practicing GPs and frontline clinicians who guide every aspect of HeAIth's development. As a non-clinician founder, this board is essential to ensure HeAIth is built with genuine clinical insight and addresses real healthcare needs.

Advisory board members shape product decisions, validate clinical accuracy, ensure workflow integration, and maintain focus on patient safety and clinical utility.

We are looking for founding clinical advisors who are:

  • Practicing GPs or frontline clinicians in the NHS
  • Passionate about improving early diagnostic support
  • Interested in healthcare technology and innovation
  • Committed to patient safety and evidence-based medicine
  • Available for quarterly meetings and ongoing consultation

Advisory board positions include equity compensation and the opportunity to shape the future of AI in UK healthcare.

Apply to join the Clinical Advisory Board

We respect that our advisors are busy practicing clinicians. The expected commitment is:

  • Quarterly Meetings: 2-hour advisory board meetings (4 per year)
  • Ad-hoc Consultation: 2-4 hours per month for product feedback, clinical validation, and guidance
  • Flexible Timing: All consultation can be scheduled around your clinical commitments
  • Remote Options: Most engagement can be done remotely via video calls

Total estimated commitment: 30-50 hours per year, with flexibility built in.

Technology & Product

Our initial MVP focuses on common primary care presentations where early diagnostic support can have the greatest impact. The full scope is being defined in consultation with our Clinical Advisory Board.

We are prioritizing conditions that are:

  • Frequently seen in primary care settings
  • Have clear evidence-based diagnostic pathways
  • Benefit from early identification and intervention
  • Can be safely supported with AI-assisted decision support

Specific clinical scope will be announced as we finalize our Clinical Advisory Board and complete clinical validation studies.

Yes. Seamless integration with existing NHS workflows and systems is a core design priority. We are planning integration with:

  • Electronic Health Records (EHR): EMIS, SystmOne, and other primary care systems
  • NHS Spine: For secure patient data access where appropriate
  • Clinical Portals: Integration into existing clinical decision support workflows
  • HL7 FHIR Standards: Modern, interoperable healthcare data exchange

We are working closely with our Clinical Advisory Board to ensure integration is smooth, non-disruptive, and actually saves clinicians time.

Pricing is still being determined and will be finalized closer to market authorization. Our goal is to make HeAIth affordable and accessible for NHS trusts and primary care practices of all sizes.

We are exploring several pricing models:

  • Per-clinician subscription
  • Per-consultation usage-based pricing
  • Trust-wide licensing
  • Value-based pricing aligned with patient outcomes

Cost reduction is a core development goal—we want HeAIth to provide clear ROI through improved efficiency and better patient outcomes.

Timeline & Development

Our current development timeline:

  • Q4 2025 - Q1 2026: Form Clinical Advisory Board, finalize clinical scope
  • Q2-Q3 2026: Clinical validation studies, ISO certification process
  • Q4 2026 - Q1 2027: MHRA submission and review
  • Q2-Q3 2027: Pilot deployment with early NHS partners
  • Q4 2027: General availability (target)

We are taking the long road—12-18 months to MHRA authorization—because patient safety isn't negotiable.

HeAIth is currently in the pre-regulatory development phase:

  • MVP Complete: Functional proof-of-concept demonstrating core capabilities
  • Clinical Advisory Board: Actively recruiting 3-5 founding GP advisors
  • Regulatory Planning: Defining MHRA pathway, ISO certification requirements
  • Funding: Pre-seed stage, planning seed round for regulatory investment

We are not yet in clinical trials and do not have regulatory approval.

We are offering non-clinical demonstrations to:

  • Potential Clinical Advisory Board members
  • NHS trust decision-makers evaluating future partnerships
  • Investors conducting due diligence
  • Healthcare technology organizations interested in collaboration

Important: Demos are for evaluation purposes only and do not involve real patient data or clinical use.

Request a demonstration

Getting Involved

We are actively recruiting 3-5 founding clinical advisors. If you are a practicing GP or frontline NHS clinician interested in shaping the future of AI-powered diagnostic support:

  1. Review the Clinical Advisory Board information
  2. Complete the online application form
  3. Participate in an initial consultation call with the founder
  4. Review and sign advisory agreement (including equity compensation terms)

Apply to join the Clinical Advisory Board

Yes. We are planning a seed funding round in Q1-Q2 2026 to fund:

  • MHRA regulatory pathway (£250k-£500k)
  • Clinical validation studies
  • ISO certification and quality management systems
  • Initial team expansion (clinical, regulatory, engineering)
  • Pilot deployment with NHS partners

We are currently in conversations with healthcare-focused investors, angel investors with NHS experience, and impact investors interested in improving UK healthcare access.

For investment inquiries: maximus.smith@heaith.co.uk (subject: "Investment Inquiry")

We welcome early engagement from NHS trusts interested in:

  • Clinical Validation Partners: Participating in MHRA-required clinical trials
  • Pilot Sites: Early deployment following regulatory authorization
  • Clinical Guidance: Having clinicians join our Advisory Board
  • Technical Integration: Providing input on EHR integration requirements

Early partners will have preferential access, pricing, and input into product development.

Request information for NHS trusts

For all inquiries, please contact:

Maximus Smith, Founder
Email: maximus.smith@heaith.co.uk

Please include a clear subject line:

  • "Clinical Advisory Board" for advisor applications
  • "Investment Inquiry" for investor questions
  • "NHS Partnership" for trust-level engagement
  • "Demo Request" for product demonstrations
  • "Regulatory Status" for compliance questions
  • "General Inquiry" for all other questions

We aim to respond to all inquiries within 48 hours.

Still have questions?

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IMPORTANT REGULATORY NOTICE

HeAIth is an investigational clinical decision support software currently in development. This product has NOT been approved by the MHRA, FDA, or any regulatory authority. It is not available for clinical use. Information on this website is for healthcare professionals, advisors, and investors only. Learn more →