Frequently asked questions.

1. What is Digital Clinical Safety?

Digital Clinical Safety refers to the processes, standards, and practices that ensure digital health technologies—such as electronic health records, mobile health apps, AI tools, and clinical decision support systems—are safe, reliable, and designed to minimise clinical risk.

2. What services do you provide?

Our services include:

  • Digital clinical safety assessments (DCB0129 / DCB0160)

  • Clinical risk management support

  • Hazard log development and review

  • Clinical safety case creation

  • Digital health product validation

  • Guidance on regulatory and NHS safety requirements

  • Training in digital clinical safety best practices

  • Fractional Clinical Safety Officer (CSO) services

3. Who are your services for?

We support:

  • Digital health companies and startups

  • NHS trusts and healthcare providers

  • Health IT vendors

  • AI/ML medical technology developers

  • System integrators and software engineering teams

4. What are DCB0129 and DCB0160?

These are NHS Digital clinical safety standards:

  • DCB0129 applies to manufacturers and developers of digital health technologies.

  • DCB0160 applies to healthcare organisations implementing or using those technologies.

We help organisations achieve full, compliant, and audit-ready documentation.

5. Why is clinical safety important in digital health?

Digital tools can directly influence clinical decision-making. Ensuring they are safe protects patients, supports regulatory approval, and introduces trust and reliability into healthcare workflows.

6. Do you work with early-stage startups?

Yes. We frequently support startups at concept, prototype, and build stages. Early engagement helps reduce cost, accelerate compliance, and avoid redesign or regulatory delays later.

7. Can you help with AI and machine learning safety?

Yes. Our support includes:

  • Algorithmic risk assessments

  • Bias and data quality evaluation

  • Guidance on NHS, UK, and international AI safety standards

8. Do you create Clinical Safety Cases and Hazard Logs?

Yes. We produce:

  • Clinical Safety Case Reports

  • Hazard Logs

  • Hazard identification workshops

  • Risk assessments and mitigation plans

  • Safety validation and evidence support

9. What experience do your Clinical Safety Officers (CSOs) have?

Our CSOs are experienced clinicians and digital safety specialists with backgrounds in:

  • NHS clinical practice

  • Health informatics

  • Patient safety and risk management

  • Regulatory and standards compliance across digital health

10. Do you offer a Fractional Clinical Safety Officer service?

Yes. Our Fractional CSO service allows organisations to access experienced Clinical Safety Officers on a flexible, part-time, or on-demand basis. This is ideal for:

  • Startups without a permanent CSO

  • Organisations needing temporary or project-based safety leadership

  • Teams scaling rapidly who need expert oversight

  • Companies preparing for audits, NHS onboarding, or regulatory submissions

Benefits include:

  • Cost-effective expert oversight

  • Continuous compliance with DCB0129/0160

  • Professional safety case ownership and governance

  • Support during product development, testing, and deployment

  • Access to ongoing advice without full-time hire commitments

11. Do you offer training?

Yes. We deliver training tailored to product teams, clinical leads, and technical staff, covering:

  • Clinical risk management

  • DCB0129/0160 compliance

  • Hazard identification

  • Safe system design principles

12. How do we get started?

You can contact us via:

We offer a free initial consultation to understand your needs and recommend the most suitable support package.