insights by iatroX

Digital Health Consultancy & Clinical Safety Officer (CSO) Services

Where evidence meets execution in digital health.

Insights by iatroX is the advisory, research, and partnership division of iatroX. It builds on the platform’s mission to make clinical knowledge accessible and safe, extending that same evidence-based discipline to organisations developing healthcare technology. We help digital-health companies, NHS partners and research groups design, validate and scale technology that clinicians can trust.

All advisory work is led by , founder of iatroX and practising UK doctor, combining frontline clinical experience with regulatory, business and technical insight.

Our Digital Health Advisory Services

Digital Clinical Safety Officer (CSO) services

End-to-end support for DCB 0129/0160 compliance, including Hazard Log development, Safety Case reporting, DTAC alignment, and ongoing clinical risk management.

Strategic and market-entry advisory

Positioning, adoption, and integration strategy for NHS and commercial healthcare contexts.

Regulatory and compliance readiness

Expert guidance on DTAC, MHRA AI regulations (SaMD), and data-protection frameworks.

Clinician validation and data insights

Access anonymised, aggregated trend analysis and conduct opt-in studies with the iatroX clinician community.

Partnerships and thought leadership

Collaborate on research, white papers, and educational content focused on the safe and effective adoption of AI in healthcare.

Our Clinical-First Approach

  • Evidence-driven: Every recommendation is grounded in clinical data, guideline frameworks and observed user behaviour.
  • Integrated: Advisory and platform activities operate within one entity, ensuring consistency between clinician insight and product development.
  • Ethical: All clinician data used for Insights projects are anonymised and aggregated; participation in research is always voluntary.
  • Practical: We focus on realistic implementation within NHS and regulatory structures, not theoretical compliance.

Pricing & engagement models

Standards & references

FAQs

What is DTAC and why does it matter?

DTAC is the NHS baseline used by buyers during procurement to ensure digital technologies meet minimum standards; developers are expected to meet DTAC for NHS entry.

What’s the difference between DCB 0129 and DCB 0160?

DCB 0129 applies to manufacturers/developers; DCB 0160 applies to adopter organisations deploying health IT.

Is my software a medical device (SaMD)?

It depends on intended purpose and functionality. If it qualifies as SaMD, MHRA obligations (classification, documentation, post-market) apply.