Executive Summary
Pilots spark enthusiasm, but too many stall when safety, evidence, or compliance questions arrive.
This series set out to bridge that gap. What began as theoretical best practice has evolved into a practical, resource-aware toolkit that Trust directors can use to guide projects from prototype to safe, scalable adoption.
The Strategic Themes
1. Honest Resource and Timeline Planning
Every post acknowledges the real cost of governance: clinical time, supplier investment, specialist expertise, and extended timelines. This honesty is what makes the guidance usable in board discussions.
2. Shared Accountability
Suppliers cannot dump safety and compliance responsibilities onto Trusts — nor can Trusts assume suppliers will manage everything. The series shows how shared accountability frameworks close the governance gaps that often undermine projects.
3. Integration with Trust Processes
Frameworks are mapped directly onto existing governance: risk registers, incident reporting systems, quality committees, and procurement frameworks. This ensures digital safety isn't a parallel process, but part of the Trust's existing fabric.
4. Practical Decision Tools
Each post introduces checklists, tables, and frameworks:
- The "Seven Foundations" questions.
- Safety readiness checkboxes.
- Evidence tier ladders with scale and timelines.
- Device vs non-device decision fork.
- Living compliance pillars and success metrics.
These aren't abstract ideas — they are tools directors can use immediately in programme governance.
The Journey in Five Steps
Foundations First
Every project must answer the hard questions upfront: What is it? Why are we doing it? Who is it for? What hazards exist? This avoids wasted pilots and prepares projects for scaling.
Clinical Safety Standards in Practice
Compliance is not paperwork but practice. Hazard logs, safety dashboards, and phased rollouts embed safety as a living process, not a tick-box.
Evidence That Counts
The evidence burden scales with risk: from months-long usability checks to years-long trials. The series lays out timelines, Trust participation demands, and procurement implications — helping boards set realistic expectations.
The Fork: Non-Device vs SaMD
Device classification is a strategic decision. The intended use test is simple, but the implications for timelines, cost categories, expertise requirements, and governance pathways are profound.
Deployment & Vigilance
Go-live is the beginning of accountability. Living compliance — safety, surveillance, security, and change control — must be resourced, measured, and integrated into Trust governance.
Why This Matters for Trust Directors
The series doesn't just advocate for governance. It provides a strategic playbook for:
- Budget planning — anticipating recurring compliance costs.
- Stakeholder management — mapping responsibilities across suppliers, Trust committees, and regulators.
- Risk management — identifying stop/go decision points when evidence or safety falters.
- Scaling safely — managing compliance across multiple sites without overwhelming governance.
Closing Reflection
Digital health governance is often treated as an afterthought. This series reframes it as the strategic backbone of adoption.
For Trust boards, the key message is simple:
- Pilots excite, but governance sustains.
- Compliance isn't overhead, it's protection.
- Shared accountability is the only safe path.
This is not a theoretical framework. It is an essential toolkit for directors navigating the realities of NHS digital transformation.
Summary in One Line: From foundations to vigilance, digital health projects succeed not by chance but by governance: resource-aware, integrated, accountable, and sustained.