Insights

Digital Health Acceleration: Are We Governing Fast Enough?

Paul Fountain Edgar

Head of Health & Social Care

Date:

June 2025

key fact

Agile governance is essential to safeguard patient safety and ensure quality in rapidly evolving digital health systems.

The UK health and care system is undergoing a rapid digital transformation. From AI-powered diagnostics to virtual care platforms, the pace of innovation is accelerating—and rightly so. But as we move faster, we must ask: Are our governance and leadership structures and capabilities keeping up?

The push for faster adoption

NHS England and NICE are actively reforming how digital health technologies are assessed and adopted. The Digital Technology Assessment Criteria (DTAC) is being reviewed to reduce the burden on suppliers and improve clarity for NHS organisations. Meanwhile, NICE’s HealthTech programme is streamlining how digital and AI technologies are evaluated for clinical and cost-effectiveness.

These reforms are designed to accelerate innovation—a welcome move for patients and providers alike. But they also raise a critical challenge: How do we ensure safety, fairness, and accountability in this faster-moving environment?

The risk of regulatory fragmentation

The British Medical Association (BMA) recently raised concerns about regulatory fragmentation in AI governance across the UK health system. With multiple bodies issuing overlapping but inconsistent guidance, there’s a growing risk of confusion, inefficiency, and even harm.

This fragmentation makes it harder for health and care organisations to know which standards to follow—and for innovators to navigate the system. It also increases the burden on digital leaders who are already stretched thin.

What’s really holding back digital transformation?

In our work across the health and care sector, we’ve consistently seen that technology isn’t the main barrier—people and processes are.

We recently asked NHS professionals: “What’s the biggest barrier to digital transformation in your organisation today?”

Here’s what they told us:

A horizontal barchart with the title "What's the biggest barrier to digital transformation in your NHS organisation today?" showing fours results. Lack of digital leadership: 31%; Skills & workforce capability: 23%; Outdated infrastructure: 15%; Governance & decision making: 31%
What’s the biggest barrier to digital transformation in your organisation today?

These results are telling. Leadership and governance—not infrastructure or funding—are the top blockers. That’s why we believe a new approach is needed.

Introducing the CARES Framework

To help organisations navigate this complexity, we developed the CARES framework—a principle-based model for governing AI and digital solutions in clinical settings covering six areas: Safe, Effective, Explainable, Fair, Accountable, and Redress.

Rather than reinventing governance from scratch, CARES helps organisations extend and adapt their existing policies and controls to meet the demands of emerging technologies.

An image showing the six areas of Mason Advisory's Clinical AI Risk & Ethics Standard (CARES) framework: Safe, Effective, Explainable, Fair, Accountable and Redress.
Mason Advisory’s CARES framework

Where do we go from here?

As NICE and NHS England push for faster adoption of digital health tools, frameworks like CARES can help ensure that governance keeps pace with innovation—without compromising on safety, equity, or trust.

But we also need to address the leadership gap. Digital transformation isn’t just about tools—it’s about culture, capability, and clarity.


We love to hear from others working in digital health and governance:

  • How are you navigating the tension between innovation and regulation?
  • What’s working—and what’s missing—in your organisation’s digital leadership?

If you would like to speak to Paul regarding the insight article, email contact@masonadvisory.com. 

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