Announcing the ORCHA DH-AI Advisory Group

Supporting shared, practical foundations for safe AI in health

AI-enabled technologies are now a permanent and growing part of digital health.

From patient-facing tools to systems that influence clinical decision-making, AI is moving rapidly from experimentation into everyday use across health systems.

While ambition and innovation in this space are high, one challenge is becoming increasingly clear: assurance mechanisms have not scaled at the same pace as AI adoption.

Health systems, commissioners, regulators, and suppliers are navigating a complex landscape of emerging regulation, overlapping standards, and evolving expectations - often without shared, operational ways to assess risk, governance, and safety in practice.

In response, ORCHA has established the Digital Health AI Advisory Group.

Why this group exists

Over the past year, ORCHA has seen a significant increase in AI-enabled digital health products entering assessment pathways. These products vary widely in how AI is used, from low-risk automation and personalisation, to systems that influence diagnosis, treatment, or clinical prioritisation.

What has become clear is that treating “AI” as a single category is no longer viable.

At the same time:

• High-level AI principles are widely agreed, but difficult to apply consistently

• Health systems face fragmented, duplicative, or opaque assessment approaches

• Innovators lack clarity on what “good” looks like for governance and evidence

• Regulators and policymakers need assurance models that are practical, not theoretical

The Digital Health AI Advisory Group has been formed to help address these challenges, not by creating new rules, but by supporting the translation of existing expectations into shared, assessable practice for digital health.

The purpose of the Digital Health AI Advisory Group

The Digital Health AI Advisory Group exists to advise and inform the development of ORCHA’s AI Assurance Module, helping ensure it is:

• Proportionate to real-world risk

• Grounded in clinical and system context

• Aligned with existing and emerging regulation

• Practical for innovators to engage with

• Credible and defensible for health systems to adopt

What the group will focus on

The Advisory Group will support ORCHA across several key areas:

1. Clarifying how AI risk should be understood in health

A core principle underpinning this work is that risk is contextual.

AI-related risk depends on how a system is used, what function it performs, and the impact it may have on users and care pathways — not simply on the presence of AI itself.

The group will provide input on approaches that distinguish between:

• Different AI techniques

• Functional roles within digital health products

• Clinical and non-clinical contexts of use

This supports proportionate assurance and helps avoid both over- and under-scrutiny.

2. Advising on governance and accountability in practice

Many of the most significant challenges associated with AI in health are not purely technical. They relate to governance: ownership, oversight, change management, monitoring, and accountability over time.

The Advisory Group will help inform how governance expectations within the AI Assurance Module are:

• Clearly articulated

• Assessable in practice

• Appropriate to the level of risk and use case

• Aligned with how health systems and suppliers operate

3. Supporting regulatory alignment without duplication

ORCHA’s approach is not to invent new standards, but to align with and operationalise existing regulatory and policy frameworks relevant to AI and digital health.

The Advisory Group will provide insight on:

• Mapping regulatory principles to practical assessment criteria

• Identifying areas where guidance lacks operational clarity

• Ensuring the framework can adapt as regulation and policy continue to evolve

4. Promoting transparency and trust

A key aim of the AI Assurance Module is to support informed use, rather than binary pass/fail judgements.

The Advisory Group will help shape how assurance outcomes are communicated, with a focus on clarity around:

• What has been assessed

• In what context

• At what level of depth

• And where limitations or boundaries remain

This transparency is essential for building confidence among health systems, suppliers, clinicians, and patients.

A collaborative and evolving process

The Digital Health AI Advisory Group forms part of a wider, phased programme of work at ORCHA, alongside beta testing, academic collaboration, and engagement with policy bodies, health systems, and industry partners.

This recognises that AI assurance is not static. As technologies, use cases, and expectations change, assurance approaches must evolve - grounded in shared understanding and real-world application.

Looking ahead

The establishment of the Digital Health AI Advisory Group marks an important step in supporting safe, responsible adoption of AI across digital health.

By convening diverse expertise and focusing on practical, proportionate assurance, ORCHA aims to help create an ecosystem where:

• Innovators have clearer pathways to trust

• Health systems can adopt AI with confidence

• And patients and clinicians benefit from transparent safeguards

ORCHA will continue to share insights, milestones, and opportunities to engage as this work progresses.