When does wellness AI become a medical device?

March 9, 2026

Reflections from the MHRA AI Airlock simulation workshop

Last week, representatives from across the healthcare and AI ecosystem gathered for the first of three Phase 2 Simulation Workshops as part of the UK Medicines and Healthcare products Regulatory Agency (MHRA) AI Airlock programme.


The session brought together regulators, developers, clinicians, academics, and public and patient representatives to explore one of the most complex issues emerging in digital health: where the boundary sits between wellness AI and AI that becomes a regulated medical device.


Dr Paul Sacher, Founder of Sacher AI, was invited to participate in the workshop as an expert contributor based on his experience developing and evaluating patient facing conversational AI systems. His work spans both academic research and real world deployment of AI in healthcare settings, with a particular focus on clinical and behavioural safety in human AI interactions.


The AI Airlock is the MHRA’s first regulatory sandbox. It is designed to work alongside developers to better understand emerging AI as a Medical Device (AIaMD) technologies and help address regulatory challenges in a responsible, patient centred way.


The programme is currently in its second phase, working with seven AIaMD developers.


Two companies from the cohort took part in the workshop. TORTUS demonstrated its clinician facing AI system designed to support clinical documentation, while Numan presented its digital health platform delivering remote patient care. These demonstrations helped ground the discussion in real product scenarios and practical regulatory questions.


A central theme of the discussion was intended use. In medical device regulation, intended use determines whether a system qualifies as a medical device, how it is classified, what evidence is required, and how it must be monitored once deployed.


For AI systems, particularly large language model based conversational systems, intended use is rarely static.


Products evolve. Features expand. Systems become integrated into clinical workflows. Outputs begin to influence users, clinicians, or treatment decisions in new ways.


A system that initially sits within the wellness category can gradually cross into medical device territory, sometimes without a single clear moment where that shift occurs.


Another major focus of the workshop was post market surveillance.


Regulators increasingly expect companies to demonstrate how they monitor their AI systems once deployed and how they identify, track, and respond to risks over time. This responsibility extends across the full product lifecycle.


For teams deploying conversational AI at scale, this creates practical challenges.


Risks in large language model systems often emerge gradually across many interactions rather than appearing as a single obvious failure. In many cases, relying solely on manual review of conversations or retrospective audits is unlikely to be sustainable.


Monitoring systems therefore need to detect patterns, trends, and behavioural signals across thousands or millions of interactions.


This challenge is becoming increasingly visible across healthcare AI more broadly.


As AI systems become embedded into care pathways, even subtle product changes can shift the regulatory position of a system. Expanding features, integrating with clinical services, or increasing the influence of system outputs can all move a product closer to the regulatory definition of a medical device.


One of the most valuable aspects of the session was the level of practical nuance in the conversation.


Participants discussed how seemingly small design choices or product updates can affect regulatory classification, and how difficult it can be to detect early signals that a system may be drifting across regulatory boundaries.


The workshop also highlighted the growing diversity of AI technologies entering healthcare, including ambient voice technologies and conversational AI systems.


Overall, the workshop offered a thoughtful and grounded look at the real challenges facing teams building AI systems for healthcare today.


The boundary between wellness products and regulated medical devices is becoming increasingly complex. Understanding where that line sits, and how systems may gradually move across it, will be critical for companies developing AI in health and clinical contexts.


At Sacher AI, we work with organisations developing AI systems that interact directly with patients, clinicians, and health consumers. Our focus is on helping teams design, evaluate, and monitor these systems so that safety, behavioural impact, and regulatory expectations are addressed from the earliest stages of development.


As regulatory expectations evolve, building systems that are not only innovative but also demonstrably safe, transparent, and monitorable will become essential.


If your organisation is developing AI systems that interact directly with people in healthcare settings, you can learn more about Sacher AI’s work supporting safe and responsible AI deployment at https://sacher.ai.

Related blog updates


March 9, 2026
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Despite this, behavioural effects are rarely treated as a core requirement in AI development, evaluation, or governance. The paper brings together researchers from institutions including Imperial College London, Harvard University, Duke University, the University of Exeter, and the Alan Turing Institute. It outlines where behavioural risks arise in real world AI systems and why these risks deserve far greater attention. Behavioural risks are not edge cases When organisations think about AI risk, they often focus on incorrect outputs or technical failures. However, behavioural risks can emerge even when systems are technically accurate. AI systems influence behaviour through repeated interaction. They shape decision making, motivation, confidence, and emotional responses over time. For example, conversational systems can unintentionally: · encourage over reliance on automated advice · reinforce existing beliefs through personalisation · influence emotional regulation through tone and framing · alter motivation and goal setting behaviour · reduce appropriate help seeking in certain contexts These effects arise through well documented behavioural mechanisms such as automation bias, trust calibration, anthropomorphism, and reinforcement learning from user feedback. Yet most AI evaluation frameworks still prioritise task success and user satisfaction rather than behavioural outcomes. The growing gap between technical success and real world impact This creates a gap between technical performance and real world impact. A system can perform well on benchmarks and still shape behaviour in ways that undermine user wellbeing, decision quality, or long term outcomes. The risk becomes particularly important in domains where AI systems interact with people repeatedly and at scale. Healthcare, education, financial guidance, and emotional support tools are clear examples. In these environments, small behavioural effects can accumulate over time and remain invisible to standard performance metrics. Behavioural science is often missing from the AI lifecycle Behavioural science offers decades of research into how people think, feel, and act. It provides practical tools for understanding trust, influence, decision making, and motivation. However, behavioural expertise is still rarely embedded systematically across the AI lifecycle. In many projects behavioural scientists are not involved in system design, consulted only during ethics review, or brought in late in development when major design choices are already fixed. This often means behavioural risks are identified too late or not assessed at all. What responsible AI should look like The open letter argues that responsible AI must go beyond technical safeguards. Systems that interact directly with people must demonstrate what the authors describe as psychological competence. In practice, this means responding in ways that are emotionally appropriate, behaviourally responsible, and aligned with the user’s needs and context. Achieving this requires several shifts in how AI systems are designed and evaluated. Behavioural assumptions should be made explicit during design. Behavioural expertise should be embedded early in development. Evaluation should assess behavioural outcomes alongside technical performance. Monitoring should continue after deployment as systems evolve and users adapt. These are not theoretical concerns. They are practical requirements for building AI systems that work safely in real world environments. Why this matters for digital health and AI companies At Sacher AI we see this challenge frequently when working with digital health companies building patient facing AI systems. Teams often focus heavily on model performance, prompt design, or system architecture. These are important elements. But once systems begin interacting with people, behavioural dynamics quickly become central to product safety and effectiveness. Tone influences trust. Feedback influences motivation. Personalisation influences decision making. Without deliberate behavioural evaluation, systems can unintentionally nudge users in directions that product teams never intended. For companies operating in regulated environments such as healthcare, this also has implications for governance, compliance, and long term product risk. Bringing behavioural safety into AI development Addressing behavioural risk does not require reinventing AI governance. It requires integrating behavioural science into existing development processes. In practice this can include structured behavioural evaluation during development, adversarial testing of conversational agents, governance frameworks for human facing AI, and ongoing monitoring of behavioural outcomes once systems are deployed. Many organisations are beginning to recognise this gap and are looking for ways to assess behavioural safety earlier in their development pipeline. A broader shift in how we think about AI safety The central message of the open letter is simple. If AI systems influence human behaviour, behavioural science must be treated as foundational infrastructure for responsible AI. Technical safety alone is not enough. Understanding how people interpret, trust, and respond to AI systems is essential for building technology that works safely and effectively in the real world. Read the open letter The full paper is available in Wellcome Open Research . About Sacher AI Sacher AI works with digital health and AI companies to design, test, and deploy human facing AI systems safely and effectively. Our work combines behavioural science, AI engineering, and real world healthcare experience to help organisations build AI systems that are not only technically strong but also clinically and behaviourally safe.  If your organisation is developing AI systems that interact directly with patients or users, we are always happy to start a conversation. More information can be found at https://sacher.ai Sacher PM, Michie S, Hauser OP et al. The missing discipline in AI: a call for behavioural science . Wellcome Open Res 2026, 11:152 (https://doi.org/10.12688/wellcomeopenres.25922.1)
March 6, 2026
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An AI system that speaks to patients can provide incorrect health information, reinforce harmful behaviours, misunderstand emotional context, respond inappropriately to distress, or fail to escalate serious clinical signals. These are not rare edge cases. They are predictable failure modes of generative AI. The issue is not that the models are unintelligent. The issue is that they are probabilistic systems generating language without true understanding. That makes them powerful, but also unpredictable. For organisations deploying conversational AI in healthcare, safety therefore becomes a design challenge. Why traditional AI evaluation is not enough Most AI systems today are evaluated using benchmarks that measure reasoning ability, coding performance, knowledge retrieval, or accuracy on test datasets. These metrics are useful. But they say very little about how an AI system behaves in a real conversation with a human. When AI interacts with patients, the most important questions are different. Does the AI respond appropriately to vulnerable users? Does it avoid giving unsafe health advice? Does it communicate in a supportive and non judgemental tone? Does it recognise when it should escalate to a clinician? Does it stay aligned with clinical guidance? These are behavioural and clinical safety questions. Standard AI benchmarks do not answer them. Designing safe conversational AI At Sacher AI, our work focuses on a simple principle. If AI is going to interact with humans, it needs to be designed with human behaviour in mind. That means combining expertise from several fields including behavioural science, clinical safety, conversational design, and AI engineering. Together these disciplines help teams understand how users interpret what an AI says, how behaviour can be influenced by language, and when systems must escalate to human support. This perspective is often missing in early AI development. Many teams only start thinking about safety after an AI system is already live. By then, fixing the underlying issues becomes much harder. Stress testing AI systems before they reach patients One of the most effective ways to improve safety is to stress test AI systems before deployment. This means simulating large numbers of conversations that reflect the kinds of interactions real users might have. For example a patient feeling anxious about medication, a parent asking for advice about a child’s weight, a user frustrated by slow progress, or someone describing symptoms that may require clinical attention. By exposing AI systems to diverse scenarios, teams can identify unsafe behaviours early and improve the system before it reaches real users. At Sacher AI, this approach led us to build PromptSafe, a platform designed to evaluate conversational AI used in health and behavioural contexts. PromptSafe enables teams to simulate interactions with synthetic patient personas, define behavioural and clinical safety metrics, test AI systems across thousands of conversations, and track safety improvements over time. Monitoring AI once it is deployed Testing before launch is important, but it is not enough. AI systems continue to evolve once they are live. Models are updated, prompts change, and user behaviour shifts. This creates a second challenge which is monitoring safety during real world use. To address this, we are developing OVRSI, a system designed to monitor AI interactions and detect potential safety signals in real time. This includes identifying things like unsafe advice, emotional distress signals, guideline deviations, or escalation scenarios. When risks are detected, organisations can intervene quickly and improve the system. The future of AI in healthcare will depend on trust AI has the potential to transform healthcare by providing scalable and personalised support. But this future depends on trust. Patients, clinicians, and regulators will increasingly expect AI systems to demonstrate that they behave safely and responsibly. Organisations building human facing AI must therefore design for safety from the start. This means stress testing systems, embedding behavioural and clinical expertise into development teams, and monitoring how AI behaves in the real world. The companies that succeed will not just build powerful AI. They will build safe AI that people can trust. Book a discovery call If you are building patient facing conversational AI and want to ensure it is safe, reliable, and ready for real world deployment, we can help. At Sacher AI we work with digital health companies and AI teams to design and evaluate safe human facing AI systems. If you would like to explore how we can support your team, book a discovery call.
By Sacher AI December 13, 2024
In the rapidly evolving landscape of artificial intelligence, generative AI has become synonymous with creating images, text and video. However, its potential extends far beyond content generation—it's revolutionising the field of behavioural science, opening up unprecedented opportunities for understanding and influencing human behaviour.