Ambient Voice Technology and the digital medical device debate

Ambient Voice Technology (AVT) is rapidly emerging as a solution to the ever-growing administrative burdens on clinicians, promising to transform how medical records are created and maintained. AVT tools capture, transcribe, and even summarise clinician-patient conversations, allowing healthcare professionals to reclaim valuable time for direct patient care. Yet, as the technology advances and artificial intelligence enters the conversation, so does the debate around its regulatory status, with NHS England now taking decisive steps to treat AVT not as a mere productivity aid, but as a medical device in its own right.

Conventional speech-to-text software has long been used in healthcare settings, but what sets AVT apart is its use of AI, leveraging natural language processing and machine learning to do more than simply transcribe. Modern AVT tools, in fact, have the potential to summarise complex interactions, generate structured clinical notes, and even integrate into electronic patient record (EPR) systems.

The resulting benefits are considerable, as automatic summarisation can reduce duplication of effort, improve the consistency of data, and ensure information is captured in near real-time. Crucially, it can dramatically reduce the hours clinicians spend on manual documentation, and in a sector under pressure from staffing shortages, rising demand and budgetary constraints, these efficiencies can make a huge difference.

Alongside decision-support algorithms, predictive analytics and other forms of Software as a Medical Device (SaMD), AVT is part of a broader wave of digital health innovation with the potential to reshape modern healthcare delivery.

Yet, with innovation comes potential risk, and regulators are paying closer attention to the potential implications of AVT. The UK Medical Devices Regulations 2002 (UK MDR 2002) were not designed with AI-driven technologies in mind, creating ambiguity when it comes to how digital tools are assessed and classified, and until recently, the regulatory status of AVT remained ambiguous.

That changed on 27 April 2025, when NHS England, working with the Medicines and Healthcare products Regulatory Agency (MHRA), issued a new guidance on the use of AI-enabled ambient scribing products[1], stating that AVT systems that go beyond transcription and include summarisation must now be classified as Software as a Medical Device (SaMD).

Therefore, as any medical device, AVT tools must now demonstrate conformity with regulatory requirements, including UKCA or CE marking, the maintenance of a technical file and evidence of clinical safety assessments. Additionally, the NHS now specifically requires AVT vendors to register summarisation-capable tools as Class I medical devices with the MHRA, complete clinical safety (DCB0160) and data protection impact (DPIA) assessments, demonstrate platform assurance through DTAC, DSPT, Cyber Essentials Plus and secure approval through local ICB (Integrated Care Board) or Trust governance.

In short, the NHS now regards AVT as a technology with potential direct implications for patient safety, going beyond the productivity tool definition.

The urgency of this new stance was reinforced on 9 June, when the National Chief Clinical Information Officer issued a Priority Notification instructing organisation to immediately cease the use of any AVT tool that did not meet compliance standards and warning both institutions and individual clinicians that they could be held personally liable for harm resulting from non-compliant tools.

For AVT vendors, particularly startups, these developments amount to a seismic shift. As many companies entering the healthcare space have focused on speed of innovation rather than regulatory readiness, they have been caught by surprise by the sudden compliance requirements. In response, providers are moving quickly to register their products as Class I medical devices through the MHRA’s Public Access Registration Database. While this offers a fast pathway to NHS procurement, Class I registration relies on self-certification, placing the burden on the manufacturer to demonstrate conformity. Vendors must maintain detailed technical documentation, including risk management plans, clinical evaluation and post-market surveillance, and failure to produce this evidence on request can result in enforcement action from the MHRA and exclusion from the NHS supply chain.

Additionally, AVT products tend to evolve at a rapid pace, often moving from simple transcription into more advanced functions like summarisation, structured note generation and even clinical decision support. Each additional layer of functionality heightens the potential clinical impact, drawing the tool further into the scope of medical device regulation. Therefore, startups that have not built regulatory expertise into their development cycles may find themselves ill-prepared, risking both their commercial viability and the safety of patients.

The debate around AVT reflects a broader dilemma facing healthcare systems worldwide: how to embrace the benefits of digital innovation while ensuring safety and accountability. On one side, AVT promises to enhance clinical efficiency, reduce the risk of error and improve continuity of care, also helping ease the burden of workforce shortages by allowing clinicians to operate at the top of their licence, rather than being mired in administrative work. On the other side, the risks are real. Summarisation algorithms are not infallible and misinterpretation, omission or bias in the AI-generated record could have clinical consequences. Moreover, issues of data security, consent, and privacy remain central, particularly when dealing with sensitive patient information.

Regulation is then necessary to ensure that new technologies are safe, effective and trustworthy. Regulators now face the challenge to keep up with rapid innovation and ensure requirements and guidance evolve at the same pace as emerging technologies rather than lagging behind them.

As the UK moves towards a new set of UK Medical Device Regulations, expected to come into force in 2026 and to provide clearer rules for Software as a Medical Device, the future of AVT will depend on how well innovators, regulators, and healthcare providers can collaborate. Those who treat compliance not as a burden but as a foundation for trust will be best placed to realise the promise of AVT: a future where technology listens, understands, and ultimately supports clinicians in delivering safer, more effective care.

[1] NHS England, Guidance on the use of AI-enabled ambient scribing products in health and care settings, 27 April 2025, https://www.england.nhs.uk/long-read/guidance-on-the-use-of-ai-enabled-ambient-scribing-products-in-health-and-care-settings/