NHS England has issued guidance on the use of AI-enabled ambient scribing products in health and care settings, to support chief information officers and chief clinical information officers introduce this technology.
The guidance comes as part of series to support business case development, risk assessments, governance, data protection impact assessments, and evaluation and monitoring. A key part of the framework covers a series of considerations, posing questions to clarify the product functionality, outputs for transcription, outputs for downstream tasks, and data and system considerations.
It notes to assign a clinical safety officer and identify key risks, complete DCB0160 documentation, conduct a data protection impact assessment, plan for integration, ensure appropriate controls, and implement a monitoring framework. It states that adopters should be mindful that products using generative AI and large language models “may introduce new functions unintentionally”, and that legal and regulatory requirements should be factored into procurement.
Under regulatory compliance, the guidance notes that whilst ambient scribing products with simple or low functionality, such as those which solely generate text transcriptions, are “likely not medical devices”; those which go further with the use of generative AI for processing or summarisation “likely would qualify as a medical device” and therefore require registration with the MHRA.
Other considerations outlined in the guidance include ensuring the system supports data portability, planning and resourcing for ongoing maintenance, outlining responsibilities and costs, covering data storage and lifecycle management, and providing appropriate training for users. “Specifically, you can consider providing guidance on appropriate dictation regarding voice and words used, and reinforcing ongoing responsibility for practitioners to review and revise the outputs,” it states.
AI and ambient scribing from across the NHS
A recent HTN Now webinar focused on the practicalities of AI technologies, exploring topics including implementation, adoption, the role of data, policy, regulation, evaluation and best practices. With the help of our expert panellists, we also took a closer look at examples of AI in health and care. Panellists included Neill Crump, digital strategy director at The Dudley Group NHS Foundation Trust; Lee Rickles, CIO, director and deputy SIRO at Humber Teaching NHS Foundation Trust; and Beatrix Fletcher, senior programme manager (AI) at Guy’s and St Thomas’ NHS Foundation Trust.
Great Ormond Street Hospital shared plans at the end of last year to expand its pilot of ambient AI to 5,000 patients from a range of different healthcare settings across London, following testing in 100 outpatient appointments. The TORTUS assistant automates the process of note-taking during patient appointments, using ambient voice technology and generative AI to draft clinical notes and letters, which can then be checked by the clinician before being uploaded to the hospital’s EHR or sent out to patients.
University Hospitals Birmingham NHS Foundation Trust recently published a prior information notice looking to procure up to four digital solutions for the implementation of voice recognition software. According to the trust, the four solutions will be split into three different lots, covering digital diction, speech recognition with generative AI and outsourced transcription. The procurement process will be “subject to business case approval” with the pre-market engagement process helping to “form the tender process”.
Finalists in the HTN AI and Data Awards showcased a range of use cases for AI products and solutions across categories including the best use of AI for diagnosis, treatment and patient care, the best use of AI for promotion, communication and prevention, and the best use of AI and data for system efficiency”. Check out all of the entries here.
