NHS ruling ignites global debate: Now will Canada classify AI scribes as medical devices?

A priority notification issued June 9 by the National Health Service (NHS) for England classifying AI scribes as class 1 medical devices has AI scribe vendors, healthcare regulators and clinicians around the world debating the pros and cons of the ruling and wondering if other jurisdictions will follow suit.The notification by NHS England national chief clinical information officer Alec Price-Forbes warned clinicians against using ambient voice technologies (AVTs) that are not compliant with NHS standards issued April 27 and instructed providers to complete “a clinical safety risk assessment and data protection impact assessment prior to using these tools as part of their legal responsibilities.”Australia’s Medical Republic likened the NHS communication to a bomb dropped on the AI sector. And one pundit on social media complained about the burden medical device regulation imposes on healthcare innovation, but admitted, “When you have scribes getting deeper into clinical workflows, you can’t accept a cowboy wild west where half-baked tools deeply influence patient care.”Responding to an audience member who raised the issue at a June 25 Digital Health Canada webinar on AI Meets Primary Care, Christopher Sulway, chief of strategy at OntarioMD, said the creation of SOAP notes by AI scribes falls short of the threshold for Health Canada classification as a medical device. However, he went on to warn that new functionality, including differential diagnosis and medication suggestions could result in additional privacy, regulatory and liability issues that will need to be looked at.Read: Free AI scribes now available for 10,000 Canadian primary care providers“We are seeing vendors push into clinical decision support,” added panelist Dr. Payal Agarwal, a family physician and researcher at the Women’s College Hospital Institute for Health Systems Solutions and Virtual Care. “Technically, it may not seem like much of a jump for them but from a clinical perspective it carries a lot of risk, so we see the need for rigorous evaluation, and I suspect we will see regulatory movement in that space eventually.”While there has been no licensing or testing of AI scribes as medical devices in Canada, Women’s College Hospital Institute for Health Systems Solutions and Virtual Care teamed up with OntarioMD for a multi-phase pilot to understand their value, and both Ontario and Canada Health Infoway have carried out extensive pre-qualification processes to identify lists of AI scribe products that meet clinical, privacy and security requirements.Researchers at Women’s College Hospital’s living laboratory measured the workflow of doctors interacting with patients both with and without AI scribes and found a four-minute time saving in documentation time per encounter using the technology, said Dr. Agarwal.“We looked at errors, the quality of the notes and the ability of the technology to differentiate between speakers,” she added. In a second phase of the pilot, AI scribes were provided to 150 primary care providers for three months, resulting in estimated time savings of three hours per week on administrative tasks, improved work/life balance for clinicians and reports by patients of improved patient-provider engagement.At the time, there were only six AI scribes on the market and the goal was to understand their potential impact—not to assess them individually or confirm their adherence to any requirements.The Women’s College Hospital Institute’s living laboratory for testing new digital solutions hopes to repeat the work it did on AI scribes as new applications and functionality are introduced “because scribes are just one function,” said Dr. Agarwal. “There are also AI applications for chatbots, office assistance, clinical decision support, triage and inbox management. These are all functions that have tremendous benefit, but also potential risk, so what we’re looking to do now is build a program that leverages the success of AI scribes and allows us to repeat these evaluations for a slew of other AI tools in the market.”As the number of AI vendors mushroomed—Dr. Agarwal claims there are now 30 to 60 products on the market—both Ontario and the federal government’s Canada Health Infoway embarked on rigorous pre-qualification processes.The Ontario initiative, led by the province’s Ministry of Health in partnership with Supply Ontario and OntarioMD, identified a curated list of 20 AI scribes on June 3, and beginning June 10, eligible clinicians across Canada were able to enroll in the Canada Health Infoway program that offers a fully funded one-year licence for one of nine pre-qualified AI scribes.The pre-qualification process relieves clinicians from having to vet AI scribes on their own but probably falls short of a more thorough regulatory process for medical devices. And unlike the NHS which has warned clinicians against using products that aren’t compliant with its standards, no one is instructing Canadian clinicians using AI scribes that aren’t on the lists of products pre-qualified by Ontario and Canada Health Infoway to stop using them.AI scribe vendors and clinicians will be watching to see if Health Canada and its Medical Devices Directorate decide to classify AI scribes as medical devices and how such a decision impacts the rollout of a technology that shows so much promise for easing the administrative burden in primary care.

NHS ruling ignites global debate: Now will Canada classify AI scribes as medical devices?

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