The Care Quality Commission (CQC) has published a report into its preliminary regulatory sandbox pilot.
Carried out in August 2019, the pilot focused on the use of digital triage tools in healthcare services. The CQC worked with providers, people who use services, clinicians, technology suppliers and other stakeholders.
The sandbox programme was described as a space where providers can work with the CQC to look at how new ways of working fit with regulation.
Key findings listed in the CQC’s report include that national bodies can do more to help commission triage algorithms, and that clinicians should be able to override recommendations from these tools when they think it is in someone’s interest to do so.
The report also states: “Technology suppliers sometimes develop the clinical pathways for triage tools, which is an area with limited assurance or regulation. Although suppliers do not usually need to register with CQC, they must comply with all other relevant regulatory requirements. A similar initiative to the former accreditation scheme for guidance producers from NICE could be a valuable resource.”
The CQC report also emphasised the critical importance of involvement from other high level stakeholders in the healthcare industry, including the Medicines and Healthcare products Regulatory Agency (MHRA), the National Institute for Health and Care Excellence (NICE), NHSX and the International Standards Organisation (ISO).
One of the companies selected to work with the CQC was Doctorlink, a symptom assessment provider to the NHS.
Suzanne Ash, head of governance and medical device programme lead at Doctorlink, said: “For us, this offered a unique space where commercial interests could be put to one side, to be open about the challenges new models of care bring and focus on what really matters, how we can continue to innovate to achieve the best possible outcomes for patients.
“We are committed to the intentions and outputs of the sandbox and keen to ensure the relationships and momentum we have built through this process evolve to ensure patients continue to benefit from rapid development in digital technologies.”
Also included in the report was five recommendations for other organisations to consider.
Recommendation 1 – The Department of Health and Social Care, NHS England/Improvement and NHSX should consider including complex digital health interventions such as digital triage in the scope of their work to develop commercial standards for IT-related contracting across the NHS.
Recommendation 2 – NHSX and NHS England should work with NICE and NHS Digital to develop and publish the results of a fair test of clinical performance.
Recommendation 3 – NICE and its commissioners should consider whether its accreditation scheme, or a similar initiative, should be reopened to support tech suppliers where they are developing clinical content.
Recommendation 4 – The Department of Health and Social Care should consider whether there should be common safety-netting advice for the public for all symptom checkers and digital triage tools (even those that are not regulated as a medical device). Advice should clearly explain how to use the tools and confirm with the user whether they are happy to proceed before booking an appointment or to share the information they have provided with other health professionals.
Recommendation 5 – NHS England, analytically advanced integrated care systems, research funding bodies and Health Data Research UK should consider how they can work in partnership with technology suppliers to help healthcare providers, researchers, and commissioners to make the most of the information from these tools to improve efficiency and outcomes for people.