A public consultation on an evidence standards framework (ESF) used by local evaluators to help identify digital health technologies and their benefits has opened.
The updated framework is intended to make it easier for “innovators and commissioners to understand what good levels of evidence for digital health technologies look like”, along with supporting innovators in demonstrating a technology’s effectiveness and value when submitting it for National Institute for Health and Care Excellence (NICE) evaluation. Additionally, the framework should help commissioners to make consistent and informed decisions when they look to purchase digital health technologies.
“The framework encompasses evidence of performance relevant to the purpose of the technology and evidence of economic impact relative to the financial risk,” state NICE, adding that it also “includes associated design factors and deployment considerations.”
The public consultation provides an opportunity for individuals to offer their opinions to shape the framework. The aim is to ensure that the framework meets developer and adopter needs, and ‘enables high-quality innovation to be identified and used’.
The NHS Artificial Intelligence (AI) Lab has provided funding for NICE and partners to update the framework to make it easier to use, to include evidence requirements for AI and data-driven technologies, and to align classification with regulatory requirements.
“The development of the medical device regulatory framework and evaluation methods for digital health technologies, particularly those with adaptive algorithms, is progressing rapidly,” NICE notes within the framework.
The consultation will close on 25 April at midnight. To take part, you can read the draft version of the updated framework and the user guide, then complete an online survey through which you can share your views. Please click here for more information.
Following the consultation period, the standards framework and user guide are expected to be updated by 30 May, and published along with support tools by 28 June.