techUK respond to NICE consultation on updates to the Evidence Standards Framework for Digital Health Technologies
techUK worked with members to review the ESF and welcomed NICE’s ambition to encompass all DHTs, helping to overcome the major barriers facing suppliers in generating evidence whilst also remaining commercially active.
techUK called for several changes to the framework, which we have outlined in brief below:
- Need for further clarity on standards and categorisations
The ambition to make this framework all-encompassing has resulted in certain areas which could benefit from further clarification. In order to ensure maximal clinical benefit for patients, better value for money for the NHS, and fast-paced processes, techUK would recommend further clarity is provided on standards and categorisations.
- Need for additional detail on practice and processes
techUK called for some additional detail on how the ESF will be translated into reality. Examples of how the ESF will be shared and turned from theory into practice, ensuring standardisation across different platforms, will be necessary.
In line with this, we would welcome further clarity around how the ESF, and the role of the NICE Digital Health Office, fits into the wider digital health and innovation ecosystem, particularly in relation to work with the MHRA on regulating Software as a Medical Device, and with NHS England & Improvement on the implementation of the Digital Technology Assessment Criteria (DTAC).
- Introducing a level of proportionality for SMEs
techUK would welcome engagement with the wider system and with industry to ensure that the challenges posed to SMEs with limited resources by these changes are properly understood, of which we included several examples in our response.
Overall, it is fantastic to see NICE play a stronger role in easing the path to adoption and diffusion for DHTs. techUK applaud the intention of the ESF and welcome collaboration with industry to ensure the framework is an enabler of innovation.
If you are a member of techUK and would like to see a full copy of our response, please email [email protected]. techUK will continue to engage with the NICE Office for Digital Health across several areas of interest to members.