Health authority NICE initiates public discussion on revised HealthTech Programme Manual
NICE Revises HealthTech Programme Manual for Enhanced Evaluation of Established Technologies
The National Institute for Health and Care Excellence (NICE) has announced a significant update to its HealthTech programme manual. The purpose of this revision is to provide greater detail and formalisation of methods used when developing guidance for HealthTech products, particularly for those already in established use within the NHS, known as late-stage assessments (LSA).
This revision replaces the previous LSA interim process and methods statement with a more robust, structured approach. Chris Whitehouse, a political consultant and expert on medical technology policy and regulation, reported on this consultation.
Key features of this revision regarding LSAs include formalising the assessment process for HealthTech products that have been in use but require evaluation to determine their continued use or wider adoption within the NHS. The revision also introduces detailed methodological frameworks for late-stage evaluation, improving clarity and consistency compared to the interim guidance previously used.
The update also supports the generation and incorporation of real-world evidence and post-market data related to already established technologies. It provides clear guidelines to stakeholders on how to comment on and engage with these updated methods via an open consultation process, reflecting NICE’s commitment to transparency and stakeholder involvement.
The revised manual ensures that the HealthTech programme can efficiently and rigorously assess mature medical technologies, facilitating evidence-based decisions for NHS adoption or continued endorsement. This is critical for technologies like digital health platforms recently conditionally recommended for cardiac rehabilitation.
The consultation will run for 5 weeks, ending on 4 September 2025. The consultation provides an opportunity for industry to shape the future direction of the program. Interested parties can find more information and participate in the consultation here.
It is important to note that the consultation does not mention any specific MedTech systems or plans for their adoption or roll-out. The NHS 10 Year Plan commits to early adoption and roll-out of MedTech, but this commitment is not directly linked to the NICE consultation.
Chris Whitehouse, in his report on the NICE consultation, did not discuss the approved robotic surgery systems or the NHS 10 Year Plan. He is, however, an advisor to MedTech suppliers.
For those interested in the broader context of MedTech in the UK and EU, there is an article titled "MedTech in the UK and EU: What to Expect in 2025" in "Medical Device Manufacturing Insights". However, this article does not provide specific details about the expected changes in MedTech in 2025 or the NICE consultation.
The revised HealthTech programme manual, implemented by NICE, now includes a structured approach for the late-stage evaluation of HealthTech products that have been in use, such as digital health platforms for cardiac rehabilitation, to determine their continued use or wider adoption within the NHS. This update also supports the generation and incorporation of real-world evidence and post-market data related to established technologies, contributing to the discipline of science in the field of health-and-wellness, particularly medical-conditions management.
