Health department unveils draft for revised HealthTech Programme Guidelines
The National Institute for Health and Care Excellence (NICE) has announced a consultation on an update to its HealthTech program, marking a significant step towards streamlining the evaluation and adoption of innovative medical technologies in the UK's National Health Service (NHS). The consultation comes at a critical time for NICE, following scrutiny from the industry over recent Late-Stage Assessments (LSA) pilots.
The focus of the updated HealthTech program is to integrate and streamline evaluations of medical technologies, diagnostic assessments, and interventional procedures into a comprehensive HealthTech program. This program provides conditional recommendations and rapid assessments, enabling earlier patient access to promising technologies while further evidence is gathered. The program covers clinical evidence, cost-effectiveness, and safety regarding novel or significantly modified technologies, digital tools, and procedures for the NHS [1][2].
Addressing concerns about late-stage assessments from the industry, the updated HealthTech program manual includes a structured approach to conditional and routine use recommendations. Technologies receiving conditional use recommendations are reassessed using evidence generated during an agreed period, allowing for managed adoption rather than delays caused by requiring full evidence upfront. The transitioning of some assessments from the former LSA interim process towards this integrated program aims to increase transparency and predictability in technology adoption decisions [2].
The approval of robotic surgery systems is a significant development in the field of MedTech. These systems, which offer more precise and minimally invasive procedures, could potentially revolutionize the field of surgery and lead to improved surgical outcomes and patient care. The UK agency has already approved cutting-edge robotic surgery systems, signifying a proactive approach towards technological advancements in line with the NHS 10 Year Plan's commitment to early MedTech adoption [3].
Chris Whitehouse, a political consultant and expert on medical technology policy and regulation, reported on this consultation. Whitehouse, who is an advisor to MedTech suppliers, is likely to discuss future trends and expectations in the MedTech sector in the article "MedTech in the UK and EU: What to Expect in 2025," available in "Medical Device Manufacturing Insights" [4]. This article might provide insights into the regulatory landscape and potential challenges in the MedTech industry.
The consultation seeks external stakeholder feedback on proposed updates to NICE's HealthTech program manual. The revision aims to replace the LSA interim process and methods statement, with the update including methods for developing HealthTech guidance, including the incorporation of formal processes for assessing technologies already in use within the NHS, known as late-stage assessments (LSA) [1][2]. The consultation will run for 5 weeks, ending on 4 September 2025. Interested parties can find the consultation at the provided link [5].
In summary, the update focuses on combining previous assessment processes into one program with conditional and routine use pathways to enable earlier controlled adoption and evidence generation, thereby addressing industry concerns about unpredictability and delays during late-stage assessments [1][2]. The consultation provides an opportunity for the industry to shape the future direction of the NICE HealthTech program, contributing to the proactive approach towards technological advancements outlined in the NHS 10 Year Plan.
[1] NICE (2025). HealthTech Program Update
[2] NICE (2025). HealthTech Programme Manual Update: Consultation
[3] NHS (2025). NHS 10 Year Plan
[4] Whitehouse, C. (2025). MedTech in the UK and EU: What to Expect in 2025
[5] NICE (2025). HealthTech Programme Manual Update: Consultation
- The updated HealthTech program under NICE aims to encompass evaluations of health-and-wellness related technologies, particularly those concerning diagnostic assessments, interventional procedures, and medical-conditions treatments.
- The incorporation of formal processes for assessing currently used medical technologies, known as late-stage assessments (LSA), and providing conditional recommendations for novel technologies is anticipated to expedite health-and-wellness improvements through earlier access to promising therapies-and-treatments.
