The guidance is published and it is official. NICE has successfully completed the first assessment using the digital health technologies guidance development pilot project. The Zio XT service, which is used for detecting abnormal heart rhythms, is recommended as an option while further data is collected to address evidence gaps about the benefit for patients and the NHS.
We’re really excited by this development and the successful completion of this project paves the way for further NICE assessment of digital health technologies. Our focus is on those digital technologies with the highest clinical, financial and/or operational risk. These are defined as evidence tier 3 technologies, as outlined in the Evidence Standards Framework for Digital Health Technologies, an updated version of which will be published soon.
At NICE we are excited about the benefits that digital health technologies can bring and will work with our system partners to ensure that effective and cost-effective digital technologies reach patients in the NHS in a timely manner.
The digital health technologies pilot project focussed specifically on assessing whether our existing methods and processes could be applied to advanced digital technologies. This builds on a strong portfolio of NICE guidance on products that have digital elements, developed across our medical technologies evaluation programme, our diagnostics assessment programme and our centre for clinical guidelines.
NICE is actively working to support the full bench to bedside pathway for digital health technologies. Earlier this year, Zio XT’s developer, iRhythm Technologies, was named a winner of the Accelerated Access Collaborative’s Artificial Intelligence in Health and Care Award. NICE is working with the Accelerated Access Collaborative to ensure that the right evidence is gathered during the award for subsequent re-evaluation.
NICE is also committed to working with NHSX and the Medicines and Healthcare products Regulatory Agency (MHRA) on developing a streamlined regulatory to access pathway in England for digital health technologies.
Work is also ongoing to set standards on data quality and utility in the NHS, which will improve the data driving digital technologies. Further work across regulators in the system is ongoing to enhance and join up the advisory services available for data driven health technologies.
Developers of digital technologies for the health and care system are encouraged to engage with NICE through several routes:
- Submit details of their technology to HealthTech Connect, the secure, online database of devices, diagnostics and digital health technologies intended for use in the NHS or wider UK health and care system.
- The META tool allows developers to fill in details of their product online and then undergo a gap analysis with an adviser.
- NICE Scientific Advice can provide in-depth advice on clinical and economic evidence generation plans.
- The Office for Market Access facilitates multi-stakeholder engagement meetings for disruptive technologies to ensure all partners in the regulatory to access pathway are connected.
The next 12 months are set to be an exciting time for digital health technologies. NICE will be announcing details of how we plan to further support those developing digital products in the next few months.
We have made good progress in 2020 and we want to build on this to ensure that the best digital health technologies, supported by evidence, are reaching people using the NHS.
Our pilot project has shown we are on the right track and we look forward to supporting access to promising digital health technologies in 2021 and beyond!
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