The NICE Evidence Standards Framework for digital health and care technologies - Developing and maintaining an innovative evidence framework with global impact

Harriet Unsworth; Bernice Dillon; Lucie Collinson; Helen Powell; Mark Salmon; Tosin Oladapo; Lynda Ayiku; Gary Shield; Joanne Holden; Neelam Patel; Mark Campbell; Felix Greaves; Indra Joshi; John Powell; Alexia Tonnel

doi:10.1177/20552076211018617

The NICE Evidence Standards Framework for digital health and care technologies - Developing and maintaining an innovative evidence framework with global impact

Digit Health. 2021 Jun 24:7:20552076211018617. doi: 10.1177/20552076211018617. eCollection 2021 Jan-Dec.

Authors

Affiliations

¹ Department of Computer Science, University of Liverpool, UK.
² Centre for Health Technology Evaluation, NICE, Manchester, UK.
³ Digital, Information and Technology Directorate, NICE, Manchester, UK.
⁴ Health and Social Care Directorate, NICE, Manchester, UK.
⁵ MedCity, London, UK.
⁶ Science, Evidence and Analytics Directorate, NICE, Manchester, UK.
⁷ NHSx, London, UK.
⁸ Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.

Abstract

Objective: In 2018, the UK National Institute for Health and Care Excellence (NICE), in partnership with Public Health England, NHS England, NHS Improvement and others, developed an evidence standards framework (ESF) for digital health and care technologies (DHTs). The ESF was designed to provide a standardised approach to guide developers and commissioners on the levels of evidence needed for the clinical and economic evaluation of DHTs by health and care systems.

Methods: The framework was developed using an agile and iterative methodology that included a literature review of existing initiatives and comparison of these against the requirements set by NHS England; iterative consultation with stakeholders through an expert working group and workshops; and questionnaire-based stakeholder input on a publicly available draft document.

Results: The evidence standards framework has been well-received and to date the ESF has been viewed online over 55,000 times and downloaded over 19,000 times.

Conclusions: In April 2021 we published an update to the ESF. Here, we summarise the process through which the ESF was developed, reflect on its global impact to date, and describe NICE's ongoing work to maintain and improve the framework in the context for a fast moving, innovative field.

Keywords: Health economics; clinical evidence; digital health; general; health technology assessment.