Overview of the NICE Evidence Standards Framework for Digital Health Technologies
The "Evidence Standards Framework for Digital Health Technologies" (ESF) is a guide published by NICE (National Institute for Health and Care Excellence) to outline the necessary standards for evidence that digital health technologies (DHTs) require to demonstrate their value to facilitate purchasing decisions within the UK health and social care system. The ESF serves as a resource for evaluators, NHS innovation teams, and DHT companies to ensure high-quality and effective research is conducted to support digital health innovations. This article provides a brief lay summary of the framework helping digital health solution providers understand the documents purposes and various elements.
Purpose
The main purpose of the ESF is to provide a standardised approach for evaluating DHTs, ensuring that they are effective, safe, and provide value for money. The framework helps streamline the evaluation process, facilitating the adoption of innovative digital health solutions in the healthcare system. In addition, it aims to complement existing regulatory and technical standards across NICE’s evaluation programs.
The ESF is broken down into the following key sections:
Introduction
Provides an overview of the ESF and its importance.
Explains the framework’s role in evaluating DHTs for commissioning or purchasing decisions in the NHS.
Highlights the framework’s adaptability to regulatory changes and the fast-evolving nature of DHTs.
Section A: Technologies Suitable for Evaluation
Identifies which DHTs are suitable for evaluation using the ESF.
Excludes certain types of software, such as those integral to medical devices or those used for training healthcare professionals.
Section B: Classification of Digital Health Technologies
Classifies DHTs based on their intended purpose and the potential risk to service users and the system.
Defines three tiers (A, B, and C) based on potential risk, detailing the types of DHTs included and excluded from each tier (See Figure 1 below).
Figure 1 - NICE ESF Tier classification system
Section C: Evidence Standards Tables
There are 21 standards and these are classified into 5 groups which presents the evidence standards across different phases of the DHT product life cycle.
Depending on the classification tier of your DHT, different standards will apply and not apply to you. See Table 1 below.
Table 1 - NICE ESF evidence groups, description, standards content and relevance to DHT based on tier classification.
Section D: Early Deployment Standards for Evidence-Generation Programmes
Provides standards for early deployment of DHTs to support evidence generation.
Focuses on helping early-stage DHTs generate the necessary evidence to meet the ESF requirements.
The benefits of the ESF for DHT Innovators and the Health System
DHT Innovator Benefits:
Guideline: Developers gain an understanding of the evidence required to demonstrate their technology’s value, helping them align their development processes with the framework’s standards.
Facilitated Adoption: Meeting the ESF standards increases the likelihood of a DHT being commissioned or purchased by the NHS, providing developers with a pathway to market their innovations.
Credibility and Trust: Adherence to the ESF builds credibility with healthcare providers and stakeholders, showcasing the developer’s commitment to high-quality and effective health solutions.
Health System Benefits:
Improved Quality of Care: By ensuring that DHTs meet high standards of evidence, the framework helps integrate effective and reliable technologies into the healthcare system, improving patient outcomes.
Cost Efficiency: The framework emphasizes the economic impact of DHTs, promoting technologies that provide value for money and help reduce the financial burden on the health system.
Standardized Evaluation: Provides a consistent and transparent method for evaluating DHTs, facilitating the adoption of innovative solutions that can enhance system efficiencies and patient care.
Summary
The ESF is a vital document that provides a structured approach for evaluating digital health technologies, ensuring they are effective, safe, and provide economic value, ultimately benefiting both the health system and DHT innovators.
DHT.health can support digital health technology innovators to satisfy the requirements outlined in the NICE Evidence Standards Framework.
Information and figures sourced from the NICE ESF evidence standards framework for digital health technologies document published 9th of August 2023. Available at https://www.nice.org.uk/corporate/ecd7