Background to the framework

We have shaped an evidence framework that is intended to help evaluators, technology developers, and decision makers better understand what information is required to identify technologies of value to service users and the health and care system.

Our evidence framework has been adapted from existing frameworks including the EUnetHTA core model, and the NICE evidence standards framework for digital technologies. We have drawn from these frameworks and focused on elements that SHTG give consideration to when appraising a technology.

The evidence framework is intended to be used as a reference guide, aligned to the key evidence requirements for health technology assessment (HTA). If the needs under the relevant domains are met, we can determine the value of the technology under review.

The framework can help stakeholders understand how SHTG evaluates health technologies. SHTG advice is based on the quality and quantity of evidence available, across the domains set out in this framework.
Not all domains will be relevant for all technologies. For example, a new service may not require a UKCA or CE mark.

Some domains are particularly important for HTA. For example, technologies that are unable to demonstrate any evidence of clinical effectiveness are not ready for SHTG assessment.

It is important to make evidence-based decisions. Demands on health and care services are high and resources are limited. Evidence helps us to target our resources on what really makes a difference.

From the very early stages of technology development, planning how to gather evidence to demonstrate value will help with discussions between technology developers and decision makers.

This framework is relevant across all health technologies.

This broad definition means that health technologies considered by SHTG include:

SHTG does not consider medicines, which is the remit of the Scottish Medicines Consortium (SMC).

To address domains relevant to digital technologies (such as health apps, wearable devices, telemedicine) beyond those in the evidence framework, completion of the NHS England Digital Technology Assessment Criteria (DTAC) supports our decision making. The DTAC supports the commissioning of digital technologies in NHS England and social care services and was launched in 2021. It sets out baseline standards for clinical safety, data protection, technical security, interoperability and usability and accessibility.

Of the DTAC standards, some are deemed ‘must haves’ (clinical safety, data protection, medical device regulation) and others are best practice (cybersecurity, interoperability). The DTAC process is outline in Additional domain 1.

SHTG is not a regulator so cannot mandate the regulatory aspects of DTAC.

The purpose of HTA is to inform decision making. The value and impact of HTA is strongly linked to the implementation of its recommendations.

Five domains are set out in this evidence framework. These are:

Domain 1: the technology and its value
Domain 2: safety, acceptability and credibility
Domain 3: demonstrating the performance of the technology
Domain 4: capturing the cost and value for money of the technology, and
Additional domain 1: Digital Technology Assessment Criteria (DTAC)

For more information on the Scottish Health Technologies Group, contact the team at the email or visit our webpages at shtg.scot.