How to get help understanding Evidence Standards for Digital Health Technologies

The proposed idea behind the DTAC is to equip local and national NHS and social care teams with the guidance needed to evaluate and make decisions on which health technologies they should procure or recommend to patients. With so many health apps and digital technologies available for use, the DTAC is vital in the decision-making process of digital technology procurement in the UK. The DTAC will be used to evaluate all types of DH (digital health) technologies which includes:

• Public facing health apps
• Digital systems e.g. electronic patient records 

The NHS (which includes hospitals, CCGs and national bodies) and social care will be encouraged to use the DTAC to assess DH technologies. Using the criteria outlined by the DTAC, the path between development and procurement for the NHS and social care should be clearer. The DTAC is not mandatory as of this moment of time, however, the criteria set out by the DTAC helps the system to assess products much quicker and consistently while also guiding you through the legislative requirements and good practice.

The criteria set out by the DTAC are focused on 5 core areas and are as follows:

• Clinical safety - assessed to ensure that baseline clinical safety measures are in place and that organisations undertake clinical risk management activities to manage this risk.
• Data protection - assessed to ensure that data protection and privacy is ‘by design’ and the rights of individuals are protected.
• Technical assurance - assessed to ensure that products are secure and stable.
• Interoperability - assessed to ensure that data is communicated accurately and quickly whilst staying safe and secure.
• Usability and accessibility - products are allocated a conformity rating having been benchmarked against good practice and the NHS service standard

Buyers and those considering health technologies should ask the developer to complete the DTAC and provide the evidence required as requested in this form.

NICE evidence standards framework for DH technologies

A framework exists that describes the level of evidence needed to demonstrate the effectiveness and value for digital technologies that have distinct functions and risks. The Evidence Standards Framework for DH technologies was created by NHS England, the National Institute for Health and Care Excellence (NICE), Public Health England, MedCity and DigitalHealth.London. The evidence standards framework covers evidence standards for effectiveness and economic impact (NICE, 2021).

a)   Evidence for effectiveness standards

 The first step is to identify which tier your DH technology fits into by describing the main function of your DH technology. Each tier has its own set of evidence standards that the DH technologies must meet. 

The diagram below shows the different evidence tiers (NICE, 2021).

The evidence standards for each tier shows two levels of evidence:

• Minimum standard
• Best practice standard

The evidence standards framework for DH technologies states that the contextual questions listed should be used to identify any potential specific risks that may be associated with the DH technology. For DH. technologies that have a higher potential risk (those that have any potential specific risks), it is recommended that the best practice standards for evidence should be used. If there are no real specific potential risks, then the minimum evidence standards can be used.

The contextual questions that answer whether the DH technology has a higher potential risk are detailed below:

1. Are the intended users of the DH technology considered to be in a potentially vulnerable group such as children or at-risk adults?
2. How serious could the consequences be to the user if the DH technology failed to perform as described?
3. Is the DH technology intended to be used with regular support from a suitably qualified and experienced health or social care professional?
4. Does the DH technology include machine learning algorithms or artificial intelligence?
5. Is the financial or organisational risk of the DH technology expected to be exceedingly high?

The evidence needed for each Tier of the DH technologies can be seen in TABLE 3, 4 5 of this NICE document.

a)   Evidence for economic impact standards

The evidence for the economic impact standards can be separated into three categories:

• Key economic information (Table 6)
• Appropriate economic analysis (Tables 7 & 8)
• Economic analysis reporting standards (Table 9) 

Information regarding evidence in the above three categories can be found here.

 Why are they important to businesses?

 These standards are core to DH technologies. DH technologies consist of a broad range of products that include apps, software and online platforms. DH technologies are being developed at a pace which has resulted in a wealth of new DH technologies in the market. However, this rapid development of DH technologies has resulted in products entering the market with little evidence that shows effectiveness and economic impact.

The use of the DTAC and the NICE evidence standards framework for DH technologies will provide the NHS with tools that will help them identify what technologies have decent quality evidence to show that they are indeed both clinically effective and cost effective. This will help inform the decisions on NHS purchasing decisions.

These tools are also particularly good guidance for companies when designing and developing their technologies so they can collect evidence simultaneously.

SEHTA SimDH partnership delivering workshops

SEHTA (South East Health Technologies Alliance) in partnership with London South Bank University's South Bank Innovation has just completed the delivery of the Simulation for Digital Health (SimDH) Programme for its second cohort, helping to “fast-track” the success of the health-tech companies by providing one-to-one support and group workshops to SMEs registered on the programme between June - October 2021.

SEHTA have been commissioned to deliver the. programme to five cohorts over 3 years to support up to 100 health-tech start-ups and SME companies.

SimDH is co-funded by LSBU and the European Regional Development Fund (ERDF). The SimDH Programme utilises the academic knowledge within London South Bank University (LSBU) with the comprehensive knowledge and experience of its industry partners which is passed on to participants via a range of bespoke support including regular workshops and one-to-one support, to build knowledge & skills as well as designing, evaluating and supporting the launch of new products and services.

Apply to SimDH to access SEHTA’s standards & assessments workshops 

SEHTA will deliver Cohort 3 from January – May 2022.

Cohort 3 Workshop topics are:

• Introduction to Digital Health Landscape in the UK and Overseas
• Standards Strategy & Assessments for DigitalHealth Technologies
• Value Proposition & Gathering the Evidence
• Strategy & Business Model for Digital HealthTechnology Businesses
• Business Models for Health Tech companies
• Understanding the NHS: Structure, drivers & priorities inc, post-COVID landscape
• Navigating procurement & frameworks for digital health companies
• Accessing Funds
• Public Sector Funding: writing a successful grant application

If you are interested in applying for Cohort 3 of this free to attend programme, applications are now open until Sunday 5 December 2021.

Find out more about the programme, check eligibility criteria and apply via www.simdh.com

South East Health Technologies Alliance (SEHTA) is a health technology network organisation, providing business support for the benefit of our members who represent health technology SMEs, health professionals, care providers and academia. Founded in 2005 as an organisation to understand and meet the needs of small healthcare businesses, we are one of the largest networks of individuals from Academia, Business and Care/Clinicians (with over 1300 members), with the purpose of improving the health and care of the citizens of the UK as well as increasing wealth. We do this by offering support on a one-to-one basis through our business support services and one-to-many through workshops, training and other events. 

Find out more about SEHTA at www.sehta.co.uk.

References 

NHSX. (2021). Digital Technology Assessment  Criteria (DTAC). Retrieved from NHSX:  https://www.nhsx.nhs.uk/key-tools-and-info/digital-technology-assessment-criteria-dtac/

NICE. (2021, April 23). Evidence standards  framework for digital health technologies. Retrieved from NICE: https://www.nice.org.uk/corporate/ecd7