NHSX publishes new standard for digital health technology

NHSX recently published a draft Digital Health Technology Standard^[1] aimed at streamlining the way health innovations such as apps and other digital tools are reviewed and assessed by the NHS.  The new standard is particularly important against the current background of the response to the Covid-19 pandemic and the use of technology in aiding the fight against the disease.

Who are NHSX?

NHSX is the technology and digital unit of the UK National Health Service (NHS). It is a joint unit bringing together teams from across the Department of Health and Social Care, NHS England, and NHS Improvement with the aim of driving the digital transformation of care. NHSX’s programme teams cover a wide range of innovative technologies including:

• artificial intelligence
• cyber security
• digital urgent and emergency care – including NHS 111 online
• digitising pharmacy
• digitising providers – including global digital exemplars, our most digitally advanced trusts
• elective care – including e-referrals
• primary care digital transformation – including GP systems, data and digital services

New standard for digital health technology

The new standard will consolidate and replace existing standards as part of NHSX’s wider programme of work which aims to speed up how health technologies are reviewed, commissioned and scaled across the NHS and social care, and to provide clearer guidance to support digital health technology developers.  This has particular import given the widespread criticism of the way the UK government and the Department of Heath and Social Security in particular has responded to Covid-19 in procuring the necessary equipment and technology required.

The new standard will help commissioners by streamlining and speeding up the procurement and decision-making processes, enabling the NHS to procure and adopt relevant, safe and innovative technologies more quickly, providing a single source of assured products and services.

Consultation on the standard closed on 22 April 2020[2]. The final version is expected to be published soon.

Core components

The draft standard has 10 components with a rationale for why developers need to comply with it, and links to all relevant guidance needed to support applications. These components of the standard must be met by digital health technologies and are summarised below:

1. Developers must comply with the principles set out in the Code of Conduct for Data-Driven Health and Care Technologies;^[3]
2. Products should be designed to achieve a clear outcome for users or the system;
3. Products should also be designed so that they are easy to use and accessible to all users;
4. Products must be clinically safe to use;
5. Users’ information must be collected, stored and processed by products in a safe, fair, ethical and lawful way
6. Products must meet industry best practice security standards;
7. Products must also meet all regulatory and legal requirements, e.g. MHRA registration and CE marking where applicable;
8. The best possible use of open standards should be made;
9. Developers should ensure products are appropriately tested and that they are fit for purpose; and
10. Products’ achievement of clinical, social, economic or behavioural benefits should be evidenced.

COVID-19 driving increased adoption

It seems clear that the current situation is speeding up the adoption of digital tools and technologies across the NHS. Many digital health developers believe that changes being made now to primary care services will lead to a long-term shift in attitudes to ‘digital first’. For example, NHSX recently launched a scheme which sends daily text messages to those registering via NHS 111 online as self-isolating with suspected symptoms of coronavirus in order to check up on their progress and wellbeing. Further, we have seen a massive spike in the usage of NHS’s various platforms such as the NHS website, NHS App and Electronic Prescribing Service (EPS), with NHS 111 online seeing a leap from an average 10,000 users per day to an average of almost 550,000 throughout March.

Other resources

Digital health developers and those running digital health products should also consult with Public Health collection of resources^[4] to help anyone developing or running a digital health product to conduct an evaluation, from defining how it works, to choosing evaluation methods and analysing the data.

Engaging with NHSX

NHSX runs monthly surgeries for digital innovators to meet with the Digital Innovation Team enabling them to learn more about developers and their products, and to enable developers to see for advice on issues, such as scaling within the NHS. Developers can register using NHSX’s Innovation Surgery Registration form^[5].

^[1] https://www.nhsx.nhs.uk/media/documents/NHS_Digital_Health_Technology_Standard_draft.pdf

[2] https://www.nhsx.nhs.uk/key-tools-and-info/designing-and-building-products-and-services/

^[3] https://www.gov.uk/government/publications/code-of-conduct-for-data-driven-health-and-care-technology/initial-code-of-conduct-for-data-driven-health-and-care-technology

^[4] https://www.gov.uk/government/collections/evaluating-digital-health-products

^[5] https://docs.google.com/forms/d/e/1FAIpQLSeXcJmcGr5THZ2pNErMyqwbFXDmWCP8lIl7eRXt2whpM6dL0g/viewform