Contracting with the NHS: HealthTech considerations

For any HealthTech business looking to enter the market in England, whether that is to supply hardware (such as wearables), software (such as apps or entire operating systems) or data analytical tools, any market analysis will in all probability identify ‘the NHS’ as a key target for revenue generation. Comparative to how the business might approach other targets such an analysis might throw up, the route to contracting with the NHS is quite unique.

‘The NHS’ is comprised of numerous bodies, each with their own autonomy to procure goods and services, predominantly at their discretion, and the bargaining power that comes with being part of a wider system. With that comes an ability to dictate certain commercial terms, as well as the form of contract entered into, with NHS England’s suite of standard contracts largely forming the foundation of most dealings (mandatorily in many cases) for the sake of consistency across bodies.

Putting commercial provisions aside which, like in most transactions, remain up for negotiation within the parameters of each party’s position of strength, suppliers should not expect to be able to materially negotiate the contract’s ‘standard’ provisions. The NHS contracts in this way for a number of reasons, including for efficiency, and many (if not most) NHS bodies will not entertain diverting resource to negotiating the tried and tested, even on the occasions where they have scope to do so. As a consequence, suppliers need to be prepared to comply with obligations that they would not ordinarily expect to see in their dealings with the independent sector such as:

• Evidencing compliance with the relevant regulatory framework or standards, be that Medical Device Regulations, Data Coordination Board Standards, CQC registration, ISO27001 or otherwise from the off;
• In-depth provisions around information governance and the need for compliance with the NHS’s Information Governance toolkit (a tool for the supplier to assess itself against the Department of Health’s policies and standards);
• Accessibility to information as a consequence of the NHS body’s freedom of information obligations;
• An expectation that the supplier’s workforce will conduct itself in a manner consistent with the values outlined in the NHS Constitution; and
• Having in place a complaints policy that is consistent with the NHS body’s own obligations under the Local Authority Social Services and National Health Service Complaints (England) Regulations 2009.

It would also be sensible for HealthTech suppliers to take a look at:

• NHSX’s Digital Technology Assessment Criteria for Health and Social Care (DTAC) from February 2021 – this sets the baseline criteria for digital health technologies (DHTs) being supplied into the NHS and social care; and
• The National Institute for Health and Care Excellence (NICE) evidence standard framework for DHTs issued in March 2019, along with its nuanced guidance for DHTs incorporating AI where applicable - this outlines the evidence that the supplier should be capable of making available or producing to demonstrate their products’ value in the UK health and care system and this serves as a useful checklist for suppliers to ensure any initial hurdles to accessing the NHS market and they make their approach to the relevant bodies at the right time.

Contact Clare Auty or Joel Nixon to discuss how we can help you.