0370 270 6000

Contracting with the NHS: HealthTech considerations

17 March 2021

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:

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

Focus on...

Legal updates

The Net Zero Supplier Roadmap: recommendations to help achieve Net Zero

Steps NHS organisations should take now to help reach its target of reducing carbon emissions by 80% by 2036-2039.

View

Legal updates

Care Quality Commission (CQC) revisions to its Transitional Monitoring Approach - what should providers be thinking about?

With the Care Quality Commission now considering consultation responses in respect of its long-term regulatory approach, life goes on under their Transitional Monitoring Approach.

View

Legal updates

The White Paper overview [Part 4] - Integration and innovation: working together to improve health and social care for all - additional proposals

We set out and consider each legal proposal in the section on working together and supporting integration and innovation. The Government has put forward an additional series of targeted proposals to improve social care, public health, and quality and safety.

View

Legal updates

To tender or not? A first look at the proposed NHS Provider Selection Regime

This article looks at some of the key points set out in the Consultation Paper and invite you to join our working group to discuss and consider the proposed regime.

View

The content on this page is provided for the purposes of general interest and information. It contains only brief summaries of aspects of the subject matter and does not provide comprehensive statements of the law. It does not constitute legal advice and does not provide a substitute for it.

Mailing list sign up

Select which mailings you would like to receive from us.

Sign up