NHS guidance on effective data partnerships

On 12 July 2023, the NHS Centre for Improving Data Collaboration (CIDC) released its long-awaited guide on effective NHS data partnerships (which was further updated on 25 July 2023). This guidance follows on from a number of previous data-related statements and guides including "Better, broader, safer: using health data for research and analysis" - The Goldacre Review (April 2022)   and  Data saves lives: reshaping health and social care with data (June 2022).

The guide focusses predominantly on how NHS data should be accessed, and how the NHS should be remunerated for that data access and use, in research and development (and possibly commercialisation) activities.

Data access

Perhaps unsurprisingly given NHS England's recent announcements regarding the adoption of secure data environments (SDEs) (see here), the planned default method of accessing NHS data is via an SDE which would allow users to access, review and manipulate data within the SDE without it ever leaving that environment. Other options are acknowledged as possible but not favoured, such as (the previously adopted) extraction and transfer of pseudonymised NHS data to third parties to use on their own systems, or provision of limited aggregated data via an NHS environment.  

Remuneration for data access

As to ensuring the NHS receives fair value for the sharing of its data, three headline points to note are:

• the NHS intends always to charge some fee for data access - with such fee being determined by the use not user (commercial use resulting in higher fees);
• the NHS remuneration should be "proportional to the NHS's contribution to that [ultimate commercial value]"; and
• the NHS acknowledges that it does not necessarily need to own any rights in IP generated using the data provided it is remunerated appropriately (and indeed notes that "owning foreground IP may not be the most effective way for your organisation to maximise public benefit, especially financial benefit" and "generally, it is best for marketable foreground IP to be held by the partner with a track record of taking products to market").

The latter is of particular note as such a requirement for the NHS Trust to own resulting IP would likely inhibit the volume and types of partnerships industry would be willing to enter into with the NHS.

In terms of how remuneration could be structured, the guide suggests that NHS Trusts consider one-off fixed amounts, subscription-style fees, milestone payments linked to developmental/commercial success of any resulting product generated from, or which uses, the NHS data, royalty payments, or any combination of the foregoing. Importantly, the guide acknowledges that what will be appropriate will vary depending "on [the NHS Trust and the partner's] respective contributions, roles, responsibilities, risks and investment". Notably, the guide refers to data curation or clinical input by the NHS Trust as an example of additional services the NHS Trust might provide and, which the guide implies, might warrant greater remuneration.

Internal governance

The guide observes that "protracted negotiations that delay or block valuable innovation" should be avoided and that a "consistent, efficient approach that aligns incentives for all parties is preferred to optimizing each individual negotiation". Similarly, the guide recommends NHS Trusts implement their own data strategies regarding how they will approach data sharing requests to ensure consistency. As such, we might see NHS Trusts take a holistic look at their data assets and the related services they might provide, and adopt one standardised approach with little room for negotiation. However, while we might see limited contractual negotiation, the guide also advocates establishing internal NHS governance structures to review and approve new partnerships, which may still cause delays.

The guide also covers a number of other related topics, including how to ensure data sharing partnerships comply with data protection laws and patient confidentiality laws, as well as how an NHS trust might communicate its data sharing position with patients and considerations for selecting a data partner. In amongst this guidance are indications of the NHS' proposed contracting approach on certain points, including non-exclusive licences, change of control provisions, and change control mechanisms for revisions to project scope.

While this guide focusses on data sets, the CIDC comments that further guidance will be issued shortly with regard to the treatment of other "knowledge" assets such as clinician input and research as part of a refreshed IP Policy.