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Data sharing standard 5e - Commercial Purpose

This standard is part of a series of guidance documents to support the various stages of a DARS application.

 

Standard description

Commercial purpose

This section of the application/agreement applies where:

  1. any of the controllers involved charge (or permit the charging of) a fee for the use of data and/or
  2. any party involved in the application receives any form of commercial benefit1 (including intangible or indirect commercial benefits such as positive publicity for a commercial venture) from the use of data, for example commercial funders or sponsors.

In such cases, the purpose would be deemed commercial or more commonly – as applications may have several purposes – would be deemed to include a purpose which is commercial. Section 5e is the appropriate place to record the commercial interest of a funder or funders.

The applicant must be able to clearly demonstrate that there is a benefit to health and social care in England and Wales in order for NHS Digital to be confident that they are meeting the requirements under the Health and Social Care Act 2012 as amended by the Care Act 2014, which stipulate that NHS Digital (the HSCIC) may only disseminate information under its general dissemination power in section 261(1) for the purposes of the provision of health care or adult social care or for the promotion of health. This would enable data to be made available for a wide range of health and care related purposes – including for the commissioning of those services, and the epidemiological research that is needed at the earlier stages of developing new treatments – but not for solely commercial purposes such as for commercial insurance.

NHS Digital will not approve requests for data where the purpose is for marketing purposes, including promoting or selling products or services, market research or advertising.

A commercial organisation can receive approval to access data for the purposes of providing services or developing/maintaining a product for profit if it is clearly demonstrated that the provision of such products or services may benefit the health and social care system in England and Wales.  In such scenarios:

  1. The application must clearly explain the nature of the recipients of the products/services (e.g. NHS, commercial, charities, etc.) and the benefits to those organisations from receiving the products/services;
  2. It must be clearly explained how the provision of the products/services will lead to benefits to the health and social care system in England and Wales2 ;
  3. The application should (in combination with section 5d - Benefits) provide a transparent assessment of how the commercial interests are proportionately balanced with the benefits to the health and social care system and to the interests of the data subjects.  This may include for example detail on the nature and split of the customer base, or proportion of income derived from each customer segment.  This is particularly relevant if the legal basis is not Public Task.

Read note 1

1For example, commercial funders or sponsors who are likely to benefit from press coverage / public relations as a consequence of the processing and/or publication of the outputs.

Read note 2

2The requirement for benefit to accrue to England and Wales is a policy position adopted by NHS Digital based on a number of factors.  It is acknowledged that benefits accruing outside of England and Wales may still benefit England and Wales.  For example, outputs which advance the state of treatment on a particular disease may enhance the evidence base leading to improved treatments in the NHS.  Making research outputs available open access and/or providing relevant summaries for clinicians and policy makers in the UK, would strengthen the case for this.

If the applicant is requesting data for a purpose requested, commissioned and/or funded by an organisation with a commercial interest:

  1. The application must clearly explain the interests of the commercial organisation in requesting/commissioning/funding the work including any benefits which may accrue noting that benefits may be delayed, indirect or non-financial.  This should include acknowledgements of any potential conflicts of interest – e.g. if the commercial organisation holds a patent on a drug or treatment being studied or on a rival drug or treatment to that being studied. 
  2. The application must clearly explain any outputs which will be delivered to the commercial organisation and the purposes for their provision.
  3. The application must clarify whether the commercial organisation may influence the outputs of the work including the method of dissemination; the ability to suppress findings or receiving any exclusive access to findings.

If the data will be requested and/or used by a commercial arm of a non-commercial organisation, such as a registered charity: 

  1. The application must clearly explain the role of the commercial arm and the reasons for its involvement in addition to or as opposed to that of the non-commercial organisation.
  2. The application must clearly stipulate whether the commercial arm will make profit from the use of the data (e.g. providing a service for financial reward/recompense) and/or recover its costs from external clients.
  1. When there is any involvement of a pharmaceutical company, insurance company, management consultancy or any organisation where the public may have particular concerns about their involvement in health and social care, there may be additional scrutiny.  Such scrutiny for example might include consideration of whether there are any conflicts of interest in relation to this application.
  2. For avoidance of doubt, the application may have a commercial use or aspect, but it cannot be solely for commercial purposes (as stated in the explanatory note to s122 of the Care Act 2014)

Last edited: 31 March 2021 8:50 am