The newly formed tech unit, NHSX will be assuming responsibility of the sharing of NHS patient data with industry.
In a new guidance document published on 15th July, it sets out defining principles for data-sharing agreements and provides new guidance for the use of data sharing for commercial purposes.
The guidance has been published in anticipation that NHS organisations will enter into an increasing number of arrangements. It aims to ensure these are done so in a way which is safe, ethical, evidenced and transparent, so that people know what data is shared and the right privacy and safeguarding is in place.
The 5 principles have been defined:
Principle 1: Any use of NHS data, including operational data, not available in the public domain must have an explicit aim to improve the health, welfare and/or care of patients in the NHS, or the operation of the NHS. This may include the discovery of new treatments, diagnostics, and other scientific breakthroughs, as well as additional wider benefits. Where possible, the terms of any arrangements should include quantifiable and explicit benefits for patients which will be realised as part of the arrangement.
Principle 2: NHS data is an important resource and NHS organisations entering into arrangements involving their data, individually or as a consortium, should ensure they agree fair terms for their organisation and for the NHS as a whole. In particular, the boards of NHS organisations should consider themselves ultimately responsible for ensuring that any arrangements entered into by their organisation are fair, including recognising and safeguarding the value of the data that is shared and the resources which are generated as a result of the arrangement.
Principle 3: Any arrangements agreed by NHS organisations should not undermine, inhibit or impact the ability of the NHS, at national level, to maximise the value or use of NHS data. NHS organisations should not enter into exclusive arrangements for raw data held by the NHS, nor include conditions limiting any benefits from being applied at a national level, nor undermine the wider NHS digital architecture, including the free flow of data within health and care, open standards and interoperability.
Principle 4: Any arrangements agreed by NHS organisations should be transparent and clearly communicated in order to support public trust and confidence in the NHS and wider government data policies.
Principle 5: Any arrangements agreed by NHS organisations should fully adhere to all applicable national level legal, regulatory, privacy and security obligations, including in respect of the National Data Guardian’s Data Security Standards, the General Data Protection Regulation (GDPR) and the Common Law Duty of Confidentiality.
The principles are said to be subject to further development, with this refined version of the principles should now be factored into decisions taken by the NHS and partners when entering into data agreements.
In addition to the guidance the DHSC has also announced is it to develop the concept of a National Centre of Expertise (the ‘Centre’), which would oversee the policy framework, provide specialist commercial and legal advice to NHS organisations entering data agreements, develop standard contracts and guidance, and ensure that the advantages of scale in the NHS can deliver benefits for patients and the NHS.
The Centre will sit in NHSX and its core functions will include:
- providing hands-on commercial and legal expertise to NHS organisations – for potential agreements involving one or many NHS organisations (eg for cross-trust data agreements or those involving national datasets). This could include providing support to negotiate and execute agreements, and assessing and building capability within NHS organisations where useful. The Centre will develop and provide tailored legal advice on relevant issues (eg intellectual property, state aid).
- providing tools and products including good practise guidance and examples, standard contracts, and methods for assessing the value of different partnership models to the NHS.
- signposting NHS organisations to relevant expert sources of guidance and support on matters of ethics and public engagement, both within the NHS and beyond.
- engagement and understanding the landscape – building relationships and credibility with the research and industry community, regulators, and with NHS organisations and patient organisations, including developing insight into demand for different datasets and identifying and communicating opportunities for agreements that support data-driven research and innovation.
- developing benchmarks and scenarios to provide NHS organisations with reference points on what ‘good’ looks like in agreements involving their data, taking into account demand for data, market conditions and the international context, and setting clear and robust standards on transparency and reporting to underpin and support public trust.
