JISC

Clinical recordings (such as images, videos and scans) have long been one of the mainstays of healthcare education. In recent years the subject matter of such images has remained largely constant but increasingly they are recorded digitally and viewed online. This new format and medium has so enabled duplication and onward transmission of recordings that processes and guidelines created to safeguard patients’ interests and guide the practice of clinicians, teachers and technicians no longer fulfil their purpose.

Introduction

This report is the result of a study on the practicalities of sharing and exchanging clinical recordings in support of teaching and research in the UK. This project, ‘CHERRI’ (Common Healthcare Educational Recordings Reusability Infrastructure - Practice, Interoperability and Ethics), has carried out surveys of existing practice, researched the medico-legal context and developed a consent and licensing model that it is anticipated will meet the needs of all those concerned.

Current Practice

Despite UK-wide data protection and human rights legislation and guidance from bodies such as the GMC, current practice regarding the acquisition and use of clinical recordings for academic non-clinical settings (CRANCS) in the UK is highly varied. The project’s survey and interviews revealed that most practitioners were aware of relevant legislation and national guidance relating to patient consent and confi dentiality but did not know how to translate these into processes in the local context, here images would often be acquired in a clinical setting but used in an educational one. For some the process stops at acquiring informed consent and the recording, others try to log subsequent usage while many, faced with uncertainty and risk are turning away from the use of CRANCS altogether.

The uncertainty in practice did not only relate to consent; there were often conflicting or unclear issues of ownership and copyright. As an example, although the NHS asserts ownership of all recordings acquired in its clinical environments this has yet to be tested in law. From the CHERRI project the following problems were identified: lack of common process and standards at a local level, lack of connection between terms of consent and subsequent use, unnecessary duplication in local contexts as a safety measure, and a pervading culture of risk and uncertainty that is leading to both individual and institutional anxiety and loss of utility.

CHERRI Consent and Licensing Model

The two principal issues are therefore ones of consent and ownership. Whatever solution is applied needs to accommodate both of these. CHERRI has developed a conceptual Consent and Licensing Model (or C+LM) that integrates the two to provide a solution that addresses both the uncertainty and the disconnectedness ofcurrent practice. C+LM licensing will need to be simple and easy to understand. As one way of achieving this it is recommended that it follows the same kind of model used by Creative Commons and provisional discussions have taken place regarding the creation of ‘Clinical Commons’ licences.

Conclusions

The law and guidance on the use of CRANCS from professional and statutory bodies set out to protect the interests of patients, and generally practitioners are aware of these. However, local protocols do not take cognisance of the explosion in numbers and mobility of digitised images and thus current practice in the creation, use and reuse of CRANCS is generally non-standardised thereby creating risks and uncertainty for all concerned. It’s difficult to create complete safety in this area without sacrificing the utilitarian or ‘greater good’ aspects. Prohibiting the use of CRANCS for teaching and research would undermine the effectiveness of both and may impact on the competence of future healthcare professionals. Furthermore, seeking explicit consent for all images is impossible and would make the whole system unwieldy but current public opinion and the law lend most support to the rights of the individual patient in this area and standardised practice must take account of that. Guidance on consent must continue to be updated to reflect changing societal opinion, the law and public concerns about the use of CRANCS. It must continue to clarify for practitioners the reasonable expectations that patients have to be kept informed about the use of their images and when explicit consent is required.

A common activity framework is required to support the current position regarding the storage and use of CRANCS. It is absolutely essential for any large-scale and dynamic exchange of these kinds of recordings. In its absence the continued use of CRANCS is creating risks and problems for both individuals and institutions and as a result their use may dwindle and utility is being lost. It is also essential that a robust, simple to use and commonly acknowledged mechanism for handling consent with respect to clinical recordings is adopted across the UK. The CHERRI common consent and licensing model (C+LM) is proposed to address the problems. Based on the simplicity of Creative Commons it seeks to accommodate specific clinical responsibilities and issues. The challenge now is to disseminate this proposal and develop it in consultation with key stakeholders in Further and Higher Education, the NHS, GMC and other professional bodies towards the implementation of a practical and efficient UK-wide process. As the healthcare environment is subject to frequent change the framework will require review and updating over time. Undertaking the work is not currently within the JISC’s remit although it may be of interest to a number of educational and healthcare organisations. Arrangements will need to be made to monitor the situation and action adjustments over time as and when they are required.

Recommendations

• That all creators and users of CRANCS should be better educated and supported in the use of such recordings, and that this training and support is normalised as much as possible both for quality assurance and economies of scale purposes.

1. This requires that we challenge complacency about current practices in obtaining and recording consent, and in the use of images without knowledge that consent has been obtained
2. Further work must be undertaken in consultation with the DOH/NHS, GMC, BMA, IMI & Royal Colleges, patient group representatives and other interested parties to develop a consensus view on recommendations for practice and the production of ommon national (and preferably international) guidelines and documentation for gaining consent for clinical recordings
3. A 3 tier consent model and organised databases should be adopted pending further guidance, along with clear procedures for gaining consent, storage, sharing and withdrawal of clinical recordings
4. Once national procedures and guidance are adopted, these should be publicised as widely as possible to professionals involved with CRANCS and also to the lay public. This will require adequate investment in appropriate training and in promoting the use of these guidelines

• That guidance from the GMC and other professional bodies, on use of patient recordings for teaching and research should continue to be regularly updated to take account of changing public and societal attitudes and concerns about use of CRANCS. The situations requiring explicit consent may change over time and even now further clarification is required around consent for ‘non-identifiable images’
• That a common consent and license model for CRANCS is developed and adopted UK-wide (preferably in other jurisdictions although this would need to be explored further as to how practical it is)
• That any model adopted in the UK adheres to UK/European law and encompasses both consent and IPR dimensions of a recording
• That the licensing model is based on Creative Commons and that this Clinical Commons is set up and run either by CC or a qualified UK agency. There is an issue of jurisdiction here. The most useful model would be truly international with local rendering (as per Creative Commons) and as such a trans-national organisation such as Creative Commons would seem to be the logical home. However, it may be that medico-legal concerns would require management of a consent and licensing model to be at a national level and undertaken by a responsible NGO such as the NHS in the UK
• That all CRANCS are tagged (potentially visibly) with a C+LM mark or icon to indicate its provenance and conditions of use. This icon should represent the different forms of use at a small enough resolution not to interfere with the recording
• That practitioners refuse to use non-C+LM materials because they lack sufficient provenance and guarantee of patients’ interests. This clearly illustrates the compliance rather than enforcement nature of the approach but the current environment and the availability of resources mean that an enforcement approach is impractical
• That any central repository must adhere to the C+LM before any clinical materials are stored there. This combines issues of technical infrastructure, community-specific requirements and appropriate workflows. A national system like JORUM would need to accommodate the additional metadata, access controls and workflows associated with C+LM to safely store and supply access to CRANCS. This may indicate that separate systems will be required for CRANCS with access limited to healthcare education and its affiliates
• That all relevant UK agencies (such as the GMC, NHS, legal groups etc) have input to and support the development of this common model and that steps are taken to develop the relationship between the NHS and the tertiary education sector (for instance by raising the profile of the NHS-HE Forum and making its work more transparent)

Read the final report below