Understanding the ethical and legal considerations of Digital Pathology
The past 20 years have witnessed the growing digitalisation of histopathology services as a result of developments in whole slide image (WSI) scanning, storage, and analysis . The implementation of Digital Pathology (DP) has been relatively slow in the United Kingdom (UK), although rapid changes are on the horizon . Currently, there are 41 pathology units in the UK, with approximately 1256 consultants. A UK 2018 survey found that 60% of pathology units have access to a DP scanner . Following recent investment in DP infrastructure, five Artificial Intelligence (AI) Centres of Excellence have been established in the UK, aiming to develop the country's DP and imaging expertise. These are: the Industrial Centre for AI Research in Digital Diagnostics (I‐CAIRD) based in Glasgow, the London Medical Imaging and Artificial Intelligence Centre for Value‐Based Healthcare, the National Consortium of Intelligent Medical Imaging (NCIMI) in Oxford, the National Pathology Imaging Co‐operative (NPIC) based in Leeds, and the Pathology image data Lake for Analytics, Knowledge and Education (PathLAKE) based in Coventry. The adoption of DP is part of the strategy set out by the NHS Long Term Plan for digitally enabled care and the UK Government's Industrial Life Sciences Strategy . Stakeholders relevant to the digitalisation of pathology in the UK include The National Data Guardian, The Information Commissioner's Office (ICO), Alan Turing Institute, Health Data Research UK, Care Quality Commission, Public Health England, NHS Digital, and NHSX . Internationally, the World Health Organisation (WHO), in partnership with the International Telecommunication Union (ITU), has established a Focus Group on Artificial Intelligence for Health (FG‐AI4H) with the aim of identifying opportunities for standardisation and applications of AI to health issues on a global scale . DP involves the creation of digital images by using a scanning device to provide high‐resolution images that can be viewed on a platform. This provides a stage platform for developing and utilising AI algorithms, for recognising subtle patterns in tissue to assist diagnosis or derive novel insights into disease . Generation of data from DP creates challenges for the histopathology community with regard to data management, processing, and security. The UK Government has stated that protecting patient data is a legal requirement of paramount importance . This is echoed globally, with guidelines, policies, and legislations aiming to ensure appropriate application of DP (Table ). Literature discussing the potential benefits of DP/AI rarely mention the ethical and legal considerations of access to, and processing of, patient data . Advice/guidance on medical ethics and data governance exists, although the depth to which these topics are explored varies significantly (Table ). This is complicated by WSI data often being generated primarily for diagnostic purposes but having other uses, i.e. teaching and research. This complex situation is compounded when collaborating with industry partners, and by political uncertainty such as the UK's recent withdrawal from the European Union (EU) and working across jurisdictions. It is unclear whether present frameworks and guidelines are useful to histopathologists or if there is a need for additional pathology‐focused guidelines . In this paper, we present the results of an electronic survey (e‐survey) aiming to evaluate UK histopathologists' current levels of understanding of, and confidence with, the legal and ethical aspects of DP and their perceived training needs. We evaluate whether the rise of DP has created this need with the move from tissue‐based work (where there is experience with legislation) to image/data‐centred practice with different considerations; although targeted specifically at DP rather than AI, we also discuss relevant overlapping issues.   We developed an e‐survey comprising 22 questions using the online platform ‘SurveyMonkey’ ( www.surveymonkey.co.uk ). The questionnaire (supplementary material, S1) was developed with input from the Royal College of Pathologists (RCPath) Digital Pathology Working Group. Information provided to gain consent included: study purpose, approximate completion time, confirmation of anonymity, and details of principal investigators. ‘SurveyMonkey’ collected the data; their privacy policy was present on their website at the time of completion. Consent was implicit by completion of the survey. No ethics approval was required. Initially, a pilot e‐survey was developed to assess the usability and technical functionality of the e‐survey and tested by a pre‐selected cohort (three consultant histopathologists and one specialty trainee) as a closed survey. The e‐survey was structured with single sequential questions and question formats included: forced‐choice, Likert scales, yes/no options, and open‐ended/free text questions. The topics were: Demographics, Background, Training, Guidelines and Legislation, Consent, and Data sharing. Participants could review and amend answers prior to submission. Following the pilot e‐survey, questions were rephrased to avoid testing specific knowledge and to gauge general understanding. Following satisfactory completion of the pilot e‐survey, the open e‐survey web link was circulated via social media (Twitter) and e‐mail through the RCPath Digital Pathology Working Group network, RCPath Trainee Committee network, the PathLAKE digital pathology consortium, National Pathology Imaging Co‐operative (NPIC), and to membership of The Pathological Society of Great Britain and Northern Ireland and the British Division of the International Academy of Pathology (BDIAP). The survey was voluntary with no incentives offered. The survey link remained active between 14 July 2020 and 6 September 2020 and was closed only after several reminders had been sent out; only a few additional responses were gathered. The responses were automatically collected by the ‘SurveyMonkey’ platform which has mechanisms to prevent duplication by individuals. Survey responses were analysed using descriptive statistics. Inductive analysis of free text answers (supplementary material, S1 – Questions 20 and 22) was performed using open coding with a final coding frame developed specifically for this study. Both sections were coded together and went through two independent rounds of open coding to determine the relevant themes. The codes were then cross referenced to determine the following four main meta‐categories: Governing Data, Validating Data, Ownership and Third‐Party Access, and Inclusivity and Transparency. Ambiguous and uncategorised comments were not reported. This manuscript has been prepared in accordance with the CHERRIES guidelines .   Response In total, we received 198 responses including 194 histopathologists. Three advanced biomedical scientists and one clinical scientist also completed the survey, although it was stated that the survey was targeted at histopathologists specifically. As these responses represented only 2% of the overall responses, they were included in the analysis and we postulate that they represent scientists who use DP in their role. There was an overall completion rate of 79% with minor variations in response rates to individual questions having been indicated. Consultants and specialty doctors with >20 years of clinical experience were the most common responders (35%, 70/198). Most respondents were based in England, working in the NHS tertiary referral centres in NHS posts with no funded academic time (Table ). The most common experience with DP was ‘External Quality Assurance (EQA)’ (82%, 160/196), followed by ‘Teaching or training’ (72%, 142/196). The most common experience with consultants was ‘EQA’ (93%, 136/146), whereas for trainees it was ‘Teaching or training’ (94%, 44/47) (Table ). Forty‐three percent (85/198) of respondents had been involved in research using digital scanned slides; a further 6% (12/198) were planning to do so in the future. Two percent (4/196) had no experience in any of the stated areas of DP. Training Eighty‐eight percent of respondents (168/190) working in an NHS centre (190/198) reported having been offered NHS mandatory training in information governance, 4% (8/190) had not, and the remaining 7% (14/190) were ‘Not sure’. Nearly a quarter of all respondents (24%, 48/198) had undertaken additional training in information governance. Respondents reported attending a variety of additional online and face‐to‐face courses over the years (Table ). When asked about their need/desire for training, 39% (27/70) of ‘consultants and specialty doctors with over 20 years' experience’ wanted additional training, whereas approximately half of those with 5–20 years' experience (51%, 39/77) and trainees (51%, 24/47) wanted additional training. Those wanting further training called for this to be specific to DP and to be delivered in an online Continuing Professional Development (CPD)‐accredited format. Summary of current available training, format, and content proposed by respondents is presented in Table . Confidence in applying guidelines/legislation Table outlines respondents' confidence ratings concerning their understanding of policy/legislations and ethical guidelines. The Data Protection Act 2018 ( DPA 2018 ) had the highest confidence ratings . At the other end of the spectrum, respondents were least confident in their knowledge of the (now defunct) EU – US Privacy Shield , followed by the NHS National Data Opt‐out . Regarding ethical guidance, all three groups reported predominantly ‘Not at all confident’ in their understanding of all three guidelines. There seemed to be higher confidence levels for legislation (General Data Protection Regulation [GDPR] and DPA 2018) compared to ethical guidance . Comparing responses of those who had or had not received additional training revealed confidence ratings were higher across respondents who had undergone additional training. Understanding of the UK legislation and application for REC approval Forty‐one percent (82/198) of respondents selected ‘I do not know’ in connection with circumstances where the use of digital scanned slide images would fall under relevant legislation (i.e. GDPR and DPA 2018). Approximately one‐third of research active respondents (31%, 26/85) stated that they did not know when a particular use is covered by legislation versus 50% (50/101) of non‐researchers. The responses are summarised in Table . With regard to the Research Ethics Committee (REC), we asked under which circumstances would one not require REC approval for the use of digital images. The majority of respondents answered ‘Diagnostic reporting’ (84%), ‘Teaching or training’ (82%), ‘Audit’ (81%), and ‘In an EQA’ (80%). Five percent responded that ‘No REC approval’ was required for any of the proposed activities (Figure ). Consent Forty percent (79/197) of all respondents stated ‘I do not know’ when asked if there was a statement on the consent procedure/investigation form in their NHS Trust for the use of data and/or tissue in research. Research active respondents were more familiar with this statement as would be expected as it is of less relevance to non‐research active pathologists. Only 25% (21/85) of those undertaking research responded with ‘I do not know’ compared to 51% (52/101) of those not undertaking research. Interestingly, 6% (12/197) of overall respondents reported that there was no such statement. When asked how confident respondents were in their understanding and interpretation of the appropriate use of consent in connection with scanned slide images in research, 47% (93/198) were ‘Not confident at all’ and only 2% (4/198) were ‘Completely confident’. Fewer research active respondents reported feeling ‘Not at all confident’ (26%, 22/85) compared with non‐research active respondents (64%, 65/101). These findings are summarised in Figure . Data sharing Six percent (11/198) of all respondents had shared images outside of the EU and 7% (14/197) with industry, both for the purpose of research. On the issue of public awareness of data sharing with industry, 68% (133/195) of respondents thought that the public were ‘Not at all aware’ that anonymous data could be shared with industry. Two percent (3/195) thought they were ‘Completely aware’. Digitalisation of pathology At the end of the e‐survey, we provided respondents with the opportunity to comment on the digitalisation of pathology. Analysis of their comments revealed four main themes: (1) governing data, (2) validating data, (3) Ownership and third‐party access, and (iv) inclusivity and transparency, with comments about governing data generating nearly 10 times more than anything else. Governing data Respondents commented on the need to maintain patient confidentiality and/or anonymity, if and when consent was needed and the need for data security (most notably, whether images were protected against hacking, breaches, or data loss during storage, transfer, or while working from home). Finally, this theme contained comments about the lack of, and need for, training on DP information governance. Validating data Respondents noted concerns around the risks and benefits of DP or AI‐driven diagnosis compared to traditional histopathology. Salient risks identified were the possibility for errors and misdiagnoses, the mixing up of slides, reproducibility of diagnosis, cost effectiveness of the new digital system, and the effects of digitalisation on pathologists' labour or behaviour. Regarding the latter, job loss, outsourcing, new liabilities, and overconfidence in AI were noted as possible negative outcomes of implementing digital workflows. Ownership and third‐party access Respondents raised questions about who owns data in the context of third‐party access, along with comments about the ethical risks of commercialisation and what constitutes a fair exchange for the sharing of DP data with for‐profit organisations. Inclusivity and transparency Respondents commented on the need for transparency about data uses and the inclusion of the views and opinions of the public in decisions about these uses. They suggested patients should be aware of how their data would be used and that patient preferences should be taken into consideration.   In total, we received 198 responses including 194 histopathologists. Three advanced biomedical scientists and one clinical scientist also completed the survey, although it was stated that the survey was targeted at histopathologists specifically. As these responses represented only 2% of the overall responses, they were included in the analysis and we postulate that they represent scientists who use DP in their role. There was an overall completion rate of 79% with minor variations in response rates to individual questions having been indicated. Consultants and specialty doctors with >20 years of clinical experience were the most common responders (35%, 70/198). Most respondents were based in England, working in the NHS tertiary referral centres in NHS posts with no funded academic time (Table ). The most common experience with DP was ‘External Quality Assurance (EQA)’ (82%, 160/196), followed by ‘Teaching or training’ (72%, 142/196). The most common experience with consultants was ‘EQA’ (93%, 136/146), whereas for trainees it was ‘Teaching or training’ (94%, 44/47) (Table ). Forty‐three percent (85/198) of respondents had been involved in research using digital scanned slides; a further 6% (12/198) were planning to do so in the future. Two percent (4/196) had no experience in any of the stated areas of DP.   Eighty‐eight percent of respondents (168/190) working in an NHS centre (190/198) reported having been offered NHS mandatory training in information governance, 4% (8/190) had not, and the remaining 7% (14/190) were ‘Not sure’. Nearly a quarter of all respondents (24%, 48/198) had undertaken additional training in information governance. Respondents reported attending a variety of additional online and face‐to‐face courses over the years (Table ). When asked about their need/desire for training, 39% (27/70) of ‘consultants and specialty doctors with over 20 years' experience’ wanted additional training, whereas approximately half of those with 5–20 years' experience (51%, 39/77) and trainees (51%, 24/47) wanted additional training. Those wanting further training called for this to be specific to DP and to be delivered in an online Continuing Professional Development (CPD)‐accredited format. Summary of current available training, format, and content proposed by respondents is presented in Table .   Table outlines respondents' confidence ratings concerning their understanding of policy/legislations and ethical guidelines. The Data Protection Act 2018 ( DPA 2018 ) had the highest confidence ratings . At the other end of the spectrum, respondents were least confident in their knowledge of the (now defunct) EU – US Privacy Shield , followed by the NHS National Data Opt‐out . Regarding ethical guidance, all three groups reported predominantly ‘Not at all confident’ in their understanding of all three guidelines. There seemed to be higher confidence levels for legislation (General Data Protection Regulation [GDPR] and DPA 2018) compared to ethical guidance . Comparing responses of those who had or had not received additional training revealed confidence ratings were higher across respondents who had undergone additional training.   UK legislation and application for REC approval Forty‐one percent (82/198) of respondents selected ‘I do not know’ in connection with circumstances where the use of digital scanned slide images would fall under relevant legislation (i.e. GDPR and DPA 2018). Approximately one‐third of research active respondents (31%, 26/85) stated that they did not know when a particular use is covered by legislation versus 50% (50/101) of non‐researchers. The responses are summarised in Table . With regard to the Research Ethics Committee (REC), we asked under which circumstances would one not require REC approval for the use of digital images. The majority of respondents answered ‘Diagnostic reporting’ (84%), ‘Teaching or training’ (82%), ‘Audit’ (81%), and ‘In an EQA’ (80%). Five percent responded that ‘No REC approval’ was required for any of the proposed activities (Figure ).   Forty percent (79/197) of all respondents stated ‘I do not know’ when asked if there was a statement on the consent procedure/investigation form in their NHS Trust for the use of data and/or tissue in research. Research active respondents were more familiar with this statement as would be expected as it is of less relevance to non‐research active pathologists. Only 25% (21/85) of those undertaking research responded with ‘I do not know’ compared to 51% (52/101) of those not undertaking research. Interestingly, 6% (12/197) of overall respondents reported that there was no such statement. When asked how confident respondents were in their understanding and interpretation of the appropriate use of consent in connection with scanned slide images in research, 47% (93/198) were ‘Not confident at all’ and only 2% (4/198) were ‘Completely confident’. Fewer research active respondents reported feeling ‘Not at all confident’ (26%, 22/85) compared with non‐research active respondents (64%, 65/101). These findings are summarised in Figure .   Six percent (11/198) of all respondents had shared images outside of the EU and 7% (14/197) with industry, both for the purpose of research. On the issue of public awareness of data sharing with industry, 68% (133/195) of respondents thought that the public were ‘Not at all aware’ that anonymous data could be shared with industry. Two percent (3/195) thought they were ‘Completely aware’.   At the end of the e‐survey, we provided respondents with the opportunity to comment on the digitalisation of pathology. Analysis of their comments revealed four main themes: (1) governing data, (2) validating data, (3) Ownership and third‐party access, and (iv) inclusivity and transparency, with comments about governing data generating nearly 10 times more than anything else. Governing data Respondents commented on the need to maintain patient confidentiality and/or anonymity, if and when consent was needed and the need for data security (most notably, whether images were protected against hacking, breaches, or data loss during storage, transfer, or while working from home). Finally, this theme contained comments about the lack of, and need for, training on DP information governance. Validating data Respondents noted concerns around the risks and benefits of DP or AI‐driven diagnosis compared to traditional histopathology. Salient risks identified were the possibility for errors and misdiagnoses, the mixing up of slides, reproducibility of diagnosis, cost effectiveness of the new digital system, and the effects of digitalisation on pathologists' labour or behaviour. Regarding the latter, job loss, outsourcing, new liabilities, and overconfidence in AI were noted as possible negative outcomes of implementing digital workflows. Ownership and third‐party access Respondents raised questions about who owns data in the context of third‐party access, along with comments about the ethical risks of commercialisation and what constitutes a fair exchange for the sharing of DP data with for‐profit organisations. Inclusivity and transparency Respondents commented on the need for transparency about data uses and the inclusion of the views and opinions of the public in decisions about these uses. They suggested patients should be aware of how their data would be used and that patient preferences should be taken into consideration.   Respondents commented on the need to maintain patient confidentiality and/or anonymity, if and when consent was needed and the need for data security (most notably, whether images were protected against hacking, breaches, or data loss during storage, transfer, or while working from home). Finally, this theme contained comments about the lack of, and need for, training on DP information governance.   Respondents noted concerns around the risks and benefits of DP or AI‐driven diagnosis compared to traditional histopathology. Salient risks identified were the possibility for errors and misdiagnoses, the mixing up of slides, reproducibility of diagnosis, cost effectiveness of the new digital system, and the effects of digitalisation on pathologists' labour or behaviour. Regarding the latter, job loss, outsourcing, new liabilities, and overconfidence in AI were noted as possible negative outcomes of implementing digital workflows.   Respondents raised questions about who owns data in the context of third‐party access, along with comments about the ethical risks of commercialisation and what constitutes a fair exchange for the sharing of DP data with for‐profit organisations.   Respondents commented on the need for transparency about data uses and the inclusion of the views and opinions of the public in decisions about these uses. They suggested patients should be aware of how their data would be used and that patient preferences should be taken into consideration.   DP has genuine potential to develop an integrated global pathology community. The COVID‐19 pandemic has catalysed the urgency of DP adoption with the Food and Drug administration (FDA) relaxing restrictions to facilitate remote working for histopathologists and guidance on remote DP reporting being issued by the RCPath . The growth of interest in DP services highlights the urgent action needed to ensure that ethical/legal considerations do not lag behind the technical development. Our survey has demonstrated that, despite growing DP use, histopathologists acknowledge a lack of confidence in their knowledge and understanding of the key issues of consent, legislation, and ethical guidelines. Although some of the issues raised are not in the domain for the practicing histopathologist, many are. It is important those working directly with the images are mindful that different governance considerations are required depending on the intended use. According to respondents' experiences, there is a lack of resources/training available to support histopathologists in navigating these areas (Table ). There is a paucity of specific guidance on the legal and ethical issues in the context of diagnostic DP. RCPath has professional guidance which ‘aims to give pragmatic and specific guidance on validation and verification of DP for clinical use’ and the focus is to assist the introduction of DP for primary diagnosis while maintaining safety . Therefore, its purpose is not for research guidance or future applications and ethics falls outside of its remit. It includes a brief general legal section, highlighting the complex nature of such issues and advises involvement of information governance officers. It is important that support resources are highlighted, although an awareness of this area helps people to understand when it is appropriate to seek further help. Globally, there are numerous country‐specific guidelines for the implementation and use of DP, at times more framed in the context of telepathology (Table ). The issues of data governance and cybersecurity are raised, although often only discussed superficially in the context of implementation rather than specific day‐to‐day guidance and not always extended to alternative uses for the data beyond diagnostic reporting. With regard to ethical guidance for diagnostic DP, the RCPath currently has no specific guidelines. However, focusing on the use of DP for AI development, there is a current drive by the UK Government to ‘create an ecosystem that ensures we get the use of AI “right” in health care’ through their development of NHSX . A 2019 report explored a novel governance framework emphasising the softer ethical considerations of ‘should versus should not’ in the development of AI solutions as well as legislative regulations of ‘could versus could not’. It integrates the 2018 Code of Conduct for Data‐Driven Health and Care Technology from the Department of Health and Social Care, which aims to promote the development of AI with the Nuffield Council on Bioethics' Principles for Data Initiatives . Although the above guidance exists, it is not specific to DP but AI, however the majority of our respondents were unaware of it. More specific ethical guidance is available in Canada, which has a clearly established WSI workflow integrated with telepathology and a specific ‘ Code of ethics for storage and transmission of electronic laboratory data ’ . Additionally, in 2005, updated in 2013, the Canadian Standards Association (CSA) developed a voluntary code based on the work of the ‘ Guidelines Governing the Protection of Privacy and Transborder Flows of Personal Data’ , created by the international ‘Organization for Economic Cooperation and Development (OECD)’. This has been endorsed by many Canadian companies as the national standard on privacy protection . Understanding and implementing guidelines depend on background knowledge of the area. The acquisition of even a background level of understanding of these topics appears to be limited. From the authors' experience, available courses include generic governance/GDPR, with content not directly applicable to pathology. The GDPR is legislation in force in the EU for the processing of personal data, either within the EU or such data related to people in the EU  (supplementary material, S1 – Question 9). The DPA 2018 is the UK's implementation of the GDPR (supplementary material, S1 – Question 9) . Under these regulations, personal data (‘information related to an identified or identifiable living individual’) is classed as special category personal data when it includes health data . The application of the GDPR in the context of DP research is dependent on the data being processed, e.g. fully anonymised data does not fall under the ambit of the GDPR, whereas pseudonymised data may . In terms of our questionnaire (supplementary material, S1 – Question 13), the use of digital scanned slides images falls under the relevant UK data protection legislation if there is (1) a patient name and potentially (2) a histology (accession) number on the slide, or (3) the slide is pseudonymised. We say ‘potentially’ as the ICO is currently undertaking a review of its anonymisation guidance and a first draft has been shared for consultation . It states ‘Data protection law does not explicitly define “anonymous information”’ . It goes on to state that ‘In the ICO's view, the same information can be personal data to one organisation, but anonymous information in the hands of another organisation. Its status depends greatly on its circumstance’ . Once finalised and published, this new guidance may assist researchers to navigate this complex area. Until the guidance is published, a cautious approach is advised, and local information governance teams should be consulted. According to the NHSX document AI – How to get it right , the ‘data access stage’ can also cause a lot of confusion, especially in determining the legal basis for processing data (direct patient care or secondary) and if their project should be classed as research or not. For instance, developing a piece of software using medical data should always be considered as a secondary use regardless of whether that software is eventually used to provide direct care to the patient. It should also be classed as research and having approval obtained from the Health Research Authority (HRA) . The legal basis for data processing under the GDPR for AI‐based pathology research when using anonymised images is not consent as in many other patient settings but often legitimate interest under Article 6 of the GDPR. Under certain circumstances, if it is judged that the GDPR/DPA applies then, in the UK, a data protection impact assessment may need to be completed . In the UK, the Common Law Duty of Confidentiality guidelines apply to personal information and are separate from data protection legislation (supplementary material, S1 – Question 9). They state that information given in confidence must not be shared with a third party without an individual's valid consent (or some other legal basis) . This includes data that are anonymised as such data would be derived from a data set that would require consent from a data subject. There is also the application of the National Data Opt‐Out , which is a service that ‘allows patients to opt out of their confidential patient information being used for research and planning’, although this does not apply to anonymised information  (supplementary material, S1 – Question 9). Difficulties interpreting legislation and guidelines can be compounded for researchers conducting multi‐centre, multi‐jurisdictional studies . There is a drive to develop International Best Practice Guidance with involvement from the Global Digital Health Partnership (GDHP) – a collaboration of world governments and the WHO . The WHO has also partnered with the ITU to establish an FG‐AI4H with the aim of identifying opportunities for international standardisation . Along with the appropriate application of legislation and guidelines, understanding when REC approval is needed is also essential for DP research. REC approval is required for any image analysis projects using patient data and therefore would NOT usually be required for diagnostic reporting, teaching or training, audit, service improvement, quality control or quality assurance, or use in an EQA (supplementary material, S1 – Question 14). The UK 2019 State of the Nation Survey built up a picture of critical issues surrounding ethics and regulation . It revealed a 50/50 split in whether AI developers sought ethical approval. The current complex governance framework and lack of clarity around the development of AI technologies may be impeding innovation. Indeed, one of the NHSX's objectives is to ensure that in all future funding applications the expectation of ethical compliance is made clear. We acknowledge that some of the issues in our survey are more relevant to pathologists undertaking research. However, it is useful for all pathologists to be aware of them so that data are not inadvertently used for secondary purposes without the appropriate permissions. A final consideration for DP research is the issue of data sharing. The majority of respondents in our e‐survey felt that the public were unaware that their anonymised data could potentially be shared with third parties. A 2020 UK survey of 2095 individuals found that 63% were unaware that the NHS gives third parties access to data . Research has shown that the sharing of data can be viewed positively by patients, subject to the expectation that such data will be used to further the common good, is transparent, and benefits should be shared . NHS, academia, and industry partnerships can bring synergistic skills into a collaboration, as industry often has greater experience of gaining regulatory approvals, potentially accelerating development to patient benefit . The NHSX recognises people are neither aware that information within their health records has enormous research potential nor how it can be used in practice . There are significant public concerns that commercial organisations may harvest and use their data . Beyond the scope of this paper, there is also the issue of the NHS being given perpetual fair value for the use of data. The focus of the survey was DP rather than AI, although these fields are inherently linked because WSI creates the raw data for building algorithms. Some respondents raised concerns about AI‐driven diagnosis, such as overconfidence in its performance. Algorithm development faces ethical challenges such as avoiding bias, maintaining openness about which data sets are used, and making it as clear as possible to users how an algorithm works. These challenges again underline the need for training histopathologists to understand and explain results from AI tools. It would be prudent to run this process in parallel with the DP roll out. It is beyond the scope of this article to provide guidance on specific legal or ethical questions, and we intend only to present the general background, considerations, and potential issues that may arise in the DP setting. We also acknowledge that there may be no clear answer to some questions raised. We have emphasised that the governance, legal, and ethical frameworks underpinning DP are complex and there is a lack of confidence in these areas. Highlighting these issues should not hinder the development of DP but instead help to build solid foundations for a safe and secure platform for our patients. Histopathologists should be specifically trained and assisted to help them navigate these areas. Specific training resources calling attention to the complexities should be developed to support histopathologists that are utilising DP. Finally, there were issues raised in this study, such as data commercialisation, cybersecurity, and the role of industry, which are outside the scope of this article but that clearly warrant further study in their own right.   CC, LB and CV devised the initial concept. CC, CV, LB, RC and PM designed and developed the initial pilot e‐survey and subsequent analysis. CC, CV, FM, NH, LB, RC, PM, MA, DT, TS and GB were all involved in the design and development of the e‐survey. CC constructed the survey using the online platform and, along with CV, tested the e‐survey prior to circulation. LB, CV and DT arranged circulation of the e‐survey. CC, NH and FH were involved in the collection and collation of results. All authors were involved in the analysis of results, writing and editing the paper, and reviewed the article prior to submission.   Appendix S1. Questionnaire Click here for additional data file.   