“Building Trust in Health Data” Conference Report

“Building Trust in Health Data” i~HD Annual Conference 2023

The European Institute for Innovation through Health Data (i~HD) held its annual conference in its birthplace Ghent, Belgium on Thursday 30th November and Friday 1st December this year. We were pleased to welcome over 200 people in person and approximately 100 people online participating in this event.

Through the combination of keynote speakers and parallel tracks we examined some of the hottest topics in health data today. As one would expect, the proposed Regulation on the European Health Data Space, this high profile EC proposal for scaling up health data access for citizens across borders and data sets for research, attracted a lot of attention in our content. Patients were centre stage in a number of our keynote talks and tracks. The conference also took forward the inspiring recommendations that arose from our dedicated data quality conference held a year ago in Porto.

Pre-conference tutorial

On 29 November, i~HD organised a tutorial called “Unveiling the Dynamic Complexity of Health Data Quality”. Around 50 participants joined the preliminary session which featured an introduction to Health Data Quality and the use of Real-World Data through use cases presented by different hospitals in Belgium.

Before the conference started, participants and speakers were invited to a welcome evening reception in the City Hall of Ghent, hosted by Deputy Mayor for International Solidarity Hafsa El-Bazioui.

Thursday morning opened with a welcome from Geert Thienpont, the CEO of i~HD, explaining the history that led to the formation of our Institute and the main focus of our mission. This was followed by a welcome on behalf of the city of Ghent from Sofie Bracke, Alderwoman of Economy, Trade, Sports and Ports.

The audience then heard a remote talk from Dr. Frank Vandenbroucke, Deputy Prime Minister and Minister of Social Affairs and Public Health, Belgian Federal Government. He emphasised the commitment of the Belgian government through its forthcoming European Presidency to the European Health Data Space, to work across Member States to oversee its adoption and development. In parallel, he emphasised the work being undertaken with Belgium to grow the health data ecosystem for the benefit of patient care, quality improvement and research.

The opening keynote speakers were introduced by Professor Dipak Kalra, President of i~HD. Dr. Andrzej Ryś, Visiting Researcher at the Oxford University, and Principal Adviser (until recently Directorate-General) for Health and Food Safety (DG SANTE) from European Commission gave the opening talk to introduce the audience to the vision of the European Health Data Space (EHDS), providing precious insight into the historical background that led to this initiative and how it is going to be implemented in the coming years. Although some of the audience were familiar with the EHDS, his portrait in the context of wider European strategy for health and data, innovation and upholding benefits to citizens, was unique and inspiring.

His talk was followed by the second keynote speaker, Magda Chlebus, Executive Director, Science Policy and Regulatory Affairs, The European Federation of Pharmaceutical Industries and Associations (EFPIA). She explained the commitment of the Pharma industry to pre-competitive collaboration across stakeholders in order to maximise the benefits to all from health data. She described the innovations introduced through public private partnership projects within the IMI and IHI programmes, in particular EHR4CR, EMIF and EHDEN. She confirmed the strong commitment from industry to support the EHDS, to contribute data to it and to accelerate research by using it.

The session also debated whether it is ethical and appropriate for patients to have some return from the benefit that their health data has enabled, and whether this should be directed to individuals, to health systems or more broadly to society.

The conference was then divided into three parallel tracks:

One track focused on the safe experience of medicines by patients. It brought together three European projects (UNICOM, Gravitate-Health, ConcePTION) that have each tackled different aspects of this, alongside some inspiring invited speakers. This track ran through the morning and afternoon of Thursday, and included live demonstrations of software developed in the projects, showing how a patient changing countries could safely receive continuity of medication even though their existing medicinal products are not marketed in the destination country, and how the patient could understand the new unfamiliar medication they had been given. The additional challenge of ensuring the safe use of medicines by women of childbearing age, pregnant or breastfeeding, was also explored, illustrated through an innovative website offering patient friendly information about which medicines have evidence of safety in pregnancy.

A second track took a deep dive on data quality. The morning session focused on hospitals, the quality of data collected within their electronic health record systems, how this could be assessed and what strategies could be adopted for how data quality could be improved. The session was organised in collaboration with the European Association of Hospital Managers, and built on an important theme that was raised and initially examined a year ago in the Porto conference. The afternoon session of this track shifted focus to medical technologies, digital health tools in particular, and was organised in collaboration with MEDVIA and MedTechEurope. This track explored the importance of patient generated data through digital technologies, the importance of data quality for safe and effective patient care when using such technologies, and also when reusing this patient generated data for research.

The third parallel track examined two important challenges to scaling up the ability to leverage health data at a pan-European scale, which the EHDS has the potential to address. The morning session explored the opportunity provided through the mandated adoption of the European Electronic Health Record exchange Format, which is embedded within the EHDS proposed Regulation. The audience heard from European projects that are each developing interoperable patient summaries, for different use cases, and how the cross border exchange of patient record extracts could enable safer and more effective continuity of care. The afternoon session considered public trust in the secondary use of data, especially for research. The audience learned about different models of patient involvement in this, preference setting and trust in allowing their data to be reused for research, and how transparency to the public can be delivered in practice. These models include data altruism, health data intermediaries, broad consent and dynamic consent.

In between the morning and the afternoon sessions of each track, after lunch and networking time, there were early afternoon keynote talks. The audience first heard remotely from Dr. Emmanuel Bacry, Chief Scientific Officer, Health Data Hub France and co-ordinator of the HealthData@EU pilot project. He explained the infrastructure and governance approach being implemented in France to enable multiple public and private organisations to gain access to French national data sets relating to different aspects of health, healthcare, and reimbursement, and how this access is being architected. He then went on to explain an exciting European Commission funded pilot project to implement several use cases of the secondary use of data as early demonstration of the EHDS.

His talk was complemented by the second afternoon note keynote speaker, Frank Callewaert, Technology Officer, Microsoft Belgium, Luxembourg & European Union Institutions. He inspired the audience by presenting many technological innovations that are already being adopted across healthcare to unlock the knowledge inside health data and to make this available on a massive scale, across Europe. Through this, the audience learned that some of the challenges that are well recognised with leveraging health data may to some extent have technological solutions that are already here.

The conference dinner in an old Franciscan church in the city at the end of the first day.

Friday started off with keynote talks putting the patient centre stage. Dr. Mavis Machirori and Anna Studman, Senior Researchers at the Ada Lovelace Institute, presented on the importance of equity and inclusion of all of society, without discrimination or bias, in access to health care services and representation within health data. They presented the results of research investigations into these issues, and good practice strategies that we should all adopt.

Then Anca Toma, Executive Director, European Patients’ Forum spoke to us about patient empowerment and the importance of partnering with patients in care and research. The EPF was founded to improve the engagement of patients in clinical research, but now pursues a broader mission to support their pan-European network of national patient organisations, to represent their collective voice in negotiation with European policy-makers. The EPF hosts and runs the DataSavesLives initiative (in which i~HD is also involved), which is having a growing impact across Europe.

The meeting was then again divided into three parallel tracks:

One track examined artificial intelligence. The morning session discussed the requirements of ethical and transparent AI development, as stipulated in the EU AI Act. How to achieve explainability, to whom and with what trust-building objectives, was explored. The meeting learned from European projects that are developing innovative AI including how they are tackling ethics and transparency, including GenoMed4All and IDERHA. The afternoon session looked more closely at the challenge of data bias and what measures AI developers could take to ensure they use representative data.

Day 2 of the data quality track started with the soft launch of a forthcoming European project to develop the data quality label for the EHDS. The Grant Agreement will shortly be signed, and this project will commence in early 2024. The audience heard about some important inputs to this quality label: initiatives that have already formalised some aspects of data quality measurement and a quality pipeline. The afternoon session focused on data quality skills and education. The need to invest in this was highlighted during last year’s conference. The session introduced the audience to the importance of raising data quality skills across multiple stakeholders in the health ecosystem. An online real time survey tool was used throughout the session to collect and then discuss audience opinions about who needs education, about what, how this should be delivered and how it should be funded.

The third track looked at how digital health is helping to put patients more strongly in the driving seat of their own health and care. This session was organised jointly with the Digital Health Uptake project. The audience learned about digital health innovations being developed and piloted by EC projects including ADLIFE, AIDAVA, H2O, eCream…., which were also demonstrated. The audience and developers discussed their good design practices and patient empowerment impacts. There was discussion about the benefits to health systems from more empowered patients. The afternoon session transitioned into how patients and health systems can be confident about trusting novel health and wellness apps. The care decisions supported by apps, and the data collected and generated by them, has to be trustworthy. The Label2Enable project, which is establishing and promoting the certification of apps according to an ISO Technical Specification (ISO-EN TS 82304-2), was presented and its value discussed.

As the day before, keynote talks were scheduled after lunch. Dipak Kalra introduced and moderated discussion with three speakers. Dr Steve MacFeely, Data and Analytics Director, WHO explained the importance of making valid inferences and learning correctly from health data. This includes knowing the provenance and context in which the data originated. Scaling up data sharing to a European scale also requires measures to assure public trust.

Dr Bernardo Sousa-Pinto, Assistant Professor, Department of Community Medicine, University of Porto presented the work undertaken over several years to develop a patient-friendly app and guidance system to support patients with respiratory conditions. He explained how the development teams across Europe have engaged strongly with patients, and established a trusted data analytics flow that enables iterative learning and improvement.

Kristof Vanfraechem, founder and CEO of Data for Patients, then spoke about the importance of engaging patients and patient organisations with digital health and health data uses. He explained the important role of expert patients who combine their patient experience with a good understanding of health ICT and data. Such experts can also support patient organisations who sometimes need guidance on how to respond to the novel health data landscape.

The second day of the conference closed with a panel discussion about a Societal Compact on the secondary use of health data. Dipak Kalra first explained this to the audience, as a proposed undertaking by organisations who wish to make use of health data (e.g. for research) to adhere to several ethical principles, to commit to using health data only for permitted purposes (which are the same as those specified in the draft EHDS Regulation) and to commit to adopting robust organisational personnel and technical data protection and information security practices.

The panel discussion was moderated by Bleddyn Rees, Chair, The Digital Health Society, who had co-led the development of the Compact along with Dipak Kalra and i~HD. The panel members were Kyriacos Hatzaras, Programme Officer, The European Commission DG CONNECT, Meni Styliadou, Founder and Co-Lead of IMI H2O, Gözde Susuzlu Briggs – Project Coordinator, European Patients’ Forum, Aneta Tyszkiewicz, Associate Director for Digital and Data, EFPIA, Jan Vekemans, Country Sales Manager, InterSystems Benelux. The panel members were broadly supportive of this Compact and felt it needs to be enforced by a designated neuronal body (i.e. it needs to have a home and an owner), that it needed to be framed in more precise legal wording, and that organisations signing up to it need to be issued with a trust-mark of some kind that can become a label the public and data providers can look for. With these arrangements, the panel felt that it has the potential to achieve its objective of contributing to greater societal trust in the secondary use of health data whilst at the same time being acceptable to public and provide data users to sign. Wider consultation is needed, especially among patient organisations, for whom a simpler low-jargon version is needed (and possibly multi-lingual translations). There was discussion about whether this could be adopted globally, but it was generally felt it first needed to be “road tested” in Europe on which it is for the moment focused (i.e. aligning with the GDPR and EHDS).

Dipak closed the meeting by thanking the i~HD team for having organised such a smooth, high quality and interesting conference, the many speakers who each contributed to interesting and relevant sessions, and the audience who contributed a lot during discussions. Plans for the i~HD conference next year are in development.

Together with the chairs, speakers and participants, a step forward was made in building trust in the use and re-use of health data during the i~HD Annual conference in Ghent on 30 November – 01 December 2023.