What Does It Take To Inspire Public Trust In Health Data?

As Chair at the Digital Health Society (the DHS) – powered by ECHAlliance – could you please explain how the organization can increase the societal trust towards data-driven healthcare? Where does the public fear about the misuse of health data come from, and how to reduce them? The DHS believes that in order to develop, let alone increase societal trust, we have to explain simply to people what data-driven healthcare means. Therefore, to facilitate the development of digital health and increase societal trust, we hold our Annual Summit. We also use Round Tables of all stakeholders involved in healthcare (e.g., patient groups, healthcare providers & professionals, regulators, researchers and industry) to develop understanding, inform, and inform reach consensus views. Three critical factors and enablers were identified: transparency (the who, what and why of data use and reuse); citizens should be able to authorize who may use their health data and for what purpose; education and skills training for the public on health, data and digital for all ages from primary school onwards. Fear is a strong emotion and must not be ignored or belittled. Citizen trust in public bodies, let alone industry varies considerably between Member States (contrast the trust in Finland with the concerns in Germany). This fear is linked to the history of Member of States and their cultures as well as failures by them to secure other types of public data from loss or hacking. Providing balanced information which explains to citizens the benefits of using health data to treat them and for research into large populations to develop new and better treatments (drugs, devices and outcomes) is essential to building trust and developing an understanding of the societal good of data-driven healthcare. Patients also need to be reassured that health data is not going to be used to disadvantage them (e.g. insurance, access to treatment or career promotions). Also explaining the security measures to ensure privacy by design and governance measures to ensure ethical use by approved users. Let me repeat this question regarding healthcare professionals: How to strengthen trust from doctors, nurses, medical workers? I think healthcare professionals understand the benefits of health data both for patient care and research. Technology has promised to transform healthcare since the invention of the radio! The frustration of clinicians relates to systems that do not talk to each other ( interoperability), the need for multiple logins and data input which – instead of giving them more time with patients – have the opposite effect and consume more of their time than paper records. These problems require better data system design, interoperability standards and the involvement of clinicians. Can you name the five most essential acceptance criteria for societal trust in the use of health data that can be applied by digital health providers or healthcare facilities that plan to monitor patients’ health remotely? I think criteria do not vary materially with the particular use of health data. So my five would be:

• Transparency for the use of the data – the 3 W's: Who, what and why
• The benefits for the patient
• Security of the data (by design)
• The ability of the patient to control the use of that data
• The ability of the patient to access and understand that data

When we talk about transparent and fair data sharing, we must discuss a new data economy where citizens can control their data. However, is it possible since our data circulate in different repositories and is used by dozens of service providers? In the B2C consumer market, this is likely to be much harder to achieve as many providers of devices and apps reserve rights in their terms and conditions to use the data captured. However, in other sectors, this approach is part of the free service, e.g., apps. In contrast, patient data inside health systems has its own complications. It is easy to overlook that not all Member States have EHR systems, or where they do, patients enjoy convenient or simple access. Giving patients the ability to know what health data exists about them, give consent to access that data and what it is being used for is fundamental to creating data-driven healthcare. This is technically possible, but it requires a political will and resources. Even the bigger challenge will be to create so-called European Health Data Spaces EHDS. It requires not only trust but also close cooperation between different stakeholders. Is the willingness to cooperate already there or does it need to be boosted? The key cooperation is at the Member State level, and you would think that the principle of solidarity should drive the development of EHDS. The importance of health data for public health and patient treatment could not have been better illustrated than during the COVID-19 pandemic. Citizens across Europe have become used to understanding infection rates and the importance of real-time reliable health data. However, the challenge in health laws are a Member State competency. I have no doubt that harmonized European health laws and a European Health Union would be in the interests of patients in Europe. After all, what is more important to you consumer rights or life, death and the quality of life? Is there the necessary political will and are the Member States able to rise above individual self-interest (everyone thinks their standards are best and/or give them competitive economic advantages!)? Sadly I am not optimistic, but the pandemic has given us a greater opportunity than ever before to realize this ambition. Almost during every digital health conference, we hear that “we should harness the potential of data in healthcare.” So why haven’t we managed to do it so far? I think there is a range of reasons why we have yet to see the full potential of health data, including:

• EHRs are not yet universal across Europe
• Siloed health data systems
• Proprietary systems
• Interoperability constraints
• Data quality and access to data
• Alignment of Standards adoption
• Audit processes and traceability of sources of data must be embedded into policies and architectures to ensure transparency.

Do we need more regulations, education, or maybe new technical improvements to inspire trust in digital health? It is not a choice between these but rather a combination of all. I believe digital and health literacy are essential to developing societal trust in digital health and data-driven healthcare. Transparency and accountability are imperative too. Also, regulation is interesting. I am a supporter of harmonized health laws. The EU has new laws coming for the EHDS and the Data Governance Act. However, as a recent report on GDPR illustrated, even for EU regulations, there is a range of interpretations and opt-outs.  The key with legislation is the quality of the laws and how effectively they are enforced. Also, technology changes far faster than we are able to pass laws, so the key is to take an informed risk management perspective as we all do in the rest of our lives. So it would be helpful to see a risk management approach incorporated into legislation. Let’s wrap up our talk. ECHAlliance and I~HD have published a white paper, “Calls to Action on Health Data Ecosystems.” What are the key recommendations highlighted in the document? There are 7 Calls to Action published in January 2021 following our Round Tables in 2020:

1. Raise the digital literacy & skills of all stakeholders
2. Generate and value trustworthy Real-World Evidence
3. Accelerate interoperability across Europe and globally
4. Demonstrate benefits to society from data access, use and reuse
5. Adopt a risk stratification approach
6. Build a trustworthy framework for data access and use
7. Adopt a transformational approach to health data.

To download the white paper “Calls to Action on Health Data Ecosystems,” click here.