People with rare diseases who have engaged with researchers to find a diagnosis or treatment for their conditions can appreciate the enormous value sets of biomedical data needed to find answers. But for the population at large, concerns about who has access to sensitive personal information can overshadow the benefits of data sharing.
In November 2019, the Data Saves Lives initiative launched in Europe to create a forum for stakeholders to address issues around data sharing, educate the public about the importance of health data, and improve the understanding of how it is used.
The European Patients’ Forum, an umbrella organization of chronic disease patient advocacy groups, and the European Institute for Innovation through Health Data, which is working to develop trustworthy uses of health data, leads the multi-stakeholder initiative. As part of the effort, the initiative assembles a network of national health data ambassadors. They will soon be on hand to promote the responsible use of health data across Europe.
“The Data Saves Lives initiative is providing the platform to galvanize the community, to ask the serious questions, to do the thinking and reflection, and to be able to contribute to, for example, the European health data space,” said Nicola Bedlington, special advisor at European Patients’ Forum. “It is bringing together a united, multi-stakeholder perspective, recognizing that health data is everybody’s business.”
Bedlington said there is a sense in Europe that health data can be manipulated and exploited. There’s also a belief that patients should own their own data, they should have a say about how it is used, and the policy environment that it sits within should be patient-centered. As such, she believes the patient community is viewed as a trusted convener of the initiative.
“Much of the initiative’s early work is focused on educating the public because it would be difficult to engage people in the initiative without an understanding of data sharing around health data,” said Gözde Susuzlu, project coordinator of Data Saves Lives Initiative. “There was not enough knowledge about what it is. People are afraid of the unknown, and they didn’t know what to do.”
Because of that, Susuzlu said the initiative is addressing such things as what data sharing involves, the implications for health data under the European Union’s sweeping 2016 General Data Protection Regulation, the safe ways to share data, who owns health data, and what data donation is.
“We realized there were big gaps with all these concepts and in understanding the issues,” she said.
Alastair Kent, former executive director of Genetic Alliance UK, said when the European Union was crafting the General Data Protection Regulation, lawmakers on the committee responsible for the legislation didn’t see the relationship between health data and public health issues. That mobilized patients around the issue.
“The input from patients to that campaign was very much along the lines that there are bigger things in life than privacy,” he said. “The opportunity to share our data under properly regulated circumstances with clinicians, researchers, and other legitimate interests, such that we have the opportunity to gain insight into our conditions and develop disease-modifying strategies and interventions, can actually be more important than the strict preservation of our confidentiality.”
He noticed that many people with a rare condition note that their confidentiality is gone as soon as they walk out their front door because anyone who sees them can tell they have a major health problem with which they must contend. They argue that rather than a “spurious notion of confidentiality,” they want to talk about the proper framework for allowing data to flow where it is felt to be appropriate.
He believes Data Saves Lives initiative can play a critical role in building the framework, the understanding, as well as the moral imperative to share data safely as a legitimate part of doing science. But what’s also needed is the infrastructure to do so, which is where he sees RARE-X playing a critical role.
“Building a common framework, such as RARE-X, which will allow for that infrastructure to be created is potentially going to make a huge difference in terms of creating the critical mass to allow us to engage the academic, clinical, and commercial sector in the potential for better understanding and reacting to new knowledge such that the natural history of these terrible conditions can be altered and we can improve the quality of life for those affected.”