Data co-operatives: Giving BIG choices to the patient

By European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan

‘Big Data’ is a huge area, especially in healthcare. We are sharing more personal data than ever before these days and this stored information will keep expanding and is certainly not going to go away.

‘Big Data’ is a huge area, especially in health care. We are sharing more personal data than ever before these days and this stored information will keep expanding and is certainly not going to go away.

Big Data can be used to drive innovation in translational research and health outcomes tailored to the individual - offering the potential to revolutionize the effectiveness of health interventions in what are increasingly cash-strapped public health-care systems.

Personal health data comes from a multitude of sources including individual patient records, clinical research recruitment, biobanking and patient-generated information: all of these data are valuable in their own way.

Scientists need to be able to work with and test on large datasets. Of course, then there are questions about how best to link these results to clinically meaningful and actionable information, and how to create tailored responses to them. These factors represent further challenges.

Meanwhile, right now, these data are stored in ‘silos’ which may not just mean one hospital but even in different departments of the same hospital so that, while the data is useful on an individual level, its broader value is being under-utilized.

Another massive issue is the debate over a patient’s right to own his or her data, and to be able to get to it whenever he or she wishes, as well as the moral and ethical concerns regarding Big Data’s usage, sharing, storage and more. It’s a practical, moral and ethical minefield.

However, one idea that is gaining popular support is the use of data cooperatives in which every patient and data donor controls when, where and how his or her data can be used.

When the medical benefits to themselves and for society in general are clearly explained, most patients are willing to share their data in a ‘controlled’ way that gives them the choices.  One reason may well be the fact that nearly everyone knows, or will know, a friend or relative who has – for example - had a heart attack or has suffered from cancer. Other common issues that we all know about are diabetes, blindness, obesity and mental illness.

There is no doubt that citizens need to be informed about the use made of their data, when they wish to be informed. However, when it comes to regulation, the legal obligation needs to be proportionate and advances in communication technology should be considered to bring together needs and realities of health research and privacy. Accountability should go hand-in-hand with flexibility for re-use of data.

The exciting new field of personalised medicine requires, in most instances, personalised data, and thus it is important to navigate the complex regulatory landscape of data protection and, in many instances, clarify the boundaries of what is and is not possible.

However, by ensuring the right regulatory frameworks that cover these issues, researchers would potentially be able to access millions of genetic markers. In turn this would accelerate science towards better understating of diseases in specific patients.  The Brussels-based European Alliance for Personalised Medicine (EAPM) believes that is vital that any regulations should strike a balance between protection of the patient while not blocking vital research.

It should also create a framework in which data co-operatives are feasible and can operate properly, thus empowering the patient and giving him or her the choice of where sensitive data can be used and where any subsequent monies should go.  Health research is already conducted within a robust ethical framework with strong safeguards supported by internationally recognized guidelines. In most European countries, it is the mission of Ethical Committees to ensure patient rights and privacy are respected. This ensures that an individual’s data are only used in research when this is proportionate to the potential benefits for society as a whole.

Ethical Committees focus in particular on the nature and relevance of patient consent, broad or specific, explicit or “opt-out” or any eventual exemption from these as applicable to the precise project they review.

Also, it is a fact that modern health care is based on evidence and this evidence comes from data. The processing of personal data is vital for clinical trials and observational research performed in industry and academia.  The EU has been at the international forefront of innovative research that has improved understanding of the causes of disease and led to the discovery and development of new treatments and diagnostics.

EAPM believes that this must continue – and data co-operatives may well be one fundamental way to help this happen.

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