Nailing down the Future
"If all you have is a hammer, everything looks like a nail" is a well-known phrase used to express the idea of cognitive bias, the idea that we all make (often unconscious) choices about situations. We can probably all recognize some of our own individual biases, but politics and regulation are also affected.
In the hardware shop of data and digital policy, the hammer is regulation and the nail……….well, what is the nail? The nail is the possibility for big data and digital to improve almost every aspect of our lives. Its transformative potential in healthcare is well-understood. Within IMI, EFPIA members and their partners in the public sector are pioneering new data networks to enhance research and development of new medicines and move us closer to the reality of personalised care. Healthcare systems are to varying degrees seizing these opportunities, with the EU past President Estonia a leader, aiming to drive things forward through its Digital Health Society Initiative.
The “what can be done” sometimes collides with the “what is permitted to be done”. The current controversy concerning interference in elections is a case in point, but there have also been less sensational examples from the healthcare sector where well-intentioned initiatives that were likely to benefit patients and improve health systems have fallen foul of regulation.
The point at issue here is that we still have research related regulations that are outdated and mainly focused on consent rather than on effective safeguards and face a raft of new regulation – GDPR, e-privacy, free-flow of data, cybersecurity (to name a few) as we seek to build a digital single market in Europe that engages public trust and promotes digital enterprise. It has been, and will continue to be, a messy process as the rules are bedded down and understood. There will be mistakes and events that test public confidence.
These events should not become the basis for regulation, however much they will inform it. We lack the right tools to navigate this space. Detailed regulatory guidance and heavy fines are not appropriate to build the Digital Single Market. One thing that is notably missing is any sense of the principles that should govern the relationship between the individual and society. In their recent report, the Ethics Advisory Group set up by the European Data Protection Supervisor suggested that “Genetic data gathering is just one of many examples requiring a move away from a traditional governance model relying on prior authorisations to a monitoring governance model, relying on a co-stewardship between individuals and re- searchers/doctors.”
It may be that the time is right to think about what these principles might be.