In 2010, the European Commission proposed the 10-year strategy, Europe 2020, aimed at stimulating economic growth across the EU bloc. An important pillar of the 2020 drive is the creation of the Digital Single Market with the use of Big Data for ‘eHealth’ and ‘mHealth’ central to the initiative. The aim is to dramatically improve the quality, efficacy and effectiveness of healthcare and management in the sector across Europe. By 2020, will Europe be ready? Health Management.org spoke to Peteris Zilgalvis Head of Unit, eHealth and Well Being, DG CONNECT at the European Commission about Big Data, security, standardisation and cross-Atlantic collaboration for a healthy Europe.
The 2020 undertaking is huge. What does a typical day look like at the DG Connect unit?
Broadly speaking, we are following up on the eHealth action plan and the mHealth green paper. Importantly, with the mHealth green paper we are facilitating a code of conduct on privacy in the framework of the data protection directive.
There is also an action being discussed on validation and certification of mHealth apps. In the area of research we are financing research on the virtual physiological human, telemedicine, mHealth, remote monitoring of chronic diseases, digital health literacy, patient empowerment in general, interoperability and standardisation.
Protection of health data is an issue on everybody’s mind these days. What is the situation vis-à-vis data protection standardisation right now in Europe?
We are hoping to complete the negotiations on the data protection regulation by the end of this year.
Right now t here is a directive that sets out the principles of data protection. Areas of sensitive data include health data, but the directive allows the member states to choose the way of implementing it. This has led to some divergence both in the protection of citizens’ data and allowing the internal market to work in a very fluid manner. For this reason we are proceeding now with a proposal for regulation which applies directly. What we mean is a citizen should be asked for consent about sensitive data, but that should be done simply and uniformly so as not to cause bureaucratic problems for people and companies wanting to operate across-borders. Once the regulation is adopted t his w ill lead t o a more uniform application of the rules.
Are there any non-negotiable points in the current directive and future regulation on data?
Yes, with a directive, EU states are supposed to achieve the aim that a citizen has the right to rectify incorrect data about themselves.
The regulation will accommodate the different legal and administrative cultures of the member states and will allow a number of ways and means of rectification, but the same provision would be implemented across the bloc. The idea is that we make things simpler by moving to a similar procedure.
What will EU citizens be seeing 5 to 10 years from now once the regulation is implemented across the bloc?
I think we will see a uniform application of data protection law across the union that will also have benefits for a freer flow of data when the citizen wants it. Take the person who is spending the winter in southern Spain who goes back home to Sweden or Britain during the summer, who may want crossborder access to their healthcare data. We’ll also see that the market for the mHealth and eHealth applications in both software and hardware will be much more dynamic.
Has the EU learnt any lessons from the U.S. following serious health data breaches there?
We have a memorandum of understanding on eHealth with the U.S. Department of Health and Human Se r vices. T his is a very active partnership, but of course we want to make sure that the European approach is developed.
What potential is there with use of Big Data in health?
The Big Data potential is huge. If personal data is for public health purposes, you have the possibility of using it in a pseudonymised form without the express consent of the citizen, provided certain safeguards are in place. If it is anonymised data, then this data is very much open for the smart use of both our healthcare authorities and companies which want to offer services that can be of use to providers and citizens.
On the whole, Big Data has the potential to meet citizens’ needs and provide jobs and growth.
I think what we are going to see is the way to use all types of data is going to increase and, as it is put together, the possibilities will be endless.
To be honest, I don’t think any data will be irrelevant.