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5th February 2020

3E – EMA and EU and eHealth

While there is much talk in the Czech Republic about the digitization of healthcare, the EU and especially the European Medicines Agency (EMA) are far way ahead. We are a country of patient registers (be they statutory ones or those maintained by expert societies), reporting care to insurance companies is digitalized and standardized, we are on a path to implement DRG (restart), we invite public tenders for eHealth infrastructure, and we have a national eHealth strategy portal. But getting Big data together to analyse and improve care is a problem. Getting an electronic statement of medical records is a problem. Sharing information between attending physicians is a problem. The use of modern IT solutions in health care is a taboo, with some exceptions that must come "from below" - from providers themselves. At least after 11 years, eRecept (electronic prescription) is not a big problem anymore (the laws conceived electronic prescription in 2007; and it has been known since 2015 that it will be mandatory from 2018).

The EU has taken a broadside approach. On its 25th anniversary, EMA - as a kind of a birthday present – published, in collaboration with Heads of Medicines Agencies, Big Data Taskforce Phase II report and 10 recommendations, which should unlock the potential of Big data in the healthcare segment. EMA recognizes the opportunities of increasing data collection across health systems and devices that can lead to a better understanding of disease, the effect of drugs, and the efficacy of medical devices in the health system. At the same time, it perceives the complexity and heterogeneity of not only the data itself but also its analysis. Yet it is not afraid to give such a project a clear and concrete framework, and instead of procrastination and maintaining the status quo, it offers a vision and commitment to take advantage of the technological capabilities of the 21st century.

What are the specific areas covered?

The most ambitious of these requirements, or the ultimate goal of the project, is the creation of a sustainable platform for accessing and analysing medical data across the European Union – the so-called Data Analysis and Real World Interrogation Network – DARWIN. Specific steps and priorities leading to this ultimate goal are:

Establishing a framework for the validity, quality and representativeness of the data and supporting the implementation of these guidelines in the Member States.
Enable data discoverability. Creating an environment for key data identification - identifying key metadata, selecting a data source, and strengthening the current ENCePP database.
Enhancing the capability to process Big data within the EU. Creation of a specialized educational program, cooperation with experts including academia, data specialists, biostatistics, epidemiologists and experts in the field of artificial intelligence and robotics.
Strengthening the European network for information sharing and submission monitoring, including Big data, its revision and inclusion in machine learning tools and subsequently guidelines. Improvement of the current EU PAS system’s transparency and study methods.
Creating hardware and software capacity for Big data analysis. Provision of a network of analytical centres connected to local regulatory authorities.
Modernise the delivery of expert advice.
Ensuring that data and analysis of data are managed within the principles of ethics and maximum security, both in relation to GDPR and technological security of storage and access. Establishment of an Ethics Advisory Council.
Cooperation with international Big data initiatives. Supporting international forums and sharing best practice in the area.
Creating an EU Big data implementation forum, which will include an active dialogue not only with key institutions across the EU and Member States, but also with patients, HCPs, industry, HTA agencies, payers, regulators and technology companies.

When this project is implemented, it may be one of the greatest advances in health care. The potential is huge, and when there is will to go in this direction (and the money), we believe that it will redefine the way we provide care.