In a few weeks, the EU-funded research project Darwin EU will announce its first batch of data partners for the ambitious real-world data-driven Horizon 2020 project. This project centres around the use of electronic health records (EHRs) from different European countries to drive research and improve responses to expected and unexpected crises. A major objective of this project hinges on exploiting national EHR data to complete observational studies quicker than industry standards.

EHR, or electronic medical records (EMR), have been adopted in multiple countries worldwide over the last few decades. Countries like Estonia and Finland have taken on a completely digitised approach to their health services, integrating EHR data to efficiently prescribe medications and improve treatment strategies. Israel, another leading adopter, has a thriving EHR technology industry that is adapting to the country’s widespread use of Big Data from its country’s healthcare systems.

Given the national-level focus on developing HER-based solutions, companies are developing AI and machine learning tools to improve the accuracy and efficiency of prescription services for several diseases. However, at the heart of the technological advancements is a solidifying interest to exploit EHR data to tackle multiple public health challenges. Darwin EU plans to be a major contributor to this movement as its data-driven objectives are a part of a major initiative to create a European Health Union, allowing efficient, normalised healthcare standards across the Union.

“The medicines regulators in Europe have a strategy for 2025 where the second pillar is data and digitalisation, so we are trying to transform medicines regulation to be data-driven,” says Peter Arlett, Head of Data Analytics and Methods Task Force at EMA. Arlett explains that Darwin EU is playing a collaborative role in this goal. “Darwin is part of a package of projects and initiatives to transform to data-driven medicines regulation.”

Adoption of EHR data systems

In some countries, EHR is deeply integrated into the entire healthcare system. In Estonia, every patient who visits a doctor immediately has their own personal e-Health record updated with new information, which can be referred to in future appointments. The information is assigned to an electronic ID card and the EHR system is upheld using blockchain technology.

Israel’s mostly centralised health system also relies on EHR data to analyse health records and find new healthcare solutions. In 2018, Israeli prime minister Benjamin Netanyahu put forth a $300 million initiative to support the country’s burgeoning data-driven healthcare system, allowing anonymised EHR data to be accessible to researchers and institutions to improve their healthcare solutions. Israel was ranked fifth in the 2020 Bloomberg Health Efficiency Index, which tracks healthcare systems with based on their efforts to improve health outcomes. At the time, however, concerns about individual data privacy were raised as with any digital platform, concerns of breach exist.

In May 2018, the EU, of which Israel is an associated state, introduced the General Data Protection Regulation (GDPR) laws to safeguard data privacy and sensitive information.

Israeli company TALIAZ ’s tool, named Predictix , uses AI and EHR data to improve mental health prescription services. Taliaz’s Predictix has been used for some time in Israel and other countries, but a recent announcement revealed that this software will soon be introduced to the UK’s National Health Service (NHS).

The Tel Aviv-based company’s collaboration with the NHS aims to combine patient management and prescription in an efficient process to support general practitioners and psychiatrists. “We are initially focusing on improving the effectiveness and utility of mental health prescribing in the Rotherham Doncaster and South Humber area, where mental health has been shown to be particularly worse than the rest of the UK. Following a successful model and approach here, the plan will be to roll out Predictix throughout the whole of the UK,” said a company spokesperson said in an email to Pharmaceutical Technology.

Exploiting EHR data

Yi Zhang, PhD, senior research associate at the Bethesda, Maryland-based nonprofit Medical Technology & Practice Patterns Institute, has used EHR data to conduct observational studies to establish “causal inference” that emulates randomised clinical trials. Causal inference refers to the process of drawing a conclusion that a specific treatment (i.e., intervention) was the “cause” of an effect. These studies are often done to understand the side effects of different therapies.

Zhang explains that observational EHR studies are often used to establish causal inference. Zhang says the development of new methods to use observational data like machine learning approaches, in addition to the availability of rich and large databases, are some reasons why there is a pivot toward research that uses EHR data to study causal inference.

Darwin EU is also contextualising the analysis of EHR data for the management of disasters, health threats, and in policy-making. In 2021, the EMA adopted a new legal mandate that strengthened its role in dealing with health threats and health crises. This includes issues related to drug shortages and research into new therapeutics, which will be addressed in the EMA’s strategy for 2025. The EMA has in-house access to six electronic healthcare datasets, and has framework contracts in place with different academic consortiums that allow access to data from 380 million European patients, says Arlett. DARWIN EU is providing federated access to health datasets and studies, he explains.

Darwin EU is part of the EMA Big Data Steering group that aims to increase the utility of Big Data in regulatory decision-making. In February, the group awarded a contract to a consortium led by Erasmus University Medical Center in Rotterdam, which is now onboarding the first data partners, says Arlett. He explains that over the next few years the project aims to onboard approximately 50 partners who will help achieve Darwin’s goal for data-driven strategies for a European Health Union.

In clinical research, Darwin’s studies are being used for the planning of trials, analysis of different drugs, and extrapolation of results. Other than this, Darwin has completed several observational studies to analyse long term effects of drugs that have been facilitated by EHR. This has included high-profile issues such as the study into reports of blood clots seen with AstraZeneca’s COVID-19 vaccine.

Arlett says plans are also underway to conduct some studies under Darwin EU next year, which would not only meet the decision-making needs of regulators, but also those of health technology assessment bodies and payers. He described a study that could meet the knowledge needs of different decision makers as the “holy grail”. “And that’s brilliant because it’s efficient, cost-effective, and it also brings the different decision-makers closer together.”

Clarification: This article has been updated to accurately represent Peter Arlett’s comments on the work done by the EMA and Darwin EU in making healthcare datasets accessible. Paragraph 12 has been updated accordingly.