The expert reports help guide the work of the HMA-EMA joint Big Data Steering Group.
For more information, see:
A report on mobile health (mHealth) data is available to explore the opportunities of using data from mobile technologies and digital interventions in regulatory decision-making.
This report focuses on mHealth data use in real-world settings, such as clinical care or the daily life of patients, to generate real-world evidence.
mHealth tools such as smartphones, health applications, smartwatches and other wearables can generate a large variety of detailed patient data like heart rate and body temperature.
However, they can also pose challenges in terms of data quality and protection of patient privacy.
The HMA-EMA joint Big Data Steering Group published this report in October 2024.
A discussion paper is available on how to introduce data analytics into the everyday work of the European medicines regulatory network.
This paper proposes so-called clusters of excellence operating at national level.
These clusters would support each other's work and share good practice in areas including data access, infrastructure and artificial intelligence.
Experts from national competent authorities represented on the HMA-EMA joint Big Data Steering Group produced this paper.
The steering group published it in March 2023.
A report exploring the potential advantages and challenges of leveraging social media data in regulatory decision-making is available.
The report specifically focuses on the use of social media data in real-world settings, such as clinical care or the daily life of patients, to generate real-world evidence that could potentially support regulatory activities.
Such data includes:
Although obtaining access to and ensuring appropriate quality and ethical use of social media data can be challenging, it might be is possible to extract valuable patient data from such sources.
In some specific cases, such as medicine abuse / misuse or misinformation, social media data might be used as a complementary source of evidence.
The HMA-EMA joint Big Data Steering Group is continuing to monitor progress in this area, as technological advances might help to overcome some of the current challenges of using such data.
EMA and the steering group are encouraging researchers in this field to conduct further studies, as this could help enhance the EU regulatory system and bring about public health benefits.
The steering group published the report in November 2024.
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