Are EU member states ready for the European Health Data Space? Lessons learnt on the secondary use of health data from the TEHDAS Joint Action.

The proposal for a regulation on the European Health Data Space (EHDS) contains provisions that would significantly change health data management systems in European member states (MS). This article presents results of a country mapping exercise conducted during the Joint Action 'Towards the European Health Data Space' (TEHDAS) in 2022. It presents the state-of-play of health data management systems in 12 MS and their preparedness to comply with the EHDS provisions.

Impact of substance type and patient characteristics on the choice of treatment setting for substance use disorder in Belgium.

Background: Specialised addiction treatment centers (SAC) and general mental health centers (GMHC) both offer care to people with substance use disorders (SUD) in Belgium, but these sectors often operate in parallel, with little collaboration. This fragmented system may lead to inefficiencies, particularly in the treatment of individuals with dual diagnoses. Despite the recognized challenges, there is limited understanding of the factors that influence whether patients with SUD are treated in SAC or GMHC.

What does it take to create a European Health Data Space? International commitments and national realities.

Public health concerns in Europe demonstrate the necessity of building a health policy that could contribute to the long-term sustainable development of the European Union (EU), as stated in the European Health Union (EHU) manifesto. The main desire to create an EHU is embodied in the launch of the European Health Data Space (EHDS). The EHDS seeks to foster a genuine single market for digital health services and products by, among other things, accelerating the uptake and implementation of harmonised and interoperable electronic health record (EHR) systems across the EU.

Outcome postponement as a potential patient centred measure of therapeutic benefit: examples in cardiovascular medicine.

The impact of randomised controlled trials (RCTs) depends heavily on the presentation of the findings. Classically, RCT findings are presented in the form of absolute risk reduction (ARR), number needed to treat (NNT) to prevent one adverse outcome, and relative risk reduction (RRR) or hazard ratio (the most favourable means for drug marketing). However, the estimation of average survival gain (i.

Limited role and benefit of ivabradine in the treatment of angina and heart failure with reduced ejection fraction.

Ivabradine is an original drug that has been approved in two indications (systolic heart failure and angina). The aim of this short review is to draw the attention of clinician prescribers to the evidence base of ivabradine. Three large randomized trials testing ivabradine versus placebo have been performed.

From evidence-based medicine to personalized medicine, with particular emphasis on drug-safety monitoring.

Nowadays, guidelines are derived from the findings of randomized controlled therapeutic trials. However, an overall significant P value does not exclude that some patients may be harmed by or will not respond to the therapeutic agent being studied. Trials in patients with a low risk of events and/or a limited chance of providing significant differences in therapeutic effects require a large patient population to demonstrate a beneficial effect.