Ever more healthcare institutions are developing their own digital tools. This obviously raises some questions: what about regulations and patient safety? Therefore, the FAMHP is organising a study day on in-house software. Please mark your calendar for 10 March 2026.
Within healthcare institutions, the use of in-house developed digital applications is booming. To enhance the quality and efficiency of care, more and more healthcare institutions nowadays develop their own software, ranging from AI triage tools over telemonitoring to clinical decision support. At times, those innovations raise questions about regulations and patient safety.
The FAMHP, in collaboration with the Federal Public Service (FPS) Health, Food Chain Safety and Environment and the National Institute for Health and Disability Insurance (NIHDI), organizes a study day on in-house software in healthcare institutions on 10 March 2026, to answer as many questions as possible. The event will take place at the Galilee building in Brussels.
Aimed at professionals who develop or implement in-house software
The study day is aimed specifically at professionals within healthcare institutions who are key actors in digital development and implementation: innovation managers, software developers, IT managers and quality managers, as well as academics with expertise in healthcare technology.
On the programme
The study day will address, among other things, the following topics:
• qualification of software as a medical device;
• regulatory pathways for medical device software developed within healthcare institutions;
• in-house exemption, cfr. Article 5(5) of the Regulation (EU) 2017/745 on medical devices (MDR) and the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR);
• MDR context and responsibilities within institutions;
• the coherence with Regulation (EU) 2024/1689 (AI Act), the European Health Data Space (EHDS) and other European initiatives.
FAMHP experts together with guest speakers from the healthcare sector, the MedTech sector and academia will share their insights, good practices and points of attention. Our FAMHP experts will outline the legal framework and explain how healthcare institutions can put these rules in practice. Participants will get plenty of opportunities to ask questions and exchange experiences.
More detailed information will follow with the final programme. Please mark your calendar on 10 March 2026. Participation is free of charge, but registration is mandatory. Registration will be possible from mid-January 2026. If you sign up via the 'save the date', you will be among the first to hear when registrations open.