Today we are publishing our latest Special Report: The European Healthcare Technology Regulation Briefing 2025.
Regulation is a topic HBI covers frequently, but this is the first time we have produced an in-depth report on healthcare technology regulation.
The decision to cover this topic stemmed primarily from the fact that the regulatory landscape for healthcare technology is in the process of being significantly altered in Europe.
There are four new pieces of EU-level regulation which are in the process of being implemented which will change the way the EU regulates healthcare technology, and could significantly impact the sector, which we chose to cover in this report: the Health Technology Assessment Regulation (HTAR), which establishes joint EU-level assessment of healthcare technologies; the European Health Data Space (EHDS), a framework to make sharing of patient data easier across the EU; the EU AI Act, the world’s first attempt at a regulatory framework for AI; and the Cyber Resilience Act, which promises to improve the sector’s cyber resilience by making it mandatory for med tech manufacturers to implement cybersecurity measures.
To get a sense of what impact these new pieces of regulation will have on the sector, we spoke to people from a variety of fields, including AI and cybersecurity experts, a health economist at the OECD, two Harvard professors, and multiple legal experts.
The report includes sections on each of the four pieces of regulation, as well as a section on whether the “Brussels effect”, whereby other countries copy the EU’s regulation (as happened with GDPR), will apply to the EU AI Act.
HBI Intelligence members can click here to download the report now.