MedTech Europe and European Commission approach on EU ArtificiaI Intelligence and Data strategy

Artificial intelligence and machine learning technologies are promising to transform healthcare by deriving new and important insights from the vast amount of data generated during the delivery of healthcare every day. Medical device manufacturers are using these technologies to innovate their products to better assist healthcare providers and improve patient care.

In this respect, the European Commission (EC) released two documents in February 2020 that represent the first pillars of its new digital strategy: “A European Data Strategy”[1] and “White Paper on Artificial Intelligence – a European Approach”[2]. With the public consultation period open until 19 May, European Citizens and the main actors of relevant sectors are invited to take action (EU Survey on AI & Big Data).

MedTech Europe, the trade association representing the medical device industry in Europe, already expressed its position by welcoming  the approach undertaken by the EC ‘’as an important commitment to harnessing the power of data for healthcare’’, and commits ‘’to provide sector-specific expertise’’ in sight of any future European framework.

In its Position paper to the European Commission, MedTech Europe proposes to target especially the following topics:

–       Addressing data fragmentation – increasing the quality and safety of data, in form of standardized formats under trustful cybersecurity safeguards. In this context, the creation of a European Health Data Space, with the active collaboration of all Member States interested, will be critical to grant access to high-quality data, which is a fundamental requirement for Artificial Intelligence in healthcare;

–       Establishing a harmonized governance framework based on ethical principles – building on sector-specific needs, as well as on existing EU legislation (MDR, IVDR, GPSD, Product Liability Directive ) and existing institutional structures;

–       Funding of AI – to invest in research and innovation, but also in resources for implementation and deployment;

–       Equipping the healthcare workforce and patients with the necessary skills – foster education and training of AI curricula for healthcare professionals, in parallel to awareness and education of “traditional” healthcare stakeholders.

If you are a medical device manufacturer thinking of potentially implementing and taking advantage of these new enabling technologies, European strategies are paving the way, so stay abreast of future developments and gear up to profit from the business opportunities.

Filippo Chierchini

Regulatory Affairs Department


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