AI in Healthcare: paving the way with standardization - CEN and CENELEC's Stakeholder Workshop

In recent years, and in the current quest for digital sovereignty, AI has become one of the top strategic priorities and a key driving force of economic growth. Healthcare is a sector in which this game-changing technology has a particularly high potential to make a huge difference for both health professionals and patients: it allows for faster data analysis and diagnoses, optimises time or outbreak monitoring, and overall provides high-quality care for its citizens. Nevertheless, AI applications must take into account existing European regulatory frameworks, health industry practices, and real world applications. Furthermore, the COVID-19 pandemic has highlighted the role such new technologies can play for an effective and efficient health system.

In this context, standards have a strategic role to play: in a quickly developing sector, they can help build trust, promote transparency, and provide a common language. To launch the discussion on this topic, CEN and CENELEC, two of the official European Standardization Organizations (ESOs), organised on 27 October 2020 the digital stakeholders’ workshop “Artificial Intelligence in healthcare: paving the way with standardization”. The event put together a variety of stakeholders coming from the industry, policy makers, research institutes, healthcare professionals, patient representatives, and the standardization community, to exchange views on the current challenges and future needs to establishing a thriving AI for healthcare in Europe.

Standards create trust in new technologies

The workshop was opened by an introduction by Javier García Díaz, CENELEC’s Vice-President Technical. He was followed by two keynote speeches from Petra Hoogendoorn, Researcher at the National eHealth Living Lab – Leiden University Medical Centre, and David Gruson, Founder of ETHIKAI and Director of the Health Programme at Jouve, who highlighted from a first-hand experience the current and future trends of AI in healthcare. The third keynote presentation was delivered by Nada Alkhayat, Policy Officer at DG SANTE - European Commission, on the EU regulatory framework for healthcare with a zoom in on AI applications.

After the keynote speeches, participants had the opportunity to exchange their views on challenges and opportunities for healthcare AI. The findings from this discussion subsequently fed into a panel discussion, which saw interventions from representatives of the industry and society on current gaps that need to be addressed, such as the need to find a balance between privacy and availability of data.

The second part of the workshop was dedicated to identifying ways in which standards can support the development of AI-based software in the healthcare sector. Also in this case, an exchange of views among participants was followed by a panel discussion, which identified some priorities and elements for CEN and CENELEC standardization activities for AI in the Healthcare sector. The role of standards in building trust and ensuring privacy, security, data quality and data sharing emerged as a particularly relevant element.

Javier García Díaz, CENELEC’s Vice-President Technical, commented: “Today’s Stakeholders’ Workshop has shown that standardization at CEN and CENELEC may be key to boost the use of AI technologies for healthcare in Europe. Several International and European standardization solutions are already being developed to support the use of AI-enabled technologies. However, the future of ‘AI Standardization’, particularly in the healthcare sector, is still broad, and there is a real need for the development of a coherent set of standards in this direction”.

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