This week, Health-ISAC®’s Hacking Healthcare® examines new AI developments within theEU. Specifically, we look at how the European Commission intends to push forward AIadoption within the health sector as outlined in the new Apply AI Strategy. We then exploresome of the larger security themes in the analysis portion.
As a reminder, this is the public version of the Hacking Healthcare blog. For additional in-depth analysis and opinion, become a member of H-ISAC and receive the TLP Amber version of this blog (available in the Member Portal.)
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Welcome back to Hacking Healthcare®.
New EU Developments to Increase AI Usage in Healthcare
Efforts to develop AI standards and regulations to facilitate the deployment of AI productsand services continues apace within the EU, and October saw new developments for thehealth sector.
In early October, the European Commission published their Apply AI Strategy.[i] Described as“the EU’s overarching Artificial Intelligence (AI) sectoral strategy,” the document “is designedto enhance the competitiveness of strategic sectors and strengthen the EU’s technologicalsovereignty” and “aims to boost AI adoption and innovation across Europe.”[ii] Importantly,healthcare, pharmaceuticals, and medical devices all appear to be covered to some degreeas described in section 2.1.
The Apply AI Strategy is split into three sections: sectoral flagships, cross-cutting challenges,and a governance mechanism. Among the most interesting of these for the health sector arethe flagship projects described in some detail within the strategy itself and its accompanyingannex.[iii], [iv] They include “propos[ing] appropriate actions to streamline and enablequicker market entry of medical devices without compromising safety” and “establish[ing] aEuropean network of AI-powered advanced screening centre[s] to accelerate theintroduction of innovative tools for prevention and diagnosis making in healthcare facilitiesand bringing healthcare services to underserved areas.”[v]
As part of these flagship initiatives, on October 21, the European Commission published anarticle detailing the launch of COMPASS-AI, a new effort to increase the use of AI inhealthcare.[vi] With a focus on cancer care and healthcare in remote areas, the intention is“to promote the responsible and effective integration of AI into clinical settings.”[vii]
Within the broader policy context, the European Commission has also stated that effortsunder the Apply AI Strategy will complement workstreams related to the AI Continent ActionPlan that was published in April earlier this year and will rely on the AI Act and existingmedical device regulations to provide a clear framework for the safe deployment of AI inhealthcare.[viii], [ix], [x]
Action & Analysis
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[i] https://digital-strategy.ec.europa.eu/en/policies/apply-ai
[ii] https://digital-strategy.ec.europa.eu/en/policies/apply-ai
[iii] Communication From The Commission To The European Parliament And The Council:Apply AI Strategy. European Commission (pg. 2-4)
[iv] Annexes to the Communication From The Commission To The European Parliament AndThe Council: Apply AI Strategy. European Commission (pg. 3)
[v] Annexes to the Communication From The Commission To The European Parliament AndThe Council: Apply AI Strategy. European Commission (pg. 3)
[vi] https://digital-strategy.ec.europa.eu/en/news/commission-launches-flagship-initiative-increase-use-ai-healthcare
[vii] https://digital-strategy.ec.europa.eu/en/news/commission-launches-flagship-initiative-increase-use-ai-healthcare
[viii] https://digital-strategy.ec.europa.eu/en/policies/apply-ai
[ix] https://digital-strategy.ec.europa.eu/en/library/ai-continent-action-plan
[x] https://digital-strategy.ec.europa.eu/en/policies/artificial-intelligence-health
[xi] https://digital-strategy.ec.europa.eu/en/policies/artificial-intelligence-health
[xii] https://www.jdsupra.com/legalnews/state-of-the-act-eu-ai-act-3732095/
[xiii] https://www.euractiv.com/news/fast-tracking-of-eu-ai-act-standards-writing-leads-to-revolt/
[xiv] https://health-isac.org/health-isac-hacking-healthcare-11-7-2024/
[xv] Annexes to the Communication From The Commission To The European Parliament AndThe Council: Apply AI Strategy. European Commission (pg. 3)
[xvi] Annexes to the Communication From The Commission To The European Parliament AndThe Council: Apply AI Strategy. European Commission (pg. 3)
[xvii] https://digital-strategy.ec.europa.eu/en/news/commission-launches-flagship-initiative-increase-use-ai-healthcare
