European Healthcare Fraud and Corruption Network
EHFCN
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ID: 314832942966-21
Lobbying Activity
Response to Requirements for Artificial Intelligence
6 Aug 2021
EHFCN AI Working Group welcomes the proposal of publishing a regulation in the field of Artificial Intelligence (AI), which will facilitate the direct establishment of common regulatory rules for all Member States. Feedback will be focused on the dispositions related to Public Health. Creating a European Artificial Intelligence Board is a step in the right direction, but the relevant articles (56 & 57) should also include a more rigorous stakeholder representation and also specific procedure of stakeholder consultation, according to the principles of transparency and representativeness. The provision of adoption of Codes of Conduct (article 69) should also include implementing acts and be linked to the relevant codes of conduct of GDPR legislation. Also codes of conduct, as soft law provisions, should be user friendly (in the field of public health the patient is considered to be the user of healthcare services), written in a clear, accessible and comprehensible language for every EU citizen (not only in english). Regarding AI Regulatory Sandboxes (articles 53 & 54) and given the fact that public health constitutes a main area of development of AI regulatory Sandboxes and also that health data are a special category of personal data (GDPR, art. 9), it would be very useful to determine the criteria of data collection with a link to GDPR legislation .
Finally the suggested categorisation of risk activities in AI could also be related to the categories of data used ( open source high-level aggregated national/regional data, or anonymised individual (health) data), incorporating a clearer definition, distinction and methodology of secondary use of data and a solid distinction between legal dispositions and ethical considerations.
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