Recital 16

In order to mitigate legal uncertainties that could discourage innovative business models, it is necessary to address the substantial compliance ambiguities and burdens associated with the provisions on smart contracts executing data sharing agreements under Article 36 of Regulation (EU) 2023/2854. The absence of harmonised standards and clear definitions for key concepts such as ‘robustness’, ‘access control’, and ‘consistency with contractual terms’, combined with the requirement for a ‘safe termination or interruption mechanism’ potentially incompatible with decentralised or public blockchain architectures built on immutable ledgers, posed challenges to innovators from a cost and opportunity perspective. Additionally, the ambiguity surrounding the performance of the conformity assessment under Article 36(2) of that Regulation risks imposing disproportionate burdens. The elimination of Article 36 of Regulation (EU) 2023/2854 would therefore promote the development and market introduction of new business models, foster innovation, and reduce barriers for emerging technologies.