Table 1.
Challenges | Explored solutions | Remaining challenges | Suggested solutions |
Lack of adequacy decision by the European Commission | Creation of clear rules for the adequacy assessment procedure | Blanket adequacy decisions easily disregard sectoral differences in applicable data protection rules | Adopt specific health research sector adequacy assessments to take into account specific trade-offs among rights, appropriate technical measures, and long-standing compliance efforts within the sector, including administrative measures |
Data anonymization and privacy-preserving data security measures are promoted as the only solutions to data protection concerns | Nonapplication of data protection rules and instead use substitute measures to meet the adequacy standard | Loss of information content of data for scientific research, anonymity of data is context dependent, and substitute measures for protection can be circumvented | Emphasize the contextual anonymity of data, for example, when the context is not changed during data processing (eg, by allowing data to be visited) |
Missing codes of conduct and certification mechanisms | Bottom-up sector-specific concretization of data protection rules and appropriate supplementary security measures | Current solutions that are not relevant to the context of genomic research or are not relevant for international data transfers [32]; fundamental rights issues raised | Link the development of codes of conduct with the sectoral adequacy assessment and the development of certification mechanisms with supplementary technical measures for international data transfers |