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Background: The article studies specific ethical issues arising from the use of big data in Life Sciences and Healthcare. Methods: Main consensus documents, other studies, and particular cases are analyzed. Results: New concepts that emerged in five key areas for the bioethical debate on big data and health are identified—the accuracy and validity of data and algorithms, questions related to transparency and confidentiality in the use of data; aspects that raise the coding or pseudonymization and the anonymization of data, and also problems derived from the possible individual or group identification; the new ways of obtaining consent for the transfer of personal data; the relationship between big data and the responsibility of professional decision; and the commitment of the Institutions and Public Administrations. Conclusions: Good practices in the management of big data related to Life Sciences and Healthcare depend on respect for the rights of individuals, the improvement that these practices can introduce in assistance to individual patients, the promotion of society’s health in general and the advancement of scientific knowledge.

Key Points for an Ethical Evaluation of Healthcare Big Data