The General Data Protection Law and its implications on Health

Impact Assessments on Data processing in the clinical-hospital scope

Authors

  • Margareth Vetis Zaganelli Universidade Federal do Espírito Santo, Università Degli Studi Di Milano-Bicocca
  • Douglas Luis Binda Filho Universidade Federal do Espírito Santo

DOI:

https://doi.org/10.1344/rbd2021.54.36005

Abstract

The General Data Protection Law provides for the protection of personal data and has significant implications in numerous areas, including in healthcare. In the health field, due to the relevant amount of sensitive data containing information on health, it is required caution from the treatment agents, since its processing is more likely to cause a high risk to the rights of the data subjects. In this regard, the art. 35 of the General Data Protection Regulation, the European legislation on the protection of personal data, determines that the carrying out of Impact Assessments is mandatory, which is not evident in the Brazilian legislation. Through exploratory research, based on a bibliographic and documentary survey, the importance of these assessments by health institutions in the treatment of sensitive data is investigated, so as to attest not only compliance with legislation, but also with stipulations present in deontological codes that value secrecy, privacy and confidentiality in doctor-patient relationship. At first, general aspects of the Brazilian law and a comparative perspective regarding the European one are discussed. Secondly, it exposes the association between treatment of sensitive data and confidentiality in healthcare. It concludes that it is important to carry out the Impact Assessment on sensitive data, an occasion in which the European experience of risk-based methodology is considered.

Author Biographies

Margareth Vetis Zaganelli, Universidade Federal do Espírito Santo, Università Degli Studi Di Milano-Bicocca

Doutora em Direito pela Universidade Federal de Minas Gerais (UFMG). Professora titular da Universidade Federal do Espírito Santo (UFES). Professora colaboradora do Projeto Jean Monnet Module "Emerging 'moral' technologies and the ethical-legal challenges of new subjectivities" do Erasmus+ European Commission. Professora Visitante Mobilidade Docente Erasmus+ na Università Degli Studi Di Milano-Bicocca - UNIMIB.

Douglas Luis Binda Filho, Universidade Federal do Espírito Santo

Graduando em Direito pela Universidade Federal do Espírito Santo (UFES). Membro dos grupos de pesquisa “Grupo de Pesquisas em Bioética” (BIOETHIK) e “Grupo de Estudos e de Pesquisas em Migrações, Fronteiras e Direitos Humanos”(MIGRARE), ambos em parceria com a Università degli Studi di Milano-Bicocca (UNIMIB, Itália).

Published

2022-02-22

How to Cite

Vetis Zaganelli, M., & Binda Filho, D. L. . (2022). The General Data Protection Law and its implications on Health: Impact Assessments on Data processing in the clinical-hospital scope. Revista De Bioética Y Derecho, (54), 215–232. https://doi.org/10.1344/rbd2021.54.36005

Issue

Section

General section