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2019 begins with changes in data protection law in Brazil: what changes in Healthcare

Categoria: Comentários

In the last days of 2018, modifications were made to data protection legislation in Brazil. Therefore, the year 2019 begins with two relevant changes in Brazilian digital health regulation.

The first came from Provisional Measure 869, dated 12/27/2018, which created the National Data Protection Agency and made changes to the Brazilian Data Protection Act (which was postponed until August 2020). This provisional measure extended the hypothesis of authorization for communication or shared use among controllers of sensitive personal health data, which now include situations in which communication is required for the adequate provision of supplementary health services, since the original law wording only allowed data sharing with the consent of the holder. This less restrictive rule should facilitate the operationalization of healthcare services for the benefit of the users themselves.

The second change is the legal forecast of digitization and use of electronic health record (EHR) systems, with the publication of Law 13787, of 12/27/2018. This law establishes the obligation to create a permanent committee to review medical records and document evaluation, in order to follow the digitization of documents. The digitization process will be subject to regulation, which should also deal with certification and electronic document management systems. In any case, the new law equates, for all legal purposes, the medical records scanned to the originals – which can be destroyed after their digitization. Once regulated, this law will complement the Brazilian Data Protection Act governing the use of digital medical records in the country.

This is just the beginning. In 2019 many other changes must come as new health technologies comes quickly and impacts healthcare around the world.

Happy New Year!

Daniel A. Dourado

12/31/2018

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