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Chile
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Law Name
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Protección de Datos de Carácter Personal, Ley 19628 (2012)
A New law was passed by the Senate in May of 2018;
https://www.camara.cl/pley/pley_detalle.aspx?prmID=11661&prmBoletin=11144-07
https://www.fayerwayer.com/2018/05/senado-aprobo-ley-proteccion-datos- personales-chile/
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Link to the Law
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https://www.leychile.cl/Navegar?idNorma=141599
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Data Transfer
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The agency responsible for the database of personal information can establish an automated procedure for transmission of data as long as the rights of the data subject are kept and the data transmitted is relevant to the organism it is being transferred to.
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Data Sharing
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The data subject must give written consent in order for data to be processed. Health related data can only be used, processed and shared with the consent of the patient. Additionally, pharmacies may use the health data for statistical purposes, but the identity of the individuals cannot be entered into any system so as to maintain the anonymity and privacy of data subjects. Data can only be processed with consent or through legal provisions.
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Data Retention
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Personal data should be deleted or cancelled when the data is no longer of legal value or when it has expired. The data should be modified when it is erroneous, inexact or incomplete. Additionally, the data subject has the right to revoke consent, without a retroactive effect. This consent should also be written.
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Governance
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There is an agency that is in charge of the database. This data collector must inform the data subject as to why the data is being collected and whom else the data will be shared with. Medical records are private and confidential. There are no specific regulations that must be followed in terms of security, it is left up to the agency in charge of the information and it is assumed that the agency will assume responsibility for damages.
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Enforcement
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There is no individual data protection authority, if there is a breach of privacy then the court handles it.
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Breach Notification
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If there is a violation of privacy, the infringer needs to pay for economic and moral damage and the data must be deleted, modified or blocked. The exact judgment for the violation is determined case by case by a civil judge.
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Heath Privacy Law
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https://www.leychile.cl/Navegar?idNorma=5595&idParte
Código Sanitario
Decreto con Fuerza de Ley N. 725 (1967)
To request authorization for provisional use in order to investigate, the requestor should, before the approval and processing of data, follow the protocol of investigation and the format for informed consent. The Institute of Public Health can authorize provisionally the distribution, sale or use of pharmaceutical products without previous registry for clinical essays or other types of scientific investigations for urgent medical uses that could affect individuals or the collective population. Pharmaceutical products and other medical elements that need the special authorization for provisional use for investigation can only investigate and be used for the specific reason they were authorized for use; the data cannot be held, distributed or transferred to anyone nor can the data be used for a distinct reason than the one it was registered for. The Institute of Public Health should have a public registry of all of the different scientific investigations that are being held on humans with pharmaceutical products or other medical products. All centers that have investigations of pharmaceutical products or other medical elements on humans must be accredited by the Institute of Public Health and conform with the standards established by the law. The Institute of Public Health will have free access to the information related to scientific investigation. There are different regulations associated with investigations on cadavers predetermined by the law. The “Servicio Nacional de Salud” will establish indispensable labs that will conduct analysis and investigations that are deemed appropriate to protect and maintain public health.
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Electronic Health Records Law
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http://www.conicyt.cl/fonis/files/2013/03/Decreto-N%C2%BA-41-Reglamento-ley- 20.584-sobre-Fichas-Cl%C3%ADnicas.pdf
Decree 41 (2012)
Electronic Health records are called “Fichas Clínicas”. The law regulates the content, administration, protection and elimination of electronic health records to maintain confidentiality. These records can be on paper or electronic and they must remain confidential and protected.
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| Notes |
A comprehensive approach to all laws and regulations for protection on personal data in Chile can be found in the link below:
https://www.derechosdigitales.org/wp-content/uploads/PVB-datos-int.pdf
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