Annex 2: Compliance With Data Protection Regulations - Sibelmed SIBELSOUND DUO Manual De Uso

SIBELSOUND

ANNEX 2: COMPLIANCE WITH DATA PROTECTION REGULATIONS

The aim of this section is to help users comply with applicable laws related to personal data processing, regulated by the LOPD
(Spanish Organic Law for Data Protection 15/1999, December 13th), and the new General Data Protection Regulation
(EU 2016/679 FROM THE EUROPEAN PARLIAMENT AND THE COUNCIL, April 27 2016), on the protection of natural persons
with regard to the processing of personal data and on the free movement of such data. The main points of such regulations are
briefly described, specifying what needs to be taken into account in order to meet their legal requirements.
IMPORTANT NOTICE
• According to the applicable laws, the user is the only person responsible for storing and processing their patients'
data according to the law.
• Observing the recommendations included herein does not guarantee, in any case, the user's full compliance with
data protection regulations.
Introduction to Applicable Regulations
The applicable data protection regulation in Spain is, mainly, the Organic Law 15/1999 from December 13th, whereby public or
private companies which hold automated files with private data, are required to implement a series of measures to guarantee the
protection of such data, and to ensure that the persons concerned can fully exercise their rights.
Apart from the aforementioned organic law, there is another applicable regulation, ROYAL DECREE 1720/2007 from December 11th,
which defines the implementation of technical and organizational measures necessary to guarantee the safety of automated files,
data processing centers, premises, equipment, systems, programs, and the people involved in the
automated processing of personal data.
Three security levels are established for personal data processing: basic, intermediate and high. Medical equipment stores data
related to patients' health; therefore, they are classified as high level. Companies and professionals which handle personal data
have, amongst others, the following obligations:
• Notification of the data files to the Spanish Data Protection Agency
• Adequacy of the data collection and processing to the LOPD (Spanish Organic Law on Data Protection)
• Drafting the Security Document
CONFIGURING THE SIBELSOUND DUO PROTECTION
The audiometer includes the option to protect the unit with an access code or PIN. This option, which can be configured by the user,
aims at protecting the equipment, and specifically the private data contained in it, against unauthorized access.
In order to comply with applicable regulations, the user must enable this option and configure their access code; it is the user's
responsibility to provide this code to authorized persons (refer to section 3.5 in this manual).
520-800-MUM · Rev 1.01
DUO
· User's manual
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