All information related to an individual is considered strictly personal. This means that only the individuals themselves can make use of it. It follows that any information relating to an individual must be suitably conserved by the doctor since the information (or the sample) is not their own "property". This applies, not only to health or genetic data, but also to any biological sample obtained. The doctor must therefore ask the individual's specific permission before handling their information. This "permission to use information" is the "consent to personal data processing" stated in the so-called "Privacy Law" (Italian Legislative Decree no. 196 of 30.6.2003 and EU Regulation 2016/679).

The signature of consent – preceded by all necessary information – is a basic preliminary step to the performance of any genetic test. This is because it enables individuals/patients to make a reasonable assessment of matters concerning them, while it commits doctors to comply with current laws and not follow their own judgment.

Therefore, every item relating to an individual and every sample obtained, must be processed and preserved in compliance with current laws, as stated in the information sheet which is provided to each individual before performing the test. The test results are communicated in person and only to the individuals who requested the test.

For this reason, the results are never communicated by telephone and are never given to individuals who have not been expressly delegated by those directly involved. All these matters are also covered by the Italian Criminal Code (art. 622), by the Italian Criminal Procedure Code (art. 200) and by the Medical Code of conduct (Chapter III), as protection of professional confidentiality.

As stated above, once the samples are collected, they are converted into numerical codes. Therefore, the analysis procedure is completely anonymous. When the analysis has been concluded, the numerical codes are reconverted into personal data. This enables the doctor to draw up a written report. Unless otherwise ordered, the samples are immediately disposed of.

The report and all data obtained by the doctor as a result of the analyses are filed in electronic form (on a computer to which only the doctor has access) or as paper documents. However, there is no obligation to keep the data in the short, medium or long term. If the data are not kept, they will be destroyed in a manner that prevents their communication or dissemination. If they are kept, the doctor is committed to ensure their complete protection, whether in electronic form or as paper documents, in compliance with the law protecting the matter (Legislative Decree 30.6.2003 no. 196 and EU Regulation 2016/679). In these cases, the data must not be used without the consent of the data subject.

 

“Total protection of data in compliance with relevant laws must be ensured"”

© 2014 DNALex. All rights reserved. Unauthorised reproduction prohibited. | webdesign