Genetic Testing

The Greek legislation provides one of the most open regulatory frameworks for genetic testing in Europe.

1. Genetic tests for clinical purposes are governed by the Oviedo Convention and the GDPR (regarding processing of genetic data). Laboratories need to ensure compliance with certain requirements, particularly the informed consent procedure and the data protection guarantees with the supervision of a Data Protection Officer. A clear strategy on incidental findings policy should also be in place.

2. Prenatal diagnoses for detecting genetic disorders in embryos and fetuses, as well as PGD offered in IVF treatment, are also regulated by special legislation. Early detection of serious genetic disorders justifies termination of pregnancy up to the 24th week. Selection of embryos in vitro for reproductive purposes is also legally allowed in cases where genetic testing with PGD reveal chromosomal or gene mutations leading to serious pathologies. Informed consent of future parents is essential precondition that involves liability issues of the attending gynecologist and biologists performing all necessary technical procedures. Data protection is also an important issue, as sensitive information may affect private and family life of the persons concerned.

Our services: Having not only experience in addressing legal issues occurred in genetic testing but also an active role in the relevant law-making and important contribution to academic initiatives, our team provides tailor-made services including:

- Preparation of legally sound information documents and consent forms

- Consultation on regulatory issues, particularly regarding professional liability

- GDPR compliance and DPO services, including impact assessment

- Representation before the administrative authorities and the courts


DISTANCE LEARNING PROGRAM

In collaboration with the International Hellenic University, BioMedLex has developed an innovative distance learning program in English.

The program consists of 24 courses in podcast format, covering a wide range of legal and ethical issues in modern Medicine and Biomedicine, from patient/doctor relationships, clinical trials and assisted reproduction, to issues of artificial intelligence in medical applications and genetic interventions in the human organism. Additional educational material is provided for each course and, upon completion of the program, the possibility of multiple-choice tests for the award of a certificate from the University.

More information and application forms can be found here.

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