Patients’ genetic data protection in Polish law and EU law – selected issues

  • Kinga Michałowska
  • Karol Magoń Cracow University of Economics
Keywords: Genetic research, genetic data, protection of genetic data, patient's rights, medical documentation.


The article entitled “Patients’ genetic data protection in Polish law and EU law – selected issues” presents issues related to the protection of patients' rights and focuses on the legal basis for genetic testing and genetic data protection. Based on a comparison of regulations of international law and regulations on genetic tests introduced in foreign legal systems, the text analyzes the assumptions for the draft of the Polish act on genetic tests performed for health purposes. It presents the patient's consent to testing, the scope of information provided to the patient, the right to disclose research results to related persons and the protection of genetic data. In reference to the regulations set out in other acts, it was noted that they do not guarantee the protection of information obtained as a result of research. Due to the particular nature of genetic data, they require increased protection, which can be guaranteed through implementation of the Act on Genetic Research. In the final part, authors presented the most important achievements of the judicature of European Court of Human Rights in the field of genetic data protection.


Download data is not yet available.

Author Biography

Karol Magoń, Cracow University of Economics
Assistant Professor in Civil and Business Law Department at Cracow University of Economics


Barańska M., Skrętkowicz J. (2007) Perspektywy terapii genowej [Prospects for gene therapy], Wiadomości Lekarskie, No. 7–8.

Bartoszewicz M. (2014) Konstytucja Rzeczypospolitej Polskiej. Komentarz [Constitution of the Republic of Poland. Comment], In: M. Haczkowska (ed.), R. Balicki, M. Bartoszewicz, K. Complak, A. Ławniczak, M, Masternak-Kubiak, ed. 1. (Warsaw).

Gendiagnostikgesetz vom 31/06 2009, BGBl. I S. 2529, 3672.

Human Genetics Commission (2002) Inside Information, Balancing the Interests in Use if Personal Genetic Data (London).

Human Tissue Act 2004, royal assignment November 15, 2004.

IBC, Report on Human Genetic Data, available at: (April 17, 2018)

Jackowski M. (2002) Ochrona danych medycznych [Protection of medical data] (Warsaw: Dom Wydaw. ABC).

Jasudowicz T., Czepek J. & Kapelańska-Pręgowska J. (2014) Międzynarodowe standardy bioetyczne. Dokumenty i orzecznictwo [International bioethical standards. Documents and case law] (Warsaw: ABC).

Kapelańska-Pręgowska J. (2011) Prawne i bioetyczne aspekty testów genetycznych [Legal and bioethical aspects of genetic tests] (Warsaw: Wolters Kluwer Polska).

Krekora-Zając D. (2014) Prawo do materiału genetycznego człowieka [The right to human genetic material] (Warsaw: LexisNexis).

Ley 14/2007 de Investigacion biomedical, Publicado en BOE núm. 159, 4.07.2007, texto unificado 2.12.2011.

Ley Orgánica 15/1999, de 13 de diciembre, de Protección de Datos de Carácter Personal, BOE no. 298, 14/12 1999.

Mednis A. (1999) Ochrona prawna danych osobowych a zagrożenia prywatności – rozwiązania polskie [Legal protection of personal data and threats to privacy - Polish solutions], In: Wyrzykowski, M. Ochrona danych osobowych [Personal data protection] (Warsaw: Inst. Spraw Publicznych)

Michałowska K. (2014) Charakter prawny i znaczenie zgody pacjenta na zabieg medyczny [Legal character and meaning of patient's consent for a medical procedure], (Warsaw: Difin).

Michałowska K. (2015) Wpływ danych medycznych i danych genetycznych na ocenę ryzyka ubezpieczeniowego w ubezpieczeniach na życie [The impact of medical data and genetic data on life insurance risk assessment], In: Gnela, B. & Szaraniec, M. (eds.) Informacja w prawie ubezpieczeń gospodarczych (Warsaw: Wolters Kluwer Polska).

Muszala A. (1998) Wybrane zagadnienia etyczne genetyki medycznej [Selected ethical issues of medical genetics] (Cracow: Wydawnictwo Naukowe Papieskiej Akademii Teologicznej).

Ordinance of the Minister of Health of 22 February 2017, JL of Ministry of Health 2017, item 8.

Podolska K. (2008) Podstawy terapii genowej (terapia genowa) [Basics of gene therapy (gene therapy)], available at: (April 17, 2018)

Recommendation R (97) 5 of the Committee of Ministers of the Council of Europe regarding the protection of medical patients (adopted by the Committee of Ministers on February 13, 1997 during a 584 meeting of the Ministers Delegates).

Regulation of European Parliament and Council (EU) 2016/679 of 27 April 2016 on the protection of individuals with regard to the processing of personal data and on the free movement such data and the repeal of Directive 95/46/EC.

Regulation of the Minister of Health of 9 November 2015 on the types, scope and patterns of medical documentation and the manner of its processing (JL of 2015, item 2069).

The Act of 27 July 2001 about laboratory diagnostics, i.e. JL of 2016, item 2245.

The Act of 29 August 1997 on the protection of personal data, i.e. JL of 2016, item 922 with changes.

The Charter of Fundamental Rights of the European Union, OJ.UE.C..2007.303.1, with amendments.

Working document on the processing of personal data concerning health in electronic health records (EHR), WP 131, Brussels, 15 February 2007.

Zákon o specifických zdravotních službách, from 6 November 2011, Zákon č. 373/2011 Sb.

How to Cite
Michałowska K., & Magoń K. (2018). Patients’ genetic data protection in Polish law and EU law – selected issues. Medicine, Law & Society, 11(1), 29-46.