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Article title Adaptation of Ukrainian Legislation in the Field of Electronic Health Data to the Law of The European Union
Authors
OLHA ROSSYLNA
Candidate of Law, Senior Researcher of the Department of Problems of Modernization of Economic Law and Legislation of the State Institution “V. K. Mamutov Institute of Economic and Legal Research of the National Academy of Sciences of Ukraine” (Kyiv, Ukraine) Researcher ID LLM-7344-2024 ORCID ID: https://orcid.org/0000-0002-1648-6063 rossylna@gmail.com
Magazine name Legal journal «Law of Ukraine» (Ukrainian version)
Magazine number 9 / 2024
Pages 64 - 73
Annotation

The relevance of the issue of electronic health data protection has increased significantly in the context of the development of digital technologies and Ukraine’s integration into the European Union. Despite some legislative initiatives, the healthcare sector is still characterised by data fragmentation, lack of a unified strategy for the development of information systems and insufficient protection of personal data. Such challenges require the adaptation of Ukrainian legislation to European standards, in particular to the provisions of the General Data Protection Regulation (GDPR), as well as the introduction of effective mechanisms for the secondary use of electronic health data.

The purpose of the article is to analyse the legislative approaches to the protection of electronic health data in Ukraine and the EU, to assess the current state of adaptation of Ukrainian legislation to European requirements and to identify the key areas for its improvement with due regard to international standards.

The study uses comparative law methods to analyse European and Ukrainian legislation in the field of electronic health data. Formal legal and system-structural methods were also used to assess legislative initiatives and their compliance with international standards.

The analysis shows that electronic health data, including disaggregated and non-personal data, is an important tool for healthcare system development. However, in Ukraine, legislation in this area remains fragmented and needs to be improved. The main challenges include the lack of a unified strategy for the development of the eHealth system, insufficient protection of personal data, and a weak legal framework for the secondary use of electronic data. It is proposed to introduce mechanisms to improve the management of electronic health data, adapt regulations to the GDPR and create a single digital platform for the efficient processing of such data.

Thus, Ukraine needs to thoroughly adapt its legislation to European requirements in the field of electronic health data protection. This will not only ensure the protection of personal data, but also create opportunities for the effective use of non-personal data in research and medical practice. It is also important to develop the infrastructure of digital healthcare services, which will facilitate Ukraine’s integration into the European healthcare area.

Keywords electronic health data; personal data; non-personal data; disaggregated data; data protection; EU law; secondary use of data; healthcare
References

Bibliography

Journal articles

1. Musiienko A, Musiienko V, ‘Aktualni aspekty normatyvno-pravovykh mekhanizmiv zakhystu personalnykh danykh v elektronnykh medychnykh reiestrakh v Ukraini’ [2022] 1 (11) DICTUM FACTUM 17–22.

2. Rossylna O, ‘Ievropeiskyi vymir personalizovanoi medytsyny ta velykykh danykh’ [2023] 2 Naukovyi visnyk DDUVS 51–56. DOI: 10.31733/2078-3566-2023-6-51-56.

3. Tokarieva K, ‘Problema zakhystu personalnykh danykh u sferi okhorony zdorovia v umovakh informatyzatsii’ [2022] 11 Yurydychnyi naukovyi elektronnyi zhurnal 496–499. DOI https://doi.org/10.32782/2524-0374/2022-11/120.

 

Websites

4. The European Health Data Space (EHDS) <https://www.european-health-data-space.com/> (accessed 10.10.2024).

5. The protection of personal data in health information systems – principles and processes for public health (World Health Organization, 2021) <https://iris.who. int/bitstream/handle/10665/341374/WHO-EURO-2021-1994-41749-57154-eng. pdf?sequence=1&isAllowed=y> (accessed 10.10.2024).

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