Patient Information and Electronic Health Records: A Legal Appraisal with Reference to European Health Data Space

Abstract

The field of medicine deals with personally identifiable health information regarding individuals. Traditionally, individual records have been stored manually. However, the increased application of information technology and digitalization caused the use of electronic health information to make the provision of healthcare. ‘Personal health information’ is unique because, it deserves legal protection. The disclosure and leakage of such information in an unauthorized way can lead to embarrassing and discriminatory circumstances. The digitalization of healthcare services has earned a reputation for enhancing quality and efficiency. The involvement of personal health information and the advent of Electronic Health Record (EHR) create a conflict on the base of privacy. The paper deals with three main objectives namely to analyse the purview of patient rights and medical information, to analyse the concept of EHR and the emergence of digital health privacy, and to study the legal aspects with reference to the regulations of the European Union and ‘Electronic Health Data Space’. Further, it extends to analyse the drawbacks in the Sri Lankan jurisdiction as well. The methodology adapted by the author in the research paper is qualitative in nature. The paper is involved with the analysis of literature pertaining to the subject of law and in addition to the desk review, the doctrinal methodology supported in the study of domestic and national legislations. In conclusion, the author has recognized the balancing of rights between the patients and clinicians in handling EHR. The author proposes a framework for Sri Lanka by setting EU Recommendation on European Health Record Exchange Format as an example to facilitate the digitalization of health data.