Data protection issues in cross-border interoperability of Electronic Health Record systems within the European Union

Abstract

This study investigates the data protection concerns arising in the context of the cross-border interoperability of Electronic Health Record (EHR) systems in the European Union. The article first introduces the policies on digital health and examines the related interoperability issues. Second, the work analyses the latest Recommendation of the European Commission on this topic. Then, the study discusses the rules and the obligations settled by the General Data Protection Regulation to be taken into account when developing interoperable EHRs. According to the data protection by design and by default provision, EHR systems should be designed ex ante to guarantee data protection rules.

Systematic Assessment of the Interoperability Requirements and Challenges of Secure Blockchain-Based Electronic Health Records

“…e information sharing among different systems and organizations requires legal frameworks to achieve information integrity [39,40].…”

“…(ii) Agreement on the technical data models to manage the data in database management systems (i) Cooperation between the informaticians, EHR IT vendors, industry process engineers, and clinicians (ii) Ability to understand and utilization of transmitted message (iii) Building a controlled vocabulary [40] (i) Exchange the clinical database information (i) Adoption of previous standards for the secure transmission of data and to report the clinical data (i) Advanced adoption for government and financial incentives, and partnership between public-private entities (ii) Identification of patients and healthcare providers [39] (i) e transmitting systems should understand the data without any ambiguity (i) Information transmission between several systems, and the receiving system process information to perform new actions (i) Ensuring different legal frameworks to operate the organizations [27] HL7 FHIR-based emerging standard Robust performance on small devices [28] HITECH Transformation of the healthcare system Interoperability, HER certification, and MIPS [29] PHR Used HL7 for fast data sharing and tethering PHR and EHIR interchangeability using APIs [30] Open EHR Designed EHR through open-source elements Validation of EHR standards through clinical implementations [31] DICOM Secure transfer of medical images and health history APIs for different health system integrations [32] SNOMED CT Present clinical methods in EHRs Accuracy, interoperability, and consistency [33] CEN/ISO EN13606 Semantic standards for EHR information sharing Privacy and security standards for interface access [34] HIPAA Privacy standards for patient's data security Confident interoperable system for EHR (ii) Dubovitskaya et al [45] explained in their study that if the system is not deployed correctly, then it is a high risk of system failure. A healthcare provider cannot update the permission and grant; therefore, when an unconscious patient reaches a medical center, the healthcare provider cannot access the patient's EHR information.…”

The dawn of digital public health in Europe: Implications for public health policy and practice

“…49 As such, interoperability must be in compliance with the current legal system, while digital health systems should be designed prospectively to guarantee adherence to data protection legislation. 50 That being said, with the GDPR, the EU has set a precedent to legislate in the field of health data, which could enable them to create more targeted legislation related to data protection and interoperability. The recommendation of the European Commission to adopt a standard format in their electronic health records is a first step in this process.…”

“…The recommendation of the European Commission to adopt a standard format in their electronic health records is a first step in this process. 50 …”

Data Protection by Design in the E-Health Care Sector

“…In detail, this Recommendation establishes wide-ranging technical specifications for secure access to EHRs and their interoperability, and promotes best practices for ensuring data protection and integrity of personal health data. Various technical specifications are indicated as a baseline for future development 1217 . Following the EC words, Member States should ensure high standards in EHR systems for protecting personal health data, and should also secure EHR networks so as to avoid data breaches and minimise security risks 1218 .…”