Health information, the fair information principles and ethics

Area of Science:

• Health Informatics
• Information Law
• Bioethics

Background:

• The traditional property-model for patient records is insufficient for advanced electronic health records (EHRs).
• EHRs function as epistemic patient analogues in information space, necessitating a paradigm shift.
• Existing legal and regulatory frameworks may not adequately address the complexities of modern EHRs.

Purpose of the Study:

• To propose a new paradigm for understanding and managing electronic patient records.
• To examine the ethical implications arising from this new paradigm.
• To explore legal and regulatory mechanisms for implementing the proposed changes, focusing on privacy, security, and access.

Main Methods:

• Conceptual analysis of the nature of advanced electronic patient records.
• Ethical framework development for patient data management.
• Review of existing legal and regulatory principles, including fair information principles.
• Exploration of potential legal and regulatory adaptations.

Main Results:

• The property-model is inadequate for advanced EHRs, which act as epistemic analogues.
• A new paradigm is necessary to govern EHRs effectively.
• Ethical considerations regarding privacy, security, and access are paramount.
• Fair information principles offer a foundation for new legal and regulatory approaches.

Conclusions:

• A paradigm shift from property-model to an epistemic analogue model is essential for advanced EHRs.
• New ethical and legal frameworks are required to manage EHRs, ensuring privacy, security, and access.
• Adapting legal and regulatory mechanisms based on fair information principles is crucial for responsible EHR governance.