Legal and ethical considerations

  • e-Health systems arise new legal and ethical considerations regarding the use and protection of personal data. An important issue when implementing a new electronic health record system (EHR) for patient data, is the system's compliance with the law on the rights of patients.
  • Although each country has its own system of law, all Member States (MS) should comply with the guidelines, standards and legislative framework set by European directives. Therefore MS have to study the adequacy of the national legislation to the European directives and present amendments accordingly which might promote the development of EHR systems at national level.
  • These studies must be also in compliance with any e-Registry based on an interoperable, extensible and functional model of a database which will enable entering certified medical data from available sources.


For epidemiological surveillance

Current state of the art for standards and legal issues in EU for Electronic Health Records

The main objectives of this deliverable are focused on a review of the legislative framework on issues relating to e-health in general and in particular to registry and EHR systems at European level.

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