Standardization and Interoperability
Standardization and interoperability
What is a standard? a standard as a document, established by consensus and approved by a recognized body, which provides, for common and repeated use, rules, guidelines or characteristics for activities or their results, aimed at the achievement of the optimum degree of order in a given context
Value and role of standards They play an important role in sustainable development and trade facilitation by promoting safety, quality and technical compatibility.  Standardization contributes to the basic infrastructure underpinning society, including health and the environment, while promoting sustainability and good regulatory practice.
What is interoperability? IEEE: Two or more parts of a system exchanging information, then using it. It is the ability to communicate and exchange data accurately, effectively, securely and consistently with different IT systems, software applications and networks in various settings, and to exchange data so that the clinical or operational purpose and meaning of the data are preserved and unaltered.
Interoperability standards for health information systems For systems to share their data, they can be divided into two broad categories: syntactic standards that indicate what a piece of information is, and; semantic standards that indicate what a piece of information means.
WHO  eHealth Standardization Coordination Group (eHSCG)   A platform to promote stronger coordination among the key players in all technical areas of eHealth standardization. It works towards the creation of cooperation mechanisms to: identify areas where further standardization is required and identify responsibilities for such activities;  provide guidance for implementation and case studies;  consider the requirements for appropriate development paths for health profiles of existing standards from different sources in order to provide functional sets for key health applications;  support activities to increase user awareness of existing standards and case studies.
Legal and ethical aspects of e-health
Paper-based health information vs. e-health
What is different about e-health? Personal data has become more available and accessible to more healthcare professionals; Machine-readable data can be more easily manipulated, new data can be generated based on existing data and in multiple format; Globalization of access to data and information as geographic boundaries are coming down allowing for more trans-border data flow;
What is different about e-health? Technological convergence has made it possible to bring information and telecommunication technologies together, more systems are interoperable with more ability to read different types of data across systems. Multiple input, multiple access, multiple locations even outside the institution or the country;
What is different about e-health? Multimedia presentation and storage of data as voice, images, text, video or a combination of these have made data more readable and understandable by both specialists and the public; International standards applied across borders, languages, systems, cultures, etc.
Areas of legal and regulatory concern in e-health Access.  The conditions (technical and legal) that control access to health data; Tracking . The possibility and need to keep track of who has accessed which data elements, when, what for; Interoperability . The assurance to exchange data between similar and /or heterogeneous systems without corruption or deletion of any parts of it;
Areas of legal and regulatory concern in e-health Common data set.  The assurance that an agreed upon set of data elements is used to exchange data between systems and institutions; Information integrity . The assurance that electronic transmission, storage and retrieval system is adequate to protect against data corruption, alteration and deletion, intentionally or unintentionally; Privacy . The assurance that sensitive and private data is fully protected and only used upon proper authorization;
Areas of legal and regulatory concern in e-health Confidentiality.  The need to safeguard the confidential nature of health data and ensure that its communication between patients and providers; Security . The assurance that the electronic system provides protection against unauthorized intruders; Storage and retrieval . The assurance that the system stores data in a form capable of timely retrieval without impairing its integrity;
Areas of legal and regulatory concern in e-health Sender verification and encryption.  The ability of the receiver of data to verify the authenticity of the sender; Data replication . The ability to reuse and replicate data between systems without losing any of its content or quality; Dispute resolution . In case of a legal these are alternatives to resolve disputes from the transmission, corruption, deletion, improper disclosure, alteration, and retention of data;
Areas of legal and regulatory concern in e-health Scalability.  The ability to expand the system into a greater scope of capability without its total replacement and ability to add features without full reconstruction; Sanction and penalty enforcement . The authority of an institution or organization to enforce penalties or sanctions imposed as a result of a dispute stemming from improper data handling, protection, security infringement,
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Standardization and Interoperability

  • 3. What is a standard? a standard as a document, established by consensus and approved by a recognized body, which provides, for common and repeated use, rules, guidelines or characteristics for activities or their results, aimed at the achievement of the optimum degree of order in a given context
  • 4. Value and role of standards They play an important role in sustainable development and trade facilitation by promoting safety, quality and technical compatibility. Standardization contributes to the basic infrastructure underpinning society, including health and the environment, while promoting sustainability and good regulatory practice.
  • 5. What is interoperability? IEEE: Two or more parts of a system exchanging information, then using it. It is the ability to communicate and exchange data accurately, effectively, securely and consistently with different IT systems, software applications and networks in various settings, and to exchange data so that the clinical or operational purpose and meaning of the data are preserved and unaltered.
  • 6. Interoperability standards for health information systems For systems to share their data, they can be divided into two broad categories: syntactic standards that indicate what a piece of information is, and; semantic standards that indicate what a piece of information means.
  • 7. WHO eHealth Standardization Coordination Group (eHSCG) A platform to promote stronger coordination among the key players in all technical areas of eHealth standardization. It works towards the creation of cooperation mechanisms to: identify areas where further standardization is required and identify responsibilities for such activities; provide guidance for implementation and case studies; consider the requirements for appropriate development paths for health profiles of existing standards from different sources in order to provide functional sets for key health applications; support activities to increase user awareness of existing standards and case studies.
  • 8. Legal and ethical aspects of e-health
  • 10. What is different about e-health? Personal data has become more available and accessible to more healthcare professionals; Machine-readable data can be more easily manipulated, new data can be generated based on existing data and in multiple format; Globalization of access to data and information as geographic boundaries are coming down allowing for more trans-border data flow;
  • 11. What is different about e-health? Technological convergence has made it possible to bring information and telecommunication technologies together, more systems are interoperable with more ability to read different types of data across systems. Multiple input, multiple access, multiple locations even outside the institution or the country;
  • 12. What is different about e-health? Multimedia presentation and storage of data as voice, images, text, video or a combination of these have made data more readable and understandable by both specialists and the public; International standards applied across borders, languages, systems, cultures, etc.
  • 13. Areas of legal and regulatory concern in e-health Access. The conditions (technical and legal) that control access to health data; Tracking . The possibility and need to keep track of who has accessed which data elements, when, what for; Interoperability . The assurance to exchange data between similar and /or heterogeneous systems without corruption or deletion of any parts of it;
  • 14. Areas of legal and regulatory concern in e-health Common data set. The assurance that an agreed upon set of data elements is used to exchange data between systems and institutions; Information integrity . The assurance that electronic transmission, storage and retrieval system is adequate to protect against data corruption, alteration and deletion, intentionally or unintentionally; Privacy . The assurance that sensitive and private data is fully protected and only used upon proper authorization;
  • 15. Areas of legal and regulatory concern in e-health Confidentiality. The need to safeguard the confidential nature of health data and ensure that its communication between patients and providers; Security . The assurance that the electronic system provides protection against unauthorized intruders; Storage and retrieval . The assurance that the system stores data in a form capable of timely retrieval without impairing its integrity;
  • 16. Areas of legal and regulatory concern in e-health Sender verification and encryption. The ability of the receiver of data to verify the authenticity of the sender; Data replication . The ability to reuse and replicate data between systems without losing any of its content or quality; Dispute resolution . In case of a legal these are alternatives to resolve disputes from the transmission, corruption, deletion, improper disclosure, alteration, and retention of data;
  • 17. Areas of legal and regulatory concern in e-health Scalability. The ability to expand the system into a greater scope of capability without its total replacement and ability to add features without full reconstruction; Sanction and penalty enforcement . The authority of an institution or organization to enforce penalties or sanctions imposed as a result of a dispute stemming from improper data handling, protection, security infringement,