Personal data protection in Electronic Health Records and the mandatory use of HL7 standards in Mexico
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1 Personal data protection in Electronic Health Records and the mandatory use of HL7 standards in Mexico Dr. Maki Esther Ortiz Domínguez Viceminister of Integration and Development of the Public Health Sector Mexican Ministry of Health May 18 th 2011 Ginebra Suiza
2 Regulatory Background Mexican legal framework regulates in detail personal data manipulation: Mexican Constitution Federal Transparency and Information Access Law Federal Personal Data Protection Law General Health Law Patients Bill of Rights Personal data protection is a fundamental right and is mandatory under federal law Personal data is confidential and as such all required measures must be taken to guarantee privacy: legal, technical Any use of personal data requires strict consent
3 Mexican Official Regulation for Electronic Health Records: NOM024-SSA Consolidates all previously mentioned legal requirements regarding personal health data protection in one single regulatory framework Establishes rules and standards that allows communication and interoperability among all health systems All requirements are mandatory for Electronic Health Records (EHR) implementations Based on a number of international standards HL7 Healthcare informatics interoperability standards ISO Quality management systems and processes ISO Information security management systems Compliance helps mitigate health data exposure and vulnerabilities
4 EHR compliance standards in Mexico IT Infrastructure requirements HL7 V3, HL7 EHR IM ICD-10, ICD-9-MC, DICOM, LOINC CURP, INEGI, CLUES HL7 EHR FM ISO 10781, ISO NOM168, NOM040, NOM017 Interoperability standards HL7 V3, EHR-S FM ISO LFPDPPP Functional requirements Security requirements Mexican Official Regulation NOM-024-SSA3-2010
5 Why HL7 in Mexico? EHR Functional Model EHR Interop. Model Tropicalization NOM024 EHR Mx Regulation -Functional Req. -Reference Model. -Security Criteria Interface Technical Specs Reference Information Model HL7 Mexico Implementation Guides
6 Implications for the Health Industry Legal certainty for those involved Patients Guarantee of privacy Right to access personal data and ask for corrections s and Medical Staff Clear game rules for data users at all management levels Augmented ease of use for interoperability and security Systems developers and providers Checklist for infrastructure and functionalities requirements that will help them become compliant Providers will adapt and evolve, becoming more competitive at an international level, due to the use of industry-wide standards
7 National Electronic Health Record System development timeline EHR funtional model National Interoperability Model NOM024-SSA Sept 2010 EHR Infrastructure - Work in progress Public Sector Institutions IMSS ISSSTE SEDENA SEMAR PEMEX 1 Entidad Federativa 1 Plataforma Estatal de Interoperabilidad 2 3 States INCMNSZ Interoperability 4 1 INER Coord. de Inst. Nacionales Plataforma de Interoperabilidad Entidad Federativa 2 Plataforma Estatal de Interoperabilidad 2 Federal s In H Juárez H GEA Coord. de Hosp. Alta Esp. Plataforma de Interoperabilidad Hn Registro Médico Voluntario Plataforma de Interoperabilidad 3 Citizens Data -All levels -All functionalities -All users -All systems -All implementations -All hospitals
8 Security criteria in NOM024-SSA Based strongly on HL7 and ISO/IEC27000 Authentication and entity authorization Access control and secure data exchange Secure routing and information ratification / verification Patient confidentiality and privacy EHR information management and analysis Auditing traceability and data synchronization Distributed EHR access and consulting
9 Long-term goals and objectives Full systems interoperability and convergence in record time Mandatory compliance of NOM024 should help save years in interoperability integration, making it a much more streamlined process because rules have been stated very early Being able to work as a more unified health sector through data integration Capability of epidemiologic contingencies response in real-time
10 Thank you!!! Dr. Maki Esther Ortiz Domínguez Viceminister of Integration and Development of the Public Health Sector
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