Secondary Use of Electronic Healthcare Data: Technological, Ethical and Legal Considerations
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1 Engagement in RDA from Southern-Eastern Europe, Mediterranean and Caucasus region Workshop Athens, Greece, June 25, 2015 Secondary Use of Electronic Healthcare Data: Technological, Ethical and Legal Considerations George Potamias, Kostas Marias, Manolis Tsiknakis Computational BioMedicine Laboratory
2 Electronic Healthcare Data (EHR): adoption trends USA / 2013, 2014 reports ~78% office-based physicians utilize some type of EHR, with about half of all physicians (48%) to have an EHR system with advanced functionalities è double the percentage for 2009 ~59% hospitals had adopted an EHR system with advanced functionalities è quadruple the percentage for 2010! 2/15
3 2ary Use of EHR data: What s all about? ethical/legal considerations Non-direct care use of personal health information (PHI) including but not limited to analysis, research, quality/ safety measurement, public health, payment, provider certification or accreditation, and marketing and other business including strictly commercial activities Safran C., et al. Toward a National Framework for the Secondary Use of Health Data: An American Medical Informatics Association White Paper. J Am Med Inform Assoc. 14(1):1-9, 2017 q anonymized data alteration of all personal/individual (health) information impossible to link individuals with their data q reversibly anonymized data anonymization in a way that re-identification may be accomplished through access to a protected key that makes it possible to link individuals with their data only through a trusted intermediary pseudo-anonymization ó informed-consent for his/her (patient) own benefit 3/15
4 EHR: Data Continuity & Sharing Europe USA Paperless environment enabling data continuity to deliver and manage patient care Stage 7 for all hospital services and supporting data sharing with all care delivery 0.2% 1.2% stakeholders Stage 6 Optimised diagnostic and care delivery efficiency by standard treatment protocols; Further reduction / elimination of medical errors & improved patient safety; 1.4% 5.2% Stage 5 Elimination of film, sharing images 15.7% 8.4% Stage 4 Improved care delivery efficiency and reduced medical errors 3.9% 13.2% Stage 3 Optimised collection of nursing and clinical information; Standardized care delivery & first improvements of care quality 5.8% 44.9% Standardized Data & Access Models Stage 2 Optimised access to diagnostic results, sharing of patient-information 20.4% 12.4% Stage 1 Improved key dept. operations and access to diagnostic information 16.5% 5.7% Stage 0 Low clinical value; mainly patient administration and hospital management 36.2% 9.0% semantic interoperability (homogenization!) 4/15
5 The vision!!! towards Personalized/Genomic medicine 5/15
6 EHR in front 6/15
7 Utilizing EHR data for Stratified cohorts emerge.mc.vanderbilt.edu 7/15
8 Exploiting EHR data: set-up & technological components Phenotypic Data/Info OncoIS Clinical Information External Phenotype Info/Data Sources Demographics History Physiological LIMS HistoPathIS Laboratory Information Indicators HistoPathology Information Tumor Sample/Tissue Hematological Biochemical Information Modeling PACS images Data Extraction Gateways Clinical Data Models Information Modeling Data Analysis DSS Genomic Data Models GeneIS External Genetic/Genotype Information Sources Genomic Information DNA-sequences Variations/SNPs/CNVs Gene-Expression profiles Genomic/Genetic Info/Data 8/15
9 From EHR data to biomarkers Prognochip a quick & dirty solution QUERY get the gene-expression/ge profiles of BRCA patients with specific <histopathology> profile a (zip) file with relevant GE profiles / anonymized RESEARCH Data Mining => GE signature(s) 9/15
10 Research Clinical Trial Extraction & Verification Direct Extraction Data Extraction from EHRs a more elaborate approach Clinical Trial Research Ø Patient recruitment Ø Stratification Single Source Ø Personalization Clinical Trial!? Representation models 10/15
11 The p-medicine approach HDOT ontology semantic interoperability services 11/15
12 Privacy preserving: (pseudo-)anonymization services T R A N S F O R M A T I O N anonymized / pseudo-anonymized data collections MAPPING Ø Remove all patient names PRIVACY Ø Calculate a pseudo-id PROFILES Ø Process text and remove identifying info perturbation suppression aggregation 12/15
13 p-medicine & Usability testing within the ECRIN infrastructure => evaluation of legal and ethical framework, data security, anonymisation, pseudonymisation, system validation 13/15
14 RDA aligning with relevant EU projects to exploit EHR data sharing & privacy-preserving technology Within the research world, medical records pose the biggest policy challenge ² The European Commission recently proposed a new Data Protection Framework to protect privacy while enabling research? But, researchers say risk making vital research unworkable!! 14/15
15 Engagement in RDA from Southern-Eastern Europe, Mediterranean and Caucasus region Workshop Athens, Greece, June 25, 2015 thank you 15/15
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