Development of a Regional Shared Electronic Health Record Pablo Serrano Balazote Planning Director. Hospital 12 Octubre. Madrid May 2017 HL7 International Conference & Working Group Meeting. Madrid

Madrid Health Community About SERMAS Madrid Health Community Third largest city and metropolitan area in Europe, with 6.3 Million citizens Spain has a public health system, population based, decentralized in regions. They are responsible of health care provision. SERMAS is the Madrid regional health service, dependent of the Government. Madrid Health Service (SERMAS) Part of the Regional Healthcare Minister

35 hospitals, 30 outpatient centers Mental health network About SERMAS Primary Care 265 centers & 163 offices Specialized care 35 hospitals, 30 outpatient centers Mental health network Emergency services Lab, transfusion and radiology central units +6.300.000 citizens +75.000 health professionals +50.000 IT users Public funding, planning and provision Population-based Direct and indirect management The Madrid Regional health service cover the care of more than 6 million people, with 75000 health care professionals. The Regional Government finances and plans and the SERMAS provides health care. The organization have a population base, with community Primary Care, gatekeeper of the system, and a reference Hospital. There are a common emergency service and central support units. Most of organizations are managed directly and 5 hospital are managed by private concessions. 2 Specialised data center 1 Contingency data center +202 applications 1 Local data center per hospital (20 large CPD’s) 670 Connected centers 634 Servers 883.49 TBytes storage capacity +50.000 PCs & 24.000 printers +50 IT services and products suppliers

Currently, IT is supporting: 100 % primary care patients with EHR About SERMAS Information Technology is a fundamental part of SERMAS, supporting all healthcare Currently, IT is supporting: 100 % primary care patients with EHR 65 % hospital patients with EHR 100 % electronic process in emergency services, and laboratory, radiology and transfusions central units Patients empowerment +10 million appointments / PHR access Currently, IT is supporting: all primary care patients with EHR ˈpeɪʃənt hɛlθ Two thirds of hospital with EHR tuː θɜːd all electronic records in emergency services, laboratory, radiology and transfusions central units trænsˈfjuːʒən and patient empowerment ɪmˈpaʊəmənt ICT Main goals Meet the needs of citizens and professionals A more efficient model Empower clinical professionals Innovation Clinical collaboration

Main healthcare information systems National document repository HCD SNS Regional view layer, professional HORUS and personal Specialized care EHR HIS SELENE HCIS IMDH F They are the currently main healthcare information systems: health records in all care levels, order manager and repositories. We will briefly describe them and their integrations. Mandate. Delay. Appointment e prescription EHR Primary Care AP Madrid Population information Cibeles

Main healthcare information systems Population information unique regional patient identification demographic repository Primary care unique EHR multidisciplinary longitudinal and problem oriented ISO 13940 accordant high degree of structured data start 25 years, normalized and unified 10 years We have a population information system Cibeles, who provide unique regional patient identification and demographics data for all the systems. In Primary care there are a unique EHR “AP Madrid”, multidisciplinary, longitudinal and problem oriented, ISO 13940 conformant, with a high degree of structured data. It began more than 25 years ago and was normalized and unified ten years ago. The electronic prescription is integrated with pharmacy offices and is currently fully implemented and is interoperable at the national level. In order to communicate levels of care, two systems was deployed to appointment and to communicate referrals and diagnostic requests from family physicians to hospitals. Electronic prescription integrated with pharmacy offices currently fully implemented interoperable at the national level Mandate. Appointment to communicate levels of care, referrals and diagnostic requests from family physicians to hospitals

Main healthcare information systems Specialized care 1997 first hospital EHR 2003-2013 13 hospitals started with EHR 2009- convert conventional into digital 10 implemented EHR currently remainder planned in next 3 years Hospitals HIMSS EMRAM stage 6 2 native, 1 transformed. 4 different EHR system, with heterogeneous information models a broad scope: inpatient, outpatient centers and mental health centers 2 EHR to emergency services and palliative care Central units laboratory, radio diagnostic and transfusion systems At the specialized care, the EHR implementation began 20 years ago, and was driven in the last decade with the opening of a set of 13 hospitals that started with EHR. In the lasts five years we are deploying two programs to convert conventional hospitals into digital ones. Currently has been implemented the EHR in 10 centers and we planned the remainder in the next three years. The implementation level has recognize with HIMSS EMRAM stage 6 for 2 new hospitals and one transformed. They are 4 different EHR system, with heterogeneous information models. These EHRs has a broad scope: inpatient, outpatient centers and mental health centers. In emergency services and palliative care there are other two EHR

Main healthcare information systems Regional repository share clinical information across all centers view layer above the systems access to structured summary patient data in the primary care EHR index clinical reports in the EHR hospitals and emergency services retrieve documents images links to PACS of the centers PHR “carpeta personal” patient can access to his personal records National repository HCD SNS integrated with the national document repository of Digital Health Record. Ten years ago to share clinical information across all centers we developed a view layer above the systems. This system access to structured summary patient data in the primary care EHR and index a set of clinical reports in the EHR hospitals and emergencies, that can be retrieve like documents. For to images the system links to PACS of the centers. Since two years the patient can access to his personal records with the same content. The document repository is integrated with the national document repository.

Regional integrations National document repository HL7 CDA Departments systems Regional view layer One of the health integration standards used in SERMAS is HL7. We have the following success stories: For the integration of demographic data between Cibeles and hospitals systems. Within each hospital, integration between EHR and departmental systems is performed using HL7 messaging for sending requests and returning results (radiology, laboratory, ...) , and for prescription with pharmacy With National document repository (HCDSNS), for submission of clinical reports using HL7 CDA. Mandante , for request (ORM), appointment (ADT) and return of results (ORU). HL7 2.x HL7 2.x EHR Primary Care EHR hospital Mandates HL7 2.x Population information

Hospital integrations Regional view layer XML Delays. Appointments Population information The core of the integration platform is a corporate engine within the SERMAS. The standard messaging used for integration between the HIS / EHR Hospital and the remains information systems is the HL7 2.6 Integration with the Corporate Patient Teacher Information System (CIBELES) uses standard HL7 2.5 messaging. Integration with the Corporate Document Manager (HORUS), based on an integration in XML format (No CDA). with the Corporate delays information (RULEQ) and multincenter appointment management (MULTICITA), in XML format. The rest of departmental information systems are based on this standard and use integration engines in different versions of MirthConnect (Pharmacy Management System, RIS, HER Emergency, Endoscopic Imaging System, Functional Testing System ...), Orion Rhapsody , Cardiac Image System) or own developments (LIS). Except for integrations with the Central Services Information Systems (SERMAS), the management and maintenance of integrations is carried out by HUDO's own staff. HL7 2.6 Departments systems HL7 2.5 HL7 2.6 Departments systems EHR

Development of a Regional Shared Repository Progress in share clinical information to facilitate continuity of care Use existing EHR systems in primary care, hospitals and electronic prescriptions The new shared system must evolve current regional and national repositories based on document towards the organizational and semantic interoperability The Madrid Region wants to progress in the electronic health record (EHR) to facilitate continuity of care, based on existing EHR systems in primary care, hospitals and electronic prescription. The new shared system must evolve current regional -Horus- and national -HCD SNS- repositories based on document towards the organizational and semantic interoperability.

Development of a Regional Shared Repository Apply the lessons learned with ISO 13606 in advanced platforms (UPV LinkERH and ISCIII) about: normalize heterogeneous EHR communicate to other systems persist in sharable data repository based on the dual model We apply the lesson learned in the advanced research platforms (LinkERH UPV, ISCIII) about normalize heterogeneous EHR systems, communicate to other systems and persist in sharable data repository with dual model. To do this architecture is required a common information model, corporate for the regional health system, transversal to care levels and providers, and cumulative longitudinal in time, allowing continuity of care and patient-centered. They has to cover high organizational concepts, reference model, clinical data structures and terminology. Need a common and corporate information model, transversal to care levels and providers, and cumulative longitudinal in time They has to cover high organizational concepts, reference model, clinical data structures and terminology

Methodology to define the model Concurrent used health informatics ISO advanced standards ISO 13940 for the concepts of continuity of care ISO 13606 reference model for clinical information Sequence organization information model with the intersection of the standards: organizational concepts and processes, and the clinical record context clinical detailed information models: editing archetypes and binding terminology Heterogeneous concepts of current systems have been matched through a correspondence schema based on the ISO 13940 and ISO 13606 reference model. ISO 13940 Healthcare organizational concepts ISO 13606 part 1 RM Information management ISO 13606 part 2 archetypes Clinical information models SNOMED CT Terminology binding To the define the information model we have used a methodology for the application of advanced ISO standards developed from the CEN working group named "concurrent use". From abstract to concrete concepts and from the enterprise viewpoint to information view. The modelling has followed this sequence: first the definition of the organization information model with the intersection of the standards: organizational concepts, workflows and processes, and the reference of the clinical record context , and then in a second step the definition of clinical detailed information models with the binding of archetypes and terminology. The heterogeneous concepts of current systems have been matched through a correspondence schema based in the model of ISO 13940 and ISO 13606 reference model.

Clinical information models Adopt the CIMI approach, base on convergence and abstraction modeling formalism : archetypes terminology: SNOMED CT reuse and align existing models HL7 FHIR, openEHR Specialize the current Spanish ISO 13606 archetypes for HCD SNS Define clinical records components -compositions, entries, elements- and their relationships (links) Matched concepts in the current systems through a correspondence schema with the model to be instantiated with legacy data To define the clinical information models we adopt the CIMI approach: archetypes like modeling formalism and SNOMED CT like terminology. And reuse and aligned existing models, with the main standards openEHR, HL7 FHIR, and specialize the spanish ISO 13606 archetypes for HCD SNS We have define Clinical records components -compositions, entries, items- and their relationships (links). We have matched concepts in the current systems through a correspondence schema with the model to be instantiated with legacy data .

Methodology to define the model Example models for Healthcare planning CONCEPT MODEL Care plan Care Plan openEHR-EHR-INTRUCTION.care_plan.v1 CEN-EN13606-COMPOSITION.PlanAsistencial.v1 Health concern Health Concern CEN-EN13606-ENTRY.ValoracionActiva.v1 Health condition Diagnosis openEHR-EHR-EVALUATION-problem_diagnosis.v1 CEN-EN13606-ENTRY.ProblemaDiagnostico.v1 Health goal Health Goal openEHR-EHR-EVALUATION-goal.v1 CEN-EN13606-ENTRY.Resultado.v1 Healthcare activity Interventions openEHR-EHR-ACTIONS.procedure.v1 CEN-EN13606-ENTRY.Procedimiento.v1 ISO 13940 ISO 13606 There are an example of models for de chapter healthcare planning, whit the ISO 13940 concept and his respective models in each standard formalism.

Implementation strategy Information sources Pharmacy AP Madrid HCIS … Data Format is represented by LinkEHR Integration engine The implementation strategy are base in tools to edit archetypes multimodel (ISO 13606-openEHR- HL7 CDA), mapper these whit data sources and produce transformation programs than the current integration engine execute XQUERY to generate communication artefact, in our case, both ISO 13606 extracts or HL7 CDA. We communicate the extract to the a repository in the Health Institute Carlos III, than process and store in a data base conformant the dual model. Rules generate Uses Mediator Extract 13606 HL7 CDA Archetypes viewer Repository Repository Desing Execution

Learned lessons Usefulness of normalization of organizational concepts of the systems with ISO 13940 Recognized good practices in modeling with ISO 13606 to fully capture the existing meaning for a shared repository Extensive use of LINK class to represent temporal sequences, flows and clinical logic connections Reflect clinical record sessions instead of secondary composite document We have show the usefulness of normalization of organizational heterogeneous concepts of the existing systems through correspondence with the concepts of ISO 13940. We have recognized good practices in the modeling with 13606 to fully capture the existing meaning for a shared repository of clinical information. Especially relevant, the extensive use of LINK class to represent temporal sequences, flows and clinical logic connections. The COMPOSITIONS have to reflect clinical record sessions instead of secondary composite document.

Acknowledgments Project team Funding SERMAS D.G. Health information systems D. G. Primary Care SD.G. Pharmacy Advisor Thank you for your attention Contact pserranob@salud.madrid.org