Implementation of the cross-institutional Electronic ... · Implementation of the cross-institutional Electronic Health Record ELGA in Austria ... Involvement of citizens ... •

Implementation of the cross-institutional Electronic

Health Record ELGA in Austria

Swiss eHealth Summit, 14. / 15.09.2015, Bern

Christian Stark

IT-Projektleiter

Klinische Informationssysteme

Tirol Kliniken GmbH

Innsbruck, Österreich

[email protected]

www.tirol-kliniken.at

• Name: Christian Stark

• Ausbildung:

– HTL Innsbruck, Nachrichtentechnik und Elektronik

– Diplomstudium Wirtschaft & Management, Management Center Innsbruck

– Masterstudiengang Medizininformatik / Informationsmanagement, Universität für

Gesundheitswissenschaften, Medizinische Informatik und Technik, Hall in Tirol

• Aktuelle Position: Projektleiter, Klinische Informationssysteme, Tirol-Kliniken

• Lehrveranstaltungen an HTL, FH und Univ.

– Projektmanagement

– Medical Information Systems & eHealth

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Agenda

• Introduction of Tirol Kliniken

• ELGA Basics

• GNT2ELGA Project

• Project Status

• Next Steps

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Introduction of Tirol Kliniken

Some Impressions from Innsbruck …

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… a Management Holding owned a 100% by the Federal State of Tirol

Tirol Kliniken manage 4 Hospital Sites in and around Innsbruck

Tirol Kliniken is …

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Number of Beds 2.461

Inpatients p.a. 119.000

Outpatient Visits p.a. 1.907.000

Staff 7.120 FTEs

Operating Budget p.a. 595 Mio €

Tirol Kliniken Key Figures

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Tirol Kliniken Hospital Sites I

State Hospital Innsbruck – University Medical Center

State Hospital Hochzirl - Natters

State Hospital Hall and Long

Term Nursing Home Hall

District Hospital Schwaz

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Tirol Klinken Hospital Sites II

Tirol ~750 000 population

12.647 km2 H

H

H H H

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Total No. of Beds: 1.560

Intensive Care Beds: 127

Inpatients p.a.: 85.600

Staff : 5.480 FTEs

State Hospital – University Medical

Center Innsbruck

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University Medical Center Innsbruck

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Clinical Information System – Cerner Millennium

Patientadministration and ERP – SAP

Intensive Care PDMS – GE Centricity Critical Care

Multimedia Archive – Siemens syngo.share

Surgery Documentation System - Carus MyMedis

Radiology - PACS Agfa Impax and RIS GE Centricity

Major IT Systems

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Tirol Kliniken IT-Strategy

Strategic IT Goals of Tirol Kliniken

– integrated comprehensive EMR

– consistent IT support for all major processes & process standardization

– IT support for QM and Research

– Cross institutional extramural electronic communication / eHealth

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Austrian Medical Reporting Networks

„Classic“ Channels for Extramural Electronic Communication

Since 2003 Tirol Kliniken have been supporting two extramural electronic communication channels

- Austrian Medical Networks (DaMe, Medicom, …) - Push-Portal health@net

medikom Gateway

intramural extramural

Clinical

Information

System

syngo.share

Referring Physician

EDIFACT-Format

pdf-A

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https://www.healthnet.or.at Tirol Kliniken Push Portal

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ELGA Basics

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eHealth Definitions

EU Directorate Gerneral for Information Society and Media

e-Health means Internet-based applications Involvement of citizens / Empowerment

Health Information Management and Systems Society (HIMSS) eHealth is “ ... the application of the Internet and other related technologies in the

healthcare industry to improve the access, efficiency, effectiveness, and quality of clinical and business processes utilized by healthcare organizations, practitioners, patients, and consumers to improve the health status of patients“.

Eysenbach sees e-Health as“… an emerging field in the intersection of medical informatics, public

health and business, referring to health services and information delivered or enhanced through the Internet and related technologies. In a broader sense, the term characterizes not only a technical development, but also a state-of-mind, a way of thinking, an attitude, and a commitment for networked, global thinking, to improve health care locally, regionally, and worldwide by using information and communication technology”.

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EU eHealth Strategy

eHealth is a major topic for EU’s Digital Agenda

EU eHealth Action Plan of 2004

covered everything from electronic prescriptions and health cards to new information systems that reduce waiting times and errors – to facilitate a more harmonious and complementary European approach to eHealth

Member States should have developed tailored national and regional eHealth strategies derived from the EU eHealth Strategy

eHealth was also a core part of the EU i2010 Strategy

„eHealth Action Plan 2012 – 2020“ is a major bulding block of Europe‘s Digital Agenda / Initiative 2020 https://ec.europa.eu/digital-agenda/en/news/ehealth-action-plan-2012-2020-innovative-healthcare-21st-century

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Core of the Austrian eHealth Strategy

ELGA = Acronym for „ELektronische GesundheitsAkte“ („Electronic Health Record“)

ELGA is an information system which enables all elegible users (citizens / patients, physicians, nurses, pharmacists etc.) to gain access to healthcare information.

e-reports

e-medikation

ELGA links data already available in different provider systems and gives access to the care providers who have a current patient contact.

ELGA-Portal can be accessed via www.gesundheit.gv.at

From Dec. 2015 on Hospitals, Nursing Homes, GPs, Pharmacies will successively be able to provide healthcare information for ELGA and access information in ELGA in a step-by-step go-live-process. The first 2 Affinity Domains that will go live are Wiener Krankenanstaltenverbund and KAGES (Steiermark)

Go-Live Date for Tiroler Landesdomäne GNT-ELGA not determined yet

More information about ELGA: www.elga.gv.at Christian Stark 18

ELGA is mandatory!

ELGA GmbH, financed by the Republic of Austria, all 9 Federal States and the Social Insurance Group, was founded in November 2009 to manage the technical and organizational implementation of ELGA.

www.elga.gv.at

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Legal Framework for

BGBl. 111/2012: ELGA Law (ELGA-G)

ELGA Implementation Guideline of the Austrian Ministery of Health (ELGA-VO)

Health Telematics Guidline 2013

Data Protection & Privacy Law 2000 (DSG 2000)

eGovernment Law

Patient Charta

Treaty for the Financing and Organisation of the Austrian Healthcare System between States and the Federation according to §15a B-VG

Hospital und Convalescence Law (KAKuG)

Physician Law 1998

Hospital Laws of the Federal States

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Implementation Guidlines

ELGA does not only standardize purely technical aspects but also content!

One key part of ELGA are Implementation Guidlines

For each document type an officially approved Implementation Guidline + LOINC must exist before it may be registered for ELGA!

Implementation Guidlines describe structure, content and technical implementation of an ELGA

Document in CDA

Generation of an Implementation Guidline requires intentsive discussions among clinical and

technical experts big effort!

Currently the following ELGA Implementation Guidelines are available Allgemeiner CDA-Implementierungsleitfaden (Version 2.05)

Implementierungsleitfaden Entlassungsbrief Ärztlich (Version 2.05)

Implementierungsleitfaden Entlassungsbrief Pflege (Version 2.05)

Implementierungsleitfaden Laborbefund (Version 2.05)

Implementierungsleitfaden Befund bildgebende Diagnostik (Version 2.05)

Implementierungsleitfaden e-Medikation (Version 2.05)

… further Implementation Guidlines will follow Christian Stark 21

Nursing Homes After Care

Patient

GP

Specialist

Pharmacy Specialist Institute

Acute Care for Inpatients

Non-ELGA Scenario

In a fragmented non-ELGA scenario patient data exist in different unconnected information silos

Source: Arge ELGA

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Integrated Patient Care with ELGA

Acute Care for Inpatients

External Institute

Pharmacy

Specialist

GP

other extramural Providers

Extramural Care

Information Documentation

Patient Index WebPortal

Security-Architecture

Health Care Provider Index

Document Registry

Identification

Nursing Homes After Care

Patient

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Relevant Initiatives and Standards for ELGA

Integrating the Healthcare Enterprise (IHE) Technical Framework IHE-Profiles Syntactical Interoperability

ability of systems to exchange data on a technical level by applying approved standards

Semantic Interoperability ability of systems to interpret data automatically via metadata (information about data)

Process Interoperability

HL7 Reference Information Model (RIM) Clinical Document Architecture (CDA)

LOINC (Logical Observation Identifiers Names and Codes)

Coding Standard for Lab-Parameters, Documents …

DICOM Including WADO (Web Access to DICOM persistent Objects)

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IHE-XDS Profile

Cross-Enterprise Document Sharing (XDS) Profile

enables registration, distribution and cross-enterprise access to information stored

in localized Electronic Medical Records of a patient

IHE XDS is the core profile for ELGA Source: ELGA GmbH

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is a virtual EHR linking Data stored in decentralized Repositories

Source: ELGA GmbH Christian Stark 27

Architecture

ELGA will be realized around the XDS-Profile via SOAP based Web Services. Source: ELGA GmbH

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Central Components of ELGA Architecture

L-PI (Local Patient Index) Local PIX of an ELGA Domain

Z-PI (Austrian Central Patient Index) Austria wide identification of patients & linking of Local Patient Indices

PAP (Policy Administration Point & Policy Repository) Administration and storage of general and individual policies

ETS (ELGA Token Service) Issues Authorization-Assertions (SAML Tickets) for ELGA Users

GDA Index (GesundheitsDiensteAnbieter … Healtcare Provider Index) Directory servicing the identification of Healthcare Providers (Hospitals, Physicians etc.)

KBS (Kontaktbestätigungsservice … Contact Confirmation Service) Saves Contact Confirmations (Kontaktbestätigungen)

A-ARR (Aggregated Audit Record Repository) & Protocol Data Warehouse Summarizes protocol messages from decentralized ARR‘s for the patient

e-Medication Central Component handling e-Medication in ELGA

ELGA Portal Provides access to ELGA for a patient / citizen

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ELGA Access System (ELGA Berechtigungssystem)

ELGA Access System (ELGA Berechtigungs-system) consists of

• ELGA-Token-Service (ETS) • Central Patient Index (Z-PI)

• Healtcare Provider Index (GDA-I)

• Policy Administration Point (PAP)

• Kontaktbestätigungsservice (KBS)

• ELGA-Access Gateways (AGW … Anbindungsgateways)

ELGA Token Service utilizes the services of Z-PI, Policy Administration Point (PAP), Healthcare Provider Index (GDA-I) and Contact Confirmation Service (KBS) to issue an ELGA Authorization Assertion (SAML-Token).

Each ELGA Domain needs one ELGA- Access Gateway („ELGA Anbindungsgateway“) to communicate with the ELGA Central Components and to enable XCA Access to other ELGA Domains.

An ELGA-Access Gateway (ELGA An-bindungsgateway) will be provided as downloadable VMWare by Bundes-rechenzentrum (BRZ). 30

Source: ELGA GmbH

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Document Query in ELGA

• Document Consumer initiates search for a patient‘s ELGA Documents

• ELGA Token Service (ETS) checks if the Document Consumer may access the patient‘s ELGA due to a confirmend patient contact.

• Via Cross-Gateway-Queries the Initiating Gateway provides a list of encounters + links to ELGA Documents for the Document Consumer.

• If the clinician on the Document Consumer side wants to fetch a document from another GDA (GesundheitsDiensteAnbieter, such as a hospital from another organization) he has to click on the document link on the ELGA encounter list.

• The requested document will be fetched from the Document Source Repository using a Retrieve Document Transaction.

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Source: ELGA GmbH

Which content must be provided for ELGA?

Content which has to be registered by Healthcare Providers when ELGA starts:

From Inpatient Stays

Physician Discharge Document

Nursing Discharge Document (if available)

From Outpatient Stays

Lab Report

Radiology Report

Other content, such as Outpatient Reports, Pathology Reports, Images (Dicom) etc.

may only be registered after the ELGA Implementation Guidline has been released on

this!

Further ELGA content will be

Outpatient Reports

Pathology Reports

Images

Mother-Child Pass

…

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Important Facts about ELGA I

ELGA is based on latest international security standards Connections between all ELGA Components (Affinity Domains, Central Components) via

closed and secure Networks

Digital Certificates

No centralized Repository Decentralized Registries and Decentralized Repositories

ELGA will start empty – no preload

ELGA will make only documents available < than 10 years old After 10 years content will be set to status “deprecated”

ELGA is an Opt Out System Opt Out only for eMedikation

Opt-Out only for eReports only e-Medication will be available in ELGA

General Opt Out no ELGA participation at all

Situative Opt Out (SOO)

Patient wants to keep all information regarding a specific encounter out of ELGA

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Important Facts about ELGA II

Additional control mechanisms available for a patient Patient can grant long term access to his ELGA for a physician or an institution he trusts Declare proxy status for other trusted persons (e.g. children, parents) Hiding specific information (documents etc.)

Access Logging Every access into a patient’s ELGA will be logged Who accessed ELGA when and from which institution? Patient can see the access protocols

ELGA Access for GPs , Hospitals or Pharmacies only in case of a patient contact GPs: ELGA can only be accessed for 28 days after the contact to the patient has been

confirmed (plugging of the eCard in the GPs office) Hospitals: ELGA can only be accessed after the patient admission has been

communicated to the „Contact Confirmation Service“. Access is possible until 28 days after discharge.

Pharmacies: ELGA can be accessed by the pharmacist for 2 hours after a patient‘s eCard was plugged in the pharmacy

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Situative Opt Out (SOO)

SOO aims for the „medical case“, which is not exactely identifiable in IT systems. So the regulations allow the following variants to realize SOO:

Visit / encounter related: SOO is valid for only a specific visit

SOO with limited duration: for all encounters in a hospital, which are within a specified time frame (standard: 28 days)

Administratively defined timeframe: case related, e.g. for a sequence of encounters belonging to the same treatment

Each GDA (GDA … GesundheitsDiensteAnbieter - each hospital of a Holding like Tirol Kliniken is a separate GDA, each GP office is a GDA) can select the most appropriate form of SOO for implementation.

An SOO always refers to a specific GDA, but not for all hospitals of a legal entity SOO Implementation Each organization has to make a desicion for one of the three possible SOO variants

SOO administration has to be implemented into patient administration system and CIS

Training of administrative personnel, nurses, physicians in handling an SOO

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Delegation of Patient Contact

• Delegation is the mechanism for enabling ELGA Access for other institutions (e.g. an external pathology, other external laboratories etc.) which are involved in patient treatment and where only specimen, tissue etc. of the patient shows up, but not the patient himself.

• Delegation means, that the patient contact from the primary treatment institution can be expanded to another secondary institution, that will be involved but which has no direct contact to the patient himself.

• After the delegation the secondary institution can access the ELGA of a patient.

• If the patient declared an SOO at the primary institution this SOO must be transferred with the delegation to the secondary institution. In this case the secondary instituion may only read in ELGA but not write into ELGA.

• All delegations will be visible for the patient in ELGA.

• Electronic Delegation Mechanism is still under discussion and construction …

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ELGA Benefit Expectations

Optimized support of cross-institutional patient-centered treatment processes

Saving costs and time

Eliminating the isolation between information silos

Seamless information exchange between intramural and extramural institutions

Avoiding double exams

Avoiding double prescriptions and Adverse Drug Events

Sustainable investment by relying on international standards and initiatives

Highest level of security encrypted mechanisms for authentication, data transfer and logging

Patient himself will be empowered to govern over his ELGA

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GNT2ELGA PROJECT

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ELGA Predecessor Project GesundheitsNetz Tirol (GNT)

ELGA Predecessor IHE Domain „GesundheitsNetz Tirol“ (GNT) is up and running since 2009

GNT Project started 2007

current GNT partners

BKH Reutte, BKH Schwaz, BKH St. Johann, University Medical Center Innsbruck and all other Hospitals of Tirol Kliniken

Go Live: October 2009

GNT-Technology , developed by ITH-icoserve

ITH-icoserve is a Siemens & Tirol-Kliniken subsidiary (ca. 70% Siemens, 30% Tilak)

is IHE a approved

What has been achieved until now?

Implementation of the IHE Affinity Domain GNT

Implementation of decentralized repositories

Registration of > 7 Mio. CDA Level 1 documents since 01-01-2009 Discharge Documents (outpatient + inpatient) Radiology Reports Dermato-Histology Reports Endoskopy Reports

Integration of GNT into local CIS

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Basic GNT Infrastructure

Local Node: Each GNT participant needs a sense Local Node providing the interface to local CIS and EHR Repository. Registration also runs via Local Node.

Community Node: Provides central IHE-Registry, ATNA Profile and the Affinity Domain-wide Patient Index (PIX)

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ATNA, BPPC, CT, NAV, ODS, PDQ (v2/v3), PIX (v2/v3), SVS, XCA, XCA-I, XCPD, XDM, XDR, XDS.b, XDS-I.b, XDS-MS, XDS-SD, XUA/XUA++ ... and many more profiles

.. with all actors.

Certified by EuroRec.

sense® is Connectathon approved

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GNT Access from Cerner Millennium

After the consent form has been printed and signed the physician confirms its existence by activating a checkbox then he can continue.

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GNT Filter Adjustment

Starting Search for encounters and documents

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Fetching a Document from another Institution

and importing it into own Repository

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GNT2ELGA Project = Project for implementing the official ELGA Domain „GNT-ELGA“ for all hospitals and nursing homes in Tirol

Plan: GNT-ELGA Domain should be ready for GIT (General Integration Test with ELGA GmbH) in Q3‘2016

Connecting all Hospitals in Tirol via a secure virtual network „GNT Backbone“

Implementation of 3 ELGA-Environments and connection to CIS, RIS, LIS, internal tests

Clarification of all topics around the operation of the GNT-ELGA infrastructure

• Monitoring, Ticketing, Business Continuity Management (BCM), SLAs

• Organizational preparations

• Administration of SOO

• Handling and communication of „delegations“

• User Training (administrative personnel, physicians, nurses etc)

• Signing Contracts with ELGA GmbH and GDAs

GIT with ELGA GmbH Go-Live of the Domain GNT-ELGA + all Tirol Klinken Hospitals Sukzessively going live with all hospitals in Tirol Predecessor „GNT Classic“ will most likely be shut down.

GNT2ELGA Project – Implementing

the official ELGA Domain for Tirol

Tirol Kliniken Registration Strategy

syngo.share Multimedia Archive is the central instance for the registration of ELGA content

CDA-Documents must be provided by Document Source System via MDM-Messages including all Meta Data necessary for registration

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Administrating SOO in GNT-ELGA

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Looking into ELGA: List of Patient Encounters plus Links to available Documents across Austria

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Sense Consumer Application showing a CDA previously fetched ELGA Document

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Project Status

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ELGA Project Plan

• Project Plan until End of 2014

Big „ELGA Master Plan“

Deadline ELGA Go-Live 01.01.2015 could not be met

• Strategy Change and current Project Plan

First 2 ELGA Domains (KAV Wien + KAGES Steiermark) will go live

01.12.2015

Thereafter about 3 – 4 month of stabilization and consolidation period

Next 2 ELGA Domains (AUVA + Niederösterreich) are planned to go live

end of Q2‘2015

All other ELGA Domains for Public Hospitals (e.g. GNT-ELGA in Tirol)

and big Clerical Hospital Organizations, such as Vinzenz Group, will be

scheduled for Go-Live soon

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Current ELGA Project Status

• Currently intensive Testing in Lab Environment with KAV

(Krankenanstaltenverbund Wien), KAGES (Steiermärkische KH

Holding), ELGA Central Components and Software Vendors

• GIT (General Integration Tests) including KAV Wien, Steiermark,

Central Components and ELGA GmbH will start soon

• Still issues to clarify

ELGA Berechtigungssystem (ELGA Access System)

ELGA Portal

Organizational Details

Ticketing System & Service Levels

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ELGA Environments

Each ELGA Domain has to provide and operate 3 environments for ELGA permanently:

• Integration Environment – To test new ELGA Access Gateway Software or new sense-Releases

• Pre-Production Environment – Shall be equivalent to PROD-Environment (ressources, release state

etc.)

– Will be needed for analysis in case of problems in PROD and for test and release of software patches / new software

• Production Environment

Tricky all 3 Enviroments have to be connected with the clincal source systems for ELGA content (e.g. CIS, LIS, RIS …) but in reality there are not always 3 separate instances for all clinical systems available.

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Tasks for Tirol Kliniken until ELGA starts

Enabling the provision of documents for ELGA in EIS (ELGA Interoperability Stage) Enhanced (CDA Level 2) or EIS Full Support (CDA Level 3)

Inpatient Stays Physician Discharge Document Nursing Discharge Document (if available)

Outpatient Stays Radiology Reports Lab Reports

Implementing the 3 ELGA Environments for our GNT-ELGA Domain Domain Registry (sense from Siemens / ITH-icoserve) Dezentralized Repository (syngo.share from Siemens / ITH-icoserve) Implementing the Registration Logic in syngo.share Integration of all Source Systems (CIS, RIS, LIS …) Seamless integration of GNT-ELGA Consumer Application into CIS (Cerner Millennium) Integration of sense Consent Application for SOO Administration Domain internal testing with all Healthcare Providers connecting to GNT-ELGA Performing the official GIT (General Integration Test)

Organizational Tasks Providing ELGA Support Structure (Ticketing System, Support Organization, SLAs, BCM etc) Training of ELGA Users (Physicians, Nurses, Administrative Staff, IT-People, etc.) Successively Go-Live with the Domain GNT-ELGA and all Hospitals in Tirol

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Some Details to be worked out …

• Generation of CDA Documents in all Source Systems (CIS, LIS, RIS …) – Applications / Tools for Clinicians to generate CDA Level 2 and 3 Documents?

– Workflow for the Generation of CDA Level 2 and 3 Documents?

– Will all Source Systems be able to provide all necessary Metadata for ELGA?

– Clarification of all technical details with vendors

• LOINC for LIS

• MDM instead of ORU

• OID Concept for all Systems in all ELGA Environments

• Public Key Infrastructure

• Usage of Certificates

• Identity Provider Mechanism for ELGA Users

• …

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ELGA – an exciting, never ending Journey …

• ELGA is scheduled to start in Dec. 2015

• Successive go live of further domains from 2016 on

• e-Medication

• Additional value for clinicians can be provided when content will be available as CDA Level 2 or 3 documents

• with CDA Level 3 content a „Patient Summary“ can be generated.

• Advanced Search Mechanisms

• Availability of further Implementation Guidlines will expand ELGA content to all kind of clinical documents and images

• Mother Child Pass etc. in ELGA

• Support for shared care of oncology and chronically ill patients (tumor boards etc.)

• …

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Thank you for your attention!

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