A Framework for the Consistent Management of eHealth

Interoperability in Greece

Dimitrios G. Katehakis

and Angelina Kouroubali

Institute of Computer Science, Foundation for Research and Technology - Hellas (FORTH), Heraklion, Greece

Keywords: Interoperability, Electronic Health Record, Public Health, Models and Frameworks, Enterprise Architecture

Adoption and Governance.

Abstract: This work presents an approach for the organized development of a countrywide framework to address the

ever-growing demand for acquiring, exchanging and exploiting patient information to support high quality

and cost-effective healthcare delivery. The national electronic health (eHealth) landscape in Greece is

examined within the context of the recent recommendation on a European electronic health record (EHR)

exchange format. Improving quality of life and well-being, in a secure and safe manner that respects the

patients’ privacy, is the key challenge. Interoperability of information and communication technology (ICT)

systems is central for reliable and efficient collaboration between the involved stakeholders, including the

patient and associated caretakers. In order to accelerate transformation towards citizen empowerment and a

more sustainable health system, national authorities need to address issues relevant to mutually beneficial

goals in a coherent manner. Practical implications are related to the sustainability of the underlying national

infrastructure required to support reliable and secure exchange of meaningful EHR data, for both primary and

secondary use, and by defining technical specifications for well-defined use cases, in a legitimate and

standardized manner, under a highly regulated environment.

1 INTRODUCTION

Electronic health records (EHRs) have the potential

to improve significantly the quality of healthcare

outcomes and as such, they are an important tool for

coordinated care. They aim at improving health

outcomes through the delivery of healthcare services

from multiple providers by ensuring that care is not

delivered in silos (McDonald, et al., 2007). As stated

in (Katehakis, et al., 2018), prerequisites for enabling

data reuse and workflow automation include well-

defined use cases, agreed terminology, and reliable

clinical content. Effective coordination of care

requires collaboration, goal oriented care planning,

tracking care activities and interventions, as well as

continuous assessment and review.

Increased healthcare needs will require a more

resilient healthcare system. This is due to population

ageing, the rising occurrence of chronic conditions,

and an increase in demand for long-term care

(OECD/EU, 2018).

https://orcid.org/0000-0002-3763-191X

https://orcid.org/0000-0002-3023-8242

In order to use and interpret EHR information in a

clinical relevant context, certain requirements are

considered to be of great priority, including

contextual information related to medical encounters

and decisions, privacy and confidentiality of

information, and disclosure law (Katehakis and

Tsiknakis, 2006).

The widespread adoption of mobile technologies

facilitates the introduction of new and innovative

ways to improve healthcare delivery. Citizens can

now use them to manage their own health and

promote healthy living and active ageing by accessing

useful information and linking to useful resources

when needed; healthcare professionals and patients

included (Kouroubali, et al., 2019). Mobile devices

are becoming an integral part of the healthcare

industry, changing how care is delivered and

received. The use of electronic medical records

(EMRs) and electronic prescription is growing across

the European Union (EU) countries, and growing

numbers of EU residents use the Internet to obtain

health information and access health services. Despite

Katehakis, D. and Kouroubali, A.

A Framework for the Consistent Management of eHealth Interoperability in Greece.

DOI: 10.5220/0007796906890695

In Proceedings of the 21st International Conference on Enterprise Information Systems (ICEIS 2019), pages 689-695

ISBN: 978-989-758-372-8

689

the fact that citizens have the right to access their

personal data, including their health data, as provided

for by (European Union, 2016) most citizens cannot

yet access (nor securely share) their health data

seamlessly across the units of their national

healthcare system.

In spite of the fact that large amounts of health

data are generated and stored electronically, during

and between citizen encounters with national and

regional health systems across Europe, they continue

to reside in data silos. Opportunities to reuse data for

better healthcare are often missed, due to the limited

interoperability among digital health solutions

(Beerenwinkel, et al., 2018). A framework to provide

for the specific set of standards, protocols,

procedures, best practices and policies to help

professionals and patients improve the cost-

effectiveness of the eHealth solutions they design,

implement, and use is considered to be essential

(Barbarella, et al., 2017; Lamine, et al., 2017).

A recent study by the Healthcare Information and

Management Systems Society (HIMSS) Europe

points out the fact that eHealth professionals should

pay more attention to the patient over the next years,

mainly due to the patient-generated data (through

wearables or other tools and gadgets made for

“consumers”) as well as health records that are owned

and managed by patients/citizens. Once a country has

reached a certain level of Electronic Medical Record

(EMR) maturity - the priorities shift towards patient

empowerment. Successful digital transformation is a

team play.

Healthcare in Greece is provided by the national

health system (NHS). It consists of a universal

healthcare system provided through national health

insurance, and private healthcare. During the past few

years, a multitude of eHealth services has been

introduced, in line with EU priorities, to control costs

and improve services in a secure manner. These

include electronic prescription (ePrescription),

electronic dispensation (eDispensation) and

electronic referral (eReferral) for primary care

electronic confirmation (eConfirmation) for

insurance status verification

, electronic

reimbursement (eReimbursement)

, electronic

appointment (eAppointment) for booking doctors’

appointments for primary care

, and a business

intelligence system (Bi-Health)

that automates

https://www.himss.eu/content/annual-european-ehealth-

survey-2018

https://www.e-prescription.gr/

https://www.atlas.gov.gr/ATLAS/Pages/Home.aspx

online retrieval of operational data for the Hellenic

Ministry of Health (MoH).

Despite the fact that significant progress has been

made to effectively link hospitals, regional health

systems, and primary care (Katehakis, et al, 2012),

still no uniform access to EHR is available

nationwide (Katehakis, 2018).

Relevant challenges for the Greek NHS have to do

with the non-optimal use of available data due to the

lack of base registries (i.e. a trusted and authoritative

source of information which can and should be

digitally reused by others), within the context of an

interoperability framework for the exchange and use

of data across different organizations. For example, a

number of organizations process information

regarding drugs administered to patients. However,

the lack of a consistent, good quality, complete,

centralized drug registry creates a number of

problems for doctors, nurses and pharmacists across

the country that eventually affect patients.

The lack of a well-defined interoperability

framework also affects other important patient care

scenarios such as the management of available beds

in public hospitals as well as providing medication for

the chronically ill.

The development of services built upon

international standards and best practices, under the

provisions of national and EU legislation, turn out to

be very important. The appropriate legal framework

and governance, independently of the maturity of the

technologies used, are key ingredients for

establishing a successful framework for accessing

and sharing EHR data at a national level, in line with

the recently introduced recommendation on a

European EHR exchange format (European

Commission, 2019). The aim of interoperability with

regard to EHR exchanges is to allow for the

processing of information consistently in a way that

the recipient can meaningfully interpret

communicated information.

In the following section, the EU framework of

cooperation towards the digital single market is

presented together with interoperability guidelines

and standards, including security and policy

considerations. The road towards developing a

national EHR, addressing relevant challenges for the

Greek NHS, is subsequently described in section 3.

Emphasis is paid on governance and sustainability

towards the development of a national domain

http://www.eopyy.gov.gr

https://www.e-syntagografisi.gr/p-rv/p

http://portal.bi.moh.gov.gr/

ICEIS 2019 - 21st International Conference on Enterprise Information Systems

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interoperability framework (DIF) for eHealth,

highlighting critical research and practical issues. The

paper concludes with some key recommendations.

2 EU FRAMEWORK OF

COOPERATION

EU member states have to make their eHealth

systems more interoperable to support citizens in

gaining greater control over their health data, to

improve clinical outcomes, and to manage the

economic and social aspects of healthcare. Technical

challenges for the implementation and adoption of

EHRs and personal health records have mostly to do

with issues relevant to interoperability, device

connectivity, security, compliance with national and

international legislation, as well as with local policies,

usability and accessibility from different devices by

users with different profiles (Katehakis, et al., 2017).

Data generated within an organization can be used

in a different manner by another organization, while

information exchange can occur within a small

network or it can expand to regions, nations and

cross-national initiatives (Sheikh et al., 2017). For

example, in order to provide effective care, clinicians

need comprehensive longitudinal data sets, while

researchers and policy makers need quality data, in

order to conduct research and support health

planning. Deeper understanding and effective clinical

interventions, as in the case of bioinformatics and

personalized medicine, require innovative use of

existing data. Standardization in medical informatics

enables the interconnection and the interoperability

between both care and research systems. Local

clinical systems can be better aligned for easier data

integration by preserving the meaning across

information systems. Both transmitter and recipient

interpret the shared information identically in

different geographical locations, with possibly

different local languages.

Interoperability is not possible without formal

standards and specifications. Organizations such as

Health Level Seven International (HL7

) and

Personal Connected Health Alliance (PCHAlliance

)

help towards the delivery of standards-based, open

specifications that can support the flow of data from

http://www.hl7.org/

http://www.pchalliance.org/

http://www.ihe.net/

https://www.ama-assn.org/practice-management/cpt-

current-procedural-terminology

https://www.snomed.org/snomed-ct

the point of capture into EHRs in the same format and

coded content. Consensus on systems requirements is

also important. Integrating the Healthcare Enterprise

(IHE

) describes how standards may be used

effectively. Standard can be used with third party

terminologies such as the Current Procedures

Terminology (CPT

) code set, the Systematized

Nomenclature of Medicine Clinical Terms

(SNOMED CT

), the Logical Observation Identifiers

Names & Codes (LOINC

), and the International

Classification of Diseases (ICD

) codes.

In an effort to guarantee the secure and free flow

of data within the EU, the new European

Interoperability Framework (EIF) was announced in

2017 (European Commission, 2017). The new EIF

provides guidance to public administrations, through

a set of recommendations, on how to improve

governance of their interoperability activities,

streamline processes supporting end-to-end digital

services, establish cross-organisational relationships,

and ensure that existing and new legislation do not

compromise interoperability efforts.

The eHealth domain in Europe uses the refined

eHealth European Interoperability Framework

(ReEIF) (eHealth Network, 2015) as the common

framework for managing interoperability in the

context of the eHealth Digital Services

Infrastructure

supported under the Connecting

Europe Facility Programme

. Member States have

taken important steps to foster interoperability with

the support of the Commission, through the activities

of the eHealth Network established under Article 14

of Directive 2011/24/EU of the European Parliament

and of the Council (also known as the cross border

healthcare directive).

The ReEIF and the new EIF provide the tools to

support the creation of a national DIF for eHealth.

According to (European Commission, 2017) four

layers of interoperability form the basis for the

interoperability framework, as presented in Figure 1.

Legal interoperability ensures that organizations

operating under different policies, legal frameworks

and strategies are able to work together.

Organizational interoperability refers to the way in

which public administrations align their

responsibilities, business processes and expectations

to achieve mutually beneficial goals. Semantic

interoperability refers to both the meaning of data and

https://loinc.org/

http://www.who.int/classifications/icd/en/

https://ec.europa.eu/cefdigital/wiki/display/EHOPERATI

ONS/eHealth+DSI+Operations+Home

https://ec.europa.eu/inea/en/connecting-europe-facility

A Framework for the Consistent Management of eHealth Interoperability in Greece

691

Figure 1: From EIF model to the ReEIF one (eHealth

Network, 2015).

the exact format of the information to be exchanged.

Technical interoperability covers the applications and

infrastructures linking systems and services,

including interface specifications, data presentation

and secure communication protocols.

Citizens across Europe want to access and share

their health data (European Commission, 2018). They

also want to be able to provide feedback on quality of

treatments. The slow deployment of interoperable

digital health solutions across European countries

remains a barrier for scaling-up integrated care

(COCIR and IHE-Europe, 2017).

In order to secure the citizen’s access to and

sharing of health data the EU is moving towards the

development of specifications for a European EHR

exchange format, based on open standards, taking

into consideration the potential use of data for

research and other purposes. The recommendation on

a European EHR exchange format sets out a

framework (European Commission, 2019) to achieve

secure, interoperable, cross-border access to, and

exchange of, electronic health data in the EU. The

framework includes:

 a set of principles that should govern access to and

exchange of EHRs across borders in the EU;

 a set of common technical specifications for the

cross-border exchange of data in certain health

information domains;

 a process to take forward the further elaboration

of a European EHR exchange format.

The aim is to deliver the right data, at the right

time, for citizens and healthcare providers, and allow

for the secure access, sharing and exchange of EHRs.

The baseline includes patient summaries,

ePrescription/ eDispensations, laboratory reports,

medical images and reports, and hospital discharge

reports, in alignment with established priorities at a

European level.

http://www.idika.gr

The General Data Protection Regulation (GDPR)

(European Union, 2016) requires patient data to be

protected and properly secured so that its

confidentiality, integrity and availability are ensured.

In addition, citizens and their healthcare professionals

must have online access to their EHRs using secure

electronic identification means (eIDAS Regulation)

(European Union, 2014), while EHR systems rely on

secure networks and information systems in order to

avoid data breaches and minimise the risk of security

incidents (Directive on security of network and

information systems - NIS Directive) (European

Union, 2016b).

The EU Agency for Network and Information

Security has published several documents on

strategies and ways of implementing privacy by

design (European Union Agency for Network and

Information Security, 2018).

3 TOWARDS A NATIONAL EHR

The development of national EHR in Greece implies

a vision for the provision of healthcare in the country

and significant technical knowledge. It has to follow

best international practices and be combined with the

existence of a national strategy. It is a long term,

evolutionary process that requires the gradual

integration and deployment of EHR information

domains over time. Already the majority of EHR

system components, within the information and

communication technology (ICT) infrastructure of

healthcare organizations, are operational in the

country (Katehakis, 2018). Key EHR information

exchange providers in Greece include:

 IDIKA (e-Government Center for Social Security

Services

) for eConfirmation (for insurance

status verification), ePrescription/ eDispensation,

eRDV (for appointment booking – directly

accessible to citizens), AHFY (citizen EHR

focused on primary care – aiming to become the

backbone of the national EHR system, under

development), and NCPeH (cross border services

for ePrescription and patientsummary).

 EOPYY (National Organization for Health Care

Services

) for eReimbursement (e-ΔΑΠΥ) and

also registries for Hepatitis C and Chronic

Myelogenous Leukemia.

 Hospitals.

 Healthcare Professionals.

The eHealth and telemedicine landscape in the

country is filled by several EHR systems, including

https://www.eopyy.gov.gr/

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clinical and non-clinical ones (e.g. for clinical trials),

communicating mostly application to application.

Despite the wide availability of EHR systems, there

exists large fragmentation of information, limited out

of the box interoperability capabilities among them,

and questionable data quality. An outstanding

example is the fact that many organizations are

directly involved in the management of

pharmaceutical products without the existence of a

common registry of medicinal products to serve as a

common point of reference (Katehakis, et al., 2018).

Synthesis of information required about medicinal

products is fragmented within the above-mentioned

entities. Communication between them, in the context

of handling their business processes related to drug

administration, is done by means of email exchanges

and spreadsheet files. Data used by each entity is

incomplete and not always up to date. Safety rules do

not usually apply on the roles and responsibilities of

data controllers involved in data management.

The Bi-Health system of the MoH

supports the

automated extraction of certain data sets from public

hospitals, related to patients, the cost of care per

hospital, the use of consumables, and others. Bi-

Health aims towards supporting documented

decisions for the improvement of public health by

extracting hidden knowledge through big data

analytics. Initial data sets, collected online, included

inpatient and outpatient data (admission, discharge

and transfer notes, charging, etc.), materials, human

resource and financial management data, as well as

appointment booking data. Still not all points of care

in the country are linked with Bi-Health.

Digitising health records and creating systems so

that citizens can access and securely share them

within and between the different actors in the health

system is an important step towards integrating digital

technologies into healthcare. That integration

requires EHRs, to be interoperable across the NHS

whereas currently many of the formats and standards

in EHR systems used across the country are

incompatible. This is because

 Solution providers propose implementations

without consulting each other.

 Interoperability agreements are too generic or

non-existent.

 No national semantic authority, responsible and

accountable for the provision of national

terminology services, is in place.

 Interoperability standards, such as HL7, are not

used in a consistent manner.

http://www.moh.gov.gr/

The key issue is that no national framework is in

place to manage consistently interoperability in the

country. Since the use case-driven approach is the

foundational methodology for documenting user

needs, the practical approach for achieving

interoperability can be summarized in the following

steps:

 identify use cases from an end-user perspective;

 select profiles and standards that support the use

case;

 refine data content, including master files, and

terminology;

 prepare implementation guides;

 organize component interoperability and cross-

implementer connectivity testing;

 educate end-users;

 support communities of practice to promote

sustainable standards-based implementation.

For each of the proposed use cases, rules need to

apply in order to determine how to accomplish

interoperability at each of the following levels:

 Legal: for providing a thorough check of how

public services will be established in regards to

consistency with relevant legislation and

corresponding data protection requirements, when

drafting legislation.

 Organizational: for documenting and integrating,

or aligning, business processes and relevant

information exchanged, while at the same time

aiming to meet the requirements of the user

community by making services available, easily

identifiable, accessible and user-focused.

 Semantic: to make sure, through the development

and use of standardized vocabularies and formats,

that the meaning of exchanged data and

information is well understood by the different

parties, resolving any possible ambiguities

regarding the notions in the healthcare domain.

 Technical: in order to ensure the use of formal

technical specifications and widely accepted and

used standards.

A national EHR will only become available when

the EMRs generated and maintained by physicians

and healthcare providers apply internationally

recognized interoperability standards (Aanestad, et

al., 2017) in a regulated manner. Interoperability

should be guaranteed in a sustainable way and not as

a one-off target or project.

In order to achieve this vision within the Greek

NHS, the following need to be in place:

A Framework for the Consistent Management of eHealth Interoperability in Greece

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 a roadmap for the development and maintenance

of national specifications, re-usable services and

other assets;

 national, reusable interoperability specifications,

compatible with the corresponding European

ones, developed through open and transparent

processes;

 mechanism and tools for compliance control,

testing and certification;

 a national semantic authority.

The introduction of a conformity assessment

scheme, considering ISO, IHE CAS

and other

successfully deployed in member states is expected to

promote the adoption and take-up of interoperability

testing of eHealth solutions and products against

identified eHealth standards and profiles. This will

require the establishment of a test and compliance

control centre in the country.

Foreseen benefits include less effort in the

introduction of new services, lower cost for the

application of new solutions, a solid ground to

support better research, less red tape, and more

empowered patients in control of their diseases.

4 CONCLUSIONS

A key and essential pillar to establish a National EHR

in Greece is the design and implementation of an

interoperability framework that, with the appropriate

open governance, will enable the systematic

implementation of the necessary user cases that will

populate the EHR with valid and quality elements.

Transparency will allow other public administrations,

citizens and businesses to view and understand

administrative rules, processes, data, services and

decision-making

Appropriate governance and legislation will

guarantee that consistent management of eHealth

interoperability in Greece will be applied and that all

involved parties, including health organizations and

ICT solution providers, will comply with it. For that

to happen, a thorough research is required of relevant

best practices and corresponding level of maturity

reached, in regards to eHealth interoperability and

governance, in other countries sharing a similar

profile to that of Greece.

Digitising health records and enabling their

exchange could support the creation of large health

data structures, which combined with the use of new

technologies, such as big data analytics, and artificial

https://www.euro-cas.eu/

intelligence can support the search for new scientific

discoveries.

ACKNOWLEDGEMENTS

This work has been funded, in part, by the Center for

eHealth Applications and Services, and was

implemented in co-operation with the Computational

Biomedicine Laboratory of the Institute of Computer

Science, of the Foundation for Research and

Technology – Hellas. Any opinions, results,

conclusions, and recommendations expressed in this

work are those of the authors and do not necessarily

reflect the views of the Hellenic Ministry of Health or

the European Commission.

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