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Requirements domain  Foreword
BUSINESS MODELLING DOMAIN
 Information management principles domain

 

Business Modelling Domain

 

The following models have been developed, within the report, to assist practitioners in all disciplines, including Information Communication and Technology (ICT), to establish e-Health applications within and across Member states.

 

      1. Integration and interoperability

 

  1. Figure 2 shows the different elements that need to be addressed when integration and interoperability are brought together: 

    Figure 2 shows the different elements that need to be addressed when integration and interoperability are brought together: 

 

 

  1. Figure 2:   Integration and Interoperability

     

    The following paragraphs briefly describe the areas of interest in the model: 

     

    Figure 2:   Integration and Interoperability

     

    The following paragraphs briefly describe the areas of interest in the model: 

     

  1. EU International Governance

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    1. Parliaments 

  1.  

    EU governance is directed at the highest level through the European Parliament and the parliaments of the EU countries. Each parliament operates under a parliamentary system of government in which the executive or cabinet, as in the case of the UK, is constitutionally answerable to the parliament.  The government in office is responsible for establishing the various departments, such as those dealing with law and order, treasury functions and health, and ensuring that they operate effectively in terms of efficiency, services to citizens and cost.

     

     

    EU governance is directed at the highest level through the European Parliament and the parliaments of the EU countries. Each parliament operates under a parliamentary system of government in which the executive or cabinet, as in the case of the UK, is constitutionally answerable to the parliament.  The government in office is responsible for establishing the various departments, such as those dealing with law and order, treasury functions and health, and ensuring that they operate effectively in terms of efficiency, services to citizens and cost.

     

  1. Committees 

  1.  

    Committees have been set up by the EC to determine policies for particular areas of interest.  The Health Telematics Working Group of the High Level Committee on Health, established by the EC reviewed the introduction of ICT in the health sector, the factors promoting or inhibiting its development, and areas where Community legislation could be beneficial. It paid particular attention to applications of ICT in e-Health namely health cards, virtual hospitals and provision of health-related information to health professionals and patients. Reports on their findings and recommendations are published yearly.

     

    The i2010 High Level Group was set up to study Information Space, Innovation & Investment in R&D inclusion, throughout Member states. It published a report “The Challenges of Convergence” in December 2006.

     

     

    Committees have been set up by the EC to determine policies for particular areas of interest.  The Health Telematics Working Group of the High Level Committee on Health, established by the EC reviewed the introduction of ICT in the health sector, the factors promoting or inhibiting its development, and areas where Community legislation could be beneficial. It paid particular attention to applications of ICT in e-Health namely health cards, virtual hospitals and provision of health-related information to health professionals and patients. Reports on their findings and recommendations are published yearly.

     

    The i2010 High Level Group was set up to study Information Space, Innovation & Investment in R&D inclusion, throughout Member states. It published a report “The Challenges of Convergence” in December 2006.

     

  1. Legislation 

  1.  

    To establish Directives and Policies, for common legislation and regulations within Member states, Directive 95/46/EC covers the protection of individuals with regard to the processing of personal data and on the free movement of such data.

     

     

    To establish Directives and Policies, for common legislation and regulations within Member states, Directive 95/46/EC covers the protection of individuals with regard to the processing of personal data and on the free movement of such data.

     

  1. Common Disciplines 

  1.  

    Identity management cannot be seen in isolation. Systems need to incorporate other disciplines such as security, information management and data protection. National and international standards have been written for many of these disciplines such as security and records management, to ensure standardisation whenever they are applied.

     

     

    Identity management cannot be seen in isolation. Systems need to incorporate other disciplines such as security, information management and data protection. National and international standards have been written for many of these disciplines such as security and records management, to ensure standardisation whenever they are applied.

     

  1. Projects & Initiatives 

  1.  

    The EU projects and initiatives which need to be taken into account when considering e-Health include: 

     

    The EU projects and initiatives which need to be taken into account when considering e-Health include: 

  1. Connected Health – Quality and Safety for European Citizens (see earlier) 

  2. European Interoperability Framework for Pan-European e-Government Services (see earlier)  

  3. Single European Information Space whose aim is to establish a Single European Information Space offering affordable and secure high-bandwidth communications, rich and diverse content and digital services (the first objective of i2010 HLG) .  

  1.  

     

    1. National Governance 

  1.  

    The government in each state is responsible for putting in place policies and departments, to develop and administer such services as e-Government, e-Health and e-Education. 

     

     

    The government in each state is responsible for putting in place policies and departments, to develop and administer such services as e-Government, e-Health and e-Education. 

     

    1. Regional Governance 

  1.  

    Regional governance of e-Health services will normally be administered by Health Authorities within the regions.

     

     

    Regional governance of e-Health services will normally be administered by Health Authorities within the regions.

     

    1. Local Governance 

  1.  

    Local governance will normally be managed and administered by hospital trusts or boards to deliver medical services by health centres, surgeries and specialist consultants, to the local community. 

     

     

    Local governance will normally be managed and administered by hospital trusts or boards to deliver medical services by health centres, surgeries and specialist consultants, to the local community. 

     

    1. Citizens and patients 

  1.  

    The governance described above is all put in place to provide the best possible health services, throughout Member states, to citizens and patients. 

     

    The governance described above is all put in place to provide the best possible health services, throughout Member states, to citizens and patients. 

 

      1. Stakeholders

 

  1. A stakeholder model for e-Health is shown in Figure 3 which represents a “typical” structure of a national health service. The government policies are determined by parliament and performed by the various departments and agencies.  The Connected Health initiative considers the “requirements of e-Health interoperability which aim to provide systems and services that are connected and can work together easily and effectively, while maintaining patient and professional confidentiality, privacy and security”.

    A stakeholder model for e-Health is shown in Figure 3 which represents a “typical” structure of a national health service. The government policies are determined by parliament and performed by the various departments and agencies.  The Connected Health initiative considers the “requirements of e-Health interoperability which aim to provide systems and services that are connected and can work together easily and effectively, while maintaining patient and professional confidentiality, privacy and security”.

 

 

 

  1. Figure 3: Typical stakeholders within health sector 

    Figure 3: Typical stakeholders within health sector 

 

 

  1. The following paragraphs briefly describe the areas of interest in the model. 

    The following paragraphs briefly describe the areas of interest in the model. 

 

  1. EU International Governance 

 

As described earlier 

 

  1. National Governance 

 

As described earlier 

 

    1. Health departments 

 

  1. Departments of health aim to improve people’s health and wellbeing through responsibility and accountability for the health and social care system within their particular country. 

    Departments of health aim to improve people’s health and wellbeing through responsibility and accountability for the health and social care system within their particular country. 

 

 

 

 

  1. Regional Governance 

 

In order to manage e-Health effectively the country may be divided into Regional Health Authorities. They in turn may divide their region into local areas which provide governance of the medical services within their region. 

 

  1. Local Governance 

 

As described earlier 

 

    1. Primary care 

 

Primary care covers the following establishments: 

 

      1. Health Centres house local medical services or the practice of a group of doctors 

 

      1. Surgeries provide medical practitioner that treat or advise patients 

 

    1. Secondary care 

 

Secondary care covers hospitals which provide medical and surgical treatment and nursing care for sick or injured people. 

 

    1. Tertiary Care 

 

Tertiary care provides specialist consultants to treat patients with exceptional health conditions.

 

 

  1. Professionals 

 

Medical practitioners such as consultants, doctors, nurses and radiographers, as well as administration and support staff, such as records managers 

 

  1. Support organisations 

 

Information Technology (IT) and Information Systems (IS) organisations assist in the development and support of information systems and communication networks. 

 

  1. Citizen and patients 

 

  1. The stakeholders described above aim to provide the best possible health services, throughout Member states, to citizens and patients.  

    The stakeholders described above aim to provide the best possible health services, throughout Member states, to citizens and patients.  

 

  1.  

     

      1. Networks and information flows

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There is a wide diversity in the mechanisms currently in place in the Member states for e-Health services, and it is considered that cooperation at the EU level is essential. The fundamental aim is to enable personal and medical information be made available to patients, and health practitioners, within and between Member states. Considering cross-border care, there is at present a lack of data and consideration must be given to collect complete and comparable data.  As well as managing medical data Member states must collect and monitor data on health professionals’ and patients’ mobility throughout Europe.

  1.  

    A possible network configuration for supplying e-Health services throughout Europe is illustrated in two scenarios:  

     

    A possible network configuration for supplying e-Health services throughout Europe is illustrated in two scenarios:  

 

  1. Scenario 1: A national information database for e-Health (Figure 4) 

  2. Scenario 2: An EU information database for e-Health (Figure 5) 

  1.  

    Both scenarios have the following structure: 

     

     

    Both scenarios have the following structure: 

     

  1. Level 1: Institutional database 

When a citizen or patient registers at a surgery, health centre or hospital, his or her identity credentials, specified in Table 1, are recorded on the institution’s database. If treatment is required, at any time, at any of these institutions, then the patient’s medical records, specified in Table 2 are updated on the institution’s database.  

 

  1. Level 2: Local community database 

Databases, relating to medical care of all patients, who have had or are receiving treatment in the medical institutions within the local community, may be transferred for amalgamation into a local community medical database.  

 

  1. Level 3: Regional database 

All of the medical institutions within a region, determined by the state, may transfer the medical records of all citizens residing in the region for amalgamation into a regional database.  

 

  1. Level 4: National database 

The regional databases containing the medical records of all citizens, within the state, may be transferred for amalgamation into a national medical database.  

 

  1. Level 5: EU database for e-Health 

The national medical databases containing the medical records of all citizens, within the EU, may be transferred for amalgamation into an EU database for e-Health.  

 

 

 

Because it is such an extremely large and time consuming task to develop such networks of medical databases, which contain medical records of many millions of people, it is considered that a staged and structured approach is essential. The level-by-level approach, outlined above may assist with the development of such networks. States may choose to combine some of the levels together, depending on the size of the country and the number of citizens involved, but the basic principles remain the same.  Issues of control and ownership may vary between member states and the consensus may be against a massive national database in which secure management procedures are difficult to ensure.  The alternative is for local control and ownership with protocols that govern the exchange of information.

 

The funding for developing and maintaining the databases and networks will normally be provided by the Member state. Each stakeholder, within the various levels of governance, will be responsible for managing their allocation of funds to ensure that the health services they provide are efficient and cost-effective. 

 

Member states have appreciated that implementing e-Health interoperability is a long term process requiring a sustained commitment with respect to political involvement and resources. Interoperability is probably only achieved gradually by developing application by application. 

 

Very often citizens have to travel abroad, or to other regions within their country, for business or pleasure purposes. If they become ill, or are involved in an accident, then they may require medical treatment from a medical institution, anywhere within the EU. Once the EU e-Health networks are in place then authorized personnel within the institution will have access to the medical records of the EU citizen needing treatment.  

 

It is critical that the data within the network is secure at all times and can only be accessed by authorised personnel. The security applies not only to technical aspects but also to the personnel who are managing and administrating the data. Staff need to be fully aware of their responsibilities in managing and administrating security and should be trained accordingly. The problems of security increase rapidly when databases are combined together as the volumes of data grow substantially, particularly at the level of a national medical database. In the UK alone the National Health Service has a goal of having 60 million patients on a centralised electronic health record by 2010. If an EU database is established then it will contain more than a billion records.     

 

 

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Figure 4:  National Database for e-Health

 

  1. Figure 5: EU Database for e-Health 

    Personal Identifiers / Credentials include: 

     

    Figure 5: EU Database for e-Health 

    Personal Identifiers / Credentials include: 

     

Identity 

 

Secure and protect: 

   Information

   Computer systems

Ensure stakeholders  

& representatives are bona fide 

Protect:  

   Passwords

Comply with statutes & regulations

 

 

 

Purpose for use 

Application 

Lifecycle: 

   Input

   Storage

   Access

   Maintenance

   Deletion

Authorisation 

Confidentiality 

Security 

Interoperability 

 

 

 

 

Paper 

Electronic 

  Web

  E-mails

  Mobiles

  Caads

  Etc

RFID 

 

 

 

Ensure all items are bona fide: 

Stakeholders & their representatives 

Documents and copies 

Compliance with statutes & regulations 

 

 

 

  1. Table 1 

    Health Sector – Identifiers / Credentials 

     

    Table 1 

    Health Sector – Identifiers / Credentials 

     

Identity 

Secure and protect: 

   Information

   Computer systems

 

Destroy out of date information 

 

Ensure stakeholders  

& representatives are bona fide 

 

Protect:  

   Passwords

   

Delete unsolicited emails 

 

Monitor regularly: 

   Information

   Computer systems

   Vetting of personnel

 

Comply with statutes & regulations 

 

 

Purpose for use 

 

Application 

 

Lifecycle: 

   Input

   Storage

   Access

   Maintenance

   Deletion

 

Accuracy 

 

Authentication 

 

Authorisation 

 

Confidentiality 

 

Security 

 

Interoperability 

 

Identification 

 

Matching checks 

Paper 

 

Electronic 

  Web

  E-mail

 

Cards 

 

Voice 

 

Face to face 

 

Images 

 

RFID 

 

Databases 

Ensure all items are bona fide: 

 

Person (n)  

 

Stakeholders & their representatives 

 

Documents and copies 

 

Scans match with originals 

 

Computer systems 

 

Compliance with statutes & regulations 

 

 

 

  1. Table 2 

    Table 2 

 

  1.  

     

 

To develop such a network is an extremely challenging task, taking many years to achieve because of the very large number of citizens and the vast amount of medical data involved.     

 

This challenge has also been considered by the High Level Group on Health Services and in Annex 1 of their 2006 Report it outlines options for procedure for identification and development of European Reference Networks (ERN). These are summarised in the following table. 

 

Options 

Advantages 

Disadvantages 

Option 1 – Adapting existing mechanisms 

  1. Does not require major structural changes 

  1. Relatively easy to execute in short-term perspective 

  1. Very limited in terms of budget and time 

  1. Does not guarantee long term sustainability for the networks 

  1. Does not address related practical, financial and legal issues which are specific for ERN 

Option 2 – New specific mechanism for European reference networks 

  1. Provides long-term sustainability for the networks 

  2. Opportunity to address specific practical problems of ERN, including financial and legal issues 

  3. Distribution of competence at all levels within the implementing structure  

  1. Requires new specific instrument, so lengthy institutional negotiations 

  2. Requires specific allocation of resources fro Community budget 

  3. Creation of implementing structure requires more time and resources than Option 3 

Option 3 – concentrated procedure 

  1. Provides long-term sustainability for the networks 

  2. Opportunity to address specific practical problems of ERN, including financial and legal issues 

  3. Less time and resources needed for creation of implementing structure than Option 2 

  1. Requires new specific instrument, so lengthy institutional negotiations 

  2. Requires specific allocation of resources fro Community budget 

  3. Distribution of competence at al levels within the implementing structure is less transparent than in Option 2  

 

 

 

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