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					Better Breathing

                                                Better Breathing
                                               Project No: 045225

                                                Deliverable D3.2
                             Harmonisation, Interoperability and Standard

                                             Status: Final version 1
                                                Date: 13.03.2008

D3.2: Harmonisation, Interoperability and Standard                          Page 1 of 38
Better Breathing

Project Acronym:             Better Breathing
Project Title:               Better Breathing; A new model for continuous care of chronic patients -
                             eCare, eRehabilitation, eCommunity and eLearning for patients with
                             breathing handicaps
Contract Number:             046225
Starting date:               01.06.2007                         Ending date: 31.12.2007

Deliverable Number:                                   3.2
Title of the Deliverable:                             Harmonisation, Interoperability and Standard
WP/Task related to the Deliverable:                   Adaptation and Localisation: WP3 / T3.2
Type (confidential or public):                        Public
Author(s):                                            Miguel Ángel Sarasa, Vicente Simorte & Mayte
                                                      Hurtado, TB Solutions
Contractor(s)/Member(s) Contributing:

Contractual date of delivery to the CEC:                  29.02.2008
Actual date of delivery to the CEC:                       13.03.2008

                                               Proyect Manager

                      Company name                    :         Region Syddanmark
                      Name of representative          :         Claus Duedal Pedersen
                      Address                         :         Rugaardsvej 15, 2 – 5000 Odense C
                      Phone number                    :         +45 65 43 20 30
                      Fax number                      :         +45 65 43 20 50
                      E-mail                          :
                      Project web site address        :

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Table of Contents
Executive summary ...................................................................................................... 5
Purpose and content of the deliverable ..................................................................... 6
Introduction................................................................................................................... 7
   What is healthcare interoperability? ............................................................................ 7
   Syntactic interoperability ............................................................................................. 8
   Semantic interoperability............................................................................................. 8
   EHR interoperability .................................................................................................... 9
   Relationship to standards............................................................................................ 9
Interoperability problem in the healthcare domain ................................................. 10
The Better Breathing healthcare ecosystem............................................................ 11
   Services types........................................................................................................... 11
   Devices types............................................................................................................ 12
   Main interfaces.......................................................................................................... 12
Better Breathing healthcare interoperability through industry standards............ 15
   PAN interface standards ........................................................................................... 15
   LAN interface standards............................................................................................ 17
   WAN interface standards .......................................................................................... 17
   EHR interface standards ........................................................................................... 17
Other interoperability issues to be addressed ........................................................ 20
Conclusions ................................................................................................................ 22
Appendix I: The OSI layered model .......................................................................... 23
   Communication layers............................................................................................... 23
   The seven layers of the OSI model........................................................................... 23
Appendix II: Main EHR interoperability standards .................................................. 25
   The GEHR / OpenEHR initiative ............................................................................... 25
   CEN/TC 251 and ENV/EN 13606 EHRcom .............................................................. 25
   HL7 Clinical Document Architecture (CDA) .............................................................. 26
   IHE Cross-Enterprise Document Sharing (XDS)....................................................... 26
   IHE Cross-Enterprise Sharing of Medical Summaries (XDS-MS)............................. 27
   IHE Retrieve Information for Display (RID) ............................................................... 27
Appendix III: Standards list ....................................................................................... 28
References .................................................................................................................. 38

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Better Breathing

Figure 01 – Better Breathing ecosystem of healthcare devices/services ..................... 11
Figure 02 – The Better Breathing interfaces in the reference architecture ................... 13
Figure 03 – OSI layered model..................................................................................... 23

Table 01 – The seven layers of the OSI model ............................................................ 24
Table 02 – Standards list .............................................................................................. 37

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Executive summary
           This deliverable provides an overview of the interoperability problem for the
           modules and components used in the healthcare environment within the Bet-
           ter Breathing project. It presents the challenges and needs related to wired
           and wireless personal healthcare systems, and also provides an outline of the
           various communication standards aiming to enable the interoperability.

           The ISO-OSI model is used thorough the document so as to analyze interop-
           erability on a technology level. The model is discussed in detail in Appendix I:
           The OSI layered model. It has been widely addressed in research and prac-
           tice. In addition, reference annexes are provided, containing the major stan-
           dards used to guarantee the interoperability (see them attached at the end of
           the deliverable in order to keep this document short).

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Purpose and content of the deliverable
           The core objective of the deliverable is to cover the necessary issues to en-
           sure the interoperability on technologies, devices and services inside the Bet-
           ter Breathing project. The deliverable will also analyse the potential problems
           to be addressed, as well as the solving factors about harmonisation, interop-
           erability and standards relevant for the market deployment of Better Breathing
           project. As a result, a background document on interoperability of the Better
           Breathing healthcare devices and services will be provided, discussing the
           technical issues and standards to be addressed for achieving interoperability.

           The above purposes will be addressed with the ISO-OSI model as a refer-
           ence, so as to analyze interoperability on a technology level. The model is dis-
           cussed in detail in Appendix I: The OSI layered model. It has been widely ad-
           dressed in research and practice. For the purpose of the deliverable, upper
           three layers of the OSI model will be referred to address the communication
           between medical technical systems (according to the model, two systems can
           communicate in a technical sense as long as they use common protocols from
           levels 1 through 5). When not only bit transmission is required, it is also nee-
           ded a common protocol on level 6 (also called the presentation layer, with the
           function of performing transformations on data before they are sent to lower
           levels). Finally, to actually use the medical information, a common understand-
           ing at the application level 7 will be also needed. In addition to the OSI-based
           interoperability analysis, the nature of the available standards, with respect to
           the contribution they make toward interoperability within the Better Breathing
           healthcare domain will also be explored.

           The deliverable is structured as follows: First of all, an Executive Summary, as
           well as the purpose and scope of the deliverable are set up. A scattered intro-
           duction is given next, addressing the overall need of interoperability in the
           healthcare domain. The concepts of interoperability and interoperability types
           are defined here, extending the computer science definitions to the healthcare
           specific context. Moreover, a first indication of the different types of standards
           needed to achieve such domain specific interoperability is also provided.

           The problem of interoperability in the personal healthcare domain is elabo-
           rated in more detail in the following section. A brief overview of the Better
           Breathing healthcare ecosystem (reference architecture, service and device
           types and main interfaces) is then presented. After that, the most relevant
           standards to be measured within the Better Breathing project are outlined.
           These standards are aimed to achieve the interoperability on upper-layers, as
           well as on the application layer of the OSI stack, and will be related to each of
           the main interfaces defined within Better Breathing healthcare ecosystem.

           The last sections provide finally other interoperability issues to be addressed,
           along with the concluding remarks. Reference annexes are also provided,
           containing the major standards used to guarantee the interoperability.

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           The healthcare industry must improve its delivery methods to address current
           and expected needs. Various technologies could help by extending traditional
           treatment into personal assistance and home settings. However, creating such
           a healthcare ecosystem will require interoperability.

           Personal healthcare systems, including remote patient monitoring and man-
           agement, are increasingly recognised as having the potential to help to im-
           prove the quality of care for an increasing number of patients. This patient-
           centred concept of bringing the care from the hospital or the doctor’s office to
           the patient at home results in improved quality of care. This results in longer
           independent living, in particular, for older patients.

           In addition to the care being provided in a remote and personalised way, an
           important factor for enabling the success of future healthcare systems is to
           make the last hop to the patient wireless. By introducing wireless technology,
           cumbersome cables can be eliminated, enabling greater physical mobility and
           making the system more unobtrusive and ubiquitous for the patient.

           An example for a sophisticated system solution incorporating the aspects
           mentioned above are the remote patient monitoring platforms based on
           TV/TDT (Terrestrial Digital Television). These platforms comprise daily, per-
           sonalized patient interactions, delivered via broadband connection to the
           home television. Patients receive reminders and messages, educational vid-
           eos, and feedback on their vital signs comprising blood pressure, and blood
           glucose levels, based on a tailored care plan defined by their caregiver.

           However, besides the benefits of wireless personal healthcare systems, there
           exist also several challenges and issues still unresolved. A lot of isolated and
           proprietary solutions still exist today. Indeed, there is an enormous conglom-
           eration of personal health devices and services lacking interoperability, and
           hence preventing that the interoperability issues are solved in a unified and
           standardized way. Thus, it is exactly the approach of enabling healthcare in-
           teroperability and connectivity within the context of wireless personal health-
           care, which is necessary for the success of future such systems.

           What is healthcare interoperability?

           It is widely recognised the need of medical information technology interopera-
           bility in order to improve the quality of healthcare. In order to clarify the inter-
           operability concept, the IEEE has proposed a definition of the term for its use
           by policymakers and in legal or contractual contexts. The IEEE definition of in-
           teroperability in healthcare is as follows:

                   In healthcare, interoperability is the ability of different information tech-
                   nology systems and software applications to communicate, to exchange
                   data accurately, effectively, and consistently, and to use the information
                   that has been exchanged.

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           Interoperability can be investigated in different categories in the healthcare
           domain, such as the interoperability of the messages exchanged between
           healthcare applications, the interoperability of Electronic Healthcare Records
           (EHRs), the interoperability of patient identifiers, coding terms, clinical guide-
           lines and healthcare business processes, etc. All of these categories can be
           structured in three major layers of interoperability: syntactic interoperability,
           semantic interoperability and EHR interoperability. All of these layers are
           described in the following sections.

           Syntactic interoperability

           A prerequisite for interoperability is the ability to communicate the bits running
           on the wires. Syntactic interoperability involves the ability of two or more sys-
           tems to exchange information. It entails several layers:

                •    Network and transport layer: In transferring healthcare messages be-
                     tween application systems, network and transport protocols are nee-
                     ded, such as Internet. In fact, today, TCP/IP is the de-facto on-line
                     communication standard.

                •    Application protocol layer: An application protocol standard is also
                     needed, such as HTTP or SMTP (email).

                •    Messaging protocol and message format layer: On top of this layer,
                     standard messaging protocols are also required, such as SOAP or
                     ebXML messaging.

                •    Sequencing of the messages: The sequencing of the messages also
                     needs to be standardized. For example, in Health Level 7 (HL7), when
                     “I05 RQC Request Clinical Information” message is sent, the expected
                     return message is “I05 RCI Return Clinical Information”. There are also
                     different types of messages. Each message is either one with the in-
                     tent of action or an acknowledgment one, indicating successful or error
                     transmission. Finally, for the message content to be processed cor-
                     rectly by the receiving application, the message content structure and
                     the data items in the message must be standardized, for example as
                     proposed by HL7 version 3.

           With all above, syntactic interoperability guarantees the message to be deliv-
           ered, but does not guarantee that the content of the message will be machine-
           processable and “understood” at the receiving.

           Semantic interoperability

           A common usage of the term “semantic interoperability in healthcare can be
           found in CEN/ISSS:

                    “Semantic interoperability implies that the structure of the 'documents' is
                    interpretable, and that their content is understandable. Making this con-

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                   tent understandable sometimes requires that the keys for its correct and
                   safe interpretation, such as the terminological systems used, are identi-
                   fied and easily available”

           Semantic interoperability guarantees message contents interoperability, by
           forcing them to comply with an agreed structured machine-processable stan-
           dard. Thus, semantic interoperability allows for information shared by systems
           to be understood at the level of formally defined domain concepts. Another
           important use of semantic interoperability in the healthcare domain is the inte-
           gration of data from heterogeneous sources. Semantic mediation can be used
           to convert healthcare messages defined in one standard format into another.

           EHR interoperability

           The Electronic Healthcare Record (EHR) of a patient can be defined as digi-
           tally stored healthcare information about individual’s lifetime with the purpose
           of supporting continuity of care, education and research, and ensuring confi-
           dentiality at all times. A patient’s healthcare information may be spread out
           over a number of different institutes which do not interoperate. In order to pro-
           vide continuity of care, clinicians should be able to capture the complete clini-
           cal history of a patient. An exchange of well-structured and machine proc-
           essable electronic healthcare records has not been achieved yet in practice
           due to the lack of EHR interoperability.

           Relationship to standards

           In order to achieve interoperability for the emerging healthcare ecosystem in a
           unified and standardized way, various connectivity and communication stan-
           dards should be followed. A standard is an agreement among parties within an
           area of technology. Interoperability is the result of an agreement between or
           among systems to share information.

           In healthcare information technology, standards can be basically categorised
           on data transmission standards (to provide syntactic interoperability) and
           medical terminology interpretation standards (to achieve syntactic and
           EHR interoperability). In the early stages of implementation, it is unlikely that
           every system is completely interoperable with every other. However, there will
           be an incremental movement toward this, as interoperability of clinical informa-
           tion from a variety of sources is achieved through the usage of agreed-upon
           standards. Initial efforts at achieving interoperability should be focused on the
           clinical information that is already stored in a coded and structured format, and
           that would yield the highest clinical value if made interoperable.

           Because they will supply the framework on which interoperability will develop,
           standards should be open, public and non-proprietary ones. Standards specify
           much of the detail necessary to ensure interoperability. However, some critical
           details are in the hands of the organizations that actually implement the stan-
           dards. To achieve interoperability, organizations involved in data exchange
           projects need to work together to assure that such implementation details are
           addressed consistently among the participants.

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Interoperability problem in the healthcare domain
           One of the key problems in healthcare informatics is the lack of interoperability
           among the different healthcare information systems. Typically, they consist of
           three parts: a patient-end, with personal health devices in the patient’s home,
           a back-end part for storing the data, and a care provider-end, where the per-
           sonal health consultant has access to the patient’s data.

           The devices at home are medical equipment (e.g. blood pressure and pulse
           rate meters, electrocardiographs, pulse oximeters, etc.) for measuring the pa-
           tient’s vital signs, and usually some kind of compute engine (e.g. a PC, Per-
           sonal Digital Assistant or mobile phone) for gathering the data and providing a
           user interface for the patient. The back-end part contains a server component,
           which is connected via a network (e.g. the Internet) to the patient-end part.
           Similarly, at the care provider-end, access to the patient’s data on the server
           component is enabled via some network, which could also be the Internet.

           Obviously, there is a need for intercommunication among the various compo-
           nents within the system. Focusing on the patient-end part, there are several
           alternative wireless technologies to establish a wireless link between medical
           devices and compute engines. However, the standardization process with re-
           gard to medical device interoperability lacks behind technical possibilities. Vir-
           tually, all of these solutions are specialized applications with proprietary inter-
           faces unique to the two devices being linked.

           Thus, ensuring compliance on the physical layer between two devices
           does not ensure interoperability, as there are many different ways to trans-
           mit the same information over a physical layer interface. In order to ensure in-
           teroperability between multi-vendor devices, the devices must be able to un-
           derstand the format and the content of the messages they communicate to
           each other. Hence, on the patient-end side, the problem of device interopera-
           bility has to be solved on three principle levels:

                •    On lower-layers: A standardized transport technology enabling basic
                     connectivity has to be developed.

                •    On upper-layers: Application profiles have to be developed, which de-
                     fine what capabilities of the transport technology have to be used to
                     best support the application requirements.

                •    On application level: Standardized data models and formats have to
                     be developed, which represent an abstract and unique mapping of the
                     real world entities.

           While a significant amount of problems on the lower layers has been solved
           already and mature standards are available, more work at levels closer to the
           application is needed.

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The Better Breathing healthcare ecosystem
           A big picture of the reference architecture for the Better Breathing personal
           healthcare system is given in Figure 01 – Better Breathing ecosystem of
           healthcare devices/services.

             Figure 01 – Better Breathing ecosystem of healthcare devices/services1

           The different components of the reference architecture will be described in the
           following sections.

           Services types

           The service-side is basically conformed by four health services that are envis-
           aged to be market validated during the project period. These services will re-
           quire both, access to data repositories as well as the transmission / exchang-
           ing of clinical information. The referred services are the following:

                •    ePatient Community services: These services will allow chronic pa-
                     tients to virtually meet (from their home) with other chronic patients,
                     and exchange experiences and advice on how to live with the disease.

                •    eCare services: These services will be implemented and evaluated to
                     demonstrate that eCare is feasible in the care of chronic patients. The

    Adapted from the Continua Healthcare Alliance [06].

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Better Breathing

                     services will allow registered patients to run queries and send their
                     own biometrical data-sets to healthcare professionals.

                •    eRehabilitation services: These services is intended to train the pa-
                     tient in his/her own home by use of Information and Communication
                     Technology (ICT), by treating and caring for chronic patients in their
                     own home through the deployment of communication equipment ePa-
                     tient Community / eProfessional Community.

                •    eLearning services: The Better Breathing project will also provide ef-
                     fective and pedagogical tools that the patients and/or healthcare pro-
                     fessionals can use, thus achieving greater understanding of the dis-
                     ease and their ability to manage it.

           Devices types

           Concerning the device-side, Better Breathing reference architecture breaks
           down its functionality into four main device classes:

                •    Personal Area Network (PAN) devices: PAN devices are mainly vital
                     signs sensors (such as blood pressure and pulse rate meters, electro-
                     cardiographs, pulse oximeters, spirometers, heart-rate monitors, etc).

                •    Local Area Network (LAN) devices: LAN devices aggregate and sha-
                     re (via a network) the bound PAN devices’ information (such as a
                     proxy function). A LAN device can also implement sensor functionality.

                •    Application Hosting (AH) devices: Such as personal computers, cell
                     phones, Personal Data Assistants (PDAs), set top boxes, which allow
                     the aggregation and computation.

                •    Wide Area Network (WAN) devices: These devices allow the imple-
                     mentation of managed-network-based services. They collect informa-
                     tion and host a wide range of value-adding services (for example, a
                     health monitoring service hosted on a network-based server).

           Main interfaces

           When the interoperability problem is addressed from the scope of the systems
           that have to exchange information, seven different kinds of communication
           can be identified. The IEEE definition of interoperability (implicitly) applies to
           the communication between the technological systems. The ISO-OSI model
           (see Appendix I: The OSI layered model) was developed for these kinds of in-
           terconnections. The OSI model will be used as reference to analyse the inter-
           operability problem, focusing on the Better Breathing domain-specific context.

           The connection between/among the different devices and the reference topol-
           ogy inside the Better Breathing project (i.e., the whole range from the medical

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           device at the patient’s home to the back-end services) can be addressed
           through four network interoperable interfaces, which are the centre and play a
           key role within the ecosystem interoperability. These four referred interfaces
           are depicted in the Figure 02 – The Better Breathing interfaces in the refer-
           ence architecture.

            Figure 02 – The Better Breathing interfaces in the reference architecture2

           The interfaces features are summarised in the following:

                •    Peripheral Area Network Interface (PANI): It connects an AH device
                     to a PAN device. This interface has a lower-layers component, as well
                     as an upper-layers component. The instantiations of the lower layers
                     include both, wired and wireless links. Regarding the upper layers,
                     they are implemented using optimised exchange protocols.

                •    Local Area Network Interface (LANI): It connects an AH device to a
                     LAN device. This means that LANI’s upper layers can support the sa-
                     me device data model as the PANI’s upper layers. In fact, using the
                     same device data model, regardless of the underlying OSI lower-layers
                     communications mechanism, is a key interoperability feature.

                •    Wide Area Network Interface (WANI): This interface connects an AH
                     device to one or more other devices. The WANI OSI upper-layers must
                     use a device data model compatible with the LANI upper layers’ device
                     data model. Again, the exchangeable device data model is the key
                     component for Better Breathing interoperable healthcare ecosystem.

    Adapted from the Continua Healthcare Alliance [06].

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                •    Electronic Health Records Interface (EHRI): This interface enables
                     patient-centric data communications between a WAN device and a
                     health-record device, typically at the boundary of the personal health-
                     care ecosystem. This is in contrast to the other interfaces, which sup-
                     port device centric data communications between an AH device and
                     other Better Breathing devices. The typical EHR device implements a
                     health record database or other system, managed and operated by a
                     traditional healthcare service provider (for example, an electronic-
                     health-records system that a hospital or healthcare system manages
                     and operates). The HER Interface lets multiple enterprise healthcare
                     entities exchange personal health information. The corresponding
                     health-record systems have existing industry-standard information mo-
                     dels that likely differ from the WAN device. This interface describes
                     how healthcare entities can transform the data so that all parts of the
                     larger healthcare systems can collaborate.

           Several wired and wireless standards are available for selection to establish
           connectivity at the various interfaces, as will be described in the following sec-
           tions of the present document.

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Better Breathing healthcare interoperability
through industry standards
           It’s rather difficult to encompass all the communications interfaces that various
           vendors bring to the market using proprietary technologies. Therefore, in order
           to achieve interoperability in the healthcare domain, as much as possible ex-
           isting connectivity standards and guidelines for interoperability should be fol-
           lowed. A vast amount of standards is available from different communities in
           the healthcare domain.

           As indicated in the Figure 02 – The Better Breathing interfaces in the refer-
           ence architecture, the whole range of devices and services within the Better
           Breathing architectural structure is addresses by defining interoperable inter-
           faces. Taking this into account, the process suggested for the Better Breathing
           project to develop interoperability guidelines is centred on the use of industry
           standards applicable to each of these interfaces. The most relevant specifica-
           tions related to each one of the referred interfaces are described as follows.

           PAN interface standards

           As indicated above, the Peripheral Area Network (PAN) Interface connects an
           application hosting device (such a personal computer, cell phone, PDA, set
           top box, etc) to a PAN device (spirometer, heart-rate monitor, etc.). This inter-
           face has both, a lower-layers component, encompassing the classic Open
           Systems Interconnection (OSI) layers 1 to 4, and an upper-layers component
           (encompassing the classic OSI layers 5 to 7).

           The instantiations of the lower OSI layers may include both, wired and wire-
           less links (such as USB and/or Bluetooth based technologies). Regarding the
           upper OSI layers, they can be implemented using the ISO/IEEE 11073-20601
           Optimized Exchange Protocol, which leverages work from ISO/IEEE 11073
           Medical Device Communications working group. A more detailed report on
           each of these links is given in the following.

           Wireless transport

           Wireless Area Networks (WANs) and their supporting information infrastruc-
           tures offer unprecedented opportunities to monitor state of health. These mo-
           bile point-of-care systems are now realizable due to the convergence of tech-
           nologies such as low-power wireless communication standards, plug-and-play
           device buses, handheld computers, electronic medical records, and the Inter-
           net. To increase acceptance of personal monitoring technology, advances
           must be made in interoperability (at both the system and device levels).

           In the Better Breathing architectural structure, several wireless short-range
           communication standards are available for selection so as to establish con-
           nectivity at the PAN Interface. Among them, the IEEE 802.15 (WPAN) family
           of standards has the largest impact on wireless today. Although providing lo-

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           wer data rates than IEEE 802.11, it is mainly the IEEE 802.15 family that fits
           best the requirements of small-scale personal health devices in terms of low
           power consumption and low complexity.

           For the connection of medical devices to the system, the major WPAN tech-
           nologies today (after the activities in IEEE 802.15.3 for high-rate WPAN have
           been abandoned) are IEEE 802.15.1 (better known as Bluetooth), IEEE
           802.15.4 in combination with ZigBee and Wi-Fi, amongst others.

           Bluetooth allows the wireless telemetry between the components in the point-
           of-care environment. In particular, the Bluetooth SIG Medical Devices Working
           Group is tasked with enabling interoperability between Bluetooth-enabled me-
           dical, health and fitness devices, and systems that can aggregate and perform
           operations on device data (such could be data from cellular phones, health
           appliances, set-top boxes, or PCs.) This effort includes the development of a
           profile that allows consumers to easily connect any two devices that support
           the medical device profile. Such devices have unique needs, and this working
           group aims to address those needs through focused representation of the me-
           dical and fitness device industries.

           The other major WPAN technology referred above is IEEE 802.15.4, in com-
           bination with ZigBee on top of it (with IEEE 802.15.4 defining only the physical
           and MAC layer of the OSI stack). Operating in the license-free worldwide
           2.4GHz ISM (Industrial, Scientific and Medical) band, IEEE 802.15.4 operates
           additionally in two less-crowded sub-GHz bands.

           For connections regarding the in-home network, the list includes wireless Et-
           hernet, and power line communications. Last but not least, regarding the
           connectivity from the patient’s home to the back-end services, some relevant
           standard candidates amongst others are: Cable, DSL, Cellular (e.g. GPRS or
           CDMA), WiMax, and POTS.

           Wired transport

           The USB-IF Personal Healthcare Device Working Group is tasked to enable
           personal healthcare devices to seamlessly interoperate with USB hosts. The
           group’s initial goal is to define a USB Personal Healthcare Device Class speci-
           fication. The specification will enable health-related devices, such as blood
           pressure cuffs and exercise watches, to connect via USB to consumer elec-
           tronic products such as PCs and health appliances.

           Interoperability of health-related devices and consumer electronic products will
           facilitate the communication between a patient and a doctor, an individual and
           a fitness coach, or an elderly person and a remote caregiver. For connections
           regarding the in-home network wired Ethernet, and power line communica-
           tions are also included.

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           LAN interface standards

           The Local Area Network (LAN) Interface connects an application hosting de-
           vice (personal computer, set top box, etc) to a LAN device (TV, TDT, etc). This
           means that LANI’s upper layers can support the same device data model as
           the PANI’s upper layers (this is to say, the ISO/IEEE 11073-20601 data mo-
           del). As before, using the same device data model, despite the underlying OSI
           lower-layers communications mechanism, is a key interoperability feature.

           Among the many wireless short-range communication standard activities
           worldwide, the IEEE 802.11 (WLAN) family of standards have the largest im-
           pact on wireless today, providing higher data rates than IEEE 802.15, and tak-
           ing into account that the requirements of LAN devices are also more advanced
           than the ones of small-scale personal health devices in terms of low power
           consumption and low complexity.

           It should also be a main aim to be achieved that the LANI lower layers on In-
           ternet Protocol technology allows to enable different IP-centric communica-
           tions technologies (such as Ethernet and Wi-Fi technologies).

           WAN interface standards

           The Wide Area Network (WAN) Interface connects an application hosting de-
           vice (such a personal computer, cell phone, PDA, set top box, etc) to one or
           more other devices.

           The upper OSI layers of the WAN Interface must use a device data model that
           is compatible with the LAN Interface upper layers’ device data model. It is also
           worthwhile that the WAN Interface lower layers are based on IP technology, to
           enable IP centric communications technologies, such as xDSL, DOCSIS (Da-
           ta over Cable Service Interface Specifications), PPP/POTS (Point-to-Point
           Protocol/Plain Old Telephone Service), GPRS (General Packet Radio Service)
           or EDGE (Enhanced Data Rates for GSM Evolution).

           EHR interface standards

           The PAN, LAN and WAN interfaces and standards referred above basically
           cover the lower OSI layers (physical layers). As pointed out in section
           Interoperability problem in the healthcare domain, the interoperability on appli-
           cation layer requires that devices speak a common language by means of a
           common nomenclature, data types, data exchange protocols, message syn-
           tax, and encoding rules. Therefore, to be able to exchange information among
           heterogeneous healthcare information systems, messaging interfaces must be
           used. Typically, a messaging interface gathers data from the back-end appli-
           cation systems, encodes the data into a message, and transmits the data over
           a network to another application. On the receiver side, the received messages
           are decoded, processed and the data which have been received are fed into
           the receiver’s back-end systems to be stored and processed.

D3.2: Harmonisation, Interoperability and Standard                               Page 17 of 38
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           If proprietary formats were used in messaging, the number of the interfaces to
           be developed would increase drastically. To overcome this potential problem,
           message standards are preferred, which allow that an application can, in
           principle, talk to any other application conforming to the same message stan-
           dard by using the same message interface.

           With all above, to address the Electronic Healthcare Record (EHR) interop-
           erability problem in view of the rising activities in the Better Breathing personal
           healthcare domain, system-level interoperability efforts will have to include the
           development of wearable health status monitoring systems that utilize stan-
           dards that enable upper-layer medical information exchange. The most rele-
           vant standards for the Better Breathing specific healthcare context include:

                •    Health Level 7 (HL7)

                •    HL7 Clinical Document Architecture (CDA)

                •    DICOM (Digital Image COMmunication)

                •    CORBA (for physician-side data access, viewing, and analysis)

                •    ISO 11073/IEEE 1073 family of standards, formerly also referred to as
                     IEEE 1073 – Medical Information Bus (MIB) or x73 standards.

                •    CEN EN 13606 and CEN/TC 251 EHRcom

           These standards aim to structure and mark-up the clinical content for the pur-
           pose of exchange. A description of EHR standards is given in Appendix II:
           Main EHR interoperability standards, which introduces some of the prominent
           EHR standards and then describes how each addresses technical interopera-
           bility layers: messaging layer and content interoperability layer.

           There is also an industry initiative called Integrating the Healthcare Enter-
           prise (IHE), which specified the Cross-Enterprise Document Sharing (XDS)
           integration profile for this purpose. The basic idea of IHE XDS is to store
           healthcare documents in ebXML registry/repository architecture so as to facili-
           tate their sharing.

           DICOM (Digital Image COMmunication) and HL7 (Health Level 7, referring to
           ISO-OSI 7th layer) are the most concrete and operational standards. DICOM is
           a standard for transmitting medical imaging data, including handling, storing
           and printing. HL7 is a comprehensive set of standards for the exchange of
           healthcare information between computer applications.

           Currently, the Health Level 7 (HL7) version 2 Messaging Standard is the
           most widely implemented message interface standard in the healthcare do-
           main. However, being HL7 v2 compliant does not imply direct interoperability
           between healthcare systems. This stems from the fact that version 2 mes-
           sages have no explicit information model, rather vague definitions for many

D3.2: Harmonisation, Interoperability and Standard                                 Page 18 of 38
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           data fields and contain many optional fields. This possibility provides great
           flexibility, but necessitates detailed bilateral agreements among the healthcare
           systems to achieve interoperability. To remedy this problem, Health Level 7
           version 3 has been developed, which is based on an object-oriented data
           model, called Reference Information Model (RIM). It should be noted that
           there is an interoperability problem between HL7 v2.x and HL7 v3 messages,
           as there is no well-defined mapping between HL7 v2.x and v3 ones.

           The ISO/IEEE 11073 Personal Health Data Working Group is defining trans-
           port-independent personal-health data and protocol standards. The group’s
           charter is to provide standards that address transport-independent application
           and information profiles, comprising exchange format, data representation,
           and terminology. As a result, the ISO 11073/IEEE 1073 is a family of stan-
           dards intended to enable medical devices to interconnect and interoperate
           with other medical devices, for plug-and-play interoperability between medical
           monitoring system components. ISO/IEEE 11073 utilizes the CEN TC 251 VI-
           TAL standard for physiologic information representation and access as well as
           a suite of ISO standards.

           Consequently, it is feasible to incorporate interoperability into a WAN infra-
           structure. It should be noted that, while HL7 is the most pervasive standard for
           medical information exchange in the industry, it has not been widely applied to
           point-of-care systems yet, and very few HL7-compliant homecare telemedicine
           systems exist, and HL7 has not yet been applied in systems that incorporate
           WAN technology. It is also worth noting that ISO/IEEE 11073, Health Level 7,
           CORBA, Bluetooth, and ZigBee have sensible mappings to the ISO Open
           System Interconnect model for standardized component interactions.

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 Other interoperability issues to be addressed
           To achieve interoperability within the healthcare domain, in particular, within
           Better Breathing project, further technical issues should also be addressed:

                •    Mapping the patient IDs among different healthcare applications:
                     A key issue in accessing the EHR of a patient is his/her patient identi-
                     fier. Yet different healthcare enterprises or even different departments
                     in a healthcare institute may be using diverse identifiers for the same
                     patient. Some of the possible mechanisms are as follows:

                          o    A central database containing all person identification numbers
                               linked to demographic data.

                          o    Smart card containing personal identification numbers.

                          o    Master Patient Indexes mapping patient identifiers in different
                               systems to each other.

                •    Authenticating the users across the enterprises: The users must be
                     authenticated not only in their own domain but also across enterprises.

                •    Guaranteeing all computers involved to have consistent time: For
                     distributed applications to work correctly, it is essential that the system
                     clocks and time stamps of the many computers in the network are well

                •    Authenticating nodes and obtaining audit trail: Limiting access con-
                     trol to authorized users is not enough. It is necessary to limit network
                     access between nodes and also to each node in a healthcare setting.
                     Furthermore, audit trail is essential. It is necessary to allow a security
                     officer in a healthcare institution to audit activities to detect improper
                     creation, access, modification and deletion of Protected Health Infor-
                     mation (PHI). The audit trail must contain information to answer the fol-
                     lowing questions:

                          o    For some user: which patients’ PHI was accessed?

                          o    For some patient PHI: which users accessed it?

                          o    What user authentication failures were reported?

                          o    What node authentication failures were reported?

                •    Cross-Border interoperability at European level: From all above, it
                     is clear that in order to resolve interoperability at the EU level, the is-
                     sues that need to be addressed include:

D3.2: Harmonisation, Interoperability and Standard                                   Page 20 of 38
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                          o    Providing the interoperability of the various different messaging
                               infrastructures being used.

                          o    Providing the interoperability of the various EHR standards be-
                               ing used.

                          o    Providing the interoperability of various patient identification

                          o    Providing security, privacy and authentication in accessing cli-
                               nical information.

                      Several projects are addressing these issues to propose possible al-
                      ternatives. It is a roadmap project for interoperability of healthcare sys-
                      tems leading to recommendations for actions and to preparatory ac-
                      tions at the European level. This roadmap will prepare the ground for
                      future actions as envisioned in the action plan of the healthcare Com-
                      munication COM 356 by coordinating various efforts on healthcare in-
                      teroperability in member states and the associated states.

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           Personal healthcare systems have the potential to cope with today’s major
           healthcare challenge of improving the quality of care for an increasing number
           of chronically ill patients. Today, there exist a lot of technologies and technol-
           ogy standards, but still being isolated solutions to the overall complex prob-
           lem. However, there is significant activity in industry and standardization or-
           ganizations aiming at enabling real plug-and-play multi-vendor interoperability
           in the personal healthcare ecosystem.

           At the beginning of this deliverable, it was addressed the problem that even
           though standards are vital to achieve effective communication in the net-
           worked society, from a practical point of view, it is often hard to find out what a
           particular standard actually has to offer to achieve “true” interoperability. In this
           deliverable, it has been looked at the role of standards to arrive at interopera-
           bility in a domain specific situation, the Better Breathing healthcare ecosys-
           tem. A framework has been provided to determine the kinds of issues that
           need to be addressed, and what different standards actually fulfil these needs.

           This deliverable has aimed to contribute in two main directions. Firstly, the im-
           portance of adopting a broader definition of interoperability has been stressed,
           spanning beyond the interoperability between technical systems (actual com-
           munications process itself) to the interoperability between socio-technical sys-
           tems (medical protocol negotiation process). Secondly, a framework has been
           exposed focusing the attention on relevant available standards needed to at-
           tain “true” interoperability for the particular Better Breathing project domain.

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Appendix I: The OSI layered model
           When discussing various standards and systems communications protocols, it
           is useful to have an understanding of the OSI model, from which these proto-
           cols are based. OSI (Open System Interconnection) is an ISO standard for
           worldwide communications that defines a framework for implementing com-
           munications protocols in seven layers.

           Communication layers

           While the OSI model serves as a useful teaching model for protocols, there
           are few real world examples of strict implementations of OSI. Most of the func-
           tionality in the OSI model exists in all communications systems, although pro-
           tocols and systems often use a pragmatic mixture of the various layers.

           The seven layers of the OSI model

           The theoretical OSI model is built around the concept of 7 layers. Ideally,
           communication control is passed from one layer to the next, starting at the ap-
           plication layer in the sender's domain. Each layer is insulated from the layers
           above and below, and does not know or care about the workings of other lay-
           ers. The OSI model illustrated in Figure 03 – OSI layered model provides a
           useful mechanism for discussing the application of messaging, even though
           strict adherence to the model is rare in real world.

                                           Figure 03 – OSI layered model

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           Each layer consists of the following:

               Layer    Name                Description
                                            This layer supports application and end-user processes.
                                            Communication partners are identified, quality of service
                                            is identified, user authentication and privacy are consid-
                                            ered, and any constraints on data syntax are identified.
                                            Everything at this layer is application specific. This layer
               7        Application         provides application services for file transfers, email,
                                            and other network software services. Telnet and FTP
                                            are applications that exist entirely in the application
                                            level. Tiered application architectures are part of this
                                            layer. HL7 is primarily focussed at this layer, however
                                            also crosses into lower layers.
                                            This layer provides independence from differences in
                                            data representation (e.g., encryption) by translating from
                                            application to network format, and vice versa. The pres-
                                            entation layer works to transform data into the form that
               6        Presentation
                                            the application layer can accept. This layer formats and
                                            encrypts data to be sent across a network, providing
                                            freedom from compatibility problems. It is sometimes
                                            called the syntax layer.
                                            This layer establishes, manages and terminates con-
                                            nections between applications. The layer sets up, coor-
               5        Session             dinates, and terminates conversations, exchanges, and
                                            dialogues between the applications at each end. It deals
                                            with session and connection coordination.
                                            This layer provides transparent transfer of data between
                                            end systems or hosts, and is responsible for end-to-end
               4        Transport
                                            error recovery and flow control. It ensures complete
                                            data transfer.
                                            This layer provides switching and routing technologies,
                                            creating logical paths, known as virtual circuits, for
                                            transmitting data from node to node. Routing and for-
               3        Network
                                            warding are functions of this layer, as well as address-
                                            ing, inter-networking, error handling, congestion control
                                            and packet sequencing.
                                            At this layer, data packets are encoded and decoded
                                            into bits. It furnishes transmission protocol knowledge
                                            and management and handles errors in the physical
                                            layer, flow control and frame synchronization. The data
                                            link layer is divided into two sub-layers: The Media Ac-
               2        Data Link
                                            cess Control (MAC) layer and the Logical Link Control
                                            (LLC) layer. The MAC sub-layer controls how a com-
                                            puter on the network gains access to the data and per-
                                            mission to transmit it. The LLC layer controls frame syn-
                                            chronization, flow control and error checking.
                                            This layer conveys the bit stream - electrical impulse,
                                            light or radio signal -- through the network at the electri-
                                            cal and mechanical level. It provides the hardware
               1        Physical            means of sending and receiving data on a carrier, in-
                                            cluding defining cables, cards and physical aspects.
                                            Fast Ethernet, RS232, and ATM are protocols with
                                            physical layer components

                                Table 01 – The seven layers of the OSI model

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Appendix II: Main EHR interoperability standards
           This appendix introduces and provides an overview of some of the prominent
           EHR (Electronic Healthcare Records) standards that address the interopera-
           bility within a healthcare domain. It is also described how each EHR standard
           addresses the technical interoperability layers: messaging and content layers.

           The GEHR / OpenEHR initiative

           The most noteworthy concept introduced by GEHR / OpenEHR is the “arche-
           type" concept. This approach uses a two-level methodology to model the EHR
           structure. In the first level, a generic reference model (specific to the health-
           care domain but still very general) is developed. This model typically contains
           only a few classes (e.g. role, act, entity, participation), and must be stable over
           time. In the second level, healthcare and application specific concepts (such
           as blood pressure, lab results etc.) are modelled as archetypes.

           An archetype definition basically consists of three parts: descriptive data, con-
           straint rules and ontological definitions. The descriptive data contains a unique
           identifier for the archetype, a machine-readable code describing the clinical
           concept modelled by the archetype, and various metadata such as author,
           version, and purpose. The constraint rules are the core of the archetype and
           define restrictions on the valid structure, cardinality and content of EHR record
           component instances complying to the archetype. The ontological part defines
           the controlled vocabulary (that is, the machine readable codes) that can be
           used in specific places in instances of the archetype. It may contain language
           translations of code meanings and bindings from the local code values used
           within the archetype to external vocabularies such as SNOMED or LOINC. It
           may also define additional constraints on the relationship between coded en-
           tries in the archetype based on the code value.

           CEN/TC 251 and ENV/EN 13606 EHRcom

           The CEN standard ENV 13606:2000 “Electronic Healthcare Record Commu-
           nication" is a message-based standard for the exchange of electronic health-
           care records. EN 13606, called EHRcom is a five-part standard consisting of:

                •    The Reference Model.

                •    Archetype Interchange Specification.

                •    Reference Archetypes and Term Lists.

                •    Security Features.

                •    Exchange Models (communication protocol).

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           The standard defines a list of machine-readable domain terms that can be
           used to structure EHR content, a method of specifying “distribution rules", that
           is, rules under which certain EHR content may be shared with other systems
           and, finally, request and response messages that allow systems to exchange
           subsets of an HER.

           HL7 Clinical Document Architecture (CDA)

           CDA is organized into three levels. Each level iteratively adds more mark-up
           to clinical documents, although the clinical content remains constant at all lev-
           els. “Level One" focuses on the content of narrative documents. It consists of
           two parts, the CDA Header and the CDA Body, which are based on the HL7
           data types. The document header is derived from RIM and unambiguously de-
           fines each entry in the document. The body contains the clinical document
           content, and can be either an unstructured text or can be comprised of nested
           containers such as sections, paragraphs, lists, and tables through structured
           mark-up. Hence there is no semantics in Level One body; it offers interopera-
           bility only for human-readable content. In fact, CDA Level One describes a
           kind of HTML document with a standardized header that contains additional
           information on the document.

           Level Two CDA models the fine-grained observations and instructions within
           each heading through a set of RIM Act classes. With Level Two, it is possible
           to constrain both structure and content of a document by means of a template
           and thereby increase interoperability since the receiver “knows what to ex-
           pect". However, a completely structured document where the semantics of
           each information entity is specified by a unique code will only be possible with
           Level Three providing for machine processing.

           IHE Cross-Enterprise Document Sharing (XDS)

           The basic idea of IHE XDS is to store healthcare documents in an ebXML reg-
           istry/repository to facilitate their sharing. IHE XDS is not concerned with do-
           cument content; it only specifies metadata to facilitate discovery of documents.

           In the IHE XDS integration profile, a group of healthcare enterprises that agree
           to work together for clinical document sharing is called the “Clinical Affinity
           Domain". Such institutes agree on a common set of policies such as how the
           patients are identified, the consent is obtained, the access is controlled, and
           the common set of coding terms to represent the metadata of the documents.

           As already mentioned, IHE XDS handles healthcare documents in a content
           neutral way, that is, a document may include any type of information in any
           standard format such as simple text, formatted text (e.g., HL7 CDA Release
           One), images (e.g., DICOM) or structured and vocabulary coded clinical in-
           formation (e.g., CDA Release Two, CEN ENV 13606 or DICOM SR). Given
           this, to ensure the interoperability between the document sources and the do-
           cument consumers, the clinical affinity domains also agree on the document
           format, the structure and the content.

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           IHE Cross-Enterprise Sharing of Medical Summaries

           Cross-Enterprise Sharing of Medical Summaries (XDS-MS) is a mechanism to
           automate sharing of medical summaries between care providers. The main
           characteristics of XDS-MS are as follows:

                •    XDS-MS Profile uses actors and transactions of IHE XDS. Only docu-
                     ment types used in XDS-MS are more specific medical summaries.

                •    Two types of medical summary content are currently specified: one for
                     episodic care, the other for collaborative care.

                •    XDS-MS specifies content of medical summaries by building and fur-
                     ther constraining the HL7 Clinical Document Architecture (CDA) stan-
                     dard and Care Record Summary (CRS) CDA implementation guides.

                •    Document sources provide an XML style sheet to render the content of
                     the medical summary document.

                •    Medical summaries are shared within predefined domains (called XDS
                     Affinity Domains) by storing the medical summaries in Registry Reposi-
                     tories. Note however that IHE also plans the federated XDS Affinity
                     domains. Therefore, the exchange of medical documents will not be
                     restricted to XDS Affinity Domains in the near future.

                •    Registry/Repository architectures facilitate the discovery of the medical
                     summaries in an XDS Affinity Domain.

           IHE Retrieve Information for Display (RID)

           Retrieve Information for Display (RID) provides a simple and rapid read-only
           access to patient-centric clinical information that is located outside the user's
           current application. It supports access to existing persistent documents in well-
           known presentation formats such as CDA Level One, PDF and JPEG. It also
           provides access to specific key patient-centric information such as allergies,
           current medications, and summary of reports for presentation to a clinician.

           IHE defined RID as a Web service by providing its WSDL (Web Service De-
           scription Language) description with a binding to HTTP GET.

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Appendix III: Standards list
           This compilation collects the most important standards in all technical and
           non-technical areas of healthcare.

            Category                Organisation     Name       Description
                                                                Specification for transferring neuro-
            Electronic Health                                   physiologic data between independ-
            Record                                              ent computer Systems. Defines how
                                    ASTM             E1467
                                                                vital signals such as EEG should be
                                                                stored. It has not been used in fa-
                                                                vour of VITAL.
                                                                Standard guide for description of
                                                                reservation, registration, admission,
                                                                discharge, transfer systems for Elec-
                                                                tronic Health Record (EHR) Sys-
                                    ASTM             E1239-00
                                                                tems. This guide identifies the mini-
                                                                mum information capabilities needed
                                                                by an ambulatory care system or a
                                                                resident facility R-ADT system.
                                                                Standard guide for content and
                                                                structure of the Electronic Health
                                                                Record (EHR). This guide covers all
                                                                types of healthcare services, includ-
                                                                ing those given in acute care hospi-
                                                                tals, nursing homes, skilled nursing
                                                                facilities, home healthcare, and spe-
                                    ASTM             E1384-02
                                                                cialty care environments as well as
                                                                ambulatory care. They apply both to
                                                                short term contacts (for example,
                                                                emergency rooms and emergency
                                                                medical service units) and long term
                                                                contacts (primary care physicians
                                                                with long term patients).
                                                                Standard guide for view of emer-
                                                                gency medical care in the computer-
                                                                ized-based patient record. It ad-
                                                                dresses the identification of the in-
                                    ASTM             E1744-98   formation that is necessary to docu-
                                                                ment emergency medical care in a
                                                                computerized patient record that is
                                                                part of a paperless patient record
                                                                An object-oriented model for regis-
                                                                tration, admitting, discharge, and
                                                                transfer functions in computer-based
                                                                patient record Systems. Details the
                                                                objects that make up the reserva-
                                    ASTM             E1715-01   tion, registration, admitting, dis-
                                                                charge, and transfer functional do-
                                                                main of the computer-based record
                                                                of care. It is intended to amplify
                                                                guide E1239 with an object-oriented

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            Category                Organisation     Name           Description
                                                                 Standard guide for properties of a
                                                                 Universal Healthcare Identifier. This
                                                                 guide covers a set of requirements
                                                                 outlining the properties of a national
                                    ASTM             E1714-00
                                                                 system creating a universal health
                                                                 care identifier (UHID). Use of the
                                                                 UHID is expected to be limited to the
                                                                 population of the United States.
                                                                 This standard is the European con-
            Imaging                                              tribution to the well-known DICOM.
                                                     MEDICOM     Used in imaging communication
                                                     (EN12052)   (see DICOM). EN 12052 supersedes
                                                                 the former ENV 12052, ENV12623
                                                                 and ENV12922-1.
                                                                 Profiles for medical image inter-
                                                                 change. Provides the set of profiles
                                                                 for a given user scenario. Defines
                                    CEN              CR12069
                                                                 greyscale, colour, volumetric and
                                                                 time sequences. CR 12069 is not a
                                                                 mandatory standard, it is a report.
                                                                 Proposes a classification for five
                                    FDA              63 FR 64998 types of medical image management
                                                                 Standard for electronic filing of me-
                                                     MDS A 0001 dical images with security, compati-
                                                     – 0017      bility and reproducibility. It is a Japa-
                                                                 nese standard.
                                                                 DICOM (Digital Imaging and COM-
                                                                 munications in Medicine) defines the
                                                                 coding of medical images, the proto-
                                                                 cols of interchange between both
                                                                 sides and a security policy to hide
                                                     DICOM 3.0
                                    NEMA                         information from third people. Used
                                                                 in computer tomography, image
                                                                 archives, telediagnostic, EEG, ECG.
                                                                 DICOM 3.0 has added waveform
                                                                 support to allow EEG and ECG in-
                                                                 Medical record, image, text - infor-
                                                                 mation Exchange. It is related to the
                                                                 information exchange between dif-
                                    JAMI             MERIT-9
                                                                 ferent medical providers. The previ-
                                                                 ous version used SGML. It is a
                                                                 Japanese standard.
                                                                 Healthcare Information System Ar-
            Infrastructure                                       chitecture (HISA). Describes the
            Architecture                                         Healthcare Information System Ar-
                                                                 chitecture (HISA), which is a descrip-
                                    CEN              ENV12967
                                                                 tion of the middleware layer used in
                                                                 healthcare. Used in implementations
                                                                 in Denmark. It is described with dia-

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            Category                Organisation     Name       Description
                                                                Healthcare Information Framework
                                                                (HIF). Creates a basic framework to
                                                                guide healthcare informatics devel-
                                                                opers. It is a first step in standardis-
                                    CEN              ENV12443   ing the architectures that will support
                                                                the latest approaches to the delivery
                                                                of computer systems such as are
                                                                required to provide the global infor-
                                                                Identification, administrative, and
                                                                common clinical data structure for
                                                                ICDs. This standard proposes a
                                                                standardised framework for data
                                                                structures used with respect to In-
                                                                termittently    Connected       Devices
                                    CEN              ENV12018
                                                                (ICDs). An ICD is a device that sto-
                                                                res and transmits person related
                                                                data in such a fashion that the origi-
                                                                nator of the information may not
                                                                receive confirmation of receipt by the
                                                                Interoperability of Healthcare Sys-
                                                                tems and Networks. Addresses the
                                                                interoperability of healthcare sys-
                                    ISO              DTR16056
                                                                tems and networks. Part 2 of the
                                                                standard is related to real-time e-
                                                                Health systems.
                                                                Provides interoperability of health-
            Knowledge Man-                                      care multimedia report systems. It is
                                    CEN              CR14300
            agement                                             not mandatory. It is a recommenda-
                                                                Electronic healthcare record com-
                                                                munication. Purposes a scheme to
                                                                define a healthcare record in order
                                                                the information is recognizable and
                                                                understandable in different applica-
                                                                tions. Used in EHR products. It is
                                    CEN              ENV13606   divided in four parts:
                                                                     • Part 1: Extended architec-
                                                                     • Part 2: Domain term list
                                                                     • Part 3: Distribution rules
                                                                     • Part 4: Messages for the ex-
                                                                         change of information.
                                                                Standard guide for individual rights
                                                                regarding health information. This
                                                                guide outlines the rights of individu-
            Knowledge man-
                                                                als, both patients and providers,
            agement and             ASTM             E1987-98
                                                                regarding health information and
                                                                recommends procedures for the
                                                                exercise of those rights. This guide
                                                                is intended to amplify Guide E1869.
                                                                Computer-assisted           electrocardi-
            Medical Device                                      ography. This standard has been
            Communication           CEN              ENV1064    taken up worldwide, not only by Eu-
                                                                ropean countries. Used in ECG Ma-

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            Category                Organisation     Name         Description
                                                                  Medical Data Interchange: HIS/RIS-
                                                                  PACS and HIS/RIS. Describes the
                                    CEN              ENV13939
                                                                  interchange      of   sanitary   data.
                                                                  HIS/RIS-PACS and HIS/RIS.
                                                                  Interoperability of patient connected
                                                                  medical devices. The standard sets
                                                                  up the basis of interoperability
                                                                  among patient connected devices
                                                                  taking account of VITAL standard to
                                    CEN              ENV13735     achieve device and signal interop-
                                                                  erability. Used in medical devices.
                                                                  This standard and VITAL standard
                                                                  are designed to work together. Each
                                                                  one specifies a level of interoperabil-
                                                                  Point-of-care medical device com-
                                                                  munication. Efforts are underway to
                                    IEEE                          add standards for enabling internet-
                                                                  working of medical devices across a
                                                                  Point-of-care medical device com-
                                                     IEEE         munication – Application Profiles –
                                                     1073.2.1.2   MIB Elements. MIB Element defini-
                                                                  tions from the revised DIM standard.
                                                                  Medical Device Communications –
                                                                  Transport Profile – IrDA Based –
                                                                  Cable Connected. Describes the
                                                                  IrDA-based, RS-232, cable con-
                                                                  nected transport between devices
                                                                  connectivity. It also set up the basis
                                    IEEE                          for firmware upgrades for medical
                                                                  devices. Used in medical devices.
                                                                  This new transport profile offers a
                                                                  key advantage in fostering imple-
                                                                  mentation and adoption of the IEEE
                                                                  1073 Medical Information Bus Stan-
                                                                  Point-of-care medical device com-
                                                                  munication – Application profile –
                                                                  Optional package, remote control.
                                                     ISO11073-    Describes an optional application
                                                     20301        profile optional packages for remote
                                                                  control. Some functions are similar
                                                                  or complement the European stan-
                                                                  dard ENV13735.
                                                                  HL7 Version 2.5. Old HL7 standards
            Messages                                              were focused on medical information
                                                                  exchange. With the addition of XML
                                                                  support, multimedia capabilities are
                                    ANSI             HL7v2.XML
                                                                  now reliable. Used in medical infor-
                                                                  mation Exchange. Better support for
                                                                  imaging has been introduced com-
                                                                  pared with the previous ones.

D3.2: Harmonisation, Interoperability and Standard                                           Page 31 of 38
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            Category                Organisation     Name       Description
                                                                Standard Specification for Transfer-
                                                                ring Digital Waveform Data Between
                                                                Independent Computer Systems.
                                    ASTM             E1713-95   This standard defines transferring
                                                                digital waveform data between inde-
                                                                pendent computer systems. It is also
                                                                an ANSI approved standard.
                                                                Messages for the exchange of in-
                                                                formation on medicine prescriptions.
                                                                Specifies a message, called pre-
                                                                scription dispensing report message,
                                    CEN              ENV13607   containing information about pre-
                                                                scription items that is sent from the
                                                                dispensing agent to any other party
                                                                that is legally permitted to receive
                                                                such message.
                                                                Messages for the exchange of
                                                                healthcare administrative informa-
                                                                tion. Specifies messages for the
                                                                exchange of healthcare administra-
                                    CEN              ENV12612
                                                                tive information to provide safe, effi-
                                                                cient and effective healthcare deliv-
                                                                ery within hospitals and in primary
                                                                Messages for exchange of labora-
                                                                tory information. Provides a com-
                                                                plete implementable specification of
                                                                the laboratory messages by imple-
                                                                mentation guidelines to supplement
                                    CEN              ENV1613    the message definitions. It also pro-
                                                                vides comprehensive data and struc-
                                                                tured tables. These coding schemes
                                                                are commonly used to provide pre-
                                                                cise and unambiguous representa-
                                                                tion of the data.
                                                                Messages for Patient Referral and
                                                                Discharge. It refers to referral and
                                                                discharge but also covers the re-
                                                                quest for specialist services and the
                                                                reports by the specialist service pro-
                                    CEN              ENV12538
                                                                vider, including clinic letters and
                                                                discharge summaries. Graphical or
                                                                image information that forms part of
                                                                a request for or report of a specialist
                                                                healthcare service is excluded.
                                                                Request and Report Messages for
                                                                Diagnostic Services Departments. It
                                                                provides the description of the scope
                                                                of the messages and its functionality
                                                                and implementation guidelines for
                                                                different scenarios. Used in X-rays,
                                    CEN              ENV12539
                                                                CAT, NMR, ultrasound scans,
                                                                ECGs, lung-function tests, anatomic
                                                                pathology and nuclear medicine.
                                                                The scope is limited to character-
                                                                based messages, therefore is not
                                                                related to multimedia.

D3.2: Harmonisation, Interoperability and Standard                                         Page 32 of 38
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            Category                Organisation     Name       Description
                                                                Interoperability and compatibility in
                                                                messaging and communication stan-
                                                                dards -- Key characteristics. De-
                                                                scribes a set of key characteristics to
                                                                achieve interoperability and com-
                                                                patibility in trusted health information
                                                                interchange between communicant
                                    ISO                         application systems. The key char-
                                                                acteristics describe inter-application
                                                                interoperability needs of the health-
                                                                care community, in particular the
                                                                subject of care, the healthcare pro-
                                                                fessional, the healthcare provider
                                                                organization, its business units and
                                                                the integrated data.
                                                                Clinical analyser interfaces to labo-
                                                                ratory information Systems. Speci-
                                                                fies general messages for electronic
                                                                information exchange between ana-
                                                                lytical instruments and laboratory
            Messages and
                                                                information systems within a clinical
            Medical Device          ISO              ISO18812
                                                                laboratory. Covers the specification
                                                                of messages used by communicat-
                                                                ing parties and the syntax in which
                                                                they are communicated. It does not
                                                                cover the transport mechanisms
                                                                used for the message interchange.
                                                                Safety and Security Related Soft-
            Security                                            ware Quality Standards for Health-
                                                                care. They propose several quality
                                    AENOR                       norms related to security and protec-
                                                                tion in e-Health software. It associ-
                                                                ates the system type with the appro-
                                                                priate security measures.
                                                                Standard Practice for Healthcare
                                                                Certificate Policy. Addresses the
                                                                policy for digital certificates that sup-
                                                                port the authentication, authoriza-
                                                                tion, confidentiality, integrity, and
                                                                non-repudiation requirements of
                                    ASTM             E2212-02   persons and organizations that elec-
                                                                tronically create or transact health
                                                                information. There are 3 types of
                                                                certificate: one for computerized
                                                                entities, one for individual person
                                                                and the last one for clinical individu-
                                                                Standard Guide for Properties of
                                                                Electronic Health Records and Re-
                                                                cord Systems. The standard defines
                                    ASTM                        a document structure for use by
                                                                electronic signature mechanisms
                                                                and the characteristics of the elec-
                                                                tronic signature itself.

D3.2: Harmonisation, Interoperability and Standard                                          Page 33 of 38
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            Category                Organisation     Name        Description
                                                                 Specification for management of the
                                                                 confidentiality and security of dicta-
                                                                 tion, transcription, and transcribed
                                                                 health records. It describes certain
                                                                 steps that shall be taken by those
                                                                 involved in the processes of dictation
                                    ASTM             E1902-02    and transcription of healthcare do-
                                                                 cumentation. It also seeks to identify
                                                                 certain dictation and transcription
                                                                 practices that may increase the risks
                                                                 of infringing on privacy and violating
                                                                 security of healthcare documenta-
                                                                 Standard guide on security frame-
                                                                 work for healthcare information.
                                                                 Describes a framework for the pro-
                                                                 tection of healthcare information. It
                                    ASTM             E2085-00a   addresses both storage and trans-
                                                                 mission of information. It makes use
                                                                 of well-known security algorithms
                                                                 such as SHA-1, triple-DES and oth-
                                                                 Standard guide for information ac-
                                                                 cess privileges to health information.
                                                                 This guide covers the process of
                                                                 granting and maintaining access
                                    ASTM             E1986-98    privileges to health information. It
                                                                 directly addresses the maintenance
                                                                 of confidentiality of personal, pro-
                                                                 vider, and organizational data in the
                                                                 healthcare domain.
                                                                 Standard Specification for Authenti-
                                                                 cation of Healthcare Information
                                                                 Using Digital Signatures. This speci-
                                                                 fication covers the use of digital sig-
                                                                 natures to provide authentication of
                                                                 healthcare information, as described
                                                                 in Guide E 1762. It describes how
                                                                 the components of a digital signature
                                    ASTM             E2084-00
                                                                 system meet the requirements
                                                                 specified in Guide E 1762. This in-
                                                                 cludes specification of allowable
                                                                 signature and hash algorithms,
                                                                 management of public and private
                                                                 keys, and specific formats for keys,
                                                                 certificates, and signed healthcare
                                                                 Algorithm for Digital Signature Ser-
                                                                 vices in Health Care. Defines the
                                                                 algorithm used for digital signatures
                                                                 in medicine information exchange. It
                                    CEN              ENV12388
                                                                 is required to achieve legal accept-
                                                                 ability of the information exchange.
                                                                 UNE-ENV 12388 is the Spanish
                                                                 equivalent standard.

D3.2: Harmonisation, Interoperability and Standard                                          Page 34 of 38
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            Category                Organisation     Name       Description
                                                                Security for healthcare Communica-
                                                                tions. Defines concepts for secure
                                    CEN              ENV13608   systems. Besides that, secure data
                                                                objects and secure data channels
                                                                are addressed.
                                                                Management and security of authen-
                                                                tication by passwords. It addresses
                                                                the management and security of
                                    CEN              ENV12251
                                                                authentication by passwords. Some-
                                                                times is mandatory to fulfil legal is-
                                                                Standard Specification for Health-
            Standards Meth-                                     care Document Formats. Defines
            odology                                             requirements for the headings, ar-
                                                                rangement, and appearance of sec-
                                                                tions and subsections when used
                                    ASTM             E2184-02
                                                                within healthcare documents. Use of
                                                                this specification in conjunction with
                                                                XML DTDs and the EHR (Electronic
                                                                Health Records) would further en-
                                                                hance efficiency in time and cost.
                                                                Standard specification for clinical
                                                                XML DTDs in healthcare. This guide
                                                                provides a compendium of informa-
                                                                tion for the use of E2183 XML DTDs
                                    ASTM             E2185-02   within health care. This guide de-
                                                                scribes design considerations, the
                                                                architecture of the DTDs, and im-
                                                                plementing systems using the E2183
                                                                Standard guide for identification and
                                                                establishment of a quality assurance
                                                                program for medical transcription. It
                                                                establishes a quality assurance pro-
                                                                gram for dictation, medical transcrip-
                                                                tion, and related processes. Quality
                                    ASTM             E2117-00   assurance is necessary to ensure
                                                                the accuracy of healthcare docu-
                                                                mentation. This guide establishes
                                                                essential and desirable elements for
                                                                quality healthcare documentation,
                                                                but it is not purported to be an ex-
                                                                haustive list.
                                                                Registration of information objects
            Terminology                                         used for EDI in healthcare. Defines
                                                                the registration of information ob-
                                                                jects used for EDI in healthcare for
                                                                the purpose of information inter-
                                                                change related to healthcare. It has
                                    CEN              ENV12537   two parts.
                                                                     • Part 1: The Register
                                                                     • Part 2: Procedures for the
                                                                          registration of information
                                                                          objects used for electronic
                                                                          data interchange (EDI) in

D3.2: Harmonisation, Interoperability and Standard                                        Page 35 of 38
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            Category                Organisation     Name        Description
                                                                 Medical Informatics Vocabulary (MI-
                                                                 Voc). Defines the Medical Informat-
                                                                 ics Vocabulary, which is a founda-
                                    CEN              env 12017
                                                                 tion for the development of a vo-
                                                                 cabulary of terms used in Medical
                                                                 Categorical structures of systems of
                                                                 concepts - Model for representation
                                                                 of semantics. The standard provides
                                                                 the vocabulary and the guidelines to
                                                                 describe the categorical structure of
                                                                 a concept system: the structure con-
                                                                 sists in practice of a list of involved
                                                                 categories with reference to the
                                    CEN              ENV12264
                                                                 available authoritative sources for
                                                                 detailed value. Medical Informatics
                                                                 deals with a great number of large,
                                                                 overlapping coding systems that are
                                                                 facing each other and conflicting in
                                                                 the coming Integrated Healthcare
                                                                 Information Environment. This stan-
                                                                 dard tries to solve these conflicts.
                                                                 Time Standards for Healthcare Spe-
                                                                 cific Problems. Provides a set of
                                                                 basic entities, with precisely defined
                                    CEN              ENV12381    properties and interrelationships
                                                                 among them, that is sufficient to
                                                                 allow an unambiguous representa-
                                                                 tion of time-related expressions.
                                                                 Logical Observation Identifiers Na-
                                                                 mes and Codes. The purpose of the
                                                                 LOINC database is to facilitate the
                                                                 exchange and pooling of results,
                                                                 such as blood haemoglobin, serum
                                                                 potassium, or vital signs, for clinical
                                    Regenstrief                  care, outcomes management, and
                                    Institute                    research. Used in US healthcare
                                                                 Framework. The Regenstrief Insti-
                                                                 tute provides mapping utility called
                                                                 the Regenstrief LOINC Mapping
                                                                 Assistant (RELMA) to facilitate
                                                                 searches through the LOINC data-
                                                                 Specification for relationship be-
            User Interfaces                                      tween a person and a supplier of an
                                                                 electronic personal health record.
                                                                 This specification covers the rela-
                                                                 tionship between a consumer, or-
                                                                 ganization or custodian and a man-
                                    ASTM             E2211-02
                                                                 aging organization (such as a web
                                                                 site or other organization). This
                                                                 specification will not address per-
                                                                 sonal health records (PCHR) that
                                                                 are created and managed by pa-
                                                                 tients on paper records.

D3.2: Harmonisation, Interoperability and Standard                                          Page 36 of 38
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            Category                Organisation     Name          Description
                                                                VITAL specifies a common repre-
                                                                sentation of vital signs information. It
                                                     VITAL      is non-device dependent. Used in
                                                     (ENV13734) medical device communication. It
                                                                was specially created for real time
                                                                Clinical Context Object Workgroup
                                                                Version 1.5. CCOW V1.0 defined the
                                                                overall technology-neutral context
                                                                management architecture (CMA), a
                                                                core set of data definitions, rules for
                                    HL7              CCOWV1.5
                                                                application user interfaces, and the
                                                                translation of the CMA to Microsoft’s
                                                                COM/ActiveX technology. This ver-
                                                                sion also support technology map-
                                                                ping to SOAP.
                                                                Ergonomics requirements for office
                                                                work with visual display terminals. Its
                                    ISO              ISO9241    main purpose is to set up a user-
                                                                friendly environment for general
                                                                applications (including e-Health).

                                               Table 02 – Standards list

D3.2: Harmonisation, Interoperability and Standard                                           Page 37 of 38
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            [01] DVB-Scene. Tune into Digital Convergence. The Standard for the Digital
                 World. Edition No. 16 December 2005.

           [02] Identification of different types of standards for domain-specific interop-
                erability. Robert A. Stegwee and Boriana D. Rukanova. Department of
                Business Information Systems. University of Twente.

           [03] Health Level Seven. EHR Interoperability Work Group. February 7,
                2007. Patricia Gibbons, Noam Arzt, PhD, Susie Burke-Beebe, Chris
                Chute, MD DrPH, Gary Dickinson, Tim Flewelling, Thomas Jepsen, Don
                Kamens, MD, Joanne Larson, John Ritter, Michael Rozen, MD, Sherry
                Selover and Jean Stanford.

           [04] Key Issues of Technical Interoperability Solutions in healthcare and the
                RIDE Project. Asuman Dogac, Tuncay Namli, Alper Okcan, Gokce Lale-
                ci, Yildiray Kabak and Marco Eichelberg. Software R&D Center, Dept. of
                Computer Eng., Middle East Technical University 06531, Ankara, Turkey

           [05] The EHR (Electronic Health Records) Standards: an Overview. Gerard
                Freriks. EuroRecord, October-2006.

           [06] Continua: An Interoperable Personal Healthcare Ecosystem. Randy Car-
                roll, Rick Cnossen, Mark Schnell, and David Simons. Vol. 6, No. 4. Oc-
                tober–December 2007. IEEE Computer Society.

           [07] System Interoperability Study for Healthcare Information System with
                Web Services. J.K. Zhang and W. Xu, D. Ewins. Centre for Biomedical
                Engineering, School of Engineering, Surrey University, UK. Journal of
                Computer Science 3 (7): 515-522, 2007.ISSN 1549-3636.

           [08] Towards Plug-and-Play Interoperability for Wireless Personal Healthcare
                Systems. L. Schmitt, T. Falck, F. Wartena, and D. Simons. Philips Re-
                search Europe.

           [09] Interoperability and Security in Wireless Body Area Network Infrastruc-
                tures. Steve Warren, Jeffrey Lebak, Jianchu Yao, Jonathan Creekmore,
                Aleksandar Milenkovic and Emil Jovanov. Department of Electrical &
                Computer Engineering, Kansas State University, Manhattan, KS, USA.

           [10] IST- 27074 SAPHIRE. “Intelligent Healthcare Monitoring based on a
                Semantic Interoperability Platform”. Strengthening the Integration of the
                ICT research effort in an Enlarged Europe Focus: healthcare. Develop-
                ing Security Mechanisms for sensor networks.

D3.2: Harmonisation, Interoperability and Standard                              Page 38 of 38

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