IHE in Surgery - Proposal for a new IHE domain

IHE in Surgery - Proposal for a new IHE domain Release 1.0 Oliver Burgert 1, Thomas Treichel 1 and Stefan Bohn 1 Abstract 2010-08-15 1 Innovation Center Computer Assisted Surgery (ICCAS) Universität Leipzig Semmelweisstr. 14 04103 Leipzig Germany IHE (Integrating the Healthcare Enterprise) gives guidelines on which standards in medicine shall be used in which way to achieve a specific goal. Therefore, IHE can serve as a basis to promote the usage of open standards in Computer Assisted Interventions. The paper motivates the usage of IHE in Surgery and Computer Assisted Therapy and gives examples of first IHE supplements based on already existing DICOM Supplements. An outlook on the possible focus of IHE in Surgery is given. Contents 1 Introduction to IHE 2 2 Motivation for using Standards within Surgical Assist Systems 4 3 Existing IHE Integration Profiles applicable for Image and Model Guided Therapy 4 4 Is there a need for a new IHE Domain Surgery? 6 5 Extending IHE Short Term Efforts 7 6 Extending IHE Mid-Term and Long-Term Ideas 7 7 Conclusion 7

2 1 Introduction to IHE Integrating the Healthcare Enterprise (IHE)] is an initiative by healthcare professionals and industry to improve the way computer systems in healthcare share information. IHE promotes the coordinated use of established standards such as DICOM and HL7 to address specific clinical need in support of optimal patient care. This self-image of IHE taken from the IHE Website [1] gives a good introduction to the philosophy behind the IHE Initiative: It does not aim on creating a standard by itself, but provides cookbooks giving guidelines on how existing standards or industry solutions shall be used in order to achieve a specific goal. IHE is not limited to DICOM or HL7, as an example it selected the Network Time Protocol (NTP) [2] as a basis for the Consistent Time Integration Profile (CT) [3], which defines mechanisms to synchronize the time base between multiple actors and computers. In the recent years, IHE is of growing importance as a growing number of health care institutions is requesting IHE conformance (asserted by so called Integration Statements ) of hospital IT systems as part of their tendering processes. From an industry standpoint, IHE is a valuable platform to test interoperability of systems and to focus on one single standard or a specific interpretation of a standard. Thus, IHE accelerates implementations and leads to qualitative better solutions. IHE is structured in Domains ; the IHE documents are organized in Technical Frameworks. Each Domain maintains a corresponding Technical Framework. An IHE Technical Frameworks defines specific implementations of established standards by Integration Profiles (IP). Table 1 lists the existing Domains, the sponsoring organization, and the number of Integration Profiles defined by their technical frameworks. Figure 1 gives an overview of the IHE processes. Table 1: IHE domains, sponsoring organizations and Integration Profiles developed by those domains, valid August 2010. IHE Domain Sponsor(s) # IPs (final/trial/develop) IHE Anatomic Pathology (PATH) Organization for the Modernization of French Hospital Information Systems (GMSIH), French Association for the Development of Informatics in Pathology (ADICAP), Spanish Health Informatics Society (SEIS), Spanish Society of Pathology (SEAP), French Society of Pathology)(SFP) 0 / 3 / 0 IHE Cardiology (CARD) American College of Cardiology (ACC) 4 / 2 / 0 IHE Eyecare (EYE) American Academy of Ophthalmology (AAO) 4 / 0 / 0 IHE IT Infrastructure (ITI) IHE Laboratory (LAB) IHE Patient Care Coordination (PCC) Health Information Management Systems Society (HIMSS) College of American Pathologists (CAP), Japanese Association of Healthcare Information Systems Industry (JAHIS) Health Information Management Systems Society (HIMSS), 13 / 1 / 0 6 / 1 / 0 3 / 6 / 3

3 IHE Patient Care Device (PCD) IHE Pharmacy (PHARM) IHE Quality, Research and Public Health (QRPH) American College of Physicians (ACP) American College of Clinical Engineering (ACCE), Health Information Management Systems Society (HIMSS) European Association of Hospital Pharmacists (EAHP), Nictiz, Réseau Phast Health Information Management Systems Society (HIMSS), Radiological Society of North America (RSNA) 0 / 1 / 0 0 / 0 / 2 0 / 0 / 0 IHE Radiation Oncology (RO) American Society for Radiation Oncology (ASTRO) 0 / 3 / 0 IHE Radiology (RAD) Radiological Society of North America (RSNA) 12 / 5 / 0 An IHE Domain carries out its work in two Committees: The Planning Committee is responsible for the long term strategy of a domain, initiation of new IPs and recruitment of members whilst the Technical Committee is responsible for the development of the IPs and maintenance of the Technical Framework. The Sponsor s responsibility is recruitment of domain professionals to act as clinical advisors, to serve as a secretariat and to host or arrange facilities for meetings and teleconferences of the domain committees. The feasibility of Integration Profiles is demonstrated at annually Connectathons. Further general information can be found in [4] Figure 1: Overview of the IHE process (from [1]).

4 2 Motivation for using Standards within Surgical Assist Systems At present, several research institutions and parts of the medical device industry are driving forward a movement towards open, modular systems solutions which are based on open standards. The aim is to provide interoperability on various levels of integration; this should lead to more robust systems and systems providing a wider range of functionality. Currently, most systems are using proprietary technology for the interconnection of modules, but a growing number of medical device manufacturers are starting to build new solutions based on existing standards in order to provide interoperability with third party products or, in larger companies, between departments of the same company. Unfortunately, there are many proposed solutions and/or standards which can be used to achieve a certain goal. For example, one could use Bluetooth or Wireless LAN for the wireless transmission of data between devices. Sometimes, those potential solutions are contradicting each other, sometimes there are different interpretations of the same standard. It would be helpful, to have a normative or quasi-normative body which can be used to discuss integration issues among industry members and agree on best practices which should be used industry-wide. 3 Existing IHE Integration Profiles applicable for Image and Model Guided Therapy Within the already established IHE-Domains, we identified numerous Integration Profiles, which might be useful for building modular assist systems for Image and Model Guided Therapy (IMGT). The choice of applicable IPs is strongly dependant on the application field of the targeted system. Therefore, the table might not be complete regarding all potential use cases, especially if hospital information systems or cross enterprise sharing of information is involved. Table 2: Existing IHE Integration Profiles (final or trial implementations) useful for Image and Model Guided Therapy. IP short description is taken from the IHE Wiki [5]. Domain Profile Anatomic Pathology (PATH) [APW] - Anatomic Pathology Workflow integrates the pathology department in the healthcare institution, and covers these specialties: surgical pathology, clinical autopsy, cytopathology. Cardiology (CARD) [CATH] - Cardiac Catheterization Workflow integrates ordering, scheduling, imaging acquisition, storage and viewing for Cardiac Catheterization procedures [ECHO] - Echocardiography Workflow integrates ordering, scheduling, imaging acquisition, storage and viewing for digital echocardiography [ECG] - Retrieve ECG for Display provides access throughout the enterprise to electrocardiogram (ECG) documents for review purposes IT Infrastructure (ITI) [CT] Consistent Time ensures system clocks and time stamps of computers in a network are well synchronized (median error less than 1 second). [ATNA] Audit Trail and Node Authentication authenticates systems using certificates and sends PHI-related audit events to a repository to help implement confidentiality policies. [RID] Retrieve Information for Display provides simple (browser-based) read-only access

5 to clinical information (e.g. allergies or lab results) located outside the user s current application. [EUA] Enterprise User Authentication enables single sign-on by facilitating one name per user for participating devices and software. [PSA] Patient Synchronized Application allows selection of a patient in one application to cause other applications on a workstation to tune to that same patient. [XDS] Cross Enterprise Document Sharing registers and shares electronic health record documents between healthcare enterprises, ranging from physician offices to clinics to acute care in-patient facilities and personal health records. [PWP] Personnel White Pages provides basic directory information on human workforce members to other workforce members and applications. Patient Care Device (PCD) Radiation Oncology (RO) [DEC] Device Enterprise Communication transmits information from medical devices at the point of care to enterprise applications. [NTPL-S] Normal Treatment Planning-Simple illustrates flow of treatment planning data from CT to Dose Review for basic treatments [MMR-RO] Multimodality Registration for Radiation Oncology integrates PET and MRI data into the contouring and dose review process. Radiology (RAD) [PWF] Post-Processing Workflow provides worklists, status and result tracking for postacquisition tasks, such as Computer-Aided Detection or Image Processing. [ED] Evidence Documents specifies how data objects such as digital measurements are created, exchanged, and used. [SINR] Simple Image and Numeric Report specifies how Diagnostic Radiology Reports (including images and numeric data) are created, exchanged, and used. [PERF] CT/MR Perfusion Imaging specifies encoding of Contrast Perfusion imaging data using Enhanced CT/MR DICOM objects. [DIFF] MR Diffusion Imaging specifies encoding of MR Diffusion imaging data using Enhanced MR DICOM objects. [ARI] Access to Radiology Information shares images, diagnostic reports, and related information inside a single network. The analysis of the domains in Table 1 and the relevant IPs in Table 2 shows that IHE s focus is currently on Hospital Information Systems (HIS) and Radiology. The surgical domain and especially Image and Model Guided Therapy is heavily dependant on the data provided by radiology and other clinical exams. The patient data as well as patient models derived from patient data shall be stored in the electronic patient record and/or radiology record. Therefore it is obvious that IMGT systems must be able to communicate with IHE-capable systems. Furthermore, the IT Infrastructure framework provides a set of IPs, which might equip IMGT systems with functionalities like consistent time or single sign-on. Therefore, it is apparent that IMGT systems should make use of IHE Integration profiles.

6 4 Is there a need for a new IHE Domain Surgery? In the previous paragraph, we showed that IMGT systems would benefit from using IHE. But is there a need for a new Domain Surgery or are there no specific needs and the existing Domains can incorporate IPs required for IMGT? Figure 2 shows distinguishing characteristics of the surgical domain, which will be explained in the following. Figure 2: MindMap showing distinguishing characteristics of the surgical domain. Within the Operating Room, there are specific needs regarding the technical infrastructure and communication. Besides the display of radiology images, video plays an increasing role, e.g. the transfer of microscopy or endoscopy streams to additional monitors. Further devices, like navigation systems, diagnostic equipment or OR tables, shall be integrated. The environmental conditions within the OR can be controlled, e.g. the room temperature or the room illumination. To address safety and reliability demands, there is a need for systems monitoring and diagnosis of the integrated OR equipment. These topics must be addressed by domain experts since they are very OR specific. Data generated during surgery has a growing demand for the integration in HIS. Many ORs are already physically networked, but there is only limited data exchange between medical device technology and HIS. Safety, security and reliability issues are playing an important role in this context. The handling of patient models during the surgical planning phase and intra-operatively will play an important role; currently the IMGT systems are importing data from HIS or PACS and storing their results in an undefined and often proprietary manner. The actual workflow of surgical planning must be effectively supported. Most HIS companies are treating the OR and the surgical planning phase as a black box; the existing integration efforts are currently driven by the medical device industry. Besides the before mentioned technical reasons, there are also soft factors which should be considered: The medical device industry only partially overlaps the HIS and Radiology industry. It will be easier to convince industry participants to actively participate in the development of IHE profiles if the domain is within their business model and focus. Additionally, the compliance to IHE Surgery profiles may be used as a selling argument in marketing. Furthermore, the workflow between stakeholders shows great optimization potential. For example in surgical implant planning and implant distribution implant manufacturers, planning software creators and hospitals are part of the process chain. IHE could define, how existing standards like DICOM and others shall be used in order to guarantee correct deployment and update of implant templates.

7 Last but not least, the customers are different: Surgeons are playing a major role when it comes to the decision for new OR equipment. Therefore it is important to have Connectathons integrated in major surgical events and conferences for computer assisted surgery. Surgeons are organized in their own professional societies, which must be integrated in the process of writing an IP. Obviously, there should be one or more surgery related sponsors hosting the domain. IHE Surgery shall closely cooperate with other related domains, e.g. Patient Care Devices for the integration of live patient data from anaesthesia, Radiology for radiology images and exams and Information Technology Infrastructure for the integration in the hospital s IT infrastructure. 5 Extending IHE Short Term Efforts DICOM Working Group 24 Surgery recently developed three new DICOM Supplements for Surface Segmentation Storage (Supp 132), Implant Templates (Supp 131) and Implantation Planning (134). Based on theses Supplements, we propose three new profiles, which could be the beginning of the Technical Framework Surgery: Surface Segmentation Profile (SSE), Implant Template Distribution Profile (ITD) and Implantation Plan Distribution Profile (IPD). The Profiles are describing how the corresponding DICOM SOP classes shall be used in order to fulfil clinically relevant use cases. The profiles have been discussed with several vendors of involved industries and we received good response. 6 Extending IHE Mid-Term and Long-Term Ideas The IHE Domain Surgery should focus on the most urgent needs articulated from medical device industry and clinical users of IMGT systems. An exemplary issue is the transfer of planning data between PACS, surgical planning workstation and intra-operative navigation or surgical assist systems. It will be the first task of the Planning Committee to compile a list of potential Profiles and a timeline for their competition. We envision a growing need for a vendor-independent solution for communication and supervisory control of intra-operative devices. In our lab, we implemented a prototype based on open standards [6] of the modular TIMMS architecture [7], which was used in several clinical projects. Based on this experience, we would propose e.g. Supervisory Control and Data Acquisition (SCADA) technologies for intra-operative systems monitoring and the Device Profiles for Web Services (DWPS) as well as zeroconf for the realization of Plug-and-Play interoperability. 7 Conclusion We believe that IHE could play a major role for the integration of devices and modules for Image and Model Guided Therapy. The coordinated use of standards within this industry will lead to more reliable systems and foster new applications of this technology.

8 The surgical field has its own distinguishing characteristics; therefore the creation of a Domain Surgery is reasonable. Nonetheless, there are several existing IHE Profiles, which can already be adopted by medical device industry in order to increase the interoperability of their products. The creation of a new IHE Domain Surgery will require much effort and active participation of all stakeholders. Of utter importance is the identification of one or more sponsoring organizations, which are willing to bear the costs of hosting the domain and capable of motivating their members to actively participate in the Domain s Committees. Acknowledgements This work is sponsored by funds of the European Regional Development Fund (ERDF) and the state of Saxony within the framework of measures supporting the technology sector. ICCAS is funded by the German Federal Ministry of Education and Research (BMBF) and the Saxon Ministry of Science and Fine Arts (SMWK) within the scope of the "Unternehmen Region" initiative with grant numbers 03 ZIK 031 and 03 ZIK 032. Reference [1] IHE Website: http://www.ihe.net/, accessed 2010-08-13. [2] Network Working Group: Network Time Protocol (Version 3) - Specification, Implementation and Analysis, Request for Comments: 1305, http://tools.ietf.org/html/rfc1305, accessed 2010-08-13. [3] Integrating the Healthcare Enterprise (IHE): IHE IT Infrastructure (ITI) Technical Framework, Volume 1 (ITI TF-1) Integration Profiles, Revision 7.0, http://www.ihe.net/technical_framework/upload/ihe_iti_tf_rev7-0_vol1_ft_2010-08-10.pdf, accessed 2010-08-13. [4] Eliot L. Siegel und David S. Channin: Integrating the Healthcare Enterprise: A Primer, Radiographics 21, no. 5 (2001): 1339-1341. [5] IHE Wiki: IHE Integration Profiles. http://wiki.ihe.net/index.php?title=profiles, accessed 2010-08-13. [6] Bohn S, Michael G, Franke S, Voruganti A, Burgert O, An integrated OR system based on open standards. The MIDAS Journal - Systems and Architectures for Computer Assisted Interventions; 12th International Conference on Medical Image Computing and Computer Assisted Intervention (MICCAI), London, 2009. [7] Lemke H, Vannier M, The operating room and the need for an IT infrastructure and standards, International Journal of Computer Assisted Radiology and Surgery, Vol. 1, No. 3, pp. 117-121, 2006.