ENTERPRISE IMAGE MANAGEMENT For a consolidated image strategy

White paper ENTERPRISE IMAGE MANAGEMENT For a consolidated image strategy Today, the typical healthcare enterprise consists of more or less isolated clinical data silos, loosely held together by the Electronic Patient Record or HIS. However, in recent years, this architecture has been called into question. New models, in which department-specific silos are being replaced by enterprise-wide concepts, have been proposed for better alignment with modern IT strategies and to optimize clinical outcomes and pathways. The main force that has provoked this development of a new golden standard for medical imaging IT architecture is associated with healthcare economics and the need for increased cost efficiency within healthcare IT. People are living longer and the impact this is having on society is profound. More than two-thirds of healthcare enterprise IT budgets are solely devoted to maintaining existing infrastructure 1. CIOs are therefore under immense pressure to identify and adopt best practices to lower their operating expenses and redirect savings to new investments. In addition to the sheer cost of IT, there are also other issues with the traditional PACS model, notably the migration costs and vendor lockin caused by the independent isolated silo architecture. Furthermore, in an environment where mergers and acquisitions are commonplace, the selection of IT infrastructure is strategically critical, and must support growth at all levels. The road to a future-proof solution is, however, not straightforward, and what solution represents the best match for your enterprise is a non-trivial decision. This document aims to serve as a guideline when selecting and implementing a solution that matches your needs. Firstly, we will take a look at the various drivers for change that are shaping the development, thereafter, we will analyze the different approaches that have manifested themselves in the market and, finally, we will discuss some of the challenges that must be taken into consideration when designing a solution tailored for the individual enterprise. By: Pontus Haglund, MScCE Product Marketing Manager, Sectra po-hag@sectra.com 1 Gartner (2011). IT Spending and Staffing Report

CONTENT Drivers for change...3 Clinical pathways...3 Accessibility...3 New technologies and consolidation...3 Cost of data migration...4 Data ownership controversy...4 Designing a solution...5 Vendor Neutral Archive (VNA)...5 Open standards Image enabling the EPR Cross-enterprise sharing PACS 2.0 - expanding into other -ologies...7 Clinical workflow The all-in-one solution...7 Challenges...8 Standardization or tag morphing...8 Image accessibility and prefetching...8 Non-DICOM data...9 System scalability...9 Information Lifecycle Management...9 Safety and security...10 Business intelligence...10 Selecting a partner...11 Strategic direction...11 Professional services...11 Exit strategy...12

DRIVERS FOR CHANGE Clinical pathways Healthcare providers are forced to cut costs and focus on efficiency to survive in a market where staff and capital are increasingly difficult to secure. The pressure has grown steadily over several years and individual departments are now pushed to their limits. To further improve quality and cost-effectiveness, there are several political initiatives to re-organize the healthcare system and move it away from a department-centric organization toward patient-centric care. Consequently, the efficiency of the entire care chain and the collaboration between departments is pushed to excel. However, the process to make the transformation is far from simple. In a survey among healthcare opinion leaders, 52% of respondents stated that the technical barrier to make the necessary transformation is very significant or extremely significant 2. This is reflecting the issues implied by each department maintaining their own isolated silo of information. Not only does it prevent sharing of information and work processes, it also exponentially increases system administration and the number of integration points. The result is poor economy of scale and an unnecessarily high total cost of ownership at an aggregated level. Accessibility Modern Internet technology has forever changed the way we search for and digest information. Google and other popular services set the standard for what everybody perceives as basic requirements. Healthcare IT is therefore pushed to deliver high-performance access to medical data to virtually any location. The drive toward mobile devices, cloud services, patient portals and remote access are all products of the ubiquitous network. It has enormous potential to support the development of clinical pathways and provide clinical benefit. Improved access is also driven by the demands of the patient community to be more involved in the care process and to have online access to their own clinical data. In turn, the hospitals themselves recognize the potential offered by outsourcing work to patients. Examples of such tasks include cancelling and re-booking appointments, and this can be a real win-win solution for both the hospital and the patient. New technologies and consolidation What is big data? Every day, we create 2.5 quintillion bytes of data so much that 90% of the data in the world today has been created in the last two years alone. Source: IBM, Understanding Big Data The maturity of PACS technology as well as the trend toward an ageing population has caused the number of documented digital examinations per patient to grow steadily for decades. In parallel, IT innovations and modality technology have facilitated a sharp increase in the number of images per examination (increased resolution, volumes instead of 2D images, movies instead of still images, functional dimensions, etc). Combined, the result is the merciless growth of data, representing a challenge for people and infrastructure. In addition, an increasing number of departments realize the need for structured long-term storage of digital images. Pathology is one sub-specialty that deserves special mention in terms of the challenge it constitutes from an image-handling perspective. The digital slides used by pathology require staggering amounts of data storage (some 400 MB per slide). 2 The Commonwealth Fund (July 2010), Modern Healthcare Opinion Leaders Survey

Last but not least, the evolution of clinical pathways adds fuel to the fire. The need for improved cross-departmental or even cross-enterprise workflows stimulates the merging of multiple image repositories in larger consolidated solutions. Existing systems are expanded to accommodate endoscopy, dermatology, ophthalmology and so forth. This presents a special challenge, since the data growth is not organic, but rather stepwise. The same applies to mergers and acquisitions that may require a system to double its capacity overnight. Handling big data and data growth is certainly critical when designing for the future, and scalability is the key requirement that must be fulfilled. This topic is discussed later on in this document. Cost of data migration The average lifespan of a PACS is about five to ten years. Within that time, requirements change and technological advances are made, and unless the PACS vendor is able to keep pace, the efficacy of the solution will decline incrementally. The replacement of one PACS with another inevitably triggers the need for data migration, which involves moving the entire image archive and all related information over to the new platform. Achieving this without losing valuable data is certainly no easy task and requires significant amounts of time and money. Healthcare providers are forced to think twice before taking on such projects, even if the clinical benefits of replacing an existing system with a more modern one are obvious. This unbalanced dependence on existing suppliers is naturally undesirable and prevents free market mechanisms from driving innovation forward and allowing the industry to leverage modern technology. Data ownership controversy With the traditional system architecture, data mining, data migration or advanced troubleshooting often requires the vendor to step in. Proprietary interfaces and security barriers have made it difficult or even virtually impossible for the local system administration to perform these tasks to save money or reduce lead times. The vendor could even deliberately decide not to offer assistance due to other priorities or due to concern over granting access to vulnerable parts of the system. In some cases, the level of lock-in has grown to such an extent that the owners feel that they are being held hostage, forced to pay unreasonable fees to access their own data. This controversy has created an increasing pressure on vendors towards standard compliance and standardized data access. Improved transparency is needed, combined with service level agreements that ensure the vendor will provide assistance within a reasonable timeframe when necessary.

DESIGNING A SOLUTION As a result of the driving forces discussed earlier in this document, a number of approaches to accommodate market requirements have emerged. These cover various levels of consolidation among disciplines and units and are presented and discussed below. Vendor Neutral Archive (VNA) The VNA concept has been quickly embraced by the market and heavily promoted by vendors and customers alike. The basic idea of the VNA is to harvest cost benefits from archive consolidation, while protecting investments in departmental PACS and other application level solutions. By taking the A out of PACS, and making the Archive an independent component based on open standards, it would also make it possible to replace a PACS without data migration. A future migration of the VNA itself would still be expensive, just less frequent 3. Lifecycle cost would be reduced, as would dependency on the PACS vendor, while free market competition would ensure that innovation would be driven forward. A centralized, shared archive also facilitates data exchange between departments or even between hospitals, to support clinical pathways and a continuum of care. Source: CapSite 2010, Voice of Customer (VoC): Top reasons for considering a VNA purchase However, when separating the archive from the application layer (workflow and image display), it is critical to maintain good integration between the two layers. This is easier said than done, considering the benchmark is set by proprietary state-of-the-art client-server technology. We will address some of these challenges later on in this document. Open standards To remain vendor neutral, an integral part of the VNA concept is compliance with open standards. Being essentially plug and play, the standards provide a short cut, ensuring working integration with existing systems at a relatively low cost. 3 Aunt Minnie (2012-01-16). Vendor Neutral Archive (Migration)

DICOM and HL7 are the two most important standard interfaces for medical image communication. The exact specifications can be difficult to determine, but the IHE initiative presents well-documented best practice on how to use the standards to support various scenarios. By analyzing which of the IHE profiles are necessary in your enterprise, the amount of custom integrations can be reduced and the procurement process made easier. A general consensus seems to be that a VNA must be able to ingest and manage virtually any DICOM SOP class, that is, images and related objects such as presentation states, key objects and structured reports. Furthermore, a standard DICOM Q/R interface must be available to allow external systems to search the archive and retrieve the data. Beyond this, opinions differ as vendors attempt to differentiate their offerings from competitors and customers express their views on what is required in their specific setting. Open standards are sometimes not enough and custom integrations are required. This may occur when the standard organizations have not yet offered a solution to a particular problem or if tighter integration is desired compared with that offered by standards. To facilitate such integration, and to ensure version backwards compatibility, we would recommend well-defined application programming interfaces (API). It should be noted that custom integrations increase vendor dependency and are generally more expensive to implement and maintain. However, the value of tighter integration is sometimes enough to tip the scale in favor of custom integration over standard protocols. It is a continuous balancing act and open standards should always be considered as the first alternative. Image enabling the EPR With the trend toward centralization of the Electronic Patient Record (EPR), patient history can be shared among different parts of the enterprise or among different enterprises. A natural development of a central image repository would be to implement the Image-enabled EPR, meaning a basic web viewer attached to the EPR able to display the content of the VNA. Consequently, the VNA must either have a viewer of its own or be able to interface with a third-party viewer (typically through IHE WADO). In either case, it must be possible to launch the viewer from within the EPR, which is most commonly achieved through basic URL calls, although more advanced interfacing may be desired to attain tighter integration (e.g. to embed the viewer as a more integral component in the EPR client). Cross-enterprise sharing It is also worth discussing the VNA s role as a sharing platform when it is used as a central hub for data exchange beyond the local network domain. This is important in order to achieve a continuum of care that puts the patient first by ensuring that physicians have access to all relevant medical data, regardless of location. There are many solutions to this challenge, but the IHE initiative for Cross Enterprise Document Sharing of Images (XDS- I) is gaining ground and may very well become the de facto standard for sharing in the near future. An XDS-I registry and repository coupled with a Master Patient Index may therefore be a strategically important part of a sharing solution. There are two notable issues with XDS going forward. Firstly, the centralized components XDS and MPI are still quite expensive. Secondly, a large number of existing systems do not yet support the XDS consumer and source profiles, so backwards compatibility could prove a difficult obstacle to overcome.

PACS 2.0 expanding into other -ologies After reviewing the benefits of the VNA, a natural next step would be to consider if the same fundamental benefits of consolidation could also be applied to the application layer. Obviously, maintaining best-of-breed application layer solutions from various vendors in each department is expensive and offers poor economies of scale. In the traditional departmental view of the healthcare organization, it makes sense, but not if the solution should support clinical pathways with the patient in the center. In fact, many hospitals are already in the process of implementing consolidated solutions for the application layer, providing display tools and workflows to more than one department (e.g. Radiology and Endoscopy). The idea of expanding the application layer into multiple specialties is referred to as PACS 2.0. The most common approach is to simply expand an existing PACS solution stepwise into other -ologies one at a time. This protects the investments already made in existing front-end solutions and gives all parties time to manage the change. Clinical workflow Naturally, each department has its own specific needs and requirements. Some place very high demands on diagnostic imaging tools (e.g. radiology), whereas other departments have more basic requirements where images serve as mere documentation (e.g. dermatology). When multiple departments share a consolidated solution, obviously a reasonable degree of freedom must still be allowed at the departmental level to allow diverse workflows for various clinical needs. The system must thus have sufficient flexibility in terms of configuring the user interface and workflow. An important workflow consideration is also the level of integration with department-specific information systems, both at the server level for information exchange and at the desktop level for context management. Moreover, a smooth EPR-driven workflow is required for departments where the EPR is the natural starting point. The all-in-one solution Should the consolidation of the archive (VNA) and the consolidation of the workflow layer (PACS 2.0) remain two separated layers, or eventually be merged into a single, consolidated all-in-one solution? There are arguments for and against such a model. On the one hand, it implies a more monolithic creation, which inevitably would be more difficult to replace. On the other hand, it allows for a higher degree of consolidation, a single point of integration with the EPR, and more advanced internal protocols (e.g. streaming and server-side rendering) 4. A hybrid is probably the optimal choice, meaning a VNA with an advanced diagnostic viewer (PACS 2.0) as well as great interoperability with third-party viewers that may be used in the highly specialized departments where the VNA viewer is not deemed capable of providing all the necessary functionality. 4 Clunie, David (Apr 2012). Standards & PACS Data Ownership

CHALLENGES Regardless of the approach taken by the individual healthcare enterprise, there are a number of challenges that require consideration when specifying a request for a consolidated image management solution. A few topics that we believe are particularly significant are discussed below. Standardization or tag morphing? A hot topic of debate is the concept of dynamic tag morphing. It refers to a proprietary layer between the VNA and thirdparty data consumers. Its purpose is to be able to implement a VNA, with minimum impact on existing application level systems (i.e. PACS). The idea is for the VNA to do real-time conversion of DICOM tags in outbound data to match the recipient. A specific and important example is the morphing of Medical Record Numbers for cross referencing between ID domains (e.g. IHE PIX and MIMA). Another common use case is where the Series Descriptions supplied by modalities are adapted to fit the display protocols of a specific PACS. In this latter example, you could argue that standardization on the modality side is a more cost-effective option. As the strategy of tag morphing deviates from the ideal of using open standards, it increases vendor lock-in and should be used with caution. Some go as far as to argue that it is inherently dangerous and undermines the value of attempting to standardize attributes in the first place 5. Others argue that it is an absolutely essential component 6. Both sides probably have a point, and certain tag morphing may be necessary, but the guiding principle should be to rely on standards and common agreements on formats whenever possible. In the short term, the tag morphing capabilities will make it easier to implement the VNA, but in the long term, the cost of maintaining the tag mapping library will become an issue. Image accessibility and prefetching The average time it takes to move a complete set of images from the VNA to a department-specific PACS can be quite daunting and requires some thought. Research shows that images are required for comparison several years after their acquisition, see below. The number of exams retrieved manually from the archive during March 2012 for a group of hospitals in the UK. Note that the curve is flatter than anticipated. 5 Clunie, David (February 27, 2012). UK Imaging Informatics Group: Questions & Answers: PACS Procurement & Business Cases: VNA specification: 6 Gray, Michael (June 18, 2007). DICOM Tag Morphing Essential Ingredient in Enterprise PACS Archive.

To avoid storing images in the department-specific PACS forever, a more elaborate solution is required. The problem is actually very similar to the disk storage cost issues a few years ago. When disk was an expensive storage option, the typical solution was to use disk for short-term storage and tape for long-term storage. With tape being too slow for on-demand fetching, the concept of prefetching was born. Similar solutions are required for a VNA, meaning the capability to route, prefetch or prepush data from the VNA over to the department-specific systems, based on known scheduled events (e.g. a patient being booked for a follow up of some sort). New standard protocols for high-performance on-demand streaming are under development (such as MINT), but not yet adopted by the industry in general. For certain types of data (including digital pathology slides), a streaming protocol is an absolute necessity. Non-DICOM data In the consolidation process, an important challenge is how to handle equipment that produces media on formats other than DICOM (e.g. Endoscopy video feeds, Dermatology skin photos). A paper discussing the technical approach to this in great detail was written by Michael Gray 7. Whichever design is chosen, it has to enable the capture, storage, access and exchange of the information in a clinically useful format for users and surrounding systems. A fairly common requirement is to support any file format. Although it would undoubtedly be clinically beneficial, it also requires proprietary interfaces and increases the vendor lock-in, where future data migration would make a standard PACS migration look like a walk in the park. System scalability The big data trend discussed under the Drivers for change section above is showing no sign of stopping. Any enterprisewide image management solution needs to be easily expanded to account for continuous growth. In addition, stepwise growth is an important aspect due to expansion into other -ologies or due to mergers and acquisitions that require sharing a central solution between multiple hospitals. All levels must be considered for scalability the file storage layer, database layer and server application layer and ideally be proven in the field to handle really big production volumes. When adapting the storage hardware to support organic data growth, it is desirable to leverage the advances of modern storage technology and add new hardware next to old systems. This adds the requirement of mixing and matching different storage hardware independent of vendor, for example, through an interface that will support any standard file system. Virtualization support is another common requirement in modern solutions to achieve cost savings and improved resource utilization. WMware and other virtualization platforms enable substantial savings on hardware and its maintenance. Information Lifecycle Management Managing large amounts of data is expensive and, by treating data differently depending on where it is in its lifecycle, significant cost savings can be made. This is referred to as Information Lifecycle Management (ILM). For a medical image repository, it means that when medico-legal retention periods expire it may be desirable to delete the corresponding records. Apart from saving disk storage, it also helps reduce liability, improve performance and cut back on the amount of information the users have to filter and administer. Accordingly, a useful feature of a VNA is the support for purging of images based on rules or by implementing the IHE profile for Imaging Object Change Management (IOCM). 7 Gray, Michael (2010-10-18). Best Practices Strategy for Dealing with non-dicom Data objects in a PACS-Neutral Archive

It is therefore also important to focus on the data that is in the middle of its lifecycle, that is, the data that is no longer relevant to any ongoing care cycles. Significant savings can be made if this data can be identified and moved to a lower-cost storage tier, until such time that the patient is once again involved in a care cycle that requires the old records for comparison. Rules based on clinical context (HL7 feeds) should ideally be implemented to trigger the hierarchical storage manager. Safety and security The downside of consolidation and up-scaling is the increased impact of system failure. Business continuity is therefore extremely important when designing a VNA. Enterprise healthcare is generally mission-critical and the stability and uptime of an IT solution should be proven and well documented. The architecture should aim to implement redundancy in all components, with no single point of failure that could jeopardize system availability. Disaster resilience and recovery are key considerations, where the optimal solution is a balance between cost and recovery time. Business continuity procedures should be well documented and provide clear guidance in different disaster scenarios. It is also crucial to protect the database from destructive forces and the unwanted actions of unauthorized users. Multiple access levels, strict access control and security guidelines are necessary to ensure a high level of control. WORM (Write Once Read Many) storage media is sometimes used to eliminate the risk of a virus or other malicious code corrupting or deleting the archive content. Furthermore, if digital data is stored in an enterprise repository, the mechanisms that ensure patient privacy require careful attention. Audit trails (IHE ATNA) are necessary to ensure user accountability and access restrictions, and patient consent management is often a legal requirement. A common requirement for clinical benefit is a so-called break the glass function, enabling access to restricted content in case of emergency. Patient privacy can be preserved if this is followed by an investigation to ensure that the access breach was clinically relevant. Business intelligence One of the drivers discussed in the Drivers for change section above is the data ownership controversy. To address these issues, we recommend including requirements governing transparency and full data access when designing a central archive. One approach is to request a database schema and give the system administrator full access to the database. This way, it would be possible to make various queries and full transparency would be achieved. However, such a solution presents a clear risk from a system security perspective. The consequences of human errors could be serious, causing downtime or could even corrupt or delete the entire database. A more cautious approach to achieving data ownership while maintaining system security is to replicate the production database in a secondary database used for data mining, known as a data warehouse. This enables queries to be executed without causing an increased load on the production database, or exposing it to a risk of unwanted manipulation. Adding a sophisticated business intelligence front end to the data warehouse provides the tools for management control required in a modern healthcare enterprise.

SELECTING A PARTNER In addition to the features and functions of the system itself are the requirements imposed on the supplier. Conducting a thorough due diligence investigation is even more critical than when selecting a PACS supplier, given that a VNA or PACS 2.0 has a longer predicted lifespan. Aside from the financial stability aspect, where, for example, the debt-to-equity ratio is important, such factors as the strategic direction of the provider as well as the level of professional services that can be expected should be taken into consideration. Strategic direction A consolidated medical image archive is a decades-long proposition, and a more sophisticated system than a departmental PACS. For lifecycle profitability compared with the traditional departmental PACS approach, it is argued that it should out-live the average lifetimes of two PACS 8. For enterprise decisions over such a time span, it is imperative to go beyond technical factors and financial models, given that these merely reflect the situation as it is today. Alignment with future strategy and the viability of the provider are perhaps equally important when investing in the future. Is there an outspoken direction of the company that is aligned with your future strategy? Professional services Last but not least, it is important to consider the service level, both at deployment as well as the ongoing helpdesk service. To ensure successful implementation, the obvious requirement would be to look for a company with experience in Enterprise Image Management, preferably on a large scale (while this may not be where you are today, it may very well be the reality of tomorrow). Installation, Integration and Migration are all important for successful deployment. PACS 2.0 implementations obviously require workflow domain knowledge to achieve clinical usefulness. A good starting point for the helpdesk would be a 24/7 proactive system monitoring of system status and storage consumption, combined with a responsive support helpdesk. 8 Gray, Michael (July 2011). The Anatomy of a Vendor Neutral Archive (VNA) Done Right

EXIT STRATEGY When the time comes to replace the Enterprise Image Management solution, it would of course be desirable to achieve this with minimal cost, time and effort. One way is to simply agree on the terms and conditions in a contract, based on known costs and time frames. A complementary option is to establish ground rules for the storage format itself to simplify the migration. A common approach is to request DICOM part 10 support, requesting all files in the VNA to be in a non-proprietary format, both updated and complete (including such metadata as key image information, annotations and view settings). This has the benefit of making a migration possible by simply traversing through all the stored files and building the new system s database index based on this information. This will allow for a faster migration without actually moving the files in storage. However effective the exit strategy is, the best option is still of course to avoid migration altogether. When new standards emerge and become generally accepted, they must be implemented for the VNA in order to keep up to date. The supplier s ability and willingness to provide necessary updates and upgrades for a reasonable cost is the only way to remain future proofed over time. Consequently, the company s stability and equity ratio plays a key role, and a track record (e.g. 15 years) of system upgradability without migration and forklift upgrades should be on everybody s wish list.

20 YEARS OF EXPERIENCE AND 1,400 INSTALLATIONS WORLDWIDE With more than 20 years of innovation and 1,400 installations worldwide, Sectra is a world-leading provider of IT systems and services for radiology, women s health, orthopaedics and rheumatology. Based on close cooperation with our customers and research centers, Sectra delivers solutions that provide tangible gains in productivity today and well into the future. For more information about Sectra s radiology solutions please visit sectra.com/medical. This is a marketing material and may be changed at any time without prior notice. Sectra will not be held liable for any errors or misconceptions herein. DOC-PHAD-948CJ5-2.0 2013 Sectra AB World Headquarters Sectra AB Teknikringen 20 583 30 Linköping SWEDEN Phone: +46 13 23 52 00 E-mail: info.medical@sectra.com For other regions please visit sectra.com/medical Australia/New Zealand Phone: +61 2 9420 1620 E-mail: info.anz@sectra.com Benelux Phone: +31 36 540 1970 E-mail: info.benelux@sectra.com Denmark Phone: +45 45 65 06 00 E-mail: info.dk@sectra.com Germany/Switzerland/Austria Phone: +49 221 47 45 70 E-mail: info.de@sectra.com Japan Phone: +81 42 727 8780 E-mail: info.jp@sectra.com Norway Phone: +47 67 58 97 70 E-mail: info.no@sectra.com Spain/Portugal Phone: +34 930 010 333/ +351 22 011 00 20 E-mail: info.iberia@sectra.com Sweden Phone: +46 13 23 52 00 E-mail: info.se@sectra.se United Kingdom/Ireland Phone: +44 1908 673 107 E-mail: info.uk@sectra.com USA/Canada Phone: +1 203 925 0899 E-mail: info.na@sectra.com