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Accommodating Non-DICOM Images: Is Your Enterprise Imaging Strategy Diverse Enough?

I recently wrote an article on Enterprise Imaging for Radiology Business Journal.  While I cannot reprint that article here, you can access it using this URL link to the Journal’s e-publication. The article reinforces the concept of broadening the scope of enterprise imaging beyond consideration of the traditional, DICOM-oriented departmental PACS to include images produced during such procedures as surgery, endoscopy, ophthalmology, and numerous other “oscopies” and “ologies” from bronchoscopy to urology.  It also emphasizes the need to include non-DICOM as well as DICOM images, still-frame images as well as video clips, image sets that are the result of ordered procedures, as well as image sets that are simply captured on mobile devices during office visits or encounters in departments such as dermatology and emergency.

Organizations planning on replacing a PACS, deploying a VNA, or image-enabling their EMR with a universal viewer really should develop their Enterprise Imaging Strategy before making any major system purchase.  Every component in the Enterprise Imaging Strategy needs to plug and play with all of the actors up and down the line.

 

What is the Concept of “Enterprise Imaging”?

In the world of medical imaging, the term “Enterprise Imaging” has become the latest buzzword. Exactly what is meant by this term depends on who is doing the talking. In my experience, there seems to be a considerable amount of confusion surrounding this subject, which inevitably leads to shortsightedness.

Over the last nine months, I have been asked by numerous healthcare organizations to help them develop their “Enterprise Imaging” Strategy.  Early on it occurred to me to ask the individual or organization to define their meaning of the term “Enterprise Imaging”, since defining the scope of a project is key to meeting expectations. Depending on the individual(s) participating in the initial conversation, the term “Enterprise Imaging” can mean any of the following:

  1. Providing physicians and other caregivers access to the images being managed by their radiology and possibly cardiology PACS through their smart phones and tablets.
  2. Consolidating the majority of the organization’s medical image data in a Vendor Neutral Archive (VNA).
  3. Image-enabling the organization’s Electronic Medical Record (EMR) system.
  4. Providing PACS-like functionality to imaging departments other than radiology and cardiology.
  5. Managing and Displaying clinically relevant, digital photos and video clips taken with mobile devices (personal smart phones and tablets).
  6. Exchanging medical images with affiliated (but outside) healthcare organizations, clinics, or physician groups.

In my opinion, focusing on any ONE of the above is shortsighted, as all of the above will eventually become the objective, assuming the ultimate goal of the healthcare organization is to provide all physicians and caregivers access to each patient’s complete longitudinal medical record and making this data displayable with a general-purpose viewer than can handle all of these diverse data objects.  The complete medical record would include the patient’s medical images (structured data), diagnostic reports, laboratory results, prescription details, and care summaries (unstructured data), and the multitude of health details collected during years of office visits such as age, weight, smoking status, etc. (discrete data).

The EMR currently manages the discrete data, but the unstructured and structured data is typically spread all over the enterprise in various independent silos that often do not interact with each other. To say that there exists an interfacing and data exchange issue here is a massive understatement.

Healthcare Leadership must come to terms with the breadth and complexity of this more comprehensive concept of “Enterprise Imaging”.  In order to convey this concept and eventually define the true End State of the Enterprise Imaging Strategy, I find it useful to look at the subject through several different lenses.

Thestructorr_Magnifying_Glass_clip_art_mediumThe first lens organizes the data by object type and location.  In the following summary list, we see how all of the data that should be in the patient’s longitudinal medical record is organized.

  1. Unstructured Data
    • Scanned Documents
    • Care Summaries
    • Laboratory
    • Pharmacy
    • Voice Clips (WAV, AIFF, MP3, etc.)
    • Etc.
  2. Structured Data
    • “Ologies” (image-based diagnostic procedures)
      1. Radiology
      2. Cardiology
      3. Ophthalmology
      4.  Pathology
        • Biopsy
        • Anatomical
      5. Otolaryngology
      6. Urology
      7. Others
    • “Oscopies” (examination of an organ, body cavity, or joint by viewing through an endoscope)
      1. Endoscopy
      2. Arthroscopy
      3. Laparoscopy
    • Surgery (digital video documentation of a procedure)
      1. Minimally Invasive
      2. General
      3. Robotic
    • Point-Of-Care Ultrasound (POCUS)
    • Mobile Imaging (capture of JPEG and MPEG digital images with a smart phone or tablet)
      1. Dermatology
      2. Wound Care
      3. Emergency
      4. Etc.
    • Outside Images (electronic image sharing between organizations)
  3. Health Information Exchange (structured and unstructured data sharing between organizations)

The Unstructured data is best managed by an Enterprise Content Management (ECM) solution. Most EMR solutions are well equipped to mange the Discrete data associated with the patient, but their frequently limited indexing capabilities make them ill-equipped to efficiently manage either Unstructured or Structured data objects.  In most healthcare organizations, the Structured (image) data is currently being managed in department PACS or a Vendor Neutral Archive (VNA).  Another glance at the above list will confirm the observation that most healthcare organizations have barely scratched the surface when it comes to managing the Structured data associated with each patient (radiology and cardiology and frequently the endoscopy departments that have their local PACS). The questions that must be addressed by the Enterprise Imaging Strategy is how to acquire, manage and display all of the Unstructured data and the rest of the Structured data (image data) produced outside of those departments with a PACS.  The concept of a universal viewer must include more than just the ability to display the image data managed by the department PACS.

The first two categories in the above list cover data that is internal to the organization.  The third category covers the data associated with the patient that either must come from an outside affiliated organization, or must be transferred to an outside but affiliated organization. The interfacing and data exchange issues are even more critical in making this Health Information Exchange a reality.

The second lens organizes the data by object type and location.  In the following summary list, we see how all of the image data is divided based on how/where it is managed.

  1. PACS – Department-based data management
    • Radiology
    • Cardiology
    • Endoscopy
    • Dentistry
    • Ophthalmology
  2. Non-PACS – Modality-based data management (optional back-up server)
    • Endoscopy Camera systems
    • Otolaryngology Camera systems
    • Point-Of-Care Ultrasound system
    • Surgery Camera systems
  3. Informal – Mobile device-based data capture /management
    • Dermatology
    • Wound Care
    • Emergency
    • Etc.

Once again, most organizations have barely scratched the surface regarding enterprise access to their image data.  Besides the big imaging department PACS (radiology, cardiology, and sometimes endoscopy), a large percentage of the patient’s image data is tucked away in the smaller imaging departments either on the individual imaging modalities/devices or on an optional back-up server in that department. Neither the modalities or the back-up server in these non-PACS environments are typically connected to another department’s PACS, a VNA, or a universal viewer tied to the EMR.  Consequently, all of these images are currently undiscoverable and inaccessible. The Enterprise Imaging Strategy must consider how these images will be included in the patient’s medical record and thus made available to the EMR viewer.

The Informal image category presents numerous challenges. First of all, in many healthcare organizations there is already a significant amount of “informal imaging” already in use.  Caregivers and physicians are using their personal mobile devices to take digital photos or video clips of wounds, rashes, numerous clinical conditions, and evidence of physical abuse. If these images remain on the personal device, or end up on “C” drives under the desk or on thumb drives, they are HIPAA violations waiting to happen. Transferring these mobile images to the EMR presents a different set of challenges such as how to assign unique identifiers to the images so finding them is easier and faster than searching through all of the images in the typical film roll of a camera app.  As previously stated, EMR solutions are not designed to effectively index either Unstructured or Structured data. The Enterprise Imaging Strategy must consider how these informal images will be captured, edited, appended with unique patient/study identifiers and a study description, where they will be managed, and how they will be displayed. If they are clinically relevant, they belong in the patient’s medical record.

The third lens also organizes the data by object type, but in this case we simply distinguish between DICOM and non-DICOM.

  1. DICOM
  2. Non-DICOM
    • PDF (document)
    • JPEG (still frame digital image)
    • MPEG (digital video)
    • WAV, AIFF, MP3, AU (audio files)

Most medical imaging devices in the larger imaging departments (radiology, cardiology, endoscopy, etc.) support the DICOM standard.  Consequently, most department PACS are designed to manage and display DICOM image data objects, whether the image data is stored in the PACS as a DICOM object or not. But most of the imaging devices in the other Ology and Oscopy departments that use imaging do not create DICOM image objects. Scopes and cameras produce JPEG and MPEG objects.  Voice clips and audio files can be one of several object formats.  A majority of the Unstructured data objects in the Enterprise Content Management system are PDF objects. The Enterprise Imaging Strategy must consider how to deal with both DICOM and non-DICOM data objects.

If the healthcare organization considers what truly belongs in the patient’s complete longitudinal medical record, then the term “Enterprise Imaging” becomes much more inclusive. When we view the contents through the three lenses I have presented in this document, we begin to appreciate the complexity and therefore the challenges in developing the more comprehensive strategic plan.

Current Generation of Radiology PACS is Ending

Radiology PACS is changing.  Something of a paradigm shift is occurring; from a current generation radiology PACS supporting interfaces to multiple third-party specialty applications, to a Vendor Neutral Archive (VNA) configured with multiple specialty display and workflow application plug-ins. In the former case, the PACS application is at the center of data management, and the PACS vendor continues to own the data.  In the later case, the VNA is at the center of data management, and the healthcare organization owns the data.

Slide1Ten years ago when the current generation of radiology PACS (termed R-PACS 2.0) was first introduced, the core PACS application provided all of the features and functions that a radiology department needed. This single-source, turnkey package included the tools for image acquisition and QC, both the diagnostic and the clinical display applications, and the worklist and workflow applications. The system focused almost exclusively on whatever was required to acquire, display and interpret radiology image data.  DICOM and HL7 were the ubiquitous data exchange interfaces.  The radiology PACS was a standalone system and data exchange with any other system was not considered a requirement (much to the delight of the vendors).

Slide2Over the ensuing ten years, most of the current generation PACS fell further and further behind in meeting the ever-changing needs of the evolving radiology department.  Unable to meet the requirements with in-house development, the easiest solution for many PACS vendors was to simply bolt on to their PACS the third-party applications that could meet those new requirements.  Examples include specialty processing applications for Nuclear Medicine, Digital Breast Imaging, 3D, and Fusion, as well as Discrepancy Reporting, Peer Review, and Analytics.  The latest zero-client, server-side rendering clinical viewers that so many organizations wanted to use to image-enable their EMR systems also became a bolt-on to the PACS.  The department PACS was no longer a single source solution.  Of necessity it had become a best of breed, multi-vendor solution.

Unfortunately the ten-year old current generation PACS is not even close to best-of-breed.  [1] A fat display client that requires a full pixel set download to the display platform is old technology and incapable of meeting performance expectations.  [2] The dependence on DICOM as both a data format and a transfer interface is severely limiting.  [3] The requirement that any third-party application be bound to the idiosyncrasies of the PACS is simply inefficient.  [4] The inability to support a dual-sited, fully mirrored configuration means there is no Business Continuity.   For these and many other reasons, the era of R-PACS 2.0 is coming to an end.

The PACS paradigm has shifted Slide3to PACS 3.0, which is definitely a best-of-breed ensemble of [1] VNA, [2] various diagnostic and clinical display applications, and [3] an enterprise workflow/worklist application, all of which simply plug into the neutral VNA.

A Best-Of-Breed solution implies a more difficult support paradigm, and that rightfully suggests risk.  However one must consider the fact that the R-PACS 2.0 solution that requires multiple third-party applications effectively makes those systems a multi-part solution as well…and most of the PACS vendors are not going to include those third-party apps in their SLA or their system monitoring solution.  It seems to me that meeting all of the requirements of today’s radiology department virtually demands a best-of breed solution.  Since most of the PACS vendors have clearly stated that their service support packages do not cover many of those third-party applications, these hybrid R-PACS 2.0 solutions present some degree of risk as well.

The greater risk however is the fact that these R-PACS 2.0 solutions will most likely have to substantially evolve in the next few years in order to meet the market challenges being presented by those companies whose display applications already feature the more advanced server-side rendering display technology and true BC configurations.  Such a dramatic overhaul to the R-PACS 2.0 architecture will most likely cost significant upgrade dollars…costs that are unlikely to be covered by the yearly software maintenance fees.  Unfortunately, if the PACS vendor that the healthcare system chooses to partner with does not make these dramatic upgrades, that organization will effectively be saddled with old technology for many years to come.

I invite the reader to learn more about the paradigm shift from R-PACS 2.0 to PACS 3.0 by reading my latest White Paper on the subject.  Aunt Minnie is publishing the paper as a three-part series, with the first part appearing on September 25, 2014.  Part 1 can be found at http://www.auntminnie.com/index.aspx?sec=sup&sub=pac&pag=dis&ItemID=108618

 

Today’s Radiology PACS – Shiny But Not New

It may seem a little late for commenting on observations from RSNA 2013, but then nothing has changed in the Radiology PACS market since then, so I think observations from three months ago are still valid.  Come to think of it, nothing really significant seems to have changed in Radiology PACS for several years now.  Pesky little things like bug fixes get attention each year, and functions that should have been standard years ago have finally shown up, but there have been very few major changes in system architecture.  Some semblance of Disaster Recovery has always been there, but a true Business Continuity configuration is still a reach for many of the PACS vendors.

Lots of radiology PACS on the market today are old.

havana3Interesting to see some of the PACS vendors developing a clinical display application based on server-side rendering and a zero (or at least near-zero) client. Why is the diagnostic application suite still a beefy client that requires delivery of the full lossless dataset to the remote display platform?  While the EMR user can access and view data on their Windows or Mac laptop, mobile tablet or phone, why is the radiologist still limited to a glorified PC?  Clinical image distribution and display has historically played second fiddle to the diagnostic application suite.  Why this sudden shift in focus from diagnostic to clinical?   Could it be that image enabling the EMR is the “new thing”, or simply the easier and less expensive engineering effort?  In the absence of meaningful change in system architecture and diagnostic display technology, perhaps the thinking is that a shiny new clinical viewer will serve as a differentiator among a handful of radiology PACS solutions that are otherwise old, and effectively the same core systems they were nearly ten years ago.

From my perspective, it seems that today’s Radiology PACS market is a zero sum game.  While some vendors with old technology are clearly losing market share, vendors with even “decent, old PACS” tend to lose as many existing customers as they gain new customers each year.  At 95+% market penetration, it’s a replacement market, where vendors attempt to take market share from each other.  Price pressure takes its toll on system sales revenue, so the real money is in service contracts.  But once again, if there is no net increase in customer base from year to year, that revenue stream is not growing. Only so much R&D funding is available each year, and apparently there is not enough revenue to fund “the next big thing” for Radiology PACS.   When revenues are flat or falling, profits also fall unless costs are reduced.  In addition to cutting R&D, that typically means vendors cut costs by eliminating staff through layoffs, or euphemistically “rightsizing”, “reorganizing”, spinning off or shutting down under-performing parts of their businesses.  When the Radiology PACS market went cold, the size of Radiology PACS companies shrunk.

In addition to standing pat with their existing technology, the Radiology PACS vendors have fallen behind in enhancing their solutions with those features and functions that radiologists and radiology departments need today to provide good patient care and stay competitive in their market. By and large, today’s Radiology PACS solutions do not support advance Breast Imaging packages to cover Full Field  Digital Mammography and Breast Tomosynthesis, as well as the ability to display multi-modality breast imaging presentations.  They do not include advanced diagnostic Nuclear Medicine packages to cover all the variations on mixed modality image fusion.  There is no advanced worklist functionality that can escalate studies on the read list to meet TAT requirements, no ED preliminary findings and discrepancy reporting, no call functionality and follow-up.  3D is basic if available at all, and remote access is typically poor. Today’s Radiology PACS frequently have no business analytics or data mining that would enable the department to discover and monitor the drivers of their business.

All of these highly desirable, if not necessary, features and functions are third party plugs-ins developed by smaller, more nimble and innovative vendors.  In too many cases, however, the interfaces required to plug these tools into the core Radiology PACS are not yet developed for a specific combination of vendor solutions.  It’s as though cooperating with the third party vendors to expand the core PACS through the addition of these plug-ins would be seen as an open admission that the PACS vendor has fallen behind.

Based on last year’s RSNA observations, it’s time for the PACS vendors to admit their system deficiencies, and start working on the solutions.  If keeping up with current requirements through in-house development is not feasible, then the PACS vendor must embrace the concept of third party plug-ins and get on with the development of the interfaces.  They should think of this strategy as a business necessity.  The VNA is steadily pulling image management from the department PACS.  Advanced clinical viewers that address both DICOM and non-DICOM objects will easily outperform those new PACS clinical viewers.  If a PACS vendor can’t keep up with all of the new radiology department application requirements, it will be a struggle to sell any new systems a few years from now, and that is the beginning of the end for the installed base.

Havana2As I departed Chicago last December, one strong image came to mind.  Pick any upscale neighborhood in Havana and you’re likely to see shiny cars parked at the curb.  The interesting thing is, none of these are new cars, they’re shiny old cars.  Some have new wheels, but they’re still old cars.  Today’s Radiology PACS conjured up images of Havana streets…shiny cars that are not really new, with underlying layers of faded paint covered in super-high-gloss wax.

Searching for that Next Generation PACS

I made the annual trek to Chicago this year, as usual right after Thanksgiving Day, to participate in the Radiological Society of North America meeting.  I don’t attend RSNA.  I “participate” in RSNA.  It’s like that adage that goes something like this “There are people who play the game, while there are people merely watching the game being played, and then there are those people who have no idea that a game is being played”.

I’m bringing up the adage, because I have seen it written and heard it said numerous times since the meeting that “There was nothing really new at this year’s RSNA”.  Anyone who actually holds that opinion must fall into that third group of people who have no idea that there is a game being played.

I had a number of reasons for checking out the current state of Radiology PACS.  I have clients with newly installed Vendor Neutral Archives that are now looking to replace their current PACS with a department-focused PACS that is a better fit with the VNA.  I had also recently read a very thought provoking article written by Lisa Fratt and published on line by Health Imaging on Nov 2, 2012, in which Lisa quoted lengthy comments on the state of Radiology PACS by Drs. Chang, Dreyer and Siegel.  I highly recommend reading that article, because my take away was that most of the current generation Radiology PACS, especially those in the larger booths, are not meeting the new list of expectations.

I think one of the problems that PACS vendors are having is investing development dollars at the same time they are being asked to reduce the sales price.  Today’s enlightened customer is asking for new features like multi-facility and multi-PACS workflow, powerful business analytics, and EMR integration to be packaged into a department PACS that should simply focus on what goes on inside the Radiology department.  A customer that has invested in a VNA and has already “image-enabled” the EMR with a universal viewer doesn’t need the department PACS to manage the data for its lifecycle, or provide the clinical viewer for the referring physicians.  We want the PACS vendors to add in the new workflow and analytics goodies, but reduce the overall price because of the removal of those applications that are no longer needed.  Apparently the call for a price reduction is falling on deaf ears.

Unfortunately that is the growing expectation among healthcare organizations that have invested in VNA and Universal Viewer solutions.  A growing number of providers believes that a department focused PACS is supposed to be significantly less expensive than the stand-alone, do-it-all model, that Dr. Chang refers to in the article as PACS 2.0.

Not only was I disappointed to learn after two days of RSNA booth visits that a department-focused PACS was merely 10% or so less expensive than the stand-alone model, but that the version of the PACS being demoed in the booths still does not include all the new goodies that are required.  That reminded me of yet another adage that was recently attributed to the new smaller packaging we see on the grocery shelves.  “Statements on the label such as New and Improved, really mean Smaller but just as Expensive.”

Based on what I saw at RSNA 2012, the major PACS vendors are failing to keep up with current market requirements.  So where is that next generation PACS, the one that sticks to the knitting in the department, includes the new Workflow, Analytics and EMR integration requirements, interfaces to the VNA, yet costs a good 20% less than the PACS 2.0 models?

They were there, on the floor, but you had to know where to look.  You had to be one of the people actually playing the game.

I’m going to do something I normally don’t do in my posts.  I’m going to name a few names along with the following disclaimer: I didn’t do an exhaustive search so I’m certain that I missed a few vendors and equally applicable solutions.   Therefore I am only commenting on the few that I did review.

If one were to describe the technology requirements for what we shall call the ideal next generation PACS, those requirements could be divided into three distinct subsystems: Workflow/Analytics, Visualization/Diagnostics, and Enterprise Archive/Distribution.  The adoption of the VNA and the Universal Viewer are well underway, and the arguments in favor of their deployment are well understood.  As for the other two subsystems that comprise what we think of as the department PACS, the three companies that I reviewed that offer commercially available Work Flow and Analytics Packages are: Compressus, Medicalis, and Primordial.  There are numerous companies that offer attractive Visualization/Diagnostics packages, but the application suite that I reviewed was developed by Visage Imaging.  Based on what I have seen and learned at RSNA 2012, in my opinion it is now possible to construct a next generation PACS by layering one of the three Workflow/Analytics packages on top of the Visage Imaging Visualization/Diagnostics package and interface this combination with a true VNA and the Universal Viewer package.  Once again, based on what I learned and in my opinion, that combination is substantially more potent than any of the PACS 2.0 solutions that the traditional PACS vendors are offering.

In my next blog I want to address numerous technology issues that had to be addressed by the participating vendors to make this best of bread combination work (like Directory database synchronization), and discuss some of the Service Level Agreement and Support issues that still need to be addressed.

Please stay tuned.  I think the Radiology PACS replacement market just got a whole lot more interesting.

Role of Cloud Infrastructure in Vendor-Neutral Archive Adoption

With all the recent hoopla around Cloud Infrastructure, I thought it would be worthwhile studying up on the subject, in order to learn how private and public Clouds might impact the adoption of Vendor-Neutral Archives.  While the concept of remote storage has been around for some time, the new twist that makes the subject much more interesting is the use of web services (HTTP) to exchange data with the Cloud.  Coincidentally, there has been an effort underway since early 2010 to develop a web services methodology for communicating (exchanging) medical image data between diagnostic workstations, PACS server, Vendor Neutral Archive, Intelligent Storage Solution, and freestanding UniViewer server.  The proposed web services protocol for medical imaging is called Medical Imaging Network Transport (MINT).  You can read more about MINT on their web site.  It is being suggested that MINT would replace the use of DICOM as the traditional interface between these devices.  The move from DICOM to web services is motivated by significant performance improvements (DICOM communications involves considerable overhead), as well as the opportunity to take full advantage of the rich meta data that must be included with the image data in a web services protocol.  Rather than attempt to summarize my opinions on this subject in this blog, I invite you to read the recent white paper that EMC commissioned me to write on this subject.  I think that you will find the subject somewhat stimulating.

Three-Step Strategic Plan for Achieving Meaningful Use of Medical Images

These are difficult times for Healthcare’s C-level administrators, as there are a number of major challenges looming on the horizon, appearing as dark clouds threatening to merge into a perfect storm. First and foremost I suppose would be figuring out how to support and encourage Meaningful Use according to the July 13 release of the final Stage 1 guidelines. Still no specific use of the word “images” in the text, but the same two objectives that reference the exchange of “key clinical information” are now codified in the 14 core objectives that hospitals are required to comply with at least six months before November 30, 2011 deadline. That’s the last day for eligible hospitals to register and attest to receive an incentive payment for FY 2011.

The incentives drop for every year of delay, so in this case, delay will be expensive, and effectively cost the organization precious development money.

While one may argue whether medical images should or could be included in the term “key clinical information”, there is no argument that exchanging images with outside organizations and providers based on data copied to CDs is problematic. It’s also expensive (labor and shipping costs). No wonder then that there are now twelve vendors offering either Electronic Image Share appliances or Cloud-based Image services. Should the C-level administrators look into solving this problem at the risk of taking their eyes off of the Meaningful Use issue? If the two issues are mutually exclusive, probably not.

Perhaps the darkest cloud on the horizon, because it is associated with hundreds of thousands of dollars in service fees, is the upcoming PACS data migrations. This cloud might appear to many as faint and unspecified, but make no mistake…it is there, it is coming, and it is going to be bad. Once again, should the C-level administrators spend time worrying about future data migrations, when there is only a year left to get the Electronic Health Record system up and running and meeting those Stage 1 objectives? If these two issues are mutually exclusive, probably not.

Here’s another important date bearing strong negative implications…2015; the year when Medicare payment adjustments begin for eligible professionals and eligible hospitals that are NOT meaningful users of Electronic Health Record (EHR) technology. “Adjustments” is political nice-nice for lowered reimbursements. Medical Images will most certainly be a stated inclusion in the Meaningful Use criteria by that time.

One way to look at the big picture is that there are a maximum of four years of financial incentives available for hospitals that can demonstrate support of Meaningful Use of key clinical information, for every year of eligibility. Deploying an IT and Visualization infrastructure over a five year period that will ultimately deliver all of a patient’s longitudinal medical record data to the physicians and caregivers is going to be expensive. It makes perfect sense to develop a Strategic Plan that goes after every bit of incentive funding available. That plan should and can weave all of the looming challenges into a single cohesive step plan. The aforementioned challenges are not mutually exclusive.

If one takes the position that electronic sharing of medical images outside of the organization is supportive of Stage 1 objectives, Step 1 of the Strategic Plan would be to deploy an electronic Image Share Solution. Whether that solution is an on-site, capitalized appliance or a Cloud-based service is another discussion, as the pros and cons are very organization-specific. Just make sure that the solution has upgrade potential, and is not a dead-end product.

By mid 2011 it’s time to start deploying Step 2 of the Strategic Plan…image-enabling the EHR. This might seem like an early jump on the image access issue, but we don’t know if specific mention of images will show up in the core objectives for Stage 2 or Stage 3, so why risk having to scramble to catch up? Perhaps the easiest way to image-enable the EHR would be to deploy a standalone universal viewer (display application). There are already a number of good universal viewers that require minimal server resources, feature server-side rendering, and require zero or near-zero client software. The IT department develops a simple URL interface between the EHR Portal and the universal viewer, and then individual interfaces between the universal viewer application and all of the image repositories in the enterprise (i.e. PACS). Ah but there’s the rub. All those PACS interfaces are going to be expensive to develop and maintain and replace with each new PACS, and there is no assurance that the universal viewer will be able to interpret all the variances in those disparate PACS headers.

Those of you that have been following my posts on this web site, see where this is going. The best solution, certainly the best long-term solution, is the deployment of a PACS-Neutral Archive and an associated Universal Viewer (aka UniViewer). The EHR is not designed to manage image data, relying instead on interfaces between its Physician Portal and the various established image data repositories in the enterprise. The PNA solves most of the organizations data management problems by consolidating all of the image data into a single “neutral” enterprise repository, which directly supports and encourages Meaningful Use of all the data objects that will constitute the patient’s longitudinal medical record. The problem is, most organizations will not be prepared to deploy a PACS Neutral Archive in 2011, so this would be a bit much to schedule for Step 2.

My Step 2 would be to expand the Image Share solution from Step 1 to include more storage…enough storage to accommodate the image data that the organization will start migrating from each of its department PACS. Of course this would mean making sure that the Image Share solution that is chosen in Step 1 was capable of becoming a PACS-Neutral Archive. At a minimum it would have to support bi-directional tag morphing. By the time the organization has completed the migration of the most recent 12 to 18 months of PACS image data, it will be possible to support Meaningful Use of the most relevant image data both inside and outside the organization. It is important to appreciate that the set of features/functions of a PACS-Neutral Archive required to meet the objectives of Step 2 (while the data is being migrated) is a fraction of the full set of PNA features/functions, so the cost of the software licenses required for Step 2 should be a fraction of the cost of the licenses for a complete PNA. Fortunately there are a few PNA vendors that appreciate this subtlety.

Step 3 could occur out there sometime beyond 2012, when the organization has sufficient funds approved to turn on all of the features and functions of a PNA, and purchase sufficient storage to accommodate all of the enterprise’s image data.

In this Strategic Plan, all of the major challenges looming over the horizon that have to do with images are addressed and solved in three creative yet logical Steps. Using the infrastructure to support and encourage Meaningful Use, in turn qualifies the organization for significant financial incentives that should go a long ways toward financing the Plan.

Hospitals required to demonstrate Electronic Image Sharing in 2011

Despite the key role that medical imaging plays in patient care, the inclusion of medical images in the Meaningful Use criteria for ARRA funding was supposedly all the way out in 2015.  One would think that that would give a healthcare organization plenty of time for planning, choosing a solution, budgeting and picking a vendor.

In theory, there are a number of ways to support Meaningful Use of images through the Physician Portal.  Whether you believe the best approach is [1] an Enterprise Archive with a UniViewer, [2] a multi-department PACS with its UniViewer, or [3] a continuation of individual department PACS, each with their own viewers; four-plus years would seem to be plenty of time to watch what the early adopters deploy and figure out your own strategy.

I think those four years just disappeared…in a puff.

In a recent article, Keith Dreyer, D.O., Ph.D., included a statement in his conclusion that came as something of a surprise to me.   That statement is worth repeating here in its entirety.  The underlines are mine.

“The Centers for Medicare and Medicaid Services proposed rulemaking of December 2009 suggests that providers will be required to demonstrate cross-provider patient medical data sharing by 2011. Furthermore, at least 80% of patient requests for electronic medical data must be able to be delivered within 48 hours. It is expected that medical imaging will be an important component of these requirements. As the federal government begins to require even more communication among all healthcare providers, the need for standards-based technology will undoubtedly become an integral part of the medical imaging IT infrastructure.”

“By taking a proactive approach and deploying technology such as image sharing applications, your department—and organization—will be better prepared for the impending future.”

Since this admittedly came as a surprise to me, I did a search and came up with an article in Healthcare IT News that listed the actual wording of the December rulemaking that Dr. Dreyer was interpreting.  Sure enough, in # 15 and #17 in the list of 23 Stage 1 Meaningful Use criteria, there appears a reference to “diagnostic test results”, and one can easily agree with Dr. Dreyer that that should be interpreted to include the actual images themselves.

What a timely discovery!

Medical Image (data) Sharing is already a hot subject.  By my count there are already 20 companies pitching some version of electronic Image Sharing…data transfer from site A to site B over a Virtual Private Network (VPN) or through an encryption application over the internet.  In most cases, these products are simply replacing the method of data transfer, replacing CDs with a network.  Most of these solutions fail to address a more subtle problem with data exchange between systems.  That problem is data compatibility.

All PACS systems are largely DICOM-conformant, but that conformance in and of itself does not guarantee data compatibility between different PACS.  Image data formatted by PACS A is not necessarily going to be fully compatible with PACS B just because the data is in the DICOM format.  I’ve already posted a piece on this subject on this web site. These new electronic image sharing products/services must be able to perform bi-directional dynamic tag morphing on the image data being transferred between systems in order to assure compatibility on the receiving end.

What makes Dr. Dreyer’s conclusions regarding electronic image sharing in 2011 so interesting is that they link Image Sharing with the larger subject of Meaningful Use by 2015.

I believe Meaningful Use in 2015 will depend on Ease of Use, and that strongly suggests a single consolidated image data repository and a single UniViewer, and the foundation of that concept is dynamic tag morphing…the ability to make image data from disparate PACS compatible with a single viewer.   So the PACS-Neutral Archive and the Image Sharing System have a very important key ingredient in common…Bi-directional Dynamic Tag Morphing.

There may be plenty of time to build the infrastructure necessary to achieve Meaningful Use of image data in 2015, but there’s no point in overlooking opportunities to build the stepping stones of that infrastructure this year.  An Image Sharing solution that includes the tag morphing application might easily be expanded, step-by-step, year-by-year to become the Neutral Archive an organization will need in 2015.

Picking the right Image Sharing solution, the one that grows into Neutral Archive, means having the bigger plan in place for the Neutral Archive.  Getting from 2011 to 2015 with the least number of dead-ends, restarts, forklifts, etc, means taking the time to build the big plan now.  Thank you, Dr. Dreyer, for providing a more immediate motivation.

What’s it going to take to achieve Meaningful Use of Images?

The other day a friend of mine forwarded to me a link to the Imaging Technology News eNews web site.  My friend encouraged me to look on the left bar of the web page and find the invitation to participate in their current survey.  The question was “Will PACS/RIS meet the meaningful use criteria to qualify for incentive dollars?”  If the survey is still running, you can check out the current results here.

Last time I checked, 33% thought that PACS/RIS would meet the criteria and another 30% thought that there’s a good chance it will.

I’d love to see the demographic of the survey participants, and I’d love to see a list of their assumptions.

I’m among the 30% that responded with a solid “no”, convinced that the PACS/RIS as we know it will not qualify for Meaningful Use, because it simply doesn’t have what it takes, and most likely never will.

If the survey participants gave serious thought to the question, they should have realized that the most critical component of what it takes to sustain Meaningful Use will be “ease of use”.  Most physicians are far too busy to learn and remember how to use more than one image viewer.  Most physicians are far too busy to switch back and forth between multiple viewers to assemble a montage of all the relevant clinical information in a single viewing window.  That’s exactly what will happen if we continue on the present path of developing individual URL links between the Physician Portal and the data elements being stored in each of the specialized departmental PACS, and using those department PACS viewers to view the data.  This approach shouldn’t make sense to IT, and it won’t make sense to the physician users.  So the participants must have been assuming that an all-encompassing Enterprise PACS will emerge, a single PACS that will embody all of the specialized department PACS requirements and thereby become the Uni-PACS.

In my opinion, it is highly unlikely that a current generation Radiology or Cardiology PACS or any other departmental PACS for that matter, will evolve in the next few years into an Enterprise Data Repository capable of managing the patient’s longitudinal record of all clinical information.  I seriously doubt that they will be able to manage all of the image information, much less all of the non-DICOM and non-image data objects.

Managing all of this clinical data is probably the easier part.  The harder part will be providing all of the expected display and processing applications that are specialized for each of the contributing imaging departments.  This is not to say that some of the larger vendors won’t try to become an all-encompassing enterprise PACS, or at least claim to be the Whopper of PACS, but I don’t see that happening.

In my opinion, the more likely scenario will be the Enterprise Neutral Archive fulfilling the role of the Enterprise Data Repository, and the (interfaced or embedded) UniViewer will provide the unified set of viewing tools that the physicians will use to access and view all of a patient’s clinical information, both the image and the non-image data being managed by that Neutral Archive.

Today, more and more Health Care organizations are “getting it”.  They see all of the advantages of separating the “archive” data management applications from the departmental PACS.  And it’s a natural to add a viewer to this new generation Archive.   Sooner or later, each of the PACS vendors will “get it”, and at that moment the push will be on in their R&D groups to further differentiate their department PACS products with the specialized applications unique to that department.  Their PACS will have to become an even better, specialized tool for each department, because the Neutral Archive will have already become the tool of choice for the Enterprise.  Meaningful Use will be much easier to achieve if the physicians know they only have to go to one repository and only have to use one viewing application to assemble all of the relevant clinical information in a single viewing session.  Get it?

Medical Images must be included in Meaningful Use Criteria…ASAP

A very insightful article appeared on line today in HealthImaging.com.  In it, Dr. Charles Rosen, MD, PhD, professor of neurosurgery at West Virginia University School of Medicine in Morgantown said “the government approach (to meaningful use criteria) seems ignorant of the issues”.  He’s right, and I suspect a good many others actually involved with patient care are in complete agreement.

I’ve written a commentary on this subject before.  Spending the next 2 to 3 years figuring out how to integrate Lab Results, Medication Histories and Care Summaries into the Electronic Health Repository seems like a lot of misguided effort to replace a FAX machine.   As Dr. Rosen points out, “…sharing images presents a greater challenge than contacting another facility to fax documents such as discharge summaries or lab results.”  The fact that Dr. Rosen has “…reached out to policymakers several times regarding the subject, with no response or further questions from the committee responsible” is puzzling.   Just exactly what is motivating that committee?

If you have been paying any attention to the medical image market of late, you’ve probably noticed Image Sharing products and services popping up like mushrooms after the rain.  Apparently a good many companies and Health Care Organizations believe that it is critically important to patient care to gain access to relevant medical image data, not just the associated reports.  However, the statement in the article that hospitals and facilities already exchange DICOM images on CDs, which “demonstrate that the images are needed and the data standard works across sites” is a little misleading.

True, the fact that there is a such an effort to exchange images demonstrates the importance of the image data to the patient’s record, but the reason that there are so many new efforts to replace the use of CDs as the transfer mechanism is not because everyone is tired of handling CDs and the Image Sharing movement is simply the new, techno-sexy way to exchange data.

The real problem with the current methods of image exchange based on CD transfers is that they are based on the premise that one vendor’s DICOM is going to be compatible with another vendor’s DICOM.  There are numerous real world examples that stand as evidence that this is not entirely true.   I’ve written on that subject in this blog as well.  The real objective of the new Image Sharing concept is to get the DICOM Image data created by one PACS into a neutral place, where it can be modified to meet the requirements of the recipient PACS.  Image Sharing services or products that cannot perform this dynamic data manipulation will not likely be any more successful that the CD exchange methods.

I am very encouraged to see a call for the inclusion of images in the meaningful use discussion sooner rather than later, but I also encourage those proponents not to assume that image exchange is simply a matter of a secure internet connection facilitated by a service or a server.  DICOM is not the rigid standard that many believe it to be.  There is a lot of room for “interpretation” in the DICOM standard, and most Modality and PACS vendors have taken full advantage of this opportunity to be creative.   The successful exchange application will have that something extra in the middle to make the data truly useful on the receiving end.   If we succeed in getting image data moved up in the meaningful use schedule, let’s not blow it by overlooking the details.

Whether policymakers wake up and recognize the true importance of image exchange or not, the market already recognizes the value of meaningful image exchange, and the replacement of the CD exchange methodology is long overdue.  Washington may not get it right, but the market always gets it right.