The U.S. Department of Health and Human Services' Office of the National Coordinator (ONC) recently published an interim final rule for the adoption of an initial set of standards, implementation specifications, and certification criteria in support of "meaningful use" of electronic health records (EHRs) technology in 2015.
The stimulus program, established by the American Recovery and Reinvestment Act (ARRA) of 2009, aims to incentivize EHR adoption by hospitals and physicians who provide services outside of hospital settings. Funds to pay for these systems are tied to fulfillment of the meaningful use requirements.
Given the vital role diagnostic imaging plays in patient care, the members of the Medical Imaging and Technology Alliance (MITA) are concerned that medical imaging was only mentioned in the meaningful use matrix for implementation in 2015.
Instead, we believe the inclusion of both images and imaging reports in the EHR as a criterion for meaningful use is essential, that it should occur by 2013, and that it should include an explicit recognition of the universally accepted DICOM standard.
As healthcare providers, hospitals, and vendors scramble to make different EHR systems communicate and interoperate, the experience of the medical imaging world can provide some invaluable guidance. More than 20 years ago, the manufacturers and users of digital imaging equipment recognized the need to share digital data between care providers, even if these care providers were using imaging equipment produced by different manufacturers. The main concern was to improve patient care by having access to all data, while controlling costs and improving patient safety by avoiding unnecessary repeat examinations.
Through the cooperation of the American College of Radiology (ACR) and the National Electrical Manufacturers Association (NEMA), the DICOM standard was created. This living and breathing standard has evolved through the years to address all "package" and "transportation" needs of new and existing imaging modalities and image formats.
With the nearly universal adoption and use of the DICOM 3.0 standard today, all DICOM-compliant imaging systems can be enabled to communicate with one another and to exchange patient data (such as demographics, examination properties, images, numerical data, text, and curves) reliably, securely, and efficiently.
DICOM has evolved to support new imaging technologies (including dentistry, ophthalmology, and pathology) and new storage paradigms, and it assists in creating a fully digitized record that fits in the new virtual environment of medicine. It's an industry-maintained standard that does not require federal legislation for its maintenance, control, and evolution.
The exchange of imaging exams between healthcare organizations routinely takes place today using DICOM-formatted CDs, or, online, via the transfer functions supported in DICOM. The data are then imported into medical imaging systems, often of different manufacturers, further demonstrating the well-developed interoperability of the standard.
To further address the needs of the users, the Integrating the Healthcare Enterprise (IHE) initiative has created profiles to enable medical facilities to create smooth and efficient workflows, using the medical informatics standards of DICOM and HL7, as well as other information technology standards. IHE is a collaborative effort between recognized standards groups to develop technical frameworks to guide users during implementation of multivendor configurations of electronic health records, electronic medical records (EMRs), and clinical information systems (CISs).
As such, IHE is a "cookbook" with recipes (the IHE profiles) on how to make the best use of existing standards to address specific scenarios. More than 100 systems are tested for compliance at IHE Connectathon events every year. Use of IHE profiles has resulted in healthcare providers achieving optimal care for the patient by assuring the movement of medical patient data across a wide range of clinical contexts wherever the data are meaningful, beneficial for the patient and the provider, or simply required.
Images in the EHR
A solution to the challenge of making appropriate images available in the EHR has eluded many as they struggle with the meaning of data exchange. The problem centers on the definition of the phrase "in the EHR." It should be noted that the EHR aggregates data, but it's not always the owner of the data. However, the EHR needs to know where the data are located.
To support this interoperability in imaging, the Cross-enterprise Document Sharing for Imaging (XDS-i) profile, defined by IHE, provides a solution for sharing (publishing, finding, and retrieving) imaging documents across a group of affiliated enterprises, without the need for storing multiple copies of the large imaging datasets in different locations.
Affiliated enterprises such as radiology departments, private physicians, clinics, long-term care, and acute care can access (query and retrieve) imaging documents (images and reports) of interest thru XDS-i. By using the images in DICOM standard format and utilizing the IHE profile XDS-i, the challenge is simplified without the need to define a new process.
In recent years, MITA members have seen an increasing interest in image integration capabilities. As this happens, it will improve communication between physicians and patients where a medical image can show in an instant the visual basis for the doctor's diagnosis, helping patients see what their medical condition is. It will also reduce costs as duplicative tests are reduced and improve care as images are available at the point of care.
What is an image?
It is important to understand that a medical imaging exam is not always a single image. It can be a single small image (e.g., an ultrasound image) or a group of hundreds of images (e.g., imaging of the beating heart). MRI diffusion studies can consist of thousands of images. Digital mammograms can easily produce multiple gigabytes of data, due to the high resolution required to view submillimeter-sized microcalcifications. Depending on the modality used for acquiring an image, data files can be large to support the high resolution of the study.
Images must have high spatial resolution to permit a radiologist to make a primary diagnosis, and a cardiologist requires high resolution in both the spatial and temporal domains, such as in dynamic fluorography studies. These factors, as well as the fact that we have been saving some of this data for many years, result in very large image databases, which are best maintained by special imaging systems (PACS). This results in a more economical solution while maintaining accessibility to all authorized users.
In some clinical settings, it is also possible to share the images in a smaller-than-original format when full resolution is not required. This is similar to creating thumbnails for inserting in documents. These images, however, are for documentation only, and they cannot be used to create a diagnosis or treatment plan.
Access to images based on their metadata is an elegant solution to avoid the overcrowding of an EHR, while providing full-resolution viewing capability. Through the effort of MITA in developing standards to identify acceptable compression rates and transfer mechanisms, one study may be accessed and used by many medical professionals, all for the benefit of the patient.
To fully understand the various needs for imaging information, it is necessary to explain what the different users need in terms of the results of information and the quality of images.
The image acquisition and reporting process begins with scheduling an exam. This is done in an information system -- a radiology information system, a cardiovascular information system, etc. -- which adds to an existing patient record or begins the process of creating a patient record that includes the type of exam, the desired images, the requester, the referring physician, and patient demographics.
The exam is then performed, with the imaging data being transferred in DICOM format to the PACS; the radiologist, cardiologist, or other imaging "-ologist" then views the images and creates a report of the results. The images remain in the PACS and the report is "owned" by the information system (typically part of the EHR).
A notice of exam completion and the presence of images are then reported to the relevant information system. The image data used at this point are the "full-fidelity" (maximum resolution and size) image data. With the report being available to the ordering physician and the images safely stored in the PACS, the primary steps of the exam have been achieved.
These are the acquirers of the images. They will have viewed the original acquisitions and generated the report. They will also access the full-resolution images in the future, if the need arises, to do a historical comparison of image sets from previous exams.
Physicians who interact with patients across the range of clinical practice will need access to images and imaging reports. The typical imaging information requirement for a referring physician is the report of the exam, with occasional access to a low-fidelity version of the key images from the exam. This is usually used for discussing the results of the exam with the patient. Ideal access would be via a Web-enabled viewer connecting back to the original acquisition location.
Also important is the capability to access images via the EMR or hospital information system (HIS) connection in the doctor's office, in coordination with images via the link reported after the acquisition of exam. It is important to note that no image data are actually moved, the only movement is the display via the Web. Of note, the referring physician may require access to the full-resolution datasets -- e.g., oncologists may need these data to create a radiation therapy treatment plan, and a neurosurgeon may need full-resolution images to plan the surgery.
For a patient's primary care physician, it will often be possible to provide access to an imaging report. If reference viewing is required, then access would be via a Web-enabled viewer connecting back to the original acquisition location. As stated above, it is also important here that the general practitioner has the ability to access images via the EMR or HIS connection in the doctor's office, in coordination with images via the link reported after the acquisition of the exam. Again, no image data have actually moved, only the display via the Web.
For the specialist, the imaging report would be available via HIS interface internal to the hospital. As full-fidelity images will be required by the surgeon, these can be viewed via a PACS workstation in the facility. No data are copied, as the surgeon accesses the study across the intranet from the PACS. Access to the EHR, including images, is beneficial for accuracy, full information content, and quality.
Ideally, this imaging information will be shared between healthcare facilities. This scenario could involve a primary care physician, surgeon, oncologist, or other specialist. With the design plans for the Nationwide Health Information Network (NHIN) and EHR development, the reports of all exams could be transferred between facilities via the EHR interface. By utilizing the IHE profile XDS-i(b) model, the image data, in full fidelity and with HIPAA compliance, could be accessed between cooperative institutions.
In some cases, as in surgery planning, the entire datasets would need to be transferred to the "new" facility. Even if the full XDS-i(b) support is not implemented, the DICOM standard supports query/retrieve, which can be used if an agreement is in place for cooperative exchange between the facilities.
It is also essential that patients be given access to imaging information. In the Internet-enabled society that exists today, patient portals that provide secure access via a Web browser session are possible. Patients would be accessing their information via an EHR interface in a Web browser. When the patients are within their "home" medical system, the EHR should be aware of the path and location of the requested images. These images are then displayed via a Web viewer. No data are transferred.
The current state of the art in integrating medical images into patient records is sufficiently advanced for immediate inclusion in the "meaningful use" criteria. By recognizing and endorsing the substantial work done by NEMA/MITA in DICOM, HL7, and the IHE Technical Frameworks, a comprehensive patient record that provides improvements in patient care, outcomes research, installation efficiencies, and cost reductions can be achieved today.
As such, MITA recommends including images and imaging reports in the EHR as a criterion for meaningful use beginning in 2013, and an explicit recognition of the universally accepted DICOM standard.
In the evolution of the NHIN, and with full cooperation of all providers, there should be no need for "media" transport of image data involving the burning of image data to DVD, CD, or a USB device. Through Internet connection and the use of a standards-based, secure authenticated method to access the images, studies can be shared between hospitals, care providers, and even directly with a patient.
By Rich Eaton
AuntMinnie.com contributing writer
June 16, 2010
Rich Eaton is an industry manager for MITA.
The opinions expressed in guest editorials are those of the author and do not necessarily reflect the views of AuntMinnie.com.
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