Consolidated Health Informatics

Standards Adoption Recommendation

**Multimedia Information in Patient Records**

**[Index]{.underline}**

1.  **Part I -- Sub-team & Domain Scope Identification** -- Basic
    information defining the team and the scope of its investigation.

2.  **Part II -- Standards Adoption Recommendation** -- Team-based
    advice on standard to adopt.

3.  **Part III -- Adoption & Deployment Information** -- Supporting
    information gathered to assist with deployment of the standard (may
    be partial).

**[Summary]{.underline}**

**Domain: Data from multiple media sources (e.g., images, photos,
audios, videos, faxes, etc.)**

**Standards Adoption Recommendation:**

**Digital Imaging Communications in Medicine (DICOM)**

**SCOPE**

The primary application of this standard is for combining data from
multiple media (e.g., images, photos, audios, videos, faxes, etc.) into
patient records with the objective of ensuring interoperability and
information exchange among federal agencies. This standard is useful
throughout the federal healthcare system which employs a wide variety of
medical records and patient information systems.

**RECOMMENDATION**

This DICOM recommendation has two parts and encompasses storage and
exchange of multimedia data.

**OWNERSHIP**

National Electrical Manufacturers Association (NEMA) owns the copyright
to the standard. DICOM is a standards organization administered by the
NEMA Diagnostic Imaging and Therapy Systems Division. NEMA is an
ANSI-Accredited standards developing organization

##### 

##### 

##### APPROVALS AND ACCREDITATIONS

DICOM is not ANSI accredited, however the DICOM Standard is expected to
become an ISO reference standard and has been a European Standards (EN)
for years. DICOM also partners with Integrating the Healthcare
Enterprise **(**IHE) and HL7.

**ACQUISITION AND COST**

Standards are available from
[http://medical.nema.org](http://medical.nema.org/) at a cost ranging
from \$50.00 to \$700.00.

####### Part I -- Team & Domain Scope Identification

**[Target Vocabulary Domain]{.underline}**

+-----------------------------------------------------------------------+
| Common name used to describe the clinical/medical domain or messaging |
| standard requirement that has been examined.                          |
|                                                                       |
| ## Multimedia information includ                                      |
| ing messaging format as a component of an electronic patient record.  |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| Describe the specific purpose/primary use of this standard in the     |
| federal health care sector (100 words or less)                        |
|                                                                       |
| **Multimedia Data:**                                                  |
|                                                                       |
| The primary application of this standard is for combining data from   |
| multiple media (e.g., images, photos, audios, waveforms, videos,      |
| faxes, etc.) into patient records with the objective of ensuring      |
| interoperability and information exchange among federal agencies.     |
| This standard encompasses storage and exchange of multimedia data and |
| is useful throughout the federal healthcare system which employs a    |
| wide variety of medical records and patient information systems.      |
+-----------------------------------------------------------------------+

**[Sub-domains]{.underline}** *Identify/dissect the domain into
sub-domains, if any. For each, indicate if standards recommendations are
or are not included in the scope of this recommendation.*

+---------------------------------------------------+------------------+
| **Domain/Sub-domain**                             | **In-Scope       |
|                                                   | (Y/N)**          |
+---------------------------------------------------+------------------+
| **Incorporation of multimedia information into    | **Y**            |
| patient records:**                                |                  |
+---------------------------------------------------+------------------+
| **Images**                                        | **Y**            |
+---------------------------------------------------+------------------+
| ####  Audio information                           | ####### Y        |
+---------------------------------------------------+------------------+
| **Waveform data**                                 | **Y**            |
+---------------------------------------------------+------------------+
| **Video information**                             | ####### Y        |
+---------------------------------------------------+------------------+
| **Telemedicine**                                  | ####### N        |
+---------------------------------------------------+------------------+

**[Information Exchange Requirements (IERs)]{.underline}** *Using the
table at appendix A, list the IERs involved when using this vocabulary.*

  -----------------------------------------------------------------------
  Care Management Information

  Improvement Strategy

  Population Member Health Data

  Body of Health Services Knowledge

  Resource Availability
  -----------------------------------------------------------------------

**[Team Members]{.underline}** *Team members' names and agency names
with phone numbers.*

+-----------------+-----------------------------------+---------------+
| **Name**        | **Agency/Department**             | **Phone       |
|                 |                                   | Number**      |
+-----------------+-----------------------------------+---------------+
| William         | Department of Health and Human    | 301-496-9388  |
| Heetderks,      | Services,                         |               |
| Co-Chair        |                                   |               |
|                 | National Institutes of            |               |
|                 | Health/NIBIB                      |               |
+-----------------+-----------------------------------+---------------+
| Richard Swaja,  | Department of Health and Human    | 301-451-4779  |
| Co-Chair        | Services, National Institutes of  |               |
|                 | Health/NIBIB                      |               |
+-----------------+-----------------------------------+---------------+
| Anne Altemus    | Department of Health and Human    | 301-435-3287  |
|                 | Services,                         |               |
|                 |                                   |               |
|                 | National Institutes of Health/NLM |               |
+-----------------+-----------------------------------+---------------+
| Alicia Bradford | Centers for Medicare and Medicaid | 410-786-3730  |
|                 | Services                          |               |
+-----------------+-----------------------------------+---------------+
| Lewis Berman    | Department of Health and Human    | 301-458-4096  |
|                 | Services,                         |               |
|                 |                                   |               |
|                 | Centers for Disease Control       |               |
+-----------------+-----------------------------------+---------------+
| Andrew          | Department of Veterans Affairs,   | 301-734-0093  |
| Casertano       | Veterans Health Administration    |               |
+-----------------+-----------------------------------+---------------+
| Ruth Dayhoff    | Department of Veterans Affairs,   | 301-734-0112  |
|                 | Veterans Health Administration    |               |
+-----------------+-----------------------------------+---------------+
| Elizabeth       | MITRE Corporation                 | 703-983-1076  |
| Halley          |                                   |               |
+-----------------+-----------------------------------+---------------+
| Michael         | Department of Veterans Affairs,   | 301-734-0122  |
| Henderson       | Veterans Health Administration    |               |
+-----------------+-----------------------------------+---------------+
| Peter Kuzmak    | Department of Veterans Affairs,   | 301-734-0154  |
|                 | Veterans Health Administration    |               |
+-----------------+-----------------------------------+---------------+
| Randy Levin     | Department of Health and Human    | 301-827-7756  |
|                 | Services,                         |               |
|                 |                                   |               |
|                 | Food and Drug Administration      |               |
+-----------------+-----------------------------------+---------------+
| Nancy Orvis     | Department of Defense, TRICARE    | 703-681-5611  |
|                 | Management Facility               | X6830         |
+-----------------+-----------------------------------+---------------+
| Alan Smith      | Department of Defense, TRICARE    | 703-681-7899  |
|                 | Management Facility               | x 1219        |
+-----------------+-----------------------------------+---------------+
| Steven Steindel | Department of Health and Human    | 404-639-7484  |
|                 | Services, Centers for Disease     |               |
|                 | Control                           |               |
+-----------------+-----------------------------------+---------------+
| Wesley Wei      | Centers for Medicare and Medicaid | 410-786-2486  |
|                 | Services                          |               |
+-----------------+-----------------------------------+---------------+
| Steve Wagner    | Department of Veterans Affairs,   | 603-624-5942  |
|                 | Veterans Health Administration    |               |
+-----------------+-----------------------------------+---------------+

**[Work Period]{.underline}** *Dates work began/ended.*

  ----------------------------------- -----------------------------------
  **Start**                           **End**

  October 30, 2003                    September 21, 2005
  ----------------------------------- -----------------------------------

**Part II -- Standards Adoption Recommendation**

##### Recommendation *Identify the solution recommended.*

+-----------------------------------------------------------------------+
| This recommendation has two parts and encompasses storage and         |
| exchange of multimedia data.                                          |
|                                                                       |
| Part 1 -- Storing Multimedia Data in Patient Health Records           |
|                                                                       |
| The Digital Imaging and Communications in Medicine (DICOM) Standard   |
| is recommended as the primary method for incorporating multimedia     |
| data into patient health records. In the development of this          |
| recommendation, the fundamental requirements considered for           |
| representing multimedia objects in electronic patient health records  |
| included (1) that the objects stored in the patient records are       |
| uniquely identifiable persistent entities and (2) that the objects    |
| contain patient study, study component, examination, equipment,       |
| unique identification, and other information (e.g., date, creator,    |
| body part, etc.) as attributes and metadata in addition to the        |
| objects themselves. DICOM satisfies these requirements.               |
|                                                                       |
| To mitigate risks to patient safety, it is essential that patient     |
| health record metadata be integrated with patient multimedia data and |
| communicated in a standard manner. DICOM supports these capabilities  |
| and is the preferred standard for multimedia because it records       |
| patient record metadata within the multimedia object, it provides a   |
| standard communication method for exchange of objects, and it         |
| provides a mechanism to define and validate interoperability          |
| conformance. Some specialties such as radiology heavily depend on     |
| DICOM as the standard without which interoperability would be         |
| severely compromised. Other specialties are in varying stages of      |
| adopting DICOM as the multimedia standard. Compatibility between      |
| specialties requires the use of the same standard to achieve          |
| interoperability. All multimedia specialty data must be interoperable |
| as part of the electronic health record. DICOM is the most viable     |
| candidate for achieving interoperability across specialties within    |
| the electronic health record.                                         |
|                                                                       |
| Specialties and devices that have not yet adopted DICOM for           |
| multimedia need an interim solution that incorporates the following   |
| requirements:                                                         |
|                                                                       |
| -   Multimedia data and associated metadata shall be stored and       |
|     transmitted in alternative format(s). These format(s) must be     |
|     identified and their metadata content specified by some standards |
|     body in order to allow interoperability of systems. These formats |
|     must be easily convertible to DICOM for future compatibility.     |
|     Particularly important is correct representation of patient and   |
|     study identification information.                                 |
|                                                                       |
| -   There must be standard communication mechanisms for exchange of   |
|     multimedia objects between systems.                               |
|                                                                       |
| -   To allow validation of proper behavior of interfaced systems,     |
|     conformance templates for interoperability must be developed and  |
|     cited in procurements until equivalent DICOM systems are          |
|     available.                                                        |
|                                                                       |
| \_\_\                                                                 |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |
|                                                                       |
| Part 2 -- Exchange of Multimedia Data                                 |
|                                                                       |
| The use of DICOM for electronic health record (EHR) information       |
| exchange is focused on the exchange of multimedia EHR content,        |
| instrument-produced structured reports, and the textual information   |
| necessary to properly identify the multimedia content/objects. All    |
| other textual EHR information (patient history, orders, progress      |
| notes, etc.) will be exchanged using the HL7 messaging standard       |
| already approved by the CHI.                                          |
|                                                                       |
| There are multiple scenarios in which the exchange of multimedia EHR  |
| information must occur, each of which must be supported by            |
| information exchange protocols. Multimedia is an essential part of    |
| the overall EHR content. CHI has already adopted the HL7 messaging    |
| standard (version 2.3 and later) as the standard for exchanging       |
| textual EHR information. The exchange of multimedia EHR information   |
| should be as tightly integrated with the exchange of textual EHR      |
| information as possible.                                              |
|                                                                       |
| The following six scenarios appear to cover all the possible          |
| information exchange permutations. The recommended exchange standards |
| are listed after each scenario.                                       |
|                                                                       |
| +------------------------------------------------------------------+  |
| | **Scenario #1**: Exchange of multimedia EHR information between  |  |
| | two DICOM capable systems.                                       |  |
| +------------------------------------------------------------------+  |
| | **Recommended exchange standard**: Use DICOM standard to         |  |
| | exchange information.                                            |  |
| +------------------------------------------------------------------+  |
| | **Rationale:** In this scenario, the primary purpose is to       |  |
| | exchange multimedia EHR content. In this situation, the DICOM    |  |
| | standard can be used as both the content formatting standard and |  |
| | the information exchange standard.                               |  |
| +------------------------------------------------------------------+  |
| |                                                                  |  |
| +------------------------------------------------------------------+  |
| | **Scenario #2:** Exchange of EHR information (including          |  |
| | multimedia) between two EHR systems that are HL7 and DICOM       |  |
| | capable.                                                         |  |
| +------------------------------------------------------------------+  |
| | **Recommended exchange standards**: Use DICOM for multimedia and |  |
| | associated metadata and HL7 for textual EHR information (patient |  |
| | history, orders, progress notes, etc.)                           |  |
| +------------------------------------------------------------------+  |
| | **Rationale:** In this scenario, the primary purpose is to       |  |
| | exchange both multimedia and other EHR content. In this          |  |
| | situation, the DICOM standard should be used for conveying the   |  |
| | multimedia content including associated metadata and             |  |
| | object-specific information, and HL7 should be used for exchange |  |
| | of other EHR textual information.                                |  |
| +------------------------------------------------------------------+  |
| |                                                                  |  |
| +------------------------------------------------------------------+  |
| | **Scenario #3:** Exchange of any type of EHR information between |  |
| | a sending HL7 and DICOM capable system and a receiving HL7       |  |
| | capable but non-DICOM capable system.                            |  |
| +------------------------------------------------------------------+  |
| | **Recommended exchange standards:** There are two alternatives.  |  |
| | The first would be to remediate the receiving system to          |  |
| | communicate using DICOM. The second alternative would be to use  |  |
| | HL7 (preferably XML encoded) for textual information and         |  |
| | Web-based standards (JPEG or MPEG) for multimedia, metadata, and |  |
| | object-specific information. This second alternative must        |  |
| | integrate patient metadata with the multimedia data and transmit |  |
| | it in a standard manner.                                         |  |
| |                                                                  |  |
| | It is recognized that many systems will not be able to achieve   |  |
| | either of these alternatives near-term. Hence, it is recommended |  |
| | that in those cases where either of the above solutions will not |  |
| | work, that the exchange occur using data formatted according to  |  |
| | the IHE "Portable Data for Imaging" integration profile. This    |  |
| | specification includes incorporating viewer software that allows |  |
| | the display of the DICOM objects. In places where electronic     |  |
| | links exist between sites, the exchange may occur over a secure  |  |
| | connection. For all other cases, the recommended form of         |  |
| | exchange is through fixed media (CD or DVD depending on package  |  |
| | size).                                                           |  |
| +------------------------------------------------------------------+  |
| | **Rationale:** In this scenario, the receiving system does not   |  |
| | understand the DICOM standard; therefore, absent remediation,    |  |
| | the DICOM standard could not be used. If interoperation is       |  |
| | attempted without remediation, the HL7 standard should be used   |  |
| | for textual information exchange and web based standards (JPEG   |  |
| | or MPEG) should be used for formatting the multimedia content.   |  |
| | All metadata required by DICOM for the multimedia object must be |  |
| | communicated between systems in a standard manner. In cases      |  |
| | where the DICOM image is not compatible with the native          |  |
| | software, IHE Portable Data for Imaging integration profile      |  |
| | provides a standard means of allowing the images to be viewed on |  |
| | the receiving system until native viewing software can be        |  |
| | implemented.                                                     |  |
| +------------------------------------------------------------------+  |
| |                                                                  |  |
| +------------------------------------------------------------------+  |
| | **Scenario #4:** Exchange of any type of EHR information between |  |
| | a sending HL7 capable but non-DICOM capable system and a         |  |
| | receiving HL7 capable DICOM-capable system.                      |  |
| +------------------------------------------------------------------+  |
| | **Recommended exchange standards:** The sending system should    |  |
| | use HL7 to send textual information and web based standards      |  |
| | (JPEG or MPEG) to send multimedia metadata, and object-specific  |  |
| | information. The receiving system should encapsulate this        |  |
| | information into a DICOM object.                                 |  |
| +------------------------------------------------------------------+  |
| | **Rationale:** DICOM Supplement 104 (now incorporated into DICOM |  |
| | 2004) addresses the need and ability to encapsulate information  |  |
| | sent in PDF format from non-DICOM-capable imaging modalities.    |  |
| | For multimedia information sent in non-PDF format, DICOM         |  |
| | Secondary Capture (SC) is available. In either case, the         |  |
| | resulting object is in DICOM format. All metadata required by    |  |
| | DICOM for the multimedia object must be communicated between     |  |
| | systems in a standard manner.                                    |  |
| +------------------------------------------------------------------+  |
| |                                                                  |  |
| +------------------------------------------------------------------+  |
| | **Scenario #5:** Exchange of multimedia EHR information between  |  |
| | a sending DICOM capable system and a receiving non-DICOM capable |  |
| | system. Neither system is HL7 capable.                           |  |
| +------------------------------------------------------------------+  |
| | **Recommended exchange standards:** There are two alternatives.  |  |
| | One would be to remediate the receiving system to communicate    |  |
| | using DICOM. The other would be to use CDs and DVDs formatted    |  |
| | according to the IHE Portable Data for Imaging integration       |  |
| | profile to transfer the data. This specification includes        |  |
| | incorporation of viewer software that allows the display of the  |  |
| | DICOM objects.                                                   |  |
| +------------------------------------------------------------------+  |
| | **Rationale:** In this scenario, the receiving system does not   |  |
| | understand the DICOM standard; therefore, absent remediation,    |  |
| | DICOM communications could not be used. The IHE Portable Data    |  |
| | for Imaging integration profile provides a standard means of     |  |
| | allowing the images to be viewed on the receiving system.        |  |
| +------------------------------------------------------------------+  |
| |                                                                  |  |
| +------------------------------------------------------------------+  |
| | **Scenario #6:** Exchange of multimedia EHR information between  |  |
| | a sending non-DICOM capable system and a receiving DICOM capable |  |
| | system. Neither system is HL7 capable.                           |  |
| +------------------------------------------------------------------+  |
| | **Recommended exchange standards:** There is only one option:    |  |
| | remediate the sending system to communicate using DICOM.         |  |
| +------------------------------------------------------------------+  |
| | **Rationale:** In this scenario, communication is possible only  |  |
| | if the sending system understands the DICOM standard.            |  |
| +------------------------------------------------------------------+  |
|                                                                       |
| **Future Considerations:**                                            |
|                                                                       |
| The following items are recommended for future consideration and      |
| research support to address issues related to multimedia patient      |
| information:                                                          |
|                                                                       |
| 1.  Standards committee collaborations -- As the standards continue   |
|     to develop, it is recommended that the DICOM and HL7 committees   |
|     (and others as appropriate) work together to harmonize their      |
|     standards for healthcare applications. This is particularly       |
|     desirable in the area of DICOM Structured Reports (SR) and HL7    |
|     Clinical Document Architecture (CDA) harmonization. It is         |
|     recommended that within the next year, HL7 and DICOM agree to a   |
|     harmonization method for equivalent structures found in CDA and   |
|     SR messages and maintain harmonization using an appropriate       |
|     maintenance and management structure,                             |
|                                                                       |
| 2.  Time to incorporate industry standards -- Consideration should be |
|     given to providing support for reducing the time between          |
|     implementation of industry standards and incorporation into       |
|     federal standards.                                                |
|                                                                       |
| 3.  Long-term storage and retrieval of information -- Consideration   |
|     of problems associated with the "migration" of information among  |
|     media bases, which are partly due to rapidly changing information |
|     technologies, is necessary.                                       |
|                                                                       |
| 4.  Unique identifiers -- Although assignment of unique identifiers   |
|     is mature in the DICOM Standard, efforts should be supported in   |
|     the ONCHIT initiatives to provide harmony with HL7 and other      |
|     standards.                                                        |
|                                                                       |
| 5.  Computer system firewalls -- For biomedical information exchange  |
|     between agencies, issues of computer system security and          |
|     firewalls are a larger hindrance to effortless communication than |
|     are the use of different data standards within agencies.          |
|     Additional research is needed to develop secure data systems that |
|     remain open to exchange of large data sets from the outside.      |
+-----------------------------------------------------------------------+

**[Ownership Structure]{.underline}** *Describe who "owns" the standard,
how it is managed and controlled.*

+-----------------------------------------------------------------------+
| DICOM is an international standard format for interchange of          |
| biomedical images and ancillary data. Development is coordinated by   |
| the National Electrical Manufacturers Association (NEMA) which        |
| provides a forum for standardization of electrical equipment that     |
| enables consumers to select from a range of safe, effective, and      |
| compatible electrical products. DICOM specifies a complete            |
| communications standard including a generic messaging service for     |
| exchange of imaging-related information between applications and the  |
| transfer of actual images.                                            |
|                                                                       |
| Integrating the Healthcare Enterprise (IHE) is an initiative by       |
| healthcare professionals and industry to improve the way computer     |
| systems in healthcare share information. IHE promotes the coordinated |
| use of established standards such as DICOM and HL7 to address         |
| specific clinical needs in support of optimal patient care. Systems   |
| developed in accordance with IHE communicate with one another better, |
| are easier to implement, and enable care providers to use information |
| more effectively. Physicians, medical specialists, nurses,            |
| administrators and other care providers envision a day when vital     |
| information can be passed seamlessly from system to system within and |
| across departments and made readily available at the point of care.   |
| IHE is designed to make their vision a reality by improving the state |
| of systems integration and removing barriers to optimal patient care. |
|                                                                       |
| The World Wide Web Consortium (W3C) is an international consortium    |
| that primarily pursues its mission through the creation of Web        |
| standards and guidelines. W3C also engages in education and outreach, |
| develops software, and serves as an open forum for discussion about   |
| the Web. In order for the Web to reach its full potential, the most   |
| fundamental Web technologies must be compatible with one another and  |
| allow any hardware and software used to access the Web to work        |
| together. W3C refers to this goal as "Web interoperability." By       |
| publishing open (non-proprietary) standards for Web languages and     |
| protocols, W3C seeks to avoid market fragmentation and thus Web       |
| fragmentation.                                                        |
+-----------------------------------------------------------------------+

##### Summary Basis for Recommendation *Summarize the team's basis for making the recommendation (300 words or less).*

+-----------------------------------------------------------------------+
| -   Performed an initial comprehensive review of standards and        |
|     activities dealing with various information media and eliminated  |
|     any that did not consider the type of media associated with       |
|     patient health records or were under development with a long-term |
|     deadline for completion.                                          |
|                                                                       |
| -   Developed a list of general data types and subtypes used for      |
|     patient records in the federal healthcare system.                 |
|                                                                       |
| -   Performed a comparison of each remaining standard against this    |
|     checklist.                                                        |
|                                                                       |
| -   Selected the standard that encompasses a large portion of         |
|     applicable media types and identified gaps existing in the        |
|     current standard.                                                 |
|                                                                       |
| -   Developed recommendations for a standard. Also addressed issues   |
|     that need to be considered for completeness, and options to       |
|     accommodate gaps in the recommended standard until they can be    |
|     addressed.                                                        |
|                                                                       |
| -   Input solicited from CHI Image Messaging Workgroup to ensure      |
|     compatibility among recommendations (intra-agency and             |
|     inter-agency).                                                    |
+-----------------------------------------------------------------------+

**[Conditional Recommendation]{.underline}** *If this is a conditional
recommendation, describe conditions upon which the recommendation is
predicated.*

No conditions placed on recommendation. Please refer to the "Gaps"
section in Part III of this report for additional Workgroup comments.

##### Approvals & Accreditations

Indicate the status of various accreditations and approvals:

+---------------------+----------------------+------------+-----------+
| Approvals           | Yes/Approved         | Applied    | Not       |
|                     |                      |            | Approved  |
| &                   |                      |            |           |
|                     |                      |            |           |
| Accreditations      |                      |            |           |
+---------------------+----------------------+------------+-----------+
| NEMA                | Yes                  |            |           |
+---------------------+----------------------+------------+-----------+
| IHE                 | Yes                  |            |           |
+---------------------+----------------------+------------+-----------+
| W3C                 | Yes                  | []{.mark}  |           |
+---------------------+----------------------+------------+-----------+
|                     |                      |            |           |
+---------------------+----------------------+------------+-----------+

**[Options Considered]{.underline}** *Inventory solution options
considered and summarize the basis for not recommending the
alternative(s). SNOMED must be specifically discussed.*

+-----------------------------------------------------------------------+
| **DICOM** -- Digital Imaging and Communications in Medicine (DICOM)   |
| is an evolving standard for exchange of medical information that is   |
| gaining worldwide acceptance. DICOM is a commercial, cooperative      |
| standard with basic goals of achieving intra-agency operability       |
| through negotiation and cooperation and improving workflow efficiency |
| between imaging systems and other healthcare information systems.     |
| Although initially aimed at intra-agency applications, the standard   |
| has developed to where it is also appropriate for inter-agency        |
| applications.                                                         |
|                                                                       |
| Widely used to handle radiology images, the DICOM Standard added the  |
| ability to capture/store waveforms and related information in 1999.   |
| The initial work targeted waveforms in cardiology but then was        |
| expanded to ensure its application to a broad range of waveforms      |
| needed for the medical environment. DICOM Waveforms are persistent    |
| objects that not only capture the actual waveform data, but           |
| additional information such as Patient demographics, procedure        |
| context, instrumentation information, and linkage to images and other |
| waveforms (if needed). These objects can be stored, queried and       |
| retrieved, and transmitted between various devices. The list of the   |
| currently defined waveforms is:                                       |
|                                                                       |
| \- 12-lead ECG Waveform Storage                                       |
|                                                                       |
| \- General ECG Waveform Storage                                       |
|                                                                       |
| \- Ambulatory ECG Waveform Storage                                    |
|                                                                       |
| \- Hemodynamic Waveform Storage                                       |
|                                                                       |
| \- Cardiac Electrophysiology Waveform Storage                         |
|                                                                       |
| \- Basic Voice Audio Waveform Storage                                 |
|                                                                       |
| This area is now beginning to be implemented extensively in the       |
| current standard. For example, IHE Cardiology is specifying DICOM for |
| hemodynamic waveform storage.                                         |
+-----------------------------------------------------------------------+
| **SNOMED International** deals with indexing images to patient        |
| records. The standard does not encompass the range of multimedia      |
| information (e.g.; imaging technologies, hardware, and software       |
| related to audio, video, imaging, etc.) required for this domain.     |
| However, the SNOMED Standard provides descriptive image information   |
| (or metadata) that might be required for multimedia database          |
| indexing.                                                             |
+-----------------------------------------------------------------------+
| **DIG35** is a set of metadata standards being developed by the       |
| International Imaging Industry Association to allow efficient         |
| archiving, indexing, cataloging, reviewing, and retrieving of         |
| individual data sets from a large database. Existing imaging          |
| standards upon which the DIG35 initiative is based include JPEG,      |
| MPEG-7, and XML -- all of which have been adopted as convention       |
| although the MPEG Standard continues to evolve. The intent of the     |
| 90-member association coordinating the DIG35 Standard is to develop   |
| and promote the adoption of open industry standards many of which     |
| encompass the media considered for this domain.                       |
+-----------------------------------------------------------------------+
| **IEEE1073** -- The IEEE1073 Standard is titled "Point of Care        |
| Medical Device Communication Standards" and is actually a family of   |
| standards developed to facilitate connectivity and interoperability   |
| among bedside medical devices and the general hospital support        |
| environment. The standard is relevant to several aspects of the       |
| domain especially those dealing with the need to integrate the        |
| multiplicity of bedside medical devices from multiple vendors into    |
| the modern, computer-based hospital environment. The standard is      |
| under development and does not currently encompass the broad range of |
| information required for this domain.                                 |
+-----------------------------------------------------------------------+
| ### IHE -- The Integrating the Healthcare Enterprise (IHE) initi      |
| atives have several working groups profiling standards, such as DICOM |
|  and HL7, for integrating and exchanging clinical and administrative  |
| data in healthcare. Areas being considered include radiology, cardiol |
| ogy, laboratory, pharmacy, and information technology infrastructure. |
+-----------------------------------------------------------------------+
| **HL7 --** Although intended primarily for text and coded data, the   |
| Health Level Seven (HL7) Standard enables transmission of certain     |
| waveform data. This is an emerging standard that has broad            |
| application in healthcare and research data.                          |
+-----------------------------------------------------------------------+

**[Current Deployment]{.underline}**

+-----------------------------------------------------------------------+
| *Summarize the degree of market penetration today; i.e., where is     |
| this solution installed today?*                                       |
|                                                                       |
| Although still evolving, since 1993 DICOM has expanded so that it is  |
| currently widely accepted in the radiology field. It is now also      |
| being used in ophthalmology, dentistry, endoscopy, and cardiology. As |
| the usage of DICOM increases, it will displace non-standard           |
| approaches and make interoperability more easily possible.            |
|                                                                       |
| *What number or percentage of federal agencies have adopted the       |
| standard?*                                                            |
|                                                                       |
| Those within the CHI group have adopted the standard for multimedia   |
| patient information.                                                  |
|                                                                       |
| *Is the standard used in other countries?*                            |
|                                                                       |
| Yes. Since 1999, DICOM has been an internationally-recognized         |
| standardization body with a Type A liaison to the International       |
| Standards Organization (ISO). This liaison is with ISO Technical      |
| Committee (TC) 215 on Health Formalities. ISO TC 215 has decided not  |
| to create an imaging workgroup but to rely solely on DICOM for        |
| biomedical imaging standards.                                         |
|                                                                       |
| *Are there other relevant indicators of market acceptance?*           |
|                                                                       |
| This standard is already widely accepted, and further development to  |
| incorporate multimedia concerns should pose no problems for market    |
| acceptance.                                                           |
|                                                                       |
| Virtually every radiology image acquisition device currently produced |
| has the ability to support DICOM. There is an IHE initiative in       |
| cardiology that will use DICOM. In ophthalmology, the major           |
| manufacturers of retinal cameras are now using DICOM. There are       |
| standards activities in dentistry, endoscopy, and ophthalmology that  |
| will result in further use of DICOM.                                  |
|                                                                       |
| Technical efforts to develop a joint DICOM/ISO standard on "Web       |
| Access to DICOM Persistent Objects" (WADO) are nearing completion.    |
| This capability will enable Web access to all DICOM objects, although |
| only if the viewing system knows the host system's unique internal    |
| identifiers for each individual image.                                |
+-----------------------------------------------------------------------+

**Part III -- Adoption & Deployment Information**

*Provide all information gathered in the course of making the
recommendation that may assist with adoption of the standard in the
federal health care sector. This information will support the work of an
implementation team.*

**[Existing Need & Use Environment]{.underline}**

###### Measure the need for this standard and the extent of existing exchange among federal users. Provide information regarding federal departments and agencies use or non-use of this health information in paper or electronic form, summarize their primary reason for using the information, and indicate if they exchange the information internally or externally with other federal or non-federal entities.

Column A: Agency or Department Identity (name)

Column B: Use data in this domain today? (Y or N)

Column C: Is use of data a core mission requirement? (Y or N)

Column D: Exchange with others in federal sector now? (Y or N)

Column E: Currently exchange paper or electronic (P, E, B (both), N/Ap)

Column F: Name of paper/electronic vocabulary, if any (name)

Column G: Basis/purposes for data use (research, patient care, benefits)

  ----------------------- ------- ------- ------- ------- ----------------------- --------------
  **Department/Agency**   **B**   **C**   **D**   **E**   **F**                   **G**

  Department of Veterans  Y and N Y       Y       B                               Patient care
  Affairs                                                                         

  Department of Defense   Y       Y       Y       B                               

  HHS Office of the                                                               
  Secretary                                                                       

  Administration for                                                              
  Children and Families                                                           
  (ACF)                                                                           

  Administration on Aging                                                         
  (AOA)                                                                           

  Agency for Healthcare                                                           
  Research and Quality                                                            
  (AHRQ)                                                                          

  Agency for Toxic        Y       Y       Y       B                               
  Substances and Disease                                                          
  Registry (ATSDR)                                                                

  Centers for Disease     Y       Y       Y       E       Evaluating several      Survey
  Control and Prevention                                  different vocabularies  research and
  (CDC)                                                                           surveillance

  Centers for Medicare    Y       Y       Y       B                               Medicare and
  and Medicaid Services                                                           Medicaid
  (CMS)                                                                           

  Food and Drug           Y       Y       Y       E       N/A                     Research
  Administration (FDA)                                                            

  Health Resources and                                                            
  Services Administration                                                         
  (HRSA)                                                                          

  Indian Health Service                                                           
  (IHS)                                                                           

  National Institutes of  Y       Y       Y       B                               Research and
  Health (NIH)                                                                    patient care

  Substance Abuse and                                                             
  Mental Health Services                                                          
  Administration (SAMHSA)                                                         

  Social Security         N       N       N       N       N/A                     N/A
  Administration                                                                  

  Department of           N       N       N       N       N/A                     N/A
  Agriculture                                                                     

  State Department        N       N       N       N       N/A                     N/A

  US Agency for                                                                   
  International                                                                   
  Development                                                                     

  Justice Department      N       N       N       N       N/A                     N/A

  Treasury Department     N       N       N       N       N/A                     N/A

  Department of Education N       N       N       N       N/A                     N/A

  General Services        N       N       N       N       N/A                     N/A
  Administration                                                                  

  Environmental                                                                   
  Protection Agency                                                               

  Department of Housing & N       N       N       N       N/A                     N/A
  Urban Development                                                               

  Department of           N       N       N       N       N/A                     N/A
  Transportation                                                                  

  Homeland Security       N       N       N       N       N/A                     N/A
  ----------------------- ------- ------- ------- ------- ----------------------- --------------

##### 

+-----------------------------------------------------------------------+
| **Number of Terms**                                                   |
|                                                                       |
| *Quantify the number of vocabulary terms, range of terms or other     |
| order of magnitude.*                                                  |
|                                                                       |
| *How often are terms updated?*                                        |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| ##### Range of Coverage                                               |
|                                                                       |
| #####                                                                 |
|                                                                       |
| ##### *Within the recommended vocabulary, what portions of the s      |
| tandard are complete and can be implemented now? (300 words or less)* |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| ###### **Acquisition**                                                |
|                                                                       |
| ######                                                                |
|                                                                       |
| ###### How are the data sets/codes acquired and use licensed?         |
|                                                                       |
| The DICOM Standard is available free on the Internet at               |
| [http://medical.nema.org](http://medical.nema.org/). The DICOM        |
| Committee can be reached by mail at 1300 N. 17^th^ Street, Suite      |
| 1847, Rosslyn, VA 22209.                                              |
|                                                                       |
| IHE specifications are available for free. The web address is         |
| http://www.ihe.net/.                                                  |
|                                                                       |
| W3C standards are available for free. The W3C headquarters in the US  |
| is located at MIT, 32 Vassar Street, Room 32-G515, Cambridge, MA      |
| 02139 USA. The web address is http://www.w3.org/.                     |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| ###### **Cost**                                                       |
|                                                                       |
| ######                                                                |
|                                                                       |
| ###### What is the direct cost to obtain permission to                |
| use the data sets/codes? (licensure, acquisition, other external data |
|  sets required, training and education, updates and maintenance, etc. |
|                                                                       |
| DICOM is available free on the Internet.                              |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| **Systems Requirements**                                              |
|                                                                       |
| *Is the standard associated with or limited to a specific hardware or |
| software technology or other protocol?*                               |
|                                                                       |
| No. DICOM is both vendor and platform neutral, and thus can be        |
| implemented into systems based on any technology.                     |
+-----------------------------------------------------------------------+
| **Guidance**                                                          |
|                                                                       |
| *What public domain and implementation and user guides,               |
| implementation tools or other assistance is available and are they    |
| approved by the SDO?*                                                 |
|                                                                       |
| DICOM is in widespread use and is accessible to the public.           |
|                                                                       |
| *Is a conformance standard specified? Are conformance tools           |
| available?*                                                           |
|                                                                       |
| Yes - Part l of the DICOM Standard specifies a conformance standard.  |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| **Maintenance**                                                       |
|                                                                       |
| *How do you coordinate inclusion and maintenance with the standards   |
| developer/owners?*                                                    |
|                                                                       |
| Voluntary upgrades through contacts with the DICOM Committee.         |
|                                                                       |
| *What is the process for adding new capabilities or fixes?*           |
|                                                                       |
| Continual review of multi-media requirements and standards, specific  |
| requests for upgrades and issues to be considered to the DICOM        |
| Committee.                                                            |
|                                                                       |
| *What is the average time between versions?*                          |
|                                                                       |
| Various.                                                              |
|                                                                       |
| *What methods or tools are used to expedite the standards development |
| cycle?*                                                               |
|                                                                       |
| None. The DICOM Committee should be petitioned to consider specific   |
| items related to multimedia data.                                     |
|                                                                       |
| *How are local extensions, beyond the scope of the standard,          |
| supported if at all?*                                                 |
|                                                                       |
| The DICOM Committee will decide the relevance of a request to the     |
| scope of the standard.                                                |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| **Customization**                                                     |
|                                                                       |
| *Describe known implementations that have been achieved without user  |
| customization, if any.*                                               |
|                                                                       |
| Within VHA medical facilities, approximately 250 different device     |
| models have been validated and implemented without requiring user     |
| customization. These devices are capturing approximately 500,000      |
| images per day.                                                       |
|                                                                       |
| *If user customization is needed or desirable, how is this achieved?  |
| (e.g, optional fields, interface engines, etc.)*                      |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| **Mapping Requirements**                                              |
|                                                                       |
| *Describe the extent to which user agencies will likely need to       |
| perform mapping from internal codes to this standard.*                |
|                                                                       |
| *Identify the tools available to user agencies to automate or         |
| otherwise simplify mapping from existing codes to this standard.*     |
+-----------------------------------------------------------------------+

**Compatibility**

Identify the extent of off-the-shelf conformity with other standards and
requirements:

+----------------------------------------+-------+---------+----------+
| ##                                     | ####  | #####   | Yes with |
| ###### Conformity with other Standards | ####  | ### No  | e        |
|                                        | Yes ( |         | xception |
|                                        | 100%) | ######  |          |
|                                        |       | ## (0%) |          |
+----------------------------------------+-------+---------+----------+
| NEDSS requirements                     | ##### |         |          |
|                                        | ### X |         |          |
+----------------------------------------+-------+---------+----------+
| HIPAA standards                        | **X** |         |          |
+----------------------------------------+-------+---------+----------+
| HL7 2.4 and higher                     | **X** |         |          |
+----------------------------------------+-------+---------+----------+
|                                        |       |         |          |
+----------------------------------------+-------+---------+----------+

+-----------------------------------------------------------------------+
| ## Implementation Timeframe                                           |
|                                                                       |
| *Estimate the number of months required to deploy this standard;      |
| identify unique considerations that will impact deployment schedules* |
|                                                                       |
| Approval having been achieved for waveform, audio, 3D, l-bit images,  |
| and security specification, the DICOM 2004 standard is complete with  |
| respect to multimedia applications. However, current systems may      |
| require time for re-engineering to comply with DICOM; interim         |
| exceptions will have to be made.                                      |
|                                                                       |
| *If some data sets/code sets are under development, what are the      |
| projected dates of completion/deployment?*                            |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| ## Gaps                                                               |
|                                                                       |
| *Identify the gaps in data, vocabulary or interoperability.*          |
|                                                                       |
| The following items are gaps related to multimedia data in the        |
| current DICOM standard that are being addressed and considered for    |
| future implementation:                                                |
|                                                                       |
| 1.  **Three-dimensional (3D) data** -- A DICOM proposal has been      |
|     issued for registration and fusion of 3D data and should be       |
|     approved during 2005.                                             |
|                                                                       |
| 2.  **Security** -- Some security-related issues are addressed in     |
|     DICOM, but they need to be expanded to include (l) user           |
|     identification and password, (2) information access restrictions, |
|     and (3) VPN issues.                                               |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| ## Obstacles                                                          |
|                                                                       |
| *What obstacles, if any, have slowed penetration of this standard?    |
| (technical, financial, and/or cultural)*                              |
|                                                                       |
| Examples of issues that are considered but have not been yet been     |
| extensively implemented in DICOM include:                             |
|                                                                       |
| 1.  **Audio data** -- An audio data standard is available in DICOM,   |
|     but it hasn't been implemented by vendors at this time. The       |
|     current MPEG standard is appropriate for patient audio data until |
|     the DICOM Standard is accepted.                                   |
|                                                                       |
| 2.  **Video data** -- A video standard is available in DICOM, but it  |
|     has not been                                                      |
|                                                                       |
| > implemented at this time. The current MPEG standard is appropriate  |
| > for                                                                 |
| >                                                                     |
| > patient video data until the DICOM Standard is accepted.            |
| >                                                                     |
| > 3\. **Waveform data (e.g.; ECG, EEG, etc**.) -- Although this area  |
| > has not yet been                                                    |
| >                                                                     |
| > extensively implemented in the current standard, DICOM is           |
| > recommended for                                                     |
| >                                                                     |
| > representing and storing all patient healthcare waveform data       |
| > between                                                             |
| >                                                                     |
| > systems. The ANSI-accredited HL7 Annotated ECG Waveform Data        |
| >                                                                     |
| > Standard is acceptable for use in clinical trials.                  |
+-----------------------------------------------------------------------+

***[Appendix A]{.underline}***

**[Information Exchange Requirements (IERs)]{.underline}**

  ----------------------------------- -----------------------------------
  **Information Exchange              **Description of IER**
  Requirement**                       

  Beneficiary Financial / Demographic Beneficiary financial and
  Data                                demographic data used to support
                                      enrollment and eligibility into a
                                      Health Insurance Program.

  Beneficiary Inquiry Information     Information relating to the
                                      inquiries made by beneficiaries as
                                      they relate to their interaction
                                      with the health organization.

  Beneficiary Tracking Information    Information relating to the
                                      physical movement or potential
                                      movement of patients,
                                      beneficiaries, or active duty
                                      personnel due to changes in level
                                      of care or deployment, etc.

  Body of Health Services Knowledge   Federal, state, professional
                                      association, or local policies and
                                      guidance regarding health services
                                      or any other health care
                                      information accessible to health
                                      care providers through research,
                                      journals, medical texts, on-line
                                      health care data bases,
                                      consultations, and provider
                                      expertise. This may include: (1)
                                      utilization management standards
                                      that monitor health care services
                                      and resources used in the delivery
                                      of health care to a customer; (2)
                                      case management guidelines; (3)
                                      clinical protocols based on
                                      forensic requirements; (4) clinical
                                      pathway guidelines; (5) uniform
                                      patient placement criteria, which
                                      are used to determine the level of
                                      risk for a customer and the level
                                      of mental disorders (6) standards
                                      set by health care oversight bodies
                                      such as the Joint Commission for
                                      Accreditation of Health Care
                                      Organizations (JCAHO) and Health
                                      Plan Employer Data and Information
                                      Set (HEDIS); (7) credentialing
                                      criteria; (8) privacy act
                                      standards; (9) Freedom of
                                      Information Act guidelines; and
                                      (10) the estimated time needed to
                                      perform health care procedures and
                                      services.

  Care Management Information         Specific clinical information used
                                      to record and identify the
                                      stratification of Beneficiaries as
                                      they are assigned to varying levels
                                      of care.

  Case Management Information         Specific clinical information used
                                      to record and manage the
                                      occurrences of high-risk level
                                      assignments of patients in the
                                      health delivery organization.

  Clinical Guidelines                 Treatment, screening, and clinical
                                      management guidelines used by
                                      clinicians in the decision-making
                                      processes for providing care and
                                      treatment of the
                                      beneficiary/patient.

  Cost Accounting Information         All clinical and financial data
                                      collected for use in the
                                      calculation and assignment of costs
                                      in the health organization.

  Customer Approved Care Plan         The plan of care (or set of
                                      intervention options) mutually
                                      selected by the provider and the
                                      customer (or responsible person).

  Customer Demographic Data           Facts about the beneficiary
                                      population such as address, phone
                                      number, occupation, sex, age, race,
                                      mother\'s maiden name and SSN,
                                      father\'s name, and unit to which
                                      Service members are assigned

  Customer Health Care Information    All information about customer
                                      health data, customer care
                                      information, and customer
                                      demographic data, and customer
                                      insurance information. Selected
                                      information is provided to both
                                      external and internal customers
                                      contingent upon confidentiality
                                      restrictions. Information provided
                                      includes immunization
                                      certifications and reports, birth
                                      information, and customer medical
                                      and dental readiness status

  Customer Risk Factors               Factors in the environment or
                                      chemical, psychological,
                                      physiological, or genetic elements
                                      thought to predispose an individual
                                      to the development of a disease or
                                      injury. Includes occupational and
                                      lifestyle risk factors and risk of
                                      acquiring a disease due to travel
                                      to certain regions.

  Encounter (Administrative) Data     Administrative and Financial data
                                      that is collected on patients as
                                      they move through the healthcare
                                      continuum. This information is
                                      largely used for administrative and
                                      financial activities such as
                                      reporting and billing.

  Improvement Strategy                Approach for advancing or changing
                                      for the better the business rules
                                      or business functions of the health
                                      organization. Includes strategies
                                      for improving health organization
                                      employee performance (including
                                      training requirements), utilization
                                      management, workplace safety, and
                                      customer satisfaction.

  Labor Productivity Information      Financial and clinical (acuity,
                                      etc.) data used to calculate and
                                      measure labor productivity of the
                                      workforce supporting the health
                                      organization.

  Health Organization Direction       Goals, objectives, strategies,
                                      policies, plans, programs, and
                                      projects that control and direct
                                      health organization business
                                      function, including (1) direction
                                      derived from DoD policy and
                                      guidance and laws and regulations;
                                      and (2) health promotion programs.

  Patient Satisfaction Information    Survey data gathered from
                                      beneficiaries that receive services
                                      from providers that the health
                                      organization wishes to use to
                                      measure satisfaction.

  Patient Schedule                    Scheduled procedure type, location,
                                      and date of service information
                                      related to scheduled interactions
                                      with the patient.

  Population Member Health Data       Facts about the current and
                                      historical health conditions of the
                                      members of an organization.
                                      (Individuals\' health data are
                                      grouped by the employing
                                      organization, with the expectation
                                      that the organization\'s operations
                                      pose similar health risks to all
                                      the organization\'s members.)

  Population Risk Reduction Plan      Sets of actions proposed to an
                                      organization commander for his/her
                                      selection to reduce the effect of
                                      health risks on the organization\'s
                                      mission effectiveness and member
                                      health status. The proposed actions
                                      include: (1) resources required to
                                      carry out the actions, (2) expected
                                      mission impact, and (3) member\'s
                                      health status with and without the
                                      actions.

  Provider Demographics               Specific demographic information
                                      relating to both internal and
                                      external providers associated with
                                      the health organization including
                                      location, credentialing, services,
                                      ratings, etc.

  Provider Metrics                    Key indicators that are used to
                                      measure performance of providers
                                      (internal and external) associated
                                      with the health organization.

  Referral Information                Specific clinical and financial
                                      information necessary to refer
                                      beneficiaries to the appropriate
                                      services and level of care.

  Resource Availability               The accessibility of all people,
                                      equipment, supplies, facilities,
                                      and automated systems needed to
                                      execute business activities.

  Tailored Education Information      Approved TRICARE program education
                                      information / materials customized
                                      for distribution to existing
                                      beneficiaries to provide
                                      information on their selected
                                      health plan. Can also include risk
                                      factors, diseases, individual
                                      health care instructions, and
                                      driving instructions.
  ----------------------------------- -----------------------------------