Community Updates

CDISC

Progress continues within CDISC on the development of standards to support research in a number of therapeutic areas: Pain/Analgesics (with the University of Rochester); Polycystic Kidney Disease (with Tufts University); Alzheimer’s Disease (with the Critical Path Institute’s Coalition Against Major Diseases); Oncology (with FDA and NCI); Cardiovascular Diseases (with ACC and Duke); Parkinson’s Disease (with C-Path and NINDS) and Tuberculosis (with the Gates Foundation and TB Alliance). CDISC also responded to an FDA RFP for funds to continue Therapeutic Area Standards development. [Watch for the first TA "Package" on Alzheimer’s Disease coming soon.]

Another area of standards progress is the FDA “Issues” list, which was announced in the last CDISC eNewsletter. This is a document that provides more specification in terms of exactly how the CDISC standards, specifically Study Data Tabulation Model (SDTM) and Analysis Dataset Model (ADaM) should be implemented in eSubmissions. Concurrently, an Amendment to SDTM 3.1.2 has been posted on the CDISC website for public comment. It is felt that the "issues resolutions" provided in this documentation will help ensure that regulatory submissions will receive higher quality reviews since they will enable the use of review tools and reduce the time FDA reviewers spend preparing data for reviews.

It goes without saying that if there is any chance that research studies may become part of a regulatory submission, it makes sense to collect the data in CDASH (Clinical Data Acquisition Standards Harmonization) format with the associated standardized controlled terminology. This will streamline the flow of much of the data (at least the core data) downstream since it will be in a format (with the controlled terminology) that is compatible with and supports the requested eSubmission data formats (SDTM and ADaM). This not only helps the regulatory reviewers but saves time and costs for the study sponsor as well. The enhanced development of therapeutic area standards will complement the existing core standards and augment the value of the standards.

CDISC SHARE and BRIDG continue to progress and a separate update will be done on these at a later date. In another area of the clinical research process, specifically data collection for research, the CDISC XML team has developed an extension of the Operational Data Model (which provides a transport standard to support eCRFs and the transport of case report form data). This extension supports the Study Design Model (SDM) and is called ODM-SDM. This is an exciting opportunity that will enable the transport of information on a protocol design, which can be used in study start-up, study tracking and also reporting, so that those reviewing the data from a study can comprehend the plan that was in the protocol in the first place. The SDM is also being used as the basis for research that CDISC is doing with Mayo Clinic and other collaborators on the HHS/ONC awarded Strategic Health and Research IT Projects (SHARP) in the area of Secondary Use of EHRs. This extension also will be posted on the CDISC website (www.cdisc.org) for open public review in the very near future.

CEN

In the CEN TC 251 plenary meeting in March, the members of the technical committee extended their thanks and appreciation to Mr. Molenaar for his excellent leadership over the last five years. During the same meeting, Robert Stegwee was appointed chairman of CEN TC 251 for a period of three years. Robert Stegwee brings to the position a strong background in high-level e-health architectures to serve the evolving health information environment. In his daily life, he is a consultant with Capgemini Healthcare, based in the Netherlands, and active in Capgemini’s Global Healthcare Network. In addition, Robert Stegwee is a professor of ehealth architecture and standards at the University of Twente in the Netherlands and active in several roles in the local and global HL7 community. His appointment marks the success of the Joint Initiative Council with global SDO’s (JIC, www.jointinitiativecouncil.org external link), which was co-founded by Kees Molenaar from a CEN perspective.

During his three-year appointment, Stegwee will work closely with the TC secretariat, management team and relevant stakeholders to help guide the development of global standards in health informatics based on the European Community’s priorities. This includes establishing standards for cross-border healthcare enterprise architecture, health record information models, and workflow and data management. These standards may become mandatory for all European healthcare providers and will be embedded within the global health informatics standards community.

One of his key tasks for the immediate future will be to take the European Mandate work to the next stage, building upon the well regarded E-Health Interoperability report (www.ehealth-interop.eu). Discussions are taking place with the European Commission on the way to take this important work forward, to support the interoperability requirements that have been set forward by the European Commission. Both Commissioners Neelie Kroes and John Dalli have highlighted the importance of eHealth Interoperability in their presentations to the Ministerial Conference on eHealth in Budapest, last May (http://www.youtube.com/user/eHealthWeek).

In response to the recently adopted European Directive on patients' rights in cross-border healthcare, CEN TC 251 has proposed a new joint work item with ISO TC 215 WG6 to renew and expand CEN’s specification of a standardized Electronic Medication Prescription (ENV 13607) to be used in cross-border health care. This work will involve experiences gained in the epSOS project (www.epsos.eu external link), the large-scale pilot that aims to facilitate the cross-border exchange of healthcare information. Core focal areas of the epSOS project are the patient professional summary and medication prescription.

CEN TC 251 experts are participating in, and often leading, the work in a number of joint ISO/CEN work items, especially in the areas of privacy, security and in device interoperability. During the joint ISO/CEN working group meeting in Kuopio in May, the work on the Continuity of Care has been embraced by ISO as a starting point for a joint work item, which again emphasises the influence of European experts in global standardization. Yet another example is the progress that has been made in the area of Detailed Clinical Models. The draft document was decided fit for formal comment and the work groups in both ISO and CEN expect this work to be published in 2012. These are just a few highlights from the progress that has been made in Kuopio. In late September, CEN TC 251 will meet to discuss future structure and activities.

ISO TC 215

ISO TC215 (Technical Committee 215 on Health Informatics) just completed its annual plenary in Kuopio Finland during May. Substantial progress in messaging, international public health models, terminology specifications, and privacy initiatives was achieved.

At the Kuopio meeting, they accepted the report from ISO TC215’s reorganization task force, which laid out history, current working structures, and cogent options for Technical Committee organization into the future. The task force will continue its work for six month, finalizing recommendations for organizational structure that facilitate coherent health information technology standards that are aligned with member body (countries) interests. The process redefined ISO's relationship with the Joint Initiative Council (which includes CDISC, CEN TC251, GS1, IHTSDO, ISO TC215, and HL7), where ISO TC215 now hosts the joint SDO working group as a recognized advisory committee.

A joint working group between ISO TC215 and ISO TC249 on Traditional Chinese Medicine (TCM) emphasised shared specifications for informatics standards common to western and TCM. This now complements TC215's other major joint working group with IEC TC62 on medical devices.

LOINC

Regenstrief Releases LOINC Common Lab Orders Value Set (Top 300)

Regenstrief is pleased to announce the availability of a new resource, the Common Lab Orders Value Set (current version 1.2). This value set was developed by the Lister Hill Center at the National Library of Medicine, with the help of the Regenstrief Institute and LOINC Committee, many HITSP participants, and the ACLA. The Common Lab Orders Value Set defines a collection of universal laboratory codes for use by developers of order entry systems that deliver them to laboratories, where they could be understood and fulfilled.

This list is designed to cover greater than 95% of the test ordering volume in the United States, and was developed by both empirical and consensus-driven approaches. The value set is meant to serve as a minimum 'starter set,' by nature not covering all LOINC codes or possible lab orders. It is referenced by the HITSP C80 Clinical Document and Messaging Terminology Construct in Table 2-96 "Laboratory Order Value Set" and the draft version of the ELINCS Orders Specification (http://elincs.chcf.org).

The origins and development of this list are described in detail in Preface document, and the value set is distributed in several file formats. All of these resources are available at no cost from the LOINC website at: http://loinc.org/usage

Regenstrief Releases LOINC Mapper’s Guide to Top 2000+ Lab Tests

Regenstrief also is pleased to announce the availability of another new resource, the “LOINC Mappers’ Guide to the Top 2000+ Lab Observations.” This is a collection of an empirically derived set of the most common LOINC result codes paired with a document that contains a wealth of guidance and advice about which codes to choose for a given purpose.

The Top 2000+ list contains result codes that cover about 98% of the test volume carried by three large institutions that have mapped to LOINC. We think it will be a great starter set for beginning your mapping. It has already been suggested for use in the “Plan to Plan Personal Health Record” Data Transfer standards produced by HL7 and Accredited Standards Committee (ASC) X12. A detailed Introduction document that explains how this list and the guide were developed, the Mapper's Guide (in pdf and xlsx format), and/or a simple list of the Top 2000+ terms (in csv format) are all available for download at no cost from the LOINC website: http://loinc.org/usage

LOINC Content Updates and Other Developments

In December 2010, Regenstrief Institute, Inc. and the LOINC Committee released the 46th edition of the LOINC terminology, version 2.34, which contained more than 61,000 terms and new or updated translations into Estonian, French, German, Greek, Italian, and Spanish. New content highlights from this release include the PROMIS survey, additional PhenX terms, cephalometrics terms, and a detailed cytogenetics testing template. The RELMA program now features a totally revamped search engine based on Lucene, as well as a much-improved Intelligent Mapper program that automatically produces a ranked list of candidate LOINC terms for each local term in your master file. Stay tuned for the upcoming release scheduled for the end of June 2011.

The worldwide LOINC community continues to flourish, with nearly 330 new loinc.org users and 1,400 downloads each month. In February, the loinc.org site passed 10,000 members from more than 140 countries. We are particularly excited about the growing interest in LOINC from members of the IVD (in vitro diagnostics) Industry Connectivity Consortium (IICC, http://ivdconnectivity.org) who are working to modernize the instrument interface and interoperability standards in the clinical laboratory.

MedBiquitous

This summer MedBiquitous begins new standards development projects while continuing standards development work in support of models of competency-based education and credentialing. MedBiquitous is the ANSI-accredited developer of information technology standards for healthcare education and competence assessment.

New project: Educational Achievement

MedBiquitous kicks off work on a new Educational Achievement standard at the end of the month. The proposed standard will document learner competency and make that data portable across the continuum of health professions education, allowing learners to maintain lifelong portfolios of their educational achievements. The initial specification will be produced as part of an accelerated standards development project funded by the National Board of Medical Examiners and the Association of American Medical Colleges.

Ongoing Standards Development: Competencies and Curricula

MedBiquitous working groups continue development of two specifications to support health professions education: Competency Framework and the Curriculum Inventory. The Competency Framework specification allows educators to define the relationships among a set of interrelated competencies. The competencies can then be mapped to learning resources, curriculum, educational achievements, etc. A working draft of the specification and XML schema are available. The Curriculum Inventory specification provides a common format for core data about health professions curricula, enabling the dissemination of curricular innovations and best practices. Curriculum inventory development is part of an accelerated standards development project funded by the Association of American Medical Colleges and supports the development of a Curriculum Inventory Portal for educational research and benchmarking.

Version 2: Virtual Patients and Credentialing

MedBiquitous working groups are also working on version 2 of two American National Standards: MedBiquitous Virtual Patient and Healthcare Professional Profile. Virtual Patients simulate real-life clinical scenarios for educational purposes. Version 2 of the standard will support a more distributed model of virtual patient delivery, enabling the launch of new activities and reporting of results across systems. The Healthcare Professional Profile provides a common format for profile data on healthcare professionals, including data used for credentialing. Version 2 of the standard will support the evolving Maintenance of Certification, Osteopathic Continuous Certification, and Maintenance of Licensure processes. For more information on any of these standards development efforts, visit the MedBiquitous website: www.medbiq.org