Community Updates

CDISC Releases Numerous Standards

CDISC had an extremely busy start to the year with a number of different standards coming to fruition and being released late in 2009 or early 2010. Perhaps of most interest to AMIA was the launch of the CDISC Protocol Representation Model Version 1.0 (PRM V1.0). It is intended for those involved in the planning and design of a research protocol – for any type of research. The PRM has four major sections covering a) clinical trial registration; b) eligibility criteria; c) study design and d) study assessments/timing. It is a subset of the Biomedical Research Integrated Domain Group (BRIDG) model Version 3.0.1, which is now going through a review and comment process on the path to becoming a global standard through ISO, HL7 and CDISC. You can read more about the Protocol Model our Blog and about BRIDG at http://www.cdisc.org/bridg Presentations were made about these topics and also linking healthcare and research at the AMIA Clinical Research Informatics Summit in March.

With the increasing use of electronic health records globally, CDISC has always seen the need to be able to use pre-existing data for clinical research and as such has an active Healthcare Link Initiative. CDISC and IHE (Integrating the Healthcare Enterprise) have created the inaugural working link between EHRs and clinical research systems. This groundbreaking approach uses the CDISC/IHE developed integration profile, Retrieve Form for Data-capture profile (RFD), along with CDISC standards to collect relevant data from the electronic health record for critical secondary uses such as Safety Reporting (and Biosurveillance), Clinical Research, and Disease Registries. For the Clinical Research Use case, this profile leverages CDASH (Clinical Data Acquisition Standards Harmonization) which streamlines the data collection by identifying a minimum set of data collection fields needed for clinical, scientific and regulatory purposes and thus builds in efficiencies at investigative sites. A new CDASH Implementation Guide will be out in the forthcoming months. For all information relating to CDISC activities, please visit the CDISC website www.cdisc.org.

CEN, White Paper, and EU

In December 2009, the European Commission published the results of the open public consultation on White Paper 111, which focused on modernizing ICT standardisation in the EU. Although not specific to Health Informatics, it provides broad context and is likely to have implications for future activities as it was directed at how European policy can better respond to industry and societal needs. The following is an extract from the executive summary, which shows the areas of particular interest and indicates further work will be taken on these areas as a result of the responses.

The White Paper discussed possible proposals in six main policy domains of European ICT standardisation policy:

• Attributes of ICT standards associated with EU legislation and policies
• The use of ICT standards in public procurement
• Fostering synergy between ICT research, innovation and standardisation
• Intellectual property rights in ICT standards
• Integration of fora and consortia in the ICT standardisation process
• Enhancing the dialogue and partnership with stakeholders

While the overall response to all the proposals contained in the White Paper was broadly positive, most of the respondents provided extensive comments and additional input that will facilitate further refinement of thinking on many of the issues."

More domain-specific than the White Paper was a conference declaration by the Ministers and High Level Representatives responsible for eHealth on ‘European Co-operation on eHealth,’ adopted March 15, 2010. They begin by acknowledging that “ICT for Health (eHealth) is a tool to improve quality and patient safety, to modernise national healthcare systems, to increase their efficiency and make them better adapted to the individual needs of citizens, patients, health professionals, and the challenges of an ageing society".

The overall objective seems to be to enhance quality and sustainability of healthcare systems, to make sure that ICT deployment is in the best interest of patients, healthcare professionals and society. To achieve this, a number of things were suggested that need to be addressed. Although standardisation is not headlined, the text in the bowels of the document requires work to be done, including resolving interoperability issues (i.e., legal, regulatory and organisational barriers to eHealth), support for semantic interoperability by defining a medium term strategy based on existing or emerging EU and international standards and the development of internationally recognized common standards and certification of testing to facilitate their deployment and use in all eHealth applications.

HL7 Recent Activities

Meetings

HL7 International will be participating in a series of international back-to-back meetings in Rio de Janeiro, Brazil. This meeting sequence starts Sunday, May 9, and goes through Thursday, May 20. The three meetings are:

• May 9-13: ISO TC 215 (Medical Informatics). While this is not strictly an HL7 meeting, HL7 will be actively participating in a number of TC 215 Work Groups as well as the TC 215 Joint Initiatives Council and Joint Working Group Meetings. A number of current work items that are now in ISO ballot contain all or part of existing HL7 Standards and existing HL7 work-in-progress;
• May 14-15: HL7 International’s 11th Annual Interoperability Conference (IHIC). IHIC 2010 comprises two full days of papers and presentations and serves as a meeting place for more than 35 HL7 affiliates from around the world, hosting individuals interested in interoperability and standards who wish to share their HL7implementation experience and strengthen their shared vision. (more information at: www.hl7.org)
• May 16-20: HL7’s annual Spring Working Group Meeting with a schedule of working group meetings and tutorials. (more information at: www.hl7.org )

All three meetings are being headquartered out of the Windsor Barra Hotel & Congressos Hotel.

HL7 Services Aware Interoperability Framework (SAIF)

The HL7 Architecture Board (ArB) has focused its efforts over the last two years on a Services Aware Interoperability Framework (SAIF). This work has been closely aligned to the Semantically-aware Services Oriented Architecture (sSOA) being developed within the U.S. National Cancer Institute’s Center for Biomedical Informatics and Information Technology (CBIIT)’s Big Health Program. The HL7 ArB’s work on SAIF also includes participation and contribution from architects working for Canada Health Infoway, Australia’s National eHealth Transition Authority (NEHTA), the U.S. Department of Defense, and others. Also, at the March 2010 meeting of the HIT Standards Committee of the U.S. HHS Office of the National Coordinator for Health Information Technology, Douglas Fridsma, MD, PhD, announced that the U.S. Nationwide Health Information Network would be based on SAIF. His presentation can be found here.

The internal purpose for SAIF is to provide a common framework of requirements for all HL7 Standards that explicitly support the development of semantic interoperability through services. Projects now exist in HL7 that are testing SAIF as it applies to HL7 Standards development. Findings from these projects will help shape HL7’s methodology for both our internal standards developers as well as the services specification methodology for our users. SAIF provides consistency between all HL7 artifacts, and enables a standardized approach to Enterprise Architecture (EA) development and implementation, and a way to measure the achieved consistency. It is also a way of thinking about producing specifications that explicitly describe the governance, conformance, compliance, and behavioral semantics needed to achieve computable semantic working interoperability. The intended information transmission technology might use a messaging, document exchange, or services approach. Finally, SAIF is the framework required to rationalize interoperability of standards. SAIF is an architecture for achieving interoperability, but it is not a whole-solution design for enterprise architecture management.*

The HL7 Services-Aware Interoperability Framework (HL7 SAIF) consists of four formal core components:

• Enterprise Conformance and Compliance Framework (ECCF)
• Governance Framework (GF)
• Behavioral Framework (BF)
• Information Framework (IF)

More information on SAIF and these frameworks can be found at: http://www.hl7.org and clicking on: “Find out more about the HL7 Services Aware Interoperability Framework (SAIF)"

*http://en.wikipedia.org/wiki/HL7_Services_Aware_Interoperability_Framework; authored by HL7 ArB.

ICN, IHTSDO Team Up to Ensure Common Health Terminology

The International Council of Nurses (ICN) and the International Healthcare Terminology Standards Development Organisation (IHTSDO) recently announced a collaborative agreement to advance terminology harmonization and foster interoperability in health information systems. The new agreement complements the aims of both organizations for state of the art health informatics standards. ICN will be an active participant in the work of the IHTSDO and will facilitate involvement of the nursing community through the IHTSDO Nursing Special Interest Group and ICNP® programme activities. For further information click here.

To see the most recent IHTSDO newsletter, click here.

LOINC Releases Terminology Version 2.30

Earlier this year, Regenstrief Institute and the LOINC® Committee released the 44th edition of the LOINC terminology, Version 2.30, which contains more than 57,000 terms. In addition to new terms for laboratory tests, other highlights of recent content include terms to represent the Minimum Data Set Version 3, Outcome and Assessment Information Set Version C, and newborn screening terms. The RELMA mapping program is now available with additional word indexes in five linguistic variants that allow searching in languages other than English.

The world-wide LOINC community continues to grow, with nearly 300 new loinc.org users and 1,000 downloads each month. Presently, there are more than 6,600 users from 125 different countries. In January, Regenstrief became a member of the SDO Charter Organization, whose mission is to facilitate effective coordination and collaboration on U.S. health informatics standards development. Regenstrief continues collaboration with the U.S. National Library of Medicine (NLM) and the Advisory Committee on Heritable Disorders in Newborns and Children, a collaboration that produced a Newborn Screening Coding and Terminology guide (newbornscreeningcodes.nlm.nih.gov) with tables of standard codes for newborn tests and the conditions for which they screen. In addition, NLM has worked closely with Regenstrief, HITSP, and the American Clinical Laboratory Association to develop a common laboratory orders value set of 300 LOINC codes (loinc.org/usage) that represent a preferred “starter set" covering 99 percent of lab ordering volume.

Other LOINC News

Public Laboratory LOINC Workshop and Committee Meeting (06/07/2010-06/08/2010)  LOINC Common Laboratory Orders Value Set Version 1.1 Released (04/07/2010)

U.S. National Library of Medicine (NLM) Coordinates, Produces, Names Standards

NLM is the central coordinating body for clinical terminology standards within the U.S. Department of Health and Human Services. It creates or partially supports LOINC®, RxNorm®, and SNOMED CT®, all recently named as target vocabulary standards in the certification criteria for EHR products to be used in demonstrating “meaningful use." All three also are included in the UMLS® Metathesaurus®. (See also the separate report on LOINC, above.) NLM is an active participant in the Vocabulary Task Force of the U.S. Health IT Standards Committee, one of two new federal advisory committees established under the HITECH provisions of the American Recovery and Revitalization Act (ARRA) of 2009. The activities of the Task Force may be followed via the Federal Advisory Committees section ofhttp://healthit.hhs.gov/portal/server.pt

RxNorm: NLM is the producer of RxNorm which provides normalized names for clinical drugs and links its names to many of the drug vocabularies commonly used in pharmacy management and drug interaction software. In Feb. 2010, the U.S. Department of Veterans Affairs (VA) and NLM signed an agreement that will allow inclusion of the VA’s National Drug Formulary Reference Terminology (NDFRT) in the monthly releases of RxNorm, effective June 2010. There also are weekly updates to RxNorm, covering additional drugs only.

RxTerms is a drug interface terminology derived from RxNorm designed to facilitate data entry for prescription-writing or recording medication history (e.g. in e-prescribing systems, PHRs) in the U.S.

SNOMED CT: NLM is the U.S. Member of the International Health Terminology Standards Development Organisation (IHTSDO) and as such, the U.S. National Release Center for SNOMED CT. Founded in 2007 by charter members in nine countries, the IHTSDO now has 15 Member countries, with more in the process of joining. It is an IHTSDO principle to facilitate the use of SNOMED CT in combination with other standards and to actively seek harmonization agreements with other standards development organizations. In addition to the agreement announced elsewhere in this issue, the IHTSDO expects to announce important agreements with other standards developers in the near future. James T. Case, MS, DVM, PhD, was recently appointed as NLM’s point person for SNOMED CT content development and adoption issues. Previously, he was instrumental in the development of the National Animal Health Laboratory Network and has been active in SNOMED CT and LOINC development and in HL7 for many years. Dr. Case will be coordinating U.S. input to the international release of SNOMED CT and will set up a U.S. extension that focuses on content needed rapidly for value sets required to support meaningful use.

To facilitate use of SNOMED CT in problem lists, NLM produces the CORE Problem List Subset of SNOMED CT which covers problems frequently seen in seven large health care organizations covering both ambulatory and in-patient care. The list is updated with each release of SNOMED CT and each release of the UMLS Metathesaurus