Community Updates

The NA Interchange brought into focus a closer working relationship with the FDA, culminating in a significant presence and excellent presentations and panel discussion at the conference. With open communications and renewed energy, it seems that CDISC has reached a tipping point, with the Agency looking towards faster and more numerous standards development, particularly in specific disease areas in order to augment the CDISC safety standards that cut across all type of clinical research. The focus currently is in the Oncology and Cardiovascular arenas, with a list of priorities in progress.

 

A highlight of the conference was the focus of a new session, "Standards and the Patient," which featured four presenters from different areas across the patient spectrum. Dana Pinchotti of the American College of Cardiology spoke about the use of data standards, including the Clinical Data Acquisition Standards Harmonization (CDASH) project, which defines a minimum core set of data standards for Case Report Forms. She highlighted not only the efficiency benefits of the standards but also the potential for improvements to patient care. Ms. Pinchotti’s presentation was followed by Dr. Ron Perrone of Tufts University School of Medicine, who spoke about Polycystic Kidney Disease and development of data standards, in particular a goal of establishing a new endpoint for measuring efficacy of therapies for PKD. He acknowledged that standards are integral to his work on PKD, as they will lead to an aggregated database from existing research. Using standard data means that comparative studies (which are vital to such research) can be conducted with ease. Dr. Jeff Allen, director of the Friends of Cancer Research, focused his presentation on the need for data standards in Comparative Effectiveness Research. Finally, Dr. Adam Clark, director of Scientific and Federal Affairs at FasterCures, gave a compelling presentation on EHRs and the Learning Healthcare System, opening his session with, "Be it lack of medical breakthroughs, limited resources, or restrictive policies that are stalling progress, patients pay the price of delays in life or death consequences."

 

The slides are not generally available to those who did not attend the Interchange; however, if readers are interested in seeing the slides from this session, please contact AJ de Montjoie (ademontjoie@cdisc.org). You also will find reports from the event on the CDISC Blog, which has more details of these excellent presentations and other useful information.

 

CDISC would particular welcome AMIA member input on two therapeutic area standards that are currently posted for open public review:

1. Standard Cardiovascular End Point Definitions

2. Parkinson's Disease

 

You can find full details of the review process and all the documentation on the CDISC website: For all information relating to CDISC activities, please visit the CDISC website.

 

It is a transition time within CEN TC 251. The NEN secretariat is in the process of appointing a new Chair for the coming term, as Kees Molenaar is stepping down. He will be missed by his grateful colleagues, who nevertheless recognise that the 'day job' often has to take priority over volunteer efforts. Kees works for the Ministry of Health in the Netherlands.

 

Kees Molenaar has served CEN TC251 as chairman for a full term. During his successful time as chair, Kees has steered CEN TC251 through some troubled times and his leadership has seen the TC become a respected, critical friend of many EU initiatives. He has led the European Mandate work that has culminated in the well regarded Interoperability report, a collaborative effort involving the three European Standards Organisations: CEN, CENELEC, ETSI, with representatives from IHE.

 

CEN TC251 has become increasingly influential in Health Informatics Standardisation both in Europe and also in the wider International arena in which ISO and HL7 operate. This has had a great deal to do with Kees’ leadership and presence. He was one of three founding chairs of the Joint Initiative Council (JIC, www.jointinitiativecouncil.org), which is now well established. Kees is, in fact, coming to the close of his term as chair for the Joint Initiative Counsel and has decided that this will be the opportunity for him to step down as TC chair.

 

The Secretariat, the management team, and those in the TC would like to take this opportunity, the first of many, to acknowledge and thank Kees for his excellent work, on which others can now build and take forward.

 

CEN TC 251is participating in two focused task group meetings in December, one related to the Continuity of Care work that has originated in its formal working groups and another that has been part of the medical device directives. The joint CEN/CENELEC group, addressing the standards issues related to regulation of software as a medical device, has worked with the EU Medical Device Expert Group's MDEG to review emerging draft MDEG Guidance. In this context they have examined the consequences of draft guidance for standards development (including surveying standards used by the health IT industry for their software engineering and quality standards) and have started to provide input to revision of existing ‘conventional’ medical device-oriented standards to suit ‘stand-alone software’ needs. ISO has a keen interest in both.

 

 

The new ISO work linked to the European efforts on software safety will be meeting for two days in December, at Leeds and London, U.K.

 

The next working group meetings are a combined WG1 and WG2 agenda, scheduled for January 25-27, 2011, in Dublin.

 

DICOM (Digital Imaging and Communications in Medicine – ISO 12052) is the international standard for biomedical imaging and related data. In the last few years it has been expanding its scope beyond its core support of radiology, cardiology, and dental imaging.

 

The eye care community has been involved in developing DICOM standards for the full range of ophthalmic instruments and image-based applications. To date, this includes ophthalmic photography and optical coherence tomography, refractive and visual field measurements, and intraocular lens calculations. In most of these instances, DICOM represents the first vendor-neutral interoperability standards for the data type.

 

Another pivotal development was the adoption in August of a DICOM standard for whole-slide microscopy imaging, in collaboration with the College of American Pathologists. This standard will be key to a transformation of anatomic pathology workflow from dependence on access to the glass slide to a substantially digital workflow. The technical challenges included defining a standard to handle the massive amount of data in whole-slide imaging, typically 300MB per slide after compression, with effective access at a broad range of resolutions to support rapid panning, zooming, and change of focal depth. The standard allows complete description of the optical imaging parameters for all types of histological and microscopic imaging, including epifluorescence, multispectral, differential interference contrast, and other techniques. The use of the DICOM Standard across radiology, pathology, surgery, and radiation therapy opens the door to truly integrated oncology imaging data, from screening to biopsy to diagnosis to treatment.

 

ISO TC215 is engaged in a sweeping review of its business plans and scope; its goal is 1) to ensure the coherency and internal consistency of TC215 standards and 2) to ensure the alignment of TC215 products with the needs and requirements of the member bodies. In short, we seek to make TC215 standards useful and relevant. A task force addressing this question, led by Jeremy Thorp of the U.K., made an interim report on the first six months of its activities at our last meeting in Rotterdam in October 2010. We expect the final report next May at our meeting in Finland.

 

Related to these alignment and coherency issues is the greatly improved communication and coordination that ISO TC215 enjoys with its partner organizations (CDISC, CEN TC251, GS1, IHTSDO, and HL7) through the Joint Initiative Council (JIC). JIC is convened by TC215, and provides a forum in which major international standards developers in the Health Information Technology (HIT) domain can communicate, coordinate, and synergize their resources for the better outcome and coherency of all HIT standards.

The HL7 Electronic Health Record System Functional Model (EHR-S FM) describes approximately 160 functions, with over 1,000 conformance criteria, for EHR systems. The EHR-S FM, approved as a joint ISO/HL7 standard in November 2009, has received tremendous acceptance in the industry. A number of Functional Profiles (subsets derived from the EHR-S FM) have been developed in such care delivery areas as long-term care, behavioral health, child health, and emergency services, with others (e.g., dental) in development. In addition, profiles have been developed for vital records (birth and death certificates), records management and evidentiary support (the need for the EHR system to help the organization maintain health records for legal, business, and disclosure purposes).

A number of countries have used the EHR-FM for a variety of purposes. In the U.S., for example, a number of HL7 conformance criteria have been used and modified for certification purposes, while the Netherlands has used the behavioral health profile for a national system requirements analysis and system selection.

 

Given the high level of interest in the FM, HL7 is currently working on Release 2 of the EHR-S FM, for which much clinician input is needed, and will again seek to get it approved as a joint ISO/HL7 standard. In addition, given the increased interest in PHR system standards internationally, HL7 is similarly proposing its Personal Health Record System Functional Model (PHR-S FM) as a joint ISO/HL7 standard.

 

 

In June 2010, the LOINC® team at Regenstrief was pleased to announce the launch of a new web application for searching LOINC: http://search.loinc.org

 

This program takes the very best search features of the popular desktop application RELMA® and deploys them in a new web application that you can use from anywhere. The application is built on the open source ZK® framework and has its search functions powered by Apache Lucene™, a high-performance open-source text search engine with a familiar query syntax. We consider the current version a beta release, so more refinements are in the works.

 

 

In June 2010, Regenstrief Institute, Inc. and the LOINC Committee released the 45th edition of the LOINC terminology, version 2.32, which contained more than 58,000 terms. This release included a major enhancement to the concept status designation, which now includes values of active, trial, discouraged, and deprecated. The RELMA mapping program also featured new functions for searching and browsing LOINC Parts.

 

Stay tuned for the upcoming releases scheduled for December. LOINC will include a greatly expanded set of terms for cephalometrics and translational research measurements including PROMIS and PhenX. RELMA will feature 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.

 

The worldwide LOINC community continues to grow, with nearly 300 new loinc.org users and 1,200 downloads each month. Presently, there are more than 8,800 users from 139 different countries. One of the most notable informatics events in the U.S. this summer was the publication of the final rules for "meaningful use" criteria by the Centers for Medicare and Medicaid Services, and the standards and certification criteria by the Office of the National Coordinator for Health Information Technology. These regulations will go a long way toward promoting widespread use of interoperable electronic health records in the U.S., and we are pleased that LOINC was adopted in the legislation as a content-exchange standard.

 

 

Public Clinical LOINC Committee Meeting (01/27/2010 to 01/28/2010)