# Presentation: 692006

## More and Better Data for Research:U.S. Health Data Content Standards

- Vivian A Auld
- Senior Specialist for Health Data Standards
- National Library of Medicine
- AcademyHealth
- Annual Research Meeting
- June 3, 2007

## Presidential Executive OrderApril 27,2004

- With goal of ubiquitous electronic health records and a national health information infrastructure in 10 years:
- Established new National Health Information Technology Coordinator in HHS with responsibility for strategic plan to:
- “(i) Advance the development, adoption, and implementation of *health care information technology standards* nationally through collaboration among public and private interests, and *consistent with current efforts to set* health information technology *standards for use by the Federal Government**;*
- (ii) ....”

- www.whitehouse.gov/news/releases/2004/04/20040427-4.html

## HHS Health IT

- www.hhs.gov/healthit

## Strategy for Achieving U.S. Health Data Standards

- Establish mechanism for designating U.S. Standards
- Pick best available as starting point
- Support development, maintenance, and low/no cost distribution – NLM leadership and ongoing commitment
- Coordinate development of selected standards to achieve non-overlapping, interlocking set
- Broaden participation in standards development
- Promote use and improvement

## Use Cases

- www.hhs.gov/healthit/usecases

## Healthcare Information Technology Standards Panel (HITSP)

- www.ansi.org/hitsp/

## NLM-led Support for Development and Maintenance

**1999** – LOINC (lab tests/instrument observations) - contract support
**2002** – RxNorm (clinical drugs) - direct development
**2003** – SNOMED CT contract & license for U.S-wide use *(as distributed by NLM in UMLS)*

## Unified Medical Language SystemUMLS

- umlsinfo.nlm.nih.gov

## 2007AA UMLS Metathesaurus  (Jan 2007)

- ~1,373,000 concepts
- ~4,967,000 “terms” (Eye, Eyes, eye = 1)
- ~5,546,000 unique “strings” (Eye, Eyes, eye = 3)
- ~6,773,000 “atoms” or source vocabulary strings (Eye [from MeSH], Eye [from SNOMED CT] =  2)
- 139 source **vocabularies** (121 “families”)
- 17 different languages
***Multi-purpose**** – MUST be customized for any **specific purpose*

## Letter from HHS Secretary to NCVHS Sept. 2004

- “As you requested ..., NLM to serve as the central coordinating body within HHS for PMRI [Patient Medical Record Information] terminologies. ... several ... mapping recommendations currently are being implemented by the NLM.”

## Coordination means:

- Uniform distribution of designated standard vocabularies through the UMLS Metathesaurus
- Reducing peripheral overlap and establishing explicit relationships between standard clinical vocabularies (e.g., SNOMED, LOINC, RxNorm)
- Aligning standard clinical vocabularies with standard record and message formats
- Mapping between standard clinical vocabularies and administrative code sets and/or other important vocabularies

## NLM Long Range Plan for 2006-2016

**3.2 Promote Development of “Next Generation”**
**      ****Electronic Health Records**
- Continue and enhance current standards efforts:
- Develop, support, license, disseminate vocabulary standards via UMLS
- Develop subsets, mappings, and other tools in collaboration with actual clinical systems
- Contribute to health information technology policy development
- Expand research and development to define and develop more advanced electronic health records

## Health IT at NLM

- www.nlm.nih.gov/healthit.html

## Change in Ownership of SNOMED CT

## 2003- NLM/CAP* License and Contract

- U.S-wide license for the use of SNOMED CT:
- Perpetual rights to the last version received under the contract
- Ongoing updates to the English and Spanish versions for 5 years (follow-on contracts likely)
- Free distribution to U.S. users via NLM’s Unified Medical Language System (UMLS)
- International use requires separate license from CAP
- Terms of agreement determined with extensive input/advice from HHS agencies, VA, DOD
***College of American Pathologists**

## IHTSDO principles

- Openness, fairness, transparency, and accountability to Members
- Responsible, ethical conduct to ensure long-term viability, value, utility, clinical & technical fitness of terminology products
- Collaboration with others to facilitate interoperability
- Encouragement of intellectual contributions under terms that permit others to use and distribute their own work

## April 26, 2007: Change in ownership announced

- International Health Terminology Standards Development Organi**s**ation (IHTSDO)
- Charter members from 9 countries:
- Australia, Canada, Denmark, Lithuania, Netherlands, New Zealand, Sweden, UK, USA
- Each member country represented by one entity
- NLM – the initial entity for USA

## International Health Terminology Standards Development Organisation (IHTSDO)

- www.ihtsdo.org/

## Chronology

- IHTSDO formed in Denmark - March 9, 2007
- IHTSDO IP purchase from CAP for $7.8 million and 3-yr support contract with CAP – final on April 24, 2007
- Public announcement – April 26, 2007
- NLM ends contract with CAP – April 30, 2007
- IHTSDO – SNOMED Editorial Board/WG transition meeting – May 23-25, 2007 (Chicago)
- NLM sets up new contract with IHTSDO - by June 30, 2007

## IHTSDO - Country Participation 

- Member countries
- Annual fees based on World Bank GNI values, pegged to current US fee ($5.5 million in ’07)
- Charter members (other than US) also contributed to initial IP payment
- After start-up, new members pay joining fee, as well as annual fee
- “Sponsored countries”
- For countries below a GNI threshold, a one-time payment   (8 X annual fee) provides permanent rights; can be paid by anyone, e.g., foundation

## IHTSDO Member* Rights

- Use and reformat the International release
- Create national extensions in accordance with IHTSDO standards
- Create derivatives, e.g., subsets, mappings, etc.
- Distribute the international release to “Affiliates” (=licensees) under standard license terms
- Must distribute in native format, in addition to any other formats
- Continue to use and distribute the last version received if membership ceases
*******In US, NLM**

## “Affiliate” License Terms

- One license for everyone – e.g., vendors, hospitals, researchers
- Right to use, create extensions and derivatives, incorporate international release in products
- No use fees in Member or Sponsored countries; some in non-member countries
- IHTSDO may “annex” certain extensions
- Required to check if additional requirements apply (e.g., use of national releases) for use in member countries

## IHTSDO Governance 

- General Assembly - 1 vote per member country
- Initial US member: Betsy Humphreys (Alt. Vivian Auld)
- Management Board (up to 12 members)
- Now: 9 members: 1 per member country
- NLMers cannot serve due to Contract;
- Initial US member: Andrew Wiesenthal, MD, Kaiser (Alt. Simon Cohn, MD, Kaiser & Chair, National Committee on Vital and Health Statistics)

## IHTSDO Governance 

- Executive Officers
- CEO, Chief Terminologist, Chief Technologist, Chief QA Officer
- Initial *interim* appointments:
- Ulrich Andersen (Den), CEO
- Kent Spackman (USA), Chief Terminologist
- International recruitment for permanent officers

## IHTSDO Governance 

- Committees: Content, Information Technology, Quality Assurance, R & D
- Harmonization Boards
- Jointly established with other standards bodies, e.g., WHO, LOINC, etc.

## Call for Nominations – Due 6/12/2007

- http://www.nlm.nih.gov/news/snomed_candidates.html

## What Will Be Different for U.S.?

- Annual fee NLM is paying may decrease over time
- UMLS users must review and accept new license terms (easy online process) – BY MAY 15, 2007
- SNOMED CT and its documentation will be available in in native format from NLM (on MAY 15, 2007)
- in addition to UMLS format
- Better international distribution rights for US users
- Good prospects for:
- More transparent governance, priority setting
- More efficient updating
- International collaboration on subsets, tools, etc.
- More commercial products

- www.nlm.nih.gov/snomed

## Next on the list for NLM & SNOMED CT

- New U.S. process for input to SNOMED CT development
- Begin by coordination with existing NCVHS, HITSP, AHIC activities
- Align LOINC and RxNorm development with SNOMED CT
- Tightly integrated with feedback from real clinical implementations

## Take Home Messages

- Health data standards have “arrived”; electronic health records are arriving
- Both will affect health care, public health functions, and the data available for HSR
- Get involved!
- Contribute to standards development, testing, and refinement
- Need studies evaluating the impact of standards on health care, public health, and clinical research
- Take advantage of the resources available from HHS, NLM, etc.