# Presentation: 352121

## 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 26, 2004

## Presidential Executive OrderApril 27,2004

-  With goal of ubiquitous electronic health records and a national health information infrastructure in 10 years:
- 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

## ONCHIT

- www.hhs.gov/healthit

## HIT Strategic Framework Goals JULY 2004

- Inform Clinicians
- Incentivize and reduce risk of EHR adoption
- Interconnect Clinicians
- Foster regional collaborations, develop NHIN, coordinate Federal systems
- Personalize Care
- Encourage PHRs, enhance informed consumer choice, promote use of telehealth systems
- Improve Population Heath
- Unify surveillance systems, streamline quality and health status monitoring, accelerate research and dissemination of evidence

- www.os.dhhs.gov/healthit/strategicfrmwk.html

## Report on Nationwide Health Information Exchange

- HHS issued “Request for Information” (RFI) in November 2004
- Sought recommendations on the best way to achieve widespread interoperability of health information through a nationwide health information network (NHIN)
- Received over 500 responses totaling nearly 5,000 pages of information
- Report summarizing the responses to the RFI published in June 2005
- Results used to prepare “Request for Proposal” (RFP)

- www.hhs.gov/healthit/rfisummaryreport.pdf

## HHS Requests for ProposalsJune 2005

- Nationwide Health Information Network (NHIN) prototype architectures, operational models – up to 6 awards (ONC)
- State-based assessments/plans re: security & privacy laws/business practices – up to 40 awards (ONC & AHRQ)
- EHR compliance & certification process (ONC)
- Standards harmonization process (ONC)

## HHS Secretary Leavitt’s 500-Day Plan to Transform Health Care Systems

- Expressing a clear vision of health information technology that conveys the benefits to patients, providers and payers
- Convening national collaboration re: developing setting, and certifying HIT standards and outcomes for interoperability, privacy and data exchange
- Realizing the near-term benefits of health information technology in: adverse drug-incident reporting, e-prescribing, lab and claims-sharing data, clinic registrations, insurance forms
- Creating an integrated network of population data, genetic information, and medical records to accelerate discovery
- Improving the clinical research network
- Providing early warning of threats through improved domestic and international surveillance

## Congress Drafting Health IT Bills

- www.himss.org/Content/files/LegislationCrosswalk-109thcongress.pdf

## NLM’s Role in Health Data Interoperability Standards

## Electronic Health Data Standards (including Standard Vocabularies)

- Key element of the health information technology infrastructure for:
- Effective decision support
- Safe, evidence-based, and coordinated health care
- Cost-effective care, assisted by robust market-place and increased/informed choice
- More efficient clinical, public health, and health services research
- Timely public health and bioterrorism surveillance

## Types of Health Data

- Administrative health data
- 	e.g., health insurance claims
- Clinical data
- 	e.g., lab test results, problems, diagnoses, history and physical
- Public health data
- 	e.g., disease prevalence, immunization rates, environmental monitoring
*All *potentially relevant to health services research

## Data Content Standards include:

- Data elements, e.g., gender, presenting complaint
- Descriptions of entities, e.g., birth certificate
- Messages, e.g., medication order
- Allowable values for data elements, which can be entire ***vocabularies***
- Mappings between different vocabularies
- Survey questions and any coded responses
- Guideline, protocol, and algorithm formats
- Information models that define the context for  standards

## Standard Clinical Data

- Enhanced ability to provide access to knowledge where clinical decisions are being made (e.g. guidelines, decision logic, etc.)
- Generation of research data as a by-product of health care
- Efficient exchange of data between health care and public health

## NLM Long Range Plan

- Work with other agencies and organizations to support establishment, maintenance, testing and use of health data standards.
- Active partners: *Office of the Secretary - HHS, AHRQ, CDC, CMS, FDA, other NIH components, VA, DoD, NCVHS, standards development organizations, vocabulary producers, professional associations*
- Use the UMLS Knowledge Sources and programs to facilitate maintenance and distribution of vocabulary standards.

## Federal Standards Selection Mechanisms 

**HIPAA** (1996)- *Health Insurance Portability and Accountability Act of 1996 requires administrative standards*
**NCVHS** - *National Committee on Vital and Health Statistics, a long-standing (50+ years) advisory committee to HHS expanded by HIPAA, recommends standards*
**CHI** (2001) – *Consolidated Health Informatics project, a cross-agency eGov initiative designates U.S. gov’t-wide clinical data standards; now part of the Federal Health Architecture*
**Medicare Modernization Act **(2003)* - requires e-Prescribing standards; establishes Commission on Systemic Interoperability*

## Recommended Steps to Achieving  U.S. Health Data Standards (1990-2003)

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

## Standards Have Been Selected

- U.S. *National* Administrative Standards
- HIPAA transactions and code sets _[www.cms.hhs.gov/hipaa/hipaa2/default.asp](http://www.cms.hhs.gov/hipaa/hipaa2/default.asp)_
- U.S. *Government-wide *Target Clinical Standards
- CHI message and vocabulary standards
- 	_[www.whitehouse.gov/omb/egov/c-3-6-chi.html](http://www.whitehouse.gov/omb/egov/c-3-6-chi.html)_
- U.S. *National* Public Health Reporting Standards
- PHIN (Public Health Information Network)
- 	_[www.cdc.gov/phin/index.html](http://www.cdc.gov/phin/index.html)_

## 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)*

## NLM No-Cost Distribution

- umlsinfo.nlm.nih.gov

## UMLS® Metathesaurus® a Vocabulary Database

- Preserves the meanings, hierarchical connections, and other relationships between terms present in its source vocabularies
- Adds certain basic definitional information about each of its concepts
- Establishes new relationships between concepts and terms from different source vocabularies
- Distributes many vocabularies in a common, explicit format

## 2005AB UMLS Metathesaurus  (June 2005)

- 1,196,265 concepts
- 4,752,383 unique “strings”
- 	  (Eye, Eyes, eye = 3)
- 5,578,532 source vocabulary terms
- 114 source vocabularies
- 17 different languages

## Other UMLS Resources

- Semantic Network
- SPECIALIST lexicon
- Natural language processing programs
- In combination with the Metathesaurus, powerful tools for interpretation/indexing of electronic full text

## 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- HL7 Contract ArrangementSept. 2004

- Align HL7 message standard with standard vocabularies (*NLM-initiated)*
- Specify which subsets of standard vocabularies are valid for particular message segments
- Replace HL7-maintained lists of coded values with subsets of standard vocabularies, where feasible
- Create implementation guide(s) for transmitting an entire Electronic Health Record between systems *(on behalf of HHS)*

## Mapping Projects planned/underway

- CHI standards – HIPAA code sets
- SNOMED CT - ICD-9-CM, ICD-10-CM
- SNOMED CT – CPT
- LOINC – CPT
- SNOMED CT - “other” vocabularies
- Medical Dictionary for Regulatory Affairs (MedDRA)
- International Classification of Primary Care (ICPC)
- Medcin
- Will require:
- Robust testing/validation
- Alignment of update schedules
- Draft mappings available in the UMLS Metathesaurus for testing by end of 2005

## Key NLM Assumptions about Mappings

- Participants must include:
- Producers of vocabularies on both ends; prospective users and recipients of the output, e.g., health care providers, payers, as testers and validators
- Mapping may/will prompt changes/corrections to content and adjustment to update schedules
- Mappings must be updated every time either end is updated
- Mappings will be distributed in the UMLS (not exclusively); use will be governed by terms applicable to both ends
- Mapping is still an R & D problem - it will take iteration to build highly functional maps

## Accelerate Adoption and Use

- Promote testing use of standards by Federal partners, grantees, and contractors
*CDC’s Public Health Information Network (PHIN) *(_[www.cdc.gov/phin](http://www.cdc.gov/phin)_)
*NIH emphasis on use in clinical research networks*
- Encourage manufacturers to include standard identifiers (e.g., LOINC) in device output/test kit packaging
- Collaborate with other HHS agencies to support demonstration/testing

## Broaden participation: Public Health 

- www.phdatastandards.info

## Broaden participation: Clinical Research

- nihroadmap.nih.gov

**Notes:**
Grants are trying to establish clinical research networks using standards, same standards that are being adopted on the healthcare side so that healthcare and research are aligned.

## Strategy for Adoption and Implementation of Standards

- www.nlm.nih.gov/csi/csi_home.html

**Notes:**
Came out of the Medicare Modernization Act

## Commission on Systemic Interoperability Members - appointed late 2004

**Scott Wallace**, JD, Chair, National Alliance Health IT
**Simon Cohn**, M.D, Kaiser
**Don Detmer**, M.D., Pres & CEO, AMIA
**Vicki Gregg**, CEO, BlueCross BlueShield TN
**Gary Mecklenberg**, Pres. & CEO, Northwestern Memorial Healthcare
**C. Martin Harris**, MD, CIO, Cleveland Clinic

**Herbert Pardes**, M.D., Pres. & CEO, NY-Presbyterian Hosp
**Thomas S. Priselac**, Pres. & CEO, Cedars-Sinai
**Ivan Seidenberg**, Chm. & CEO, Verizon of NY
**Frederick Slunecka**, CEO, Avera McKennan Hosp
**Bill Stead**, M.D. Assoc. Vice Chancellor for Health Affairs, Vanderbilt

## privacyruleandresearch.nih.gov

**Notes:**
This is a reminder about the NIH Web site designed to address the impact of HIPAA privacy on health services research.   They continue to add new resources.

## 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
- It’s not too early (*or too late*) to get involved:
- to contribute to standards development, testing, and refinement
- to study the impact of standards on health care, public health, and clinical research
- If you work with electronic data, the UMLS resources might be helpful