# Presentation: 028823

## Standards Harmonization Update

**Standards Harmonization Update**
**John D. Halamka, MD**
**Chairman, Health Information Technology Standards Panel and Harvard Medical School**
**Bill Braithwaite, MD PhD**
**Vice-Chair, HITSP and eHealth Foundation**
**John W. Loonsk, MD**
**Office of the National Coordinator for Health Information Technology**

## Agenda

- Standards Harmonization Context
- John Loonsk
- Health Information Technology Standards Panel (HITSP) process
- John Halamka
- HITSP Future Milestones
- Bill Braithwaite

## Standards Issues

- Most standards issues fall into four general categories:
- Gaps
- Overlap
- Adoption
- Specificity

## Standards Issues

- Adoption Issues:
- Local terms, traditions and infrastructure
- Professional services integration model
- “Coded” data vs. “Free Text” content

- This 42 year old woman with a history of persistent right lower quadrant pain with radiation to her back, hypertension, and migraine headaches was found on CT scan of the abdomen to have a retroperitoneal lesion. Serum catecholamines showed serum norepinephrine greater than 4,000 pg/ml (greater than 2,000pg/ml diagnostic of pheochromocytoma). 24 hour urine vanillyl mandelic acid was elevated at 36.1 mg (normal 2.0-7.0 mg/24 hours). Exploratory laparotomy showed a mass situated at the aortic bifurcation and a mass on the lesser curvature of the stomach. Resection of the retroperitoneal mass, two sacral/neural foramina lymph nodes, and wedge resection of the lesser curvature stomach to remove the small gastric mass was performed.

_**Display Name**_	_**Code**_
-   “Suture Removal”	  30549001
-   “procedure site”	  363704007
-   “left forearm”          	  6480008
- Code system name – SNOMED CT

- Coded Data

- Free Text

## Standards Issues

- Specificity:
- “Named standards”
- Necessary, but not sufficient
- Can be high level and subject to interpretation
- Implementation level guidance
- Can foster greater interoperability

**Implementation Level Guidance**

**“****Named” Standards**

- - LOINC
- - SNOMED
-  NCPDP
-  etc.

## Healthcare Information Technology Standards Panel 

- The HITSP is a group organized to harmonize the standards used to exchange health data in the United States
- The Panel brings together experts from across the health care IT community – from consumers to doctors, nurses, and hospitals; from those who develop healthcare IT products to those who use them; and from the government agencies who monitor the U.S. health care system to those organizations who are actually writing the standards
- The Panel’s activities are open and transparent and led by the American National Standards Institute (ANSI), a not-for-profit organization that has been coordinating the U.S. voluntary standardization system since 1918
- Cooperative partnerships have been and are being developed between and among certain standards developers

## Membership and Board Representation

- A total of 155 organizations participate in HITSP representing a broad spectrum of interests
- 17 Standards Development Organizations
- 114 non-SDOs such as clinicians, providers, safety net providers, vendors, purchasers, payers, public health professionals, and researchers
- 15 government organizations
- 9 consumer organizations
- The HITSP Board of Directors also represents multiple stakeholder groups
- 8 representatives from SDOs
- 9 representatives from non-SDOs
- 4 representatives from government appointed by ONCHIT
- 2 representative from consumer organizations

## Harmonization 101A few terms to describe the process

**Harmonization** - the selection of standards most ready for use as an interlocking set to implement in support of specific events and actions
**Context** – the coupling of an action or event and a specific request for an interoperability specification
**Gap** -- missing or incomplete standards that are required for fulfillment of the events in the given Use Case
**Overlap**  - Overlaps refer to instances where some or all of the requirements are met by multiple standards.
**Standards Development Organization** - The term “standards development organization” refers to an organization that produces standards that meet the test of HITSP Standards Readiness Criteria

## Harmonization ProcessSteps taken by industry within the context HITSP

**          ****II **
**Requirements****Analysis**

**         ****III **
**Standards **
**Identification**

**V **
**Standards**** Selection**

**VII **
**Inspection****Test**

**VIII**
**   ****Interoperability****Specification****Dissemination**

**IX****Harmonization Process Management**

**Begin****Support**

**Receive****Request**

**IV  **
**Gaps/**** Overlaps**** Resolution**

**VI **
**Interoperability****Specification **
**Construction**

**I**
** **
**Harmonization**** Request**

## HITSP Panel Process

- AHIC Working Groups, NHIN contractors or other customers prepare a Harmonization Request
- HITSP Technical Committees analyze requirements, identify candidate standards, and highlight standard gaps and overlaps
- Gaps are forwarded to SDOs for their guidance as to emerging candidate standards or new standards requirements
- Overlaps are resolved through SDO interactions
- HITSP selects the final set of standards
- The standards recommended by the Technical Committees are discussed and ratified by the HITSP panel

- 10

## HITSP Panel Process

- Technical Committees work with SDOs and other groups to produce implementation level guidance
- “Interoperability specifications”
- It may be that certain aspects of implementation guidance, especially when multiple SDOs are involved, will be created by other groups for HITSP
- HITSP work products are delivered to AHIC for their endorsement
- CCHIT will include functional criteria for interoperability based on HITSP implementation guides in its certification work

- 11

## HITSP Progress to Date

- Breakthrough area Use Cases received as requests by HITSP Technical Committees in January 2006
- Biosurveillance:  ER visits
- Electronic Health Records: Laboratory Results
- Consumer Empowerment: Electronic Clipboard and Medication History
- Chronic Care: Secure Messaging between Consumers and Providers
- Requirements analysis to understand interoperability requirements for specific scenarios completed April 2006
- Candidate standards named and gaps and overlaps identified May 2006
- Criteria used to analyze overlaps and duplications designed May 2006

## September HITSP Deliverables

- In September HITSP will deliver specific implementation level guidance – “Interoperability Specifications” for four AHIC breakthrough areas
- Interoperability specifications will . . .
- Identify standards and specific implementation context for those standards
- Describe specific value sets for unambiguous data exchange and system to system interaction
- Provide the necessary instructions to implement the specific standards in commercial and self-developed systems

## Future Milestones

- Also in 2006, HITSP will . . .
- Select standards for each breakthrough Use Case by June 30, 2006, using the HITSP approved criteria
- Pilot the remainder of the process by constructing interoperability specifications, testing and disseminating them for industry use
- Promote public awareness of HIT standards harmonization activities and provide an open, balanced and transparent review mechanism
- Develop a business model that will sustain the HITSP for as long as standards harmonization and coordination is necessary

## Q & A