BMI 516/BMI 616 Standards and Interoperability in Healthcare Module 1-2 Standards Rev 2012

BMI 516/BMI 616 Standards and Interoperability in Healthcare

Module 1-2

Standards

Rev 2012

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Module 1-2 - Standards/

Focus for Unit

Standard definition of standards

The standards value proposition

The standards process

Issues with implementing standards

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Standard Definition of “Standard”

Document, established by consensus and approved by a recognized body, that provides, for common and repeated use, rules, guidelines or characteristics for activities or their results, aimed at the achievement of the optimum degree of order in a given context

ISO/IEC Guide 2:2004 Standardization and related activities -- General vocabulary

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Parsed definition

Document, no longer a physical exemplar

established by consensus among stakeholders

approved by a recognized body, authoritative for participants

that provides for common and repeated use, not a one-off

rules, guidelines or characteristics the meat!

for activities processes or their results, products

aimed at the achievement of not guaranteed

the optimum degree of order in the eyes of the stakeholders

in a given context scope

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Case Study: Edison light bulbs c. 1893

How many standards does it take to screw in a light bulb?

Brush-Swan, U.S. base , Thomson-Houston,Perkins-Mather, Shaeffer, Edison

Photographs from http://www.sparkmuseum.com/lighting.htmConcept from David Channin, MD, Guthrie Clinic

No, seriously … how many?

Class exercise:

What problems does this pose for•Manufacturer•Customer •Distributor/Vendor •Installer/Integrator•Public Safety

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Cost Drivers in Non-Standard Solutions

Manufacturer• ?

User / consumer • ?

Distributor / System Integrator• ?

Public Safety / Regulatory• ?

Applies to light bulbs - and Healthcare IT!

Manufacturer• Tooling, supply chains, inventory, training, service

User / consumer • Choice, vertical lock-in, vendor lock-in, negotiation

disadvantage

Distributor / System Integrator• Inventory, licensing, tools, training, adapters

Public Safety / Regulatory• Safety certification, emergency preparedness training

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Screwing in light bulbs

The multiple manufacturers needed to agree to standardize

They needed to agree to use a screw base

1902 – Lampholder Manufacturers Conference• Each received a physical copy of Edison lamp gauge

1914 – standardization turned over to American Society of Mechanical Engineers• 1929 – joint custody with National Electrical Manufacturers Association• Now designated ANSI/IEC C81.63

Screw base light bulbs manufactured in 1888 will operate in lamp sockets made today – and for the foreseeable future

Will we have units of healthcare information that can be used after a full

century and more?

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Why do standards happen

Recognition of a specific problem by a critical mass of stakeholders• Manufacturers• Users / consumers (often represented by

professional organization or government)• Distributors / system integrators• Public safety / regulatory

Consensus to establish a standards-based approach to problem solution• Typically for cost reduction / mitigation

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Standards and the Economics of Interoperability

Without standards, everything is a custom integration• Custom jobs inherently expensive

• Must negotiate both financial and technical terms

• Non-expert consumers at competitive disadvantage

Standard “sockets” between components • Allow user choice of component implementer

• Allow vendors to specialize in improving components

Standards allow “retail users” to leverage best practice• Domain expertise codified into standard

• Expertise reproduced into each compliant system

Standards make a market

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Standards History

You can’t measure without a standard

Leviticus 19:36 Thou shalt have an honest balance, honest weights, an honest dry measure, and an honest liquid measure.

1875 Adoption of the “Convention du Mètre” and establishment of the International Bureau of Weights and Measures (BIPM).

So what’s the reason to measure?

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The Standards Value Proposition

Mechanisms of value

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Standards enable a market

Standards enable valuation• Objective criteria for comparisonStandards facilitate deal-making• Simplifies negotiation of the technical parameters of a

transactionStandards facilitate open markets• Customers (or political entities) cannot impose

arbitrary technical requirements that lock out certain players

• Lack of standards is a “barrier to trade”

Allow competition – reduce barriers to vendorsGrow the market – reduce barriers to customers

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Standards facilitate system design

Standards define stable system partitioning and component boundaries

• Architectural model of standard can be re-used• Removes boundary debate from system design

Standards allow focused component development

• Encourages specialized competence for components

• Allows component improvement / re-engineering• Allows incremental implementation and

verification of components

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Standards reduce interface design cost

Use of existing standard reduces cost of defining, reviewing, and documenting interfaces for specific product

Quality of interface is typically better

• SDO design review is broader than the two immediate parties to a specific implementation

• Multiple implementations to same interface provide more opportunities to debug the design

SDO manages the standard interface, rather than one of the implementing parties

• Independence from specific implementation

Costs of interface definition/design shared by all users across all products

SDO = Standards Development Organization

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Standards leverage commoditization

Standard components have larger markets• Stable interfaces allow components to be reused in

different contexts• Cost of component design amortized over more

units

Standard-related tools and services are commoditized

• Design tools and services• Testing and validation tools and services• Standard-related products becomes a market itself

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Standards reduce workforce training costs

Standards knowledge can be reused• Minimize required workforce training for new

products/projects• Training on standard can be a prerequisite for

job – moves cost of training to prior experience or basic educational system – Example: software programming language training

Standards provide a larger pool of trained candidates

Project start-up accelerated

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Standards facilitate mergers & acquisitions

Integration of acquired product lines facilitated by adherence of products to standards

• Benefit to acquiring company – simplified integration– Fits into standards based processes, allowing

reduction of redundancies– Product teams share common standards-based

domain concepts and vocabulary

• Benefits to acquired company – increased valuation

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InteroperabilityThe ability of two or more systems or components to exchange information and to use the information that has been exchanged.

StandardsA consensus specification of rules for repeatable activities or uniform characteristics of products in a given context.

Interoperability is silent on the method used to achieve the result - could be re-done for each pair of systems.

Standards provide a method that is economically effective - amortizing the cost of design and implementation over many system pairs.

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How do standards “happen”?

Government decree• Procurement (for government use – e.g., MIL-STDs)• General mandate (for broad economic policy – e.g.,

HIPAA)

Major vendor de facto (e.g., PDF)

Industry consortium / trade association • Professional society• “Consensus standard”

International standards body• Academic collaboration

To solve a specific problem

HL7

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Standards process (consortium approach)

1. Problem recognition by critical mass of stakeholders

2. Search for a relevant standards body

3. Project proposal/approval; call for participation

4. Development in committee

5. Preliminary review, revision

6. Ballot by members of standards body

7. Reconciliation of negative ballots

8. Publication

Typically 18 months to several years

May iterate through Drafts for Trial Use before reaching Normative status

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International Standards Bodies (1)

ISOInternational

Organization for Standardization

IECInternational

Electrotechnical Commission

ITUInternational

Telecommunications Union

International Treaty Standards Organizations

National Member Bodies

ANSIAmerican National

Standards Institute

AFNOR

BSI

DIN

U.S. Accredited Standards Committees

HL7

X12

ASTM

INCITS

National Member Bodies

ANSIAmerican National

Standards Institute

AFNOR

BSI

DIN

Technical Committees

TC215Healthcare Informatics

JTC1Information Technology

TC62Electrical equipment in medical practice

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International Standards Bodies (2)

ISOInternational

Organization for Standardization

IEEEInstitute of Electrical

and Electronic Engineers

HL7

Independent SDOs

IHTSDOInternational Healthcare

Terminology Standards

Development Organisation

TC215Healthcare Informatics

DICOMDigital Imaging and Communications in

Medicine

W3CWorld Wide Web

Consortium

FormalLiaison

SDOs with liaison to an ISO TC can “fast track” their approved standards to be ratified as an ISO standard

AAMIAssociation for the

Advancement of Medical

Instrumentation

TC62Electrical equipment in medical practice

IECInternational Electrotechni

cal Commission

JTC1Information Technology

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The great thing about standards –

there are so many to choose from!

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Why?

All standards start from trying to solve a specific problem• So it gets solved, but inevitably that problem turns out to be

just a piece of a larger problem• Or the technological environment has changed• So the standards developer expands the scope of their domain

to address the bigger problem or the new environment• And repeat …

Multiple standards and domains• Overlap and redundancy due to growth from niches• Conflict because domain boundaries are unclear and

information models are different (and there is turf to be protected)

●

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Case Study: DICOM (1)

1970’s – introduction of digital imaging (CT)

1983 – recognition of problem: sending digital images to printers• Radiologists wanted image printers to be decoupled from imaging

modalities• Formation of joint professional-industry committee to address

problem (ACR-NEMA)

1985 – publication of ACR-NEMA Std 300• 50-pin parallel interface (16-bit data bus), control and data elements• 1988 – publication of version 2

1993 – publication of DICOM (ver. 3.0)• Based on network communications in accordance with ISO Open

System Integration (OSI) standard model (over OSI or TCP/IP stack)• Image formats for CT, MR, CR, US, NM• Persistent information objects uniquely identified• Film print management (page compositing, printer control)

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1993 – recognition of the cardiology problem• Digital angiography – massive amounts of data (500 MB) needed

physical media for consultation• ACC-NEMA committee; decision to work with DICOM (cardiologists

cooperating with radiologists!)• 1995 – Extension to media interchange (particularly CD-R)

1993 – recognition of the workflow problem• Need to manage the process of image acquisition• European equipment manufacturers• 1995 – Extension for Modality Worklist

1995 – recognition of the reporting and vocabulary problem• Championed by persistent individual, also member of SNOMED Editorial

Board• 1998 – External coded concepts; 2000 – Structured reporting; 2001 –

DICOM controlled terminology and templates

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Workflow issues with HL7• HL7 evolved over early 1990s from focus on interdepartmental

communications, including orders to radiology (rad info system – RIS)• Disconnect on terminology, e.g.,

– DICOM Accession Number = HL7 Filler Order Number ?– DICOM Admission ID = HL7 Patient Account Number or HL7 Visit Number ?

Structured reporting issues with HL7• Parallel efforts on structured documents resulted in CDA being issued

about the same time as DICOM SR• Disconnect on units of structure - CDA modeled using HL7v3 RIM

(complex units of data), SR uses more atomic DICOM Content Items• Disconnect on fundamental purpose – CDA for human readability, SR

for machine-processable image findingsJoint HL7-DICOM working group and memorandum of understanding established • Harmonization items feed into both organizations• Both organizations want it to work

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Case Study: the CCR wars

Goal – electronic version of Massachusetts Medical Society Continuity of Care Form (used for critical patient information upon referral)

MMS partnered with ASTM E31 to standardize an XML-based representation, resulting in Continuity of Care Record (CCR)

Parallel effort in HL7 resulted in Care Record Summary (CRS) with similar scope, also XML-based (using HL7 v3 RIM and CDA)

ASTM threatened to sue HL7 for infringement of their Intellectual Property (both ANSI accredited standards organizations)

Secretary of Health and Human Services said “Work it out – without litigation”

Joint HL7/ASTM Continuity of Care Document (CCD) developed and adopted – basis for HHS recognized interoperability standards

●

ASTM HL7

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Standards alone are not the whole interoperability story

Standards are broad, abstract and flexible• Standards developers don’t want to impose too many

constraints that would limit the scope of applicability• Room for interpretation in implementation (local

customization) hinders interoperability Typically no single standard addresses full user tasks

Need to profile the specific use of specific standards for a specific purpose• A.k.a. Implementation Guides• Profiling is a different mindset from standards development

– need to impose constraintsInteroperability promotion organizations (SDOs / non-SDOs)

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Getting a standard implemented

Just because it’s written in a standard doesn’t mean you can buy it

Steps and timeline after standard approval• Product manager decides standard is a valuable feature to be added

0 - 4 years – or maybe never– Cost of implementation vs. value of feature to customer – Value/cost against other potential product features– Customer stated or unstated needs (or gov’t mandates)– Market readiness: Competitor products, availability of profile /

implementation guide

• Resources assigned to implement during next budget cycle .5 - 1 year• Development team designs, implements, tests feature in accordance

with good software practice 1 year• Commercial team rolls out product to sales force at next trade show

.5 - 1 year

Integration requires both sides of interface – limited by longer product cycle

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Framework model for types ofHealthcare IT Standards

Use Case Based Profiles and Implementation Guides

Data Interchange Standards

Health Record Content Standards

Vocabulary and Terminology Standards

Workflow

Messaging

Format

Vocabulary

Where do clinical standards fit?

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http://xkcd.com/927/licensed under a Creative Commons Attribution-NonCommercial 2.5 License

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Can you answer these questions?

What value does standardization provide to:• Manufacturers• Suppliers• Customers• Governments

How long does it take to develop a new standard?

How long does it take for a new standard to achieve broad implementation?

Why are there so many standards?

Documents

BMI 516/BMI 616 Standards and Interoperability in Healthcare Module 1-2 Standards Rev 2012