21/02/20141 Informal Consultation on Nomenclatures for Medical Devices World Health Organization, Headquarters 23-24 March 2011 Geneva, Switzerland Martin.

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Informal Consultation on Nomenclatures for Medical

DevicesWorld Health Organization, Headquarters23-24 March 2011 Geneva, Switzerland

Martin Severs Chair IHTSDO Management Board

Presentation

This full slide deck will be available to all participants It answers the WHO Conflict of Interest questions It answers the WHO ‘criteria’ questions A subset will be presented in the IHTSDO agenda slot to fill the

available time allocation [11.35 – 11.50 23rd March]

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Martin Severs: UK Representative

I am a Director and Chair [non-paid] of the Management Board of the IHTSDO which has a duty of care over tax payers money from 15 countries. The IHTSDO: Owns SNOMED CT which has medical device content Receives funding from the UK government [among others] Has a legal agreement with WHO Is in active detailed business discussion with GMDN Agency Has an MoU with Institute of Electrical and Electronic Engineers

re: the 11073 medical device informatics standards 14th December 2009

Has an ongoing dialogue with Continua Alliance

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Potential Conflicts: Organisational

The IHTSDO Strategic Position is: ‘SNOMED CT does contain medical device terminology. Its’

Member countries need that terminology enhanced to meet the prescribing, investigatory, therapeutic and clinical safety use cases, which goes beyond the regulatory use case. The IHTSDO intends to deliver that terminology unless there is a change of instruction from its Member countries’

NOTE: The IHTSDO is in harmony with and not competitive against regulatory use cases and regulatory nomenclatures.

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Key Points about IHTSDO

IHTSDO is a Danish Association [Not for Profit] [Reg: May 2007] IHTSDO owns SNOMED CT IHTSDO Controlled by its Members via published Articles of

Association: Strong Governance 1 Member: 1 vote 15 countries who are now Members; a further 8 in active discussion Business Model is national subscription and single license for users

and making product widely available Separated Management from Governance; Members stay in control. Duty to harmonise where possible {Stated in AoA} Strong values and principles: openness, transparency and fairness,

principle of avoiding duplication; effort, resources, etc

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http://www.ihtsdo.org/about-us/governance/

IHTSDO Members

Members are countries Eligible Members are all voting members of the United Nations

The Members control the organization and the Articles of Association; [subject to Danish Law]

Nine Charter [initial] Members in 2007: Australia, Canada, Denmark, Lithuania, Netherlands, New

Zealand, Sweden, United Kingdom, United States of America Six Members have subsequently joined:

Cyprus, Estonia, Singapore, Slovak Republic, Slovenia, Spain

6

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The Vision

To enhance the health of humankind by facilitating better health information management;

To contribute to improved delivery of care by clinical and social care professions;

To facilitate the accurate sharing of clinical and related health information, and the semantic interoperability of health records;

The purpose of the IHTSDO

To acquire, own and administer the rights to SNOMED CT and other relevant assets (collectively, the "Terminology Products");

To develop, maintain, promote and enable the uptake and correct use of its Terminology Products around the world;

To undertake activities required to achieve these purposes

8

IHTSDO Governance Structure

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Governing Bodies

(including Strategy and Funding)

User Input

Working Groups – Project Groups (time-limited) and Special Interest Groups (ongoing domain)

Standing Committees – expert advice, with some regional representation

General Assembly (GA)

Management Board (MB)

Harmonisation Boards

Member Forum (MF)

Affiliate Forum (AF)

Content Committee Quality Committee Technical Committee

Implementation & Innovation

Stakeholder Involvement & Representation

Stakeholder Entry IHTSDO Body

Governments & ALB’s Member [GA] or elected nominees

By right GA; Elect MB, Com, HB or WG Chair

Industry Affiliate Forum or elected nominees

By right AF: Elect MB, Com, HB or WG Chair

Clinical Bodies MoU for WG Chair or elected nominees

Elect MB, Com, HB or WG Chair

Geo-political Structural Proportionality GA, MB, & Com

Individuals Open: SIGs and most PGs. Elected nominees

By right SIGS & most PGs. Elect MB, Com, HB or WG Chair

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Global Outlook

Asia and OceaniaAfrica and theMiddle East

Europe

The Americas

IHTSDO Staff and Management Structure

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Senior Officers – support the CEO, MB and Standing Committee Chairs

Management Board (MB)

Chief Executive Officer (CEO)

Support Organisation

(Contracted with CAP STS)

IHTSDO Support Staff

Chief Terminologist Chief Quality Officer

Chief Technical Architect

Chief Implementation Officer

Financial Sustainability

Based on the attractiveness of Member [jurisdiction] fee structure set by a trusted third party linked to strong corporate governance that holds management and management activity to account

Fees are calculated based on a trusted third party metric namely the World Bank GNI Atlas

Charges [for Licenses] are based on broad categories of affiliate use e.g. per hospital AND are banded according to World Bank GNI Atlas [i.e cheaper in poorer countries] Licensing Income: minor; ideally replace it with Member Fee Charges, Fees and Banding are published on the IHTSDO web

site

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Benefits of IHTSDO Membership

Proprietary licencing model to co-ownership

New governance arrangements

Fair share funding model based on World Bank metrics

Greater adoption

Share implementation experience

Share risk

Share costs

Remove obsolescence risk and cost

Drive global patient record interoperability

Country risk cost over time

Previous

IHTSDO

Reduction

Time

RiskCost

Licensing of SNOMED CT

Single form of end-user license (Affiliate License) Permits world-wide use of International Release of SNOMED CT

Affiliates pay: No Charges to IHTSDO for use:

In any Member nation. All obligations are met by the Member through their IHTSDO membership agreement. Cost-recovery is permitted

In low income countries In approved research projects In humanitarian use cases

Charges as set by the IHTSDO for use in non-Member nations when outside no charge categories

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Understanding Licensing

CORE

Specif’s Derivatives

Documents and software

Extensions

Derivatives

Documents and software

Member’s National Release

Works licensed by Member (forming part of Member’s National Release)

International Release (licensed by IHTSDO)

Translation

Only Members can translate; [AoA] Others translators need MB permission Translation is socio-cultural representation so Members must own

and lead all initial translation specific activity [inc. funding] IHTSDO produces Translation Guidelines [will become standards] Translations are Extensions and as such can be taken up into the

International Release as and when Members decide NOTE: If in International Release;

IHTSDO owns the translation AND has the maintenance responsibility, accountability and funding

responsibility eg English [USA] and Spanish

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International Release of SNOMED CT

Documents describing the SNOMED CT standard(s) [specification(s)]

The terminology database consisting of: Concepts Descriptions Relationships

A set of specified technical tools for supporting development and request processing

International Release of SNOMED CT A set of SNOMED allied standards, which enable SNOMED to

effectively interoperate with and/or map to, other international information standards

Includes implementation standards for the successful use of SNOMED including: Translations Reference implementation instructions and resources

SNOMED CT – what is it?

SNOMED CT is a terminology

Systematized Nomenclature of Medicine (Clinical Terms)

• Collection of names and words• Relevant to the field of medicine• Organised in a structured and logically consistent manner

Basic Elements of SNOMED CT

Concepts The basic units of SNOMED CT

Descriptions These relate terms that name the concepts to the

concepts themselves. Each concept has at least two Descriptions

Relationships Relationships are the connections between concepts in

SNOMED CT Concepts are organized into nineteen SNOMED CT hierarchies.

Each hierarchy has sub-hierarchies within it

Maintenance

• Currently ~ 280 rules in editing QA checks• 83 of them are run-time data checks• 197 are batch checks, done every night (or more often closer to

release time• Categories:

• Concept Model rules – 150 (e.g. domain/range control, cardinality)

• Descriptions Model – 26• Descriptions Style – 12• General Checks – 87 (e.g. ID checks, integrity checks)

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International Release of SNOMED CT

Medical Device Content 3,853 active codes under the hierarchy

“device (physical object) 11,511 defining relationships Names for codes; generic and/or non-

proprietary

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IHTSDO Use Cases for Medical Device Content

Recording patient device profile on an electronic health record Electronic transfer of electronic patient records Electronic transfer of prescriptions Identification of patients who have been exposed to a medical

device subject to a Medical Device Alert Data aggregation for performance assessment, Clinical Governance

and management from clinical systems Interoperability between decision support systems Support for communication between electronic medical devices and

with an electronic record

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Supporting Member policies around telemedicine etc and ‘expert’ patients

Medical Device Strategy

Review, design and approve the SNOMED CT medical device concept model [July 2011]

Deliver Work Bench authoring tool [July 2011] Populate with high level concepts [July 2012] Populate the detailed elements of the concept model in the 32

specialist areas at a rate of 8 specialist areas per annum finish 2015/2016

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