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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
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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
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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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