1. 21/02/20141 Informal Consultation on Nomenclatures for Medical Devices World Health Organization, Headquarters 23-24 March 2011 Geneva, Switzerland Martin Severs Chair IHTSDO Management Board

2. 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 23 rd March] 21/02/20142

3. 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 14 th December 2009 Has an ongoing dialogue with Continua Alliance 21/02/20143

4. 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. 21/02/20144

5. 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 21/02/20145 http://www.ihtsdo.org/about-us/governance/

6. 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

7. 21/02/20147 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;

8. 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

9. IHTSDO Governance Structure 21/02/20149 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 CommitteeQuality CommitteeTechnical Committee Implementation & Innovation

10. Stakeholder Involvement & Representation StakeholderEntryIHTSDO Body Governments & ALBsMember [GA] or elected nominees By right GA; Elect MB, Com, HB or WG Chair IndustryAffiliate Forum or elected nominees By right AF: Elect MB, Com, HB or WG Chair Clinical BodiesMoU for WG Chair or elected nominees Elect MB, Com, HB or WG Chair Geo-politicalStructural ProportionalityGA, MB, & Com IndividualsOpen: SIGs and most PGs. Elected nominees By right SIGS & most PGs. Elect MB, Com, HB or WG Chair 21/02/201410

11. Global Outlook Asia and Oceania Africa and the Middle East Europe The Americas

12. IHTSDO Staff and Management Structure 21/02/201412 Committees 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 TerminologistChief Quality Officer Chief Technical Architect Chief Implementation Officer

13. 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 21/02/201413

14. 21/02/201414 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 Risk Cost

15. 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 21/02/201415

16. 21/02/201416 Understanding Licensing CORE Specifs Derivatives Documents and software Extensions Derivatives Documents and software Members National Release Works licensed by Member (forming part of Members National Release) International Release (licensed by IHTSDO)

17. 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 21/02/201417

18. 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

19. 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

20. 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

21. 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

22. 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) 21/02/201422

23. 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 21/02/201423

24. 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 21/02/201424 Supporting Member policies around telemedicine etc and expert patients

25. 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 21/02/201425