Informal Consultation on Nomenclatures for Medical Devices

1. Informal Consultation on Nomenclatures for Medical Devices World Health Organization, Headquarters23-24 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 23rd March]

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 14th December 2009 • Has an ongoing dialogue with Continua Alliance

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.

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 • 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

7. 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

9. Governing Bodies (including Strategy and Funding) User Input General Assembly (GA) Member Forum (MF) Harmonisation Boards Management Board(MB) Affiliate Forum (AF) Standing Committees – expert advice, with some regional representation ContentCommittee Quality Committee Technical Committee Implementation & Innovation Working Groups – Project Groups (time-limited) and Special Interest Groups (ongoing domain) IHTSDO Governance Structure

10. Stakeholder Involvement & Representation

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

12. Support Organisation (Contracted with CAP STS) Management Board(MB) Chief Executive Officer (CEO) IHTSDO Support Staff Senior Officers – support the CEO, MB and Standing Committee Chairs Chief Terminologist Chief Quality Officer Chief Technical Architect Chief Implementation Officer Committees IHTSDO Staff and Management Structure

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

14. 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 Risk Cost Reduction IHTSDO Time

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

16. Member’s National Release Derivatives Extensions Works licensed by Member (forming part of Member’s National Release) Documents and software Derivatives Specif’s Documents and software International Release (licensed by IHTSDO) CORE Understanding Licensing

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

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)

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

24. IHTSDO Use Cases for Medical Device Content Supporting Member policies around telemedicine etc and ‘expert’ patients 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

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