The Global Health Innovation Registry Prototyping Initiative

1. The Global Health Innovation RegistryPrototyping Initiative Fred Hosea III, Ph.D. Clinical Engineering Division (CED) of IFMBE Visiting Professor, Yachay Tech University (occasional) Ecuador World Health Organization 4th Global Forum on Medical Devices Visakhapatnam, India December, 2018

2. Disclosure • The presenter declares no conflict of interest with the materials provided. Fourth WHO Global Forum on Medical Devices

3. Currently, the fragmentation, complexity and interdependency of innovations in healthcare creates costly uncertainty, inefficiency and clinical risk for investors, regulators, insurers, government planners, health professionals, and care delivery organizations. Successful healthcare innovations must incorporate multi-disciplinary and multi-stakeholder expertise across the entire lifecycle of the innovation and the systems they interact with. Expensive journal articles, unusable Google searches, competing business interests, and siloed engineering disciplines make rational design impossibly difficult, time-consuming and expensive. Currently, no single global informational and organizational resource exists to promote convergent innovation expertise at the design stage. We propose creating a Global Health Innovation Registry, using semantic web data science tools, to promote convergence among innovators worldwide through multidiscipinary team collaborations and designs based on complementary system-lifecycle expertise. Global Health Innovation Registry

4. Security, privacy Registry Overview Credentialing, Contin. Educ. Spectrum mgt Theranostics WHO Collaborating Centres Epidemiology Behavioral health Pt. Education R&D Consortia ? Diseasemgt Maintenance, repair Universe of Innovators Human factors ONLINE REGISTRATION TEMPLATE Queries, Searches Carecontinuity Supply chain mgt Service mgt Installation Clinical trails IT integration Clinical Research Hazard alert, recall Asset mgt User training Collaboration Teams with Complementary expertise Inventory Procurement Genomics Risk mgt Operations mgt Capacity mgt Disaster mgt Innovations with system lifecycle design integrity Regulation, compliance Materials science Tech assessment FabLab CQI Incident mgt Process eng. EMRs->CHRs Standards Best Practices Help Desk Ethnography Incubator Failure anlys 3rd party svc Scheduling Network Frugal Innov Troubleshooting

5. I worked at Kaiser Permanente, 1997-2015most recently as Program Director of Research and Innovation in Clinical Technology • Regional Technology Plan production (avg $100M/yr) • Asset management (IT, BME) • Service management (IT, BME) • Process re-engineering • Wireless EMR cart deployment (10k) • Infusion pump recall mgt. (16k) • Continua Alliance Board (235 corporate members) • Garfield Center liaison http://www.spark101.org/video/garfield-centerinnovation-process/

6. People with the ability and resources to make things happen Institutions Who’s the audience? Leaders, Experts Who’s our audience?

7. 21st Century Medicine: Net-New Lifecycle Requirements 21st Century Medical Care will require significant scaling of DESIGN and LIFECYCLE MANAGEMENT mindsets, skillsets and services • Genomics • Distributed sites of member care • mobile clinics • ambulance • gym • retail • travel • worksite pods • skilled nursing facilities • assisted living • New Hospitals • Robotics • OR of the future • Interoperable clinical systems • Clinical decision-support • Clinical process re-engineering • HealthConnect integration • Simulations, prototyping • System/device testing, certification • New allied provider sites • ITIL compliance • ICE – Integrated Clinical Environments • Meaningful Use compliance • Major upgrades, conversions: IPv6, ICD-10, HL7 v3m MD-FIHR • Home care technologies, services • Self-monitoring, behavioral support • Family support technologies • PHRs • Telehealth • Telemedicine • Nanotechnologies ENTERPRISE STRATEGY 20th Century Medicine:Stand-alone Devices Plan NEW HEALTHCARE MODELS • System lifecycle • Tech assessment • Design consultation • Standards consultation • Contract consultation • Systems integration Build Lifecycle Management Infrastructure NEW INFRASTRUCTURES, CLINICAL PROCESSES • Facility upgrades • Equipment planning • Deployment, staging • Testing, safety • Asset management Run • Planned maintenance • On-call, Dispatch services • Break/fix • Hazard alerts, recalls • Patches, upgrades • Asset retirement

8. What’s YOUR burning platform? How can the Complexities possibly be aligned across so many diverse stakeholders ?!How many burning platforms can we survive, without regressing to the lowest common denominator? • Clinical Research, trials • Materials science • Nanotech engineering • Proteomics, metabolomics • Epigenetics, microbiomes • Human Factors engineering • Epidemiology • ITIL process mgt • Security, privacy • Terminology, coding, ontologies • Standards • Interoperability • Professional Body of Knowledge, Practice • Medical device design • Disaster preparedness, mgt • Health Technology Assesssment • Health technology Management • 3rd party services • Staff development • CMMS – Maintenance mgt. • Asset management • Configuration management • Change management • Telehealth, telemedicine • Electronic medical records • Reimbursement, billing • End-user training • Service management, analysis • Process engineering • Pharmaceuticals • Behavioral health promotion • Diet, lifestyle, patient education • Social media • Et cetera ………

9. COSTS of current INFORMATION DEFICIT • INTEROPERABILITY DEFECTS that prevent rational safety controls, process management, key performance metrics, system performance costing • EXPENSIVE RE-WORK is needed post-deployment to correct design defects • NON-STANDARD TERMINOLOGIES are used to track, classify, and modify innovations across the entire lifecycle, making rational analysis difficult, costly • VERTICAL R&D SILOS of specialized disciplines do not communicate, connect or cooperate with other disciplines or organizations to create interdisciplinary expertise • DISPARATE INSTITUTIONAL VALUES, priorities, and conflicting incentives for innovation waste resources • INCOMPLETE SOLUTIONS - Researchers and businesses waste precious time, effort and money pursuing partial and divergent solutions • FRAGMENTATION - Most innovators do their work without a clear idea of all the performance, regulatory , and operational requirements for successful healthcare innovation. • NON-STANDARDIZED DATA models in disparate relational databases make it almost impossible to classify, track and search for health innovations across organizations nationally or globally, resulting in piecemeal innovations that have partial or conflicting functionality, or are un-integratable with other healthcare systems. • IGNORANCE of system lifecycle functional requirements, leading to flawed performance, extra costs, re-work, and patient risk • DUPLICATION of design efforts, wasting scarce resources across organizations • SEGMENTARY design expertise fails to deliver comprehensive, end-to-end design solutions

10. THE REGISTRY WILL FORGE TIGHTER DESIGN INTEGRATION BETWEEN SECTORS AND PROFESSIONAL DOMAINS TO PROMOTE MORE ALIGNED INNOVATIONS

11. Technology Partner, Dr. Jans Aasman, Ph.D. CEO, Franz Inc. Jans Aasman is a Ph.D. psychologist and expert in the Cognitive Science - as well as CEO of Franz.com, an early innovator in Artificial Intelligence and provider of Semantic Graph Databases and Analytics. As both a scientist and CEO, Dr. Aasman continues to break ground in the areas of Artificial Intelligence and Semantic Databases as he works hand-in-hand with organizations such as Montefiore Medical Center, Blue Cross/Blue Shield, Siemens, Merck, Pfizer, Wells Fargo, BAE Systems as well as US and Foreign governments. Dr. Aasman is a frequent speaker within the Semantic technology industry and has authored multiple research papers, bylines and is one of 15 CEOs interviewed in a new book, "Startup Best Practices." Dr. Aasman spent a large part of his professional life in telecommunications research, specializing in applied Artificial Intelligence projects and intelligent user interfaces. He gathered patents in the areas of speech technology, multimodal user interaction, recommendation engines while developing precursor technology for the iPad and Siri from 1995 to 2004. He was also a part-time professor in the Industrial Design department of the Technical University of Delft.

12. Prospective Institutional Partners • International Federation of Medical and Biological Engineering, Clinical Engineering Division • Franz, Inc. • WHO Collaborating Centers • ACCE-American College of Clinical Engineering • Imperial College, London-Global Health and Development Group • PATH • Google • Kaiser Permanente, Garfield Innovation Center • Yachay Tech University • CCRI Institute • Japan Innovation Network • IUPESM • NIH-National Institute of Biomedical Imaging and Bioengineering • German Center for Research & Innovation • Henry J. Kaiser Family Foundation • Dept. of Veterans Affairs, Center for Innovation • Wyss Institute for Biologically Inspired Engineering • Alfred Mann Foundatoin • RUTE-Rede Universitaria de Telemedicina • NIST-National Institute of Standards and Technology • Enrich-European Network of Regions Improving Citizens’ Health • IDEO • Pan American Health Organization • The World Health Organization • ESTHER – Alliance for Global Health Partnerships • Kaiser Permanente Research Bank • Tapestry Networks • Bill & Melinda Gates Foundation • National Healthcare Innovation Portal • Health Innovation Exchange • Robert Wood Johnson Foundation • Medtronic AGENDA AGENDA Institutional • Institutional liaisons, partnerships • Legal, IP, MOUs • Investments, grants • Govt, academia, industry relations Clinical • Research, Quality improvement, Risk mgt. • Innovation incubation, Best practices • Process engineering, operations Technical • System, Network Architecture • Semantic Web platform • Ontology development, alignment • Design coordination

13. Prospective Institutional Partners AGENDA AGENDA Institutional • Institutional liaisons, partnerships • Legal, IP, MOUs • Investments, grants • Govt, academia, industry relations • IEEE-EMBS • Philips Healthcare • Montefiore • Rosenman Institute • AAMI • Kaiser Permanente Care Management Institute • IEEE Collabratec • Gartner • BioTech Nation • Center for Health Care Research and Policy • American Institute for Medical and Biological Engineering • Oxford University Innovation • GE • Intel • Mindray • Cerner • Siemens Healthineers • Medtronic • Johnson & Johnson • Fresenius • Stryker • Cardinal Health • Draeger Clinical • Research, Quality improvement, Risk mgt. • Innovation incubation, Best practices • Process engineering, operations Technical • System, Network Architecture • Semantic Web platform • Ontology development, alignment • Design coordination

14. More innovators will have access to design and production expertise to form partnerships that are needed to satisfy the dozens of critical success factors . • A single registry that uses globally standardized ontologies, data models and search methods will enable rapid queries with extreme precision and analytic detail, currently unavailable anywhere. This capability will enable rapid formation of complementary team collaborations to ensure integrity of design for product lifecycle. • Systematic modeling of system lifecycle requirements, enabling comprehensive design intelligence • Convergent and cooperative designs of medical devices, processes, and systems • Comprehensive design partnerships are enabled to encompass the complete lifecycle of performance requirements • Robust interoperability design and convergent planning to support adaptive health innovations BENEFITS of a Global Health Innovation Registry • Reduced re-work, inefficiencies, risks, and associated costs • Transition to standardized terminological ontologies, enabling radical transformation of data management for medical device asset and service management. • Facilitates horizontal expertise consortia, consultations, synergies • Alignment of institutional values, priorities, incentives, action • Innovators have access to a global network of innovation partners with complementary experience, connections, expertise, and model of convergence.

15. Critical Factor: The ITIL System Lifecycle Service Model(Created for IT systems, but extensible to all strategic and operational domains of healthcare) The ITIL System Lifecycle service model is a sine-qua-non of design intelligence for modern healthcare innovators. Information Technology Infrastructure Library Failure to design intelligently for every element of this integrated service model will guarantee substandard performance, economic waste, and possible clinical risk. http://g2sf.com/itil-program-requirements/

16. Critical Factor: Community-centric Model of Health Systems Design Person-centered, precision care also requires a coherent community dimension to ensure all relevant systems are represented in innovation concepts and plans. Point solutions aren’t enough. EXAMPLE: Kaiser Permanente is funneling $200 million into efforts to address housing instability. It's the first of a series of investments the system will make in community initiatives that address social determinants of health, focusing on 30-day readmissions."Affordable housing will be a significant focus of Kaiser Permanente's impact-investing portfolio to generate housing stability and improve health outcomes," said Bernard J. Tyson, chairman and CEO of Kaiser Permanente. "We hope our commitment creates a broader national conversation on homelessness and encourages other companies to join us to advance economic, social and environmental conditions for health." http://www.modernhealthcare.com/article/20180521/NEWS/180529995

17. Critical Factor: The Semantic Web solution The proposed Registry will be based on a state-of-art semantic web Big Data platform, using an IBM supercomputer which will enable unprecedented, virtually instantaneous insight into hundreds of thousands of health innovations worldwide, at their various stages of development. This will be a vital multi-disciplinary alternative to the thousands of expensive, uncoordinated and specialized journals, proprietary databases, and conferences that now broker emerging information in highly fragmented and unaffordable form, or block its availability entirely.

18. The Evolution of Semantic Data Strategies Global innovators will benefit from next generation data management capabilities, freed from limitatiosemantic web ns of disjointed relational databases. Graph databases represent complex and dyamic RELATIONSHIPS that more closely reflect interdependencies in health systems (Good) Web Ontology Language (Bad) http://wiki.opensemanticframework.org/images/thumb/4/44/Semantic_Spectrum.png/600px-Semantic_Spectrum.png

19. Many relevant Ontologies and Taxonomies are already in place • SNOMED CT • LOINC • HL7 • ICD-10 • DRG • DOLCE • OBI • ICF • ORDO • ATC • PSIMOD • CAO • FPLX • ICPC2P • GAMUTS • RH-MESH • STATO • EDAM • CPT • MEDDRA • RxNORM • NDDF • NDFRT • RADLEX • FMA • IAO • GO • UO • NCBITAXON • MF • CHEMINF • EXACT • HCPCS • HUPSON • DOID • SNMI • MESH • ECO • HP • BAO • BTO • UBERON • SSN • SYMP • MFOEM • HFO • RO • BP • DIAB • FB-BT • BRO • WHO-ART • DRON • ENVO • SIO • EFP • ZEA • UMLS • SWO • CTCAE • CHEBI • MS • BFO • GEXO • PW • PATO • BIRNLEX • NBO • DOID • MEDDRA • OBIWS • SSE • SEQ • MO • SEDI • TM-SIGNS-AND-SYMPTS • BIBLIOTEK-O • NPI • GEO • REPRODUCE-ME • SO • VIVO-ISF • ICPC2P • GAMUTS http://bioportal.bioontology.org

20. What are the typical staging requirements to create a SW platform? Stage 1 Select a domain/scope (e.g., MRI, infusionpumps, top 10 medical deviceclassesthathospitals use) Engagerelevantcollaborators Create ontologies and taxonomies that describe every concept in thedomain, withalternativelabels, potentially in otherlanguages Findall documents on web that match Use NLP toextract institutions, programs, people etc. relatedtodocuments Createinnovationsearchengineusingtaxonomy as startingpointforsearches. • Proof-of-concept demo: $50k is minimal • $1M would produce robust, usable prototype 2 FTEs/2 mos.

21. Proposed ActionPlan 2019 2020 2021 • Build professional and institutionalallianceframework • Design and executeStage 1, basedon mínimum proof-of-concept scope ($50k) • Extendscopebeyondminimal POC as additionalfunding and resourcesbecomeavailable. • Developfunding and workplanstrategiesfor 2020: Horizons 2020 • EvaluateStage 1 prototype performance • Execute Stage 2 prototype workplans. • Secure mínimum of $500k-$1M funding (institutional, philanthropic) to expand scope of prototype to include all 800+ WHO Collaborating Centers plus 100 additional innovation partner organizations. • Refine, integrate ontologies • Develop user-training resources • Evaluate system performance and value-added: user surveys • International Conference #1 • Develop funding and workplan strategies for 2021 • Execute Stage 3 workplans for global release of GHIR. • Create online training for global end-user groups • Establish formal institutional setting for permanent operation and evolution of GHIR. • Secure necessary national and international agreements to fund and support GHIR. • International Conference #2

22. What is the transformational potential of a Semantic Web platform? The Registry would centralize access to: • Technical Specifications • Component provenance, production batch • Global/universal identifiers • Use Case libraries • FAQs • Transition guides from legacy systems • Testing, Certification Criteria • Regulatory Compliance Requirements • IT Integration Requirements • Process Templates For Implementation and Operations • TCO Estimates • End-user Training Resources • Call-center Statistics on Most Frequent Problems And Incident Types • Root-cause Analyses • Solution Banks • Customer feedback and suggestions • Troubleshooting Guides • A comprehensive data universe that tracks potential innovations at every stage of the development and operational lifecycle, with comprehensively linked, normalized data about the innovation, including • It supports ITIL process maturity ratings, Gartner/ECRI capability assessments • It has built-in interoperability design guidelines and compatibility matrices that will improve integration with legacy and future business and clinical systems. • Saves archives of hazard alerts and defect analysis of comparable tools will enable empirical comparison of advances in design and functionality for HTA

23. Franz Inc. Semantic Web platform integrates and synergizes disparate data sources • International mastery of Big Data systems in science and healthcare • AllegroGraph ranked as a ‘Champion’ and Highest Ranked in Graph Database Market https://allegrograph.com/partners/

24. Franz Inc. Statement of Capabilities • Franz was awarded Corporate America’s Best in Semantic Web Technology – USA & Leader in Graph Database Products • Franz Recognized Among Top 10 Analytics Solution Providers 2016 by Pharma Tech Outlook • 2015 HiMSS Conference, Intel's Healthcare Panel, The Semantic Data Lakehttps://www.youtube.com/watch?v=eOfZXw0L-mA • Franz, Inc., the leading supplier of Semantic Graph Database technology technology has been named CIOReview Magazine’s Top 20 Most Promising Database Technology Solution providers • Montefiore Medical Center at Albert Einstein Medical College, in collaboration with Franz, Intel, Cloudera and Cisco created a scalable and extensible Learning Healthcare System platform for accountable care and precision medicine initiatives.  • Franz Inc., a leading supplier of Graph Database technology, with critical support from Stillwater SuperComputing Inc. and Intel, announced it has achieved its goal of being the first to load and query a NoSQL database with a trillion RDF statements. RDF (also known as triples or quads), the cornerstone of the Semantic Web, provides a more flexible way to represent data than relational databases and is at the heart of the W3C push for the Semantic Web..

25. Initiative Working Groups Institutional Alliance WG Clinical WG Chair Chair • Committees • Research, Quality improvement, Risk mgt. • Innovation incubation, Best practices • Process engineering • Care management lifecycle • Institutional liaisons, partnerships • Legal, IP, MOUs • Investments, grants, funding • Govt, academia, industry relations Advisory Board Advisory Board ExecutiveTeam Technical WG Core WG Chair Chair Advisory Board • Committees • System Architecture • Semantic Web platform • Ontology development, alignment • Design coordination • Overall project leadership and administration • Communications, website • Recruitment • Financial mgt., contracts • Conference, event mgt Advisory Board

26. Promoting convergent innovation among diverse collaborators will require a hybrid model of intellectual property that will be managed by a Commonwealth for Health foundation. Innovation income and operations will manage: • Registration fees • Consultations • Contracts, MOUs • Donations • Grants • Incubations • Royalties, licenses • Investments

27. Contacts • Jans Aasman, Ph.D. • CEO, Franz Inc. – Oakland, California • Email: ja@franz.com • Fred Hosea, Ph.D. • Cotacachi, Ecuador • Email: tangofred@gmail.com ACTION: If you’re interested in being part of the initiative, please email me at tangofred@gmail.com and I’ll send a link to an online form where you can indicate your areas of primary interests, expertise and experience.

28. …and what new heavenly orb may rise and shine in some new sky, from the works of our minds and our hearts this day?

29. " If we fail, let it be a noble spectacle of effort …. not a failure of inaction."

30. Global Health Innovation Registry

31. APPENDIX: Some References Here are some additional references and background resources you may find useful to explore as you think about what your role might be in the Initiative Ontology Development 101: A Guide to Creating Your First Ontology https://protege.stanford.edu/publications/ontology_development/ontology101-noy-mcguinness.html) Human factors in the design of medical devices – Approaches to meeting international standards in the European Union and USA https://www.sciencedirect.com/science/article/pii/S0003687016301879 BioPortal, the world’s most comprehensive repository of biomedical ontologies https://www.bioontology.org A user-centred approach to requirements elicitation in medical device development: A case study from an industry perspective https://www.sciencedirect.com/science/article/pii/S0003687011000603 Innovation and Design Process Ontology https://link.springer.com/chapter/10.1007%2F978-3-319-39056-7_8 A concept ideation framework for medical device design https://www.sciencedirect.com/science/article/pii/S1532046415000775 Global Innovation Centre http://unicefstories.org/global-innovation-centre/ Innovations and technologies for health and wellness https://ieeexplore.ieee.org/document/7574898/ Convergent innovation for sustainable economic growth and affordable universal health care: innovating the way we innovate https://nyaspubs.onlinelibrary.wiley.com/doi/full/10.1111/nyas.12548 The Open Biological and Biomedical Ontology (OBO) Foundry/http://www.obofoundry.org/ Semantic Interoperability of Ambient Intelligent Medical Devices and e-health Systems http://docplayer.net/2281668-Semantic-interoperability-of-ambient-intelligent-medical-devices-and-e-health-systems.html A three stage ontology-driven solution to provide personalized care to chronic patients at home https://www.ncbi.nlm.nih.gov/pubmed/23567539

32. APPENDIX: Some References Development of an Ontology-Based Configuration Management System http://ecai.ro/Arhiva/ECAI-2016%20VOLUMES/E-SESSION/10-ECAI-2016_paper_106.pdf http://www.germaninnovation.org/research-and-innovation/centers-of-innovation-in-germany Semantic Health Knowledge Graph: Semantic Integration of Heterogeneous Medical Knowledge and Services https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5337312/ Current status of ontologies in Biomedical and Clinical Informatics http://www.engr.uconn.edu/~steve/Cse300/saripalle.pdf Semantic Web Health Care and Life Sciences Community Group https://www.w3.org/community/hclscg/ Strengths and limitations of formal ontologies in the biomedical domain https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2904529/ Ontology-Based Process Modeling Using eTOM and ITIL https://link.springer.com/chapter/10.1007/978-0-387-76312-5_24 Ontology for Systems Engineering (Short Version) https://www.youtube.com/watch?v=bj8mSbHh-qA Application Of Ontology In The ITIL Domain https://www.researchgate.net/publication/232252179_Application_of_Ontology_In_the_ITIL_Domain Merck Global Health Innovation Fund http://merckghifund.com/ Ontology-Driven Monitoring of Patient’s Vital Signs Enabling Personalized Medical Detection and Alert http://www.mdpi.com/1424-8220/14/1/1598/htm