1. BMI 516/BMI 616 Standards and Interoperability in Healthcare Module 1-2 Standards Rev 2012

2. 2 / Harry Solomon / Module 1-2 - Standards/ Focus for Unit Standard definition of standards The standards value proposition The standards process Issues with implementing standards

3. 3 / Harry Solomon / Module 1-2 - Standards/ Standard Definition of Standard Document, established by consensus and approved by a recognized body, that provides, for common and repeated use, rules, guidelines or characteristics for activities or their results, aimed at the achievement of the optimum degree of order in a given context ISO/IEC Guide 2:2004 Standardization and related activities -- General vocabulary

4. 4 / Harry Solomon / Module 1-2 - Standards/ Parsed definition Document, no longer a physical exemplar established by consensus among stakeholders approved by a recognized body, authoritative for participants that provides for common and repeated use, not a one-off rules, guidelines or characteristics the meat! for activities processes or their results, products aimed at the achievement of not guaranteed the optimum degree of order in the eyes of the stakeholders in a given context scope

5. 5 / Harry Solomon / Module 1-2 - Standards/ Case Study: Edison light bulbs c. 1893 How many standards does it take to screw in a light bulb? Brush-Swan, U.S. base, Thomson-Houston, Perkins-Mather, Shaeffer, Edison Photographs from http://www.sparkmuseum.com/lighting.htmhttp://www.sparkmuseum.com/lighting.htm Concept from David Channin, MD, Guthrie Clinic No, seriously … how many? Class exercise: What problems does this pose for Manufacturer Customer Distributor/Vendor Installer/Integrator Public Safety

6. 6 / Harry Solomon / Module 1-2 - Standards/ Cost Drivers in Non-Standard Solutions Manufacturer ? User / consumer ? Distributor / System Integrator ? Public Safety / Regulatory ? Applies to light bulbs - and Healthcare IT! Manufacturer Tooling, supply chains, inventory, training, service User / consumer Choice, vertical lock-in, vendor lock-in, negotiation disadvantage Distributor / System Integrator Inventory, licensing, tools, training, adapters Public Safety / Regulatory Safety certification, emergency preparedness training

7. 7 / Harry Solomon / Module 1-2 - Standards/ Screwing in light bulbs The multiple manufacturers needed to agree to standardize They needed to agree to use a screw base 1902 – Lampholder Manufacturers Conference Each received a physical copy of Edison lamp gauge 1914 – standardization turned over to American Society of Mechanical Engineers 1929 – joint custody with National Electrical Manufacturers Association Now designated ANSI/IEC C81.63 Screw base light bulbs manufactured in 1888 will operate in lamp sockets made today – and for the foreseeable future Will we have units of healthcare information that can be used after a full century and more?

8. 8 / Harry Solomon / Module 1-2 - Standards/ Why do standards happen Recognition of a specific problem by a critical mass of stakeholders Manufacturers Users / consumers (often represented by professional organization or government) Distributors / system integrators Public safety / regulatory Consensus to establish a standards-based approach to problem solution Typically for cost reduction / mitigation

9. 9 / Harry Solomon / Module 1-2 - Standards/ Standards and the Economics of Interoperability Without standards, everything is a custom integration Custom jobs inherently expensive Must negotiate both financial and technical terms Non-expert consumers at competitive disadvantage Standard sockets between components Allow user choice of component implementer Allow vendors to specialize in improving components Standards allow retail users to leverage best practice Domain expertise codified into standard Expertise reproduced into each compliant system Standards make a market

10. 10 / Harry Solomon / Module 1-2 - Standards/ Standards History You cant measure without a standard Leviticus 19:36 Thou shalt have an honest balance, honest weights, an honest dry measure, and an honest liquid measure. 1875 Adoption of the Convention du Mètre and establishment of the International Bureau of Weights and Measures (BIPM). So whats the reason to measure?

11. 11 / Harry Solomon / Module 1-2 - Standards/ The Standards Value Proposition Mechanisms of value

12. 12 / Harry Solomon / Module 1-2 - Standards/ Standards enable a market Standards enable valuation Objective criteria for comparison Standards facilitate deal-making Simplifies negotiation of the technical parameters of a transaction Standards facilitate open markets Customers (or political entities) cannot impose arbitrary technical requirements that lock out certain players Lack of standards is a barrier to trade Allow competition – reduce barriers to vendors Grow the market – reduce barriers to customers

13. 13 / Harry Solomon / Module 1-2 - Standards/ Standards facilitate system design Standards define stable system partitioning and component boundaries Architectural model of standard can be re-used Removes boundary debate from system design Standards allow focused component development Encourages specialized competence for components Allows component improvement / re-engineering Allows incremental implementation and verification of components

14. 14 / Harry Solomon / Module 1-2 - Standards/ Standards reduce interface design cost Use of existing standard reduces cost of defining, reviewing, and documenting interfaces for specific product Quality of interface is typically better SDO design review is broader than the two immediate parties to a specific implementation Multiple implementations to same interface provide more opportunities to debug the design SDO manages the standard interface, rather than one of the implementing parties Independence from specific implementation Costs of interface definition/design shared by all users across all products SDO = Standards Development Organization

15. 15 / Harry Solomon / Module 1-2 - Standards/ Standards leverage commoditization Standard components have larger markets Stable interfaces allow components to be reused in different contexts Cost of component design amortized over more units Standard-related tools and services are commoditized Design tools and services Testing and validation tools and services Standard-related products becomes a market itself

16. 16 / Harry Solomon / Module 1-2 - Standards/ Standards reduce workforce training costs Standards knowledge can be reused Minimize required workforce training for new products/projects Training on standard can be a prerequisite for job – moves cost of training to prior experience or basic educational system –Example: software programming language training Standards provide a larger pool of trained candidates Project start-up accelerated

17. 17 / Harry Solomon / Module 1-2 - Standards/ Standards facilitate mergers & acquisitions Integration of acquired product lines facilitated by adherence of products to standards Benefit to acquiring company – simplified integration –Fits into standards based processes, allowing reduction of redundancies –Product teams share common standards-based domain concepts and vocabulary Benefits to acquired company – increased valuation

18. 18 / Harry Solomon / Module 1-2 - Standards/ Interoperability The ability of two or more systems or components to exchange information and to use the information that has been exchanged. Standards A consensus specification of rules for repeatable activities or uniform characteristics of products in a given context. Interoperability is silent on the method used to achieve the result - could be re-done for each pair of systems. Standards provide a method that is economically effective - amortizing the cost of design and implementation over many system pairs.

19. 19 / Harry Solomon / Module 1-2 - Standards/ How do standards happen? Government decree Procurement (for government use – e.g., MIL-STDs) General mandate (for broad economic policy – e.g., HIPAA) Major vendor de facto (e.g., PDF) Industry consortium / trade association Professional society Consensus standard International standards body Academic collaboration To solve a specific problem HL7

20. 20 / Harry Solomon / Module 1-2 - Standards/ Standards process (consortium approach) 1.Problem recognition by critical mass of stakeholders 2.Search for a relevant standards body 3.Project proposal/approval; call for participation 4.Development in committee 5.Preliminary review, revision 6.Ballot by members of standards body 7.Reconciliation of negative ballots 8.Publication Typically 18 months to several years May iterate through Drafts for Trial Use before reaching Normative status

21. 21 / Harry Solomon / Module 1-2 - Standards/ International Standards Bodies (1) ISO International Organization for Standardization IEC International Electrotechnical Commission ITU International Telecommunications Union International Treaty Standards Organizations National Member Bodies ANSI American National Standards Institute AFNOR BSI DIN U.S. Accredited Standards Committees HL7 X12 ASTM INCITS National Member Bodies ANSI American National Standards Institute AFNOR BSI DIN Technical Committees TC215 Healthcare Informatics JTC1 Information Technology TC62 Electrical equipment in medical practice

22. 22 / Harry Solomon / Module 1-2 - Standards/ International Standards Bodies (2) ISO International Organization for Standardization IEEE Institute of Electrical and Electronic Engineers HL7 Independent SDOs IHTSDO International Healthcare Terminology Standards Development Organisation TC215 Healthcare Informatics DICOM Digital Imaging and Communications in Medicine W3C World Wide Web Consortium Formal Liaison SDOs with liaison to an ISO TC can fast track their approved standards to be ratified as an ISO standard AAMI Association for the Advancement of Medical Instrumentation TC62 Electrical equipment in medical practice IEC International Electrotechnical Commission JTC1 Information Technology

23. 23 / Harry Solomon / Module 1-2 - Standards/ The great thing about standards – there are so many to choose from!

24. 24 / Harry Solomon / Module 1-2 - Standards/ Why? All standards start from trying to solve a specific problem So it gets solved, but inevitably that problem turns out to be just a piece of a larger problem Or the technological environment has changed So the standards developer expands the scope of their domain to address the bigger problem or the new environment And repeat … Multiple standards and domains Overlap and redundancy due to growth from niches Conflict because domain boundaries are unclear and information models are different (and there is turf to be protected)

25. 25 / Harry Solomon / Module 1-2 - Standards/ Case Study: DICOM (1) 1970s – introduction of digital imaging (CT) 1983 – recognition of problem: sending digital images to printers Radiologists wanted image printers to be decoupled from imaging modalities Formation of joint professional-industry committee to address problem (ACR- NEMA) 1985 – publication of ACR-NEMA Std 300 50-pin parallel interface (16-bit data bus), control and data elements 1988 – publication of version 2 1993 – publication of DICOM (ver. 3.0) Based on network communications in accordance with ISO Open System Integration (OSI) standard model (over OSI or TCP/IP stack) Image formats for CT, MR, CR, US, NM Persistent information objects uniquely identified Film print management (page compositing, printer control)

26. 26 / Harry Solomon / Module 1-2 - Standards/ Case Study: DICOM (2) 1993 – recognition of the cardiology problem Digital angiography – massive amounts of data (500 MB) needed physical media for consultation ACC-NEMA committee; decision to work with DICOM (cardiologists cooperating with radiologists!) 1995 – Extension to media interchange (particularly CD-R) 1993 – recognition of the workflow problem Need to manage the process of image acquisition European equipment manufacturers 1995 – Extension for Modality Worklist 1995 – recognition of the reporting and vocabulary problem Championed by persistent individual, also member of SNOMED Editorial Board 1998 – External coded concepts; 2000 – Structured reporting; 2001 – DICOM controlled terminology and templates

27. 27 / Harry Solomon / Module 1-2 - Standards/ Case Study: DICOM (3) Workflow issues with HL7 HL7 evolved over early 1990s from focus on interdepartmental communications, including orders to radiology (rad info system – RIS) Disconnect on terminology, e.g., –DICOM Accession Number = HL7 Filler Order Number ? –DICOM Admission ID = HL7 Patient Account Number or HL7 Visit Number ? Structured reporting issues with HL7 Parallel efforts on structured documents resulted in CDA being issued about the same time as DICOM SR Disconnect on units of structure - CDA modeled using HL7v3 RIM (complex units of data), SR uses more atomic DICOM Content Items Disconnect on fundamental purpose – CDA for human readability, SR for machine-processable image findings Joint HL7-DICOM working group and memorandum of understanding established Harmonization items feed into both organizations Both organizations want it to work

28. 28 / Harry Solomon / Module 1-2 - Standards/ Case Study: the CCR wars Goal – electronic version of Massachusetts Medical Society Continuity of Care Form (used for critical patient information upon referral) MMS partnered with ASTM E31 to standardize an XML-based representation, resulting in Continuity of Care Record (CCR) Parallel effort in HL7 resulted in Care Record Summary (CRS) with similar scope, also XML-based (using HL7 v3 RIM and CDA) ASTM threatened to sue HL7 for infringement of their Intellectual Property (both ANSI accredited standards organizations) Secretary of Health and Human Services said Work it out – without litigation Joint HL7/ASTM Continuity of Care Document (CCD) developed and adopted – basis for HHS recognized interoperability standards ASTM HL7

29. 29 / Harry Solomon / Module 1-2 - Standards/ Standards alone are not the whole interoperability story Standards are broad, abstract and flexible Standards developers dont want to impose too many constraints that would limit the scope of applicability Room for interpretation in implementation (local customization) hinders interoperability Typically no single standard addresses full user tasks Need to profile the specific use of specific standards for a specific purpose A.k.a. Implementation Guides Profiling is a different mindset from standards development – need to impose constraints Interoperability promotion organizations (SDOs / non-SDOs)

30. 30 / Harry Solomon / Module 1-2 - Standards/ Getting a standard implemented Just because its written in a standard doesnt mean you can buy it Steps and timeline after standard approval Product manager decides standard is a valuable feature to be added 0 - 4 years – or maybe never –Cost of implementation vs. value of feature to customer –Value/cost against other potential product features –Customer stated or unstated needs (or govt mandates) –Market readiness: Competitor products, availability of profile / implementation guide Resources assigned to implement during next budget cycle.5 - 1 year Development team designs, implements, tests feature in accordance with good software practice 1 year Commercial team rolls out product to sales force at next trade show.5 - 1 year Integration requires both sides of interface – limited by longer product cycle

31. 31 / Harry Solomon / Module 1-2 - Standards/ Framework model for types of Healthcare IT Standards Use Case Based Profiles and Implementation Guides Data Interchange Standards Health Record Content Standards Vocabulary and Terminology Standards Workflow Messaging Format Vocabulary Where do clinical standards fit?

32. 32 / Harry Solomon / Module 1-2 - Standards/ http://xkcd.com/927/ licensed under a Creative Commons Attribution-NonCommercial 2.5 LicenseCreative Commons Attribution-NonCommercial 2.5 License

33. 33 / Harry Solomon / Module 1-2 - Standards/ Can you answer these questions? What value does standardization provide to: Manufacturers Suppliers Customers Governments How long does it take to develop a new standard? How long does it take for a new standard to achieve broad implementation? Why are there so many standards?