Annotated Guide to Standards Insight

An Analysis of Health Information Standards Development Initiatives

HIMSS has published Standards Insight over the last several years to provide a business analysis and management perspective on interoperability standards. Each issue examines one or more key standards initiatives in terms of impact on healthcare information technology (HCIT) and healthcare in general. As HCIT increasingly becomes the focus of policy makers’ intent on improving patient safety, clinical outcomes and cost effectiveness, interoperability becomes a critical factor. Standards Insight is a resource for understanding the dynamics of interoperability standards and of HCIT-based strategy and investment. The accompanying annotation provides highlights and a direct link to each issue.

2005

November 2005   Katrina floods HIT with lessons learned

• Lessons learned from Hurricane Katrina
• The broken standards infrastructure
• Update on HL7, Inc.
• Coordination by use cases – role of the AHIC

October 2005   Estimating the Costs of NHIN Functions and Interoperability

• New study estimates costs to be $156 billion over 5 years
• Comparison to other estimates
• Identifying the gaps and thoughts on moving forward

September 2005   HIT and Quality Care

• The CMS quality improvement roadmap
• Quality = Profits = IT?

August 2005   The New Federal Interoperability Initiatives

• The American Health Information Community (AHIC)
• The Requests for Proposals (RFPs)
• The Unresolved Issues

July 2005   Seeking to Impose IT Simplicity on the Complex Real World of Healthcare

• An example from IHE
• Standardizing complexity

June 2005   An Analysis of Health Information Standards Development Initiatives

• HIPAA Zone
• The Era of Error
• Saving Lives - Saving Dollars
• The Coming Age of Alignment

May 2005   Defining Interoperability on the Road to Clinical Transormation

• A brief history of HIT interoperability
• Definitions
• The information value proposition
• The value of interoperability

Apr 2005   A Perspective from HIMSS 2005

• Washington is the managing partner in the public-private partnership
• Interoperability mythology
• Deciphering ONCHIT’s positions
• The regional health information organization role
• The Certification Commission for Healthcare Information Technology role
• Incentives and alignment

Mar 2005   Delivering Universal EHRs Within A National Health Information Network

• Five key points must be addressed in order to successfully deliver universal electronic health records (EHRs) within a national health information network

• Leadership, management and direction
• Roadmap and framework
• Interoperability standards
• Alignment of incentives and funding the infrastructure
• The role of the Commission on Systemic Interoperability (CSI): CSI can use its independent position to make the argument for Federal funds to create the infrastructure for interoperable EHR systems

Feb 2005   The Promise and Challenge of HCIT in 2005

• The promise and challenge of HCIT in 2005
• Speculation that HCIT spending will substantially increase
• 2005 as a year of transition from strategic vision to action plans
• What do we want to achieve?
• Resolving the issue of “minimum functionality”
• How do we do it? Solving the transition issue
• How will we pay for it? Addressing the funding issues
• The business case is the driver for individual provider investment in HCIT while Federal funding is the catalyst for infrastructure investment

Jan 2005   Request For Information For Developing A National Health Information Network

• RFI for a national health information network (NHIN) published in November 2004 by the National Coordinator for Health Information Technology
• Some answers and more questions
• A clear economic case will create the sustainable market and will be the economic engine for EHR systems and the NHIN
• The value chain
• Financial incentives
• Bottom line
• Need for financial models for building and for operating the NHIN in the RFI response

 

2004

Dec 2004   Launching the Decade of Health Information Technology

• Launching the Decade of Health Information Technology
• A 10-year goal for electronic health records and a framework for strategic action
• Achieved consensus on the functions to be expected in an EHR system
• First steps toward broad implementation of e-prescribing based on open standards
• The role of functional standards
• Minimum function sets
• Certification Commission for Health Information Technology (CCHIT)
• The goal of semantic interoperability
• Terminology model
• Static information model
• Dynamic model
• The business requirement – technical solution interface

Nov 2004   The Strategic Framework and the National Health Information Infrastructure

• The Strategic Framework and the National Health Information Infrastructure (NHII)
• The framework envisions a series of rapid development and demonstration cycles that fit within the long-term strategy
• Table: Comparison of national health information technology initiatives
• Infrastructure issues in the United States: Funding, costs of interoperability standards, payment responsibilities
• Conclusion: Request for information (RFI) inviting consortia to propose national health information network framework

Oct 2004   Converging E-Prescribing, the Electronic Health Record and the National Health Information Infrastructure

• Converging e-prescribing, the EHR and the NHII: Unresolved policy and business issues
• Rationale for convergence
• E-prescribing is a subset of EHR functionality
• Convergence is necessary to avoid duplication of infrastructure, software and services
• E-prescribing is in production use: Existing e-prescribing solutions
• Rethinking the standards development and approval process
• Market driving not market driven: Business requirements and implementation demonstrations should drive standards development

Sept 2004   Dr. David Brailer’s “Framework for Strategic Action”

• The Framework for Strategic Action
• Inform clinical practice
• Interconnect clinicians
• Personalize care
• Improve the population health
• Financial incentives: Misaligned incentives and lack of clear ROI are primary limitations
• Political implications: Recommendation to make the National Coordinator a permanent office
• What are next steps?
• Transforming the strategic framework to actions
• RFI for the NHII
• Changes by big purchasers
• Product certification and market place confusion

Aug 2004   The National Healthcare Information Technology Strategy

• Checkpoints for the National Healthcare IT Strategy: Office of the National Health Information Technology Coordinator – Dr. David Brailer named to this post
• Is the individual EHR the focal point of the strategy?
• Does the plan outline a framework for a nationwide health information infrastructure?
• Does the plan propose aligning incentives to make the business case?
• Is e-prescribing envisioned as part of EHR and NHII initiative?
• How will the national infrastructure be designed, funded and managed?
• Does the strategy require new EHR standards or does it begin with existing standards and plot a transition?
• Is the 10-year time line accelerated and how does the strategy use the planned local demonstration projects?

Jul 2004   The Medicare Modernization Act, the National Health Information Infrastructure and the Electronic Health Record

• The requirements of the Medicare Modernization Act
• The need for more than interoperability standards
• Leadership, management and direction
• Infrastructure funding
• The value proposition and aligned incentives – funding sources, use of incentives and conflicts of interest
• Roadmap and framework
• Interoperability standards
• Convergence: Hope that e-prescribing, EHR system and NHII converge in the future

Jun 2004   Washington Weighs in on HCIT: What Is the Plan For the Road Ahead?

• Healthcare information technology as a means to transform health care
• Organization and management direction
• Central point of decision, responsibility, coordination and management is needed
• Infrastructure funding – Difficult to justify; No business return; Funds must target nation-wide infrastructure
• Value proposition and aligned incentives
• Roadmap and framework – Need for “the plan”
• Interoperability standards – HCIT industry must come to consensus

May 2004   Is Healthcare Local? Implications for Interoperability

• Implications for interoperability – Issues debated in Washington
• Local health information infrastructure (LHII) as the model for the NHII
• An LHII would support the local pattern of healthcare in a community
• A Failure of imagination?
• Goal of the NHII should be to explicitly support a shared EHR
• Require technical and business transition roadmap
• IT investment

Apr 2004   2004 Annual HIMSS Conference & Exhibition and HCIT Industry Trends

• 2004 Annual HIMSS Conference & Exhibition Overview
• Shifting HCIT Initiatives: CPOE to EHR
• The need to first have a solid enterprise CIS and EHR system in place
• Progress in interoperability standards
• HL7 EHR System Functional Model and Draft Standard ballot
• HL7/IHE Technical Interoperability [combined] Demonstration
• $87 Billion Question - The Value Proposition: Study was to estimate the economic value of health information exchange based on a patient-provider encounter
• Limitations
• The trap
• Policy implications

Mar 2004   Report on the EHR System Functional Model and Standard

• Report on the EHR System Functional Model and Standard
• Background: HL7 EHR SIG; Three sections of the functional model – direct care, supportive and infrastructure
• January EHR SIG Meeting: Reviewed functional outline and other work products; The functional model as a requirement of the standard
• Next steps for the EHR-S Functional Model and DSTU: The functional outline and ballot narrative are to be available in early February
• A larger perspective on EHR Interoperability in the U.S.
• HL7’s early proposal to enable transferring entire EHRs
• IHE’s proposal of a long-term electronic health record (LR) and the care record (CR)
• Both approaches to converge on the same technical integration in the future

Feb 2004   Impact of E-Prescribing on Interoperability Standards

• Impact of e-Prescribing on interoperability standards
• Electronic prescriptions (e-prescribing) initiative with the highest potential impact
• Role of the eHealth Initiative: How it works, how to “sell” it, prove an ROI
• Design and implementation: Two-phased approach; Two models for implementation
• Incentives: physician practices, payers, patients; Prescription Drug Plans to pay incentives to those physicians that participate

Jan 2004   2004 Outlook for Interoperability Standards

• 2004 Outlook for interoperability standards
• Look back on five major events in 2003
• NCVHS recommendations on core terminologies
• IOM’s third report on patient safety problems
• HL7 and IOM’s EHR SIG: functional model and standard
• Medicare Prescription Drug, Improvement and Modernization Act
• Outlook for 2004
• Federal involvement; Electronic prescription program; Medicare bill established a new independent commission on HCIT adoption of new standards; Medicare bill authorizes three additional IOM reports
• EHR Standards in 2004
• HL7 EHR SIG – next version of EHR system functional model
• ANSI ASTM – Continuity of Care Record (CCR)
• IHE – EHR framework and roadmap: Care Record and Longitudinal Record
• Predictions for 2004: Ambulatory care setting; Federal government focus

 

2003

Dec 2003   The Continuity of Care Record Standard Initiative

• A proposed standard for exchanging basic patient data between one care provider and another with ready access to relevant patient information
• Intended for provider-to-provider communication between any care settings
• Model is based on the Patient Care Referral Form required by the Massachusetts Department of Public Health
• Analysis of the CCR within the EHR world
• CCR could address the need for cross-provider interoperability;
• CCR could define the summary data each EHR must send or receive
• Value of the CCR will be determined by interoperability with other clinical systems
• CCR is a valuable contribution to the EHR standard discussion

Sept 2003   The EHR System Functional Model and Draft Standard for Trial Use

• EHR System Functional model and Draft Standard for Trial Use (DSTU)
• Did not pass on its first ballot; Reasons behind the negative vote – lack of clarity and coherence; provider community concerns; timeline did not allow proper consideration and consensus building; this standard was directed at U.S. needs without consideration of other national initiatives
• Key decisions made during the HL7 working group meeting in Memphis
• Split the standard into two parts; (1) Model, outline and functional definitions, and (2) Realm specific care setting profiles
• Although HIMSS voted affirmatively on the DSTU, an extensive list of suggestions and comments for improvement was submitted.
• Next Steps – EHR SIG to fast track a new ballot

Jul 2003   The State of the Electronic Health Record Continued

• The Electronic Health Record Continued
• CMS and VHA propose that the HL7 EHR SIG develop an EHR functional model
• HL7 EHR SIG Plan
• EHR interoperability considerations
• Continuity of Care Record (CCR)
• EHR interoperability standards yet unknown
• A National Standard Medical Terminology
• NCVHS is addressing the creation/promotion of national terminology standards

Apr 2003   The State of the Electronic Health Record

• Defining the EHR
• IOM’s 1991 study, Computer-Based Patient Record
• ASTM EHR Standard Guide – ASTM E31’s guide
• HL7 – EHR SIG debate over “all” and “small” EHR
• ISO TC215 Working Group 1
• NCVHS – NHII and the Three Dimensions of the EHR
• A value proposition view of the EHR
• The market definition of the EHR
• Secondary uses of EHR – public health, population studies, pharmacy benefits plans, clinical trials and research, quality benchmarking and outcomes analysis
• Table of EHR Definitions
• The Universal EHR – A business concept
• Barriers and Roadmap to the Universal EHR
• The Federal role

Mar 2003   Primary Business Drivers for Interoperability Standards Initiatives

• HIMSS 2003 – Defining key industry trends
• Patient Safety
• The top business issue facing healthcare
• HCIT industry prioritizing – reduce medical errors and improve patient safety
• IOM and Leapfrog Group – Although focus has been on deaths caused by medical errors, Leapfrog’s initiatives are aimed at reducing all process errors.
• Business and politics – ‘Cost of doing business’; Is there a measurable return on investment or improvement in patient care?; Growing acceptance of integrated clinical information systems
• Final HIPAA security rules published – Final rules reflect sound security practices that make each healthcare enterprise responsible for its own IT security
• Integrated Clinical Information Systems
• Definition
• Concerns – A gap between interfacing applications at the data messaging level and at the process level; Lack of interoperability standards
• The state of interoperability standards – Critical factor in implementing and securely deploying integrated CIS

 

2002

Dec 2002   Summary and Annotations on Key Trends in 2002

• 2002 Annual Review
• February – HIMSS 2002, HCIT overview, E2E security framework
• April – Leadership in standards initiatives, Coordination of standards, ANSI HISB’s influence among SDOs
• June – National Alliance for Health Information Technology, Web technologies’ impact on HCIT interoperability
• August – technology (not business needs) driving healthcare information systems; Interoperability; Web technologies; International standards; Politics and business interests
• November – HL7 & Version 3.0 development
• The Dilemma of HL7:
• Business strategy to stakeholders
• Industry’s role: “Industry” does not have a business strategy for system interoperability
• IHE: Joint venture of HIMSS and Radiological Society of North America
• Recommendation: An HL7 and IHE Partnership

Nov 2002   HL7 – Meeting the Needs of Customers’ and Other Stakeholders

• Health Level Seven (HL7)
• History: Version 2.0 introduced in 1988 with successive point releases
• Vision for Version 3.0: Development started in 1996
• Web technologies changed messaging: Internet protocol (IP), Simple object access protocols (SOAP), Extensible mark-up language (XML)
• HCIT market changed dramatically: Business requirements, HIPAA, Clinical document architecture, Process and workflow, EHR
• HL7 organization and management: An open, voluntary, consensus-driven standards development organization accredited by the American National Standards Institute (ANSI)
• HL7 is developing the standards for implementing interoperability, but not the code itself
• Reference Information Model (RIM), Vocabularies and code sets, Semantics and syntax
• Need for business requirements to control technical development
• Process Improvement Technical Committee: For membership concerns

Aug 2002   The Relationship Between Business Requirements and Systems Interoperability Standards

• Business requirements: NAHIT identified 6 core initiatives; IT requires interoperability standards to be effective and efficient
• Why interoperability?: Business requirements should be driver; 4 core elements of a systems model; open systems, modular solutions; interoperability standards designed from the inside out
• Interoperability and Web Services; synergistic effect of interoperability and security
• The business of standards: Politics and business interests; National and international standards
• Standard Code Sets: standards must define the message format, usage, context and content; SNOMED International
• Summit on Nursing Terminology: Nursing Reference Terminology Model – 4-step model for evolving a standard code set
• National Alliance for Health Information Technology: Recruiting meeting held in June

Jun 2002   Review the Impact of Web Standards on the Healthcare Domain and on Interoperability Standards

• National Alliance for Health Information Technology
• Mission – using information systems to improve healthcare
• Defining problems to solve
• Convening stakeholders – direct stakeholders, government, SDOs and other interoperability initiatives, vendors
• Defining the perspective – scope, status and resources of current standards initiatives, what are interoperability standards, coordinate and implement standards across SDOs
• The problem set

• Impact of Web on healthcare interoperability: profound impact of the Web and associate set of technologies on information technology
• Impact of Web on clinical documents, HL7 and ASTM E31
• Use cases envisioned; lessons learned – failure to adopt standards initiatives, business priorities, need for a useable framework of standards from multiple initiatives

Apr 2002   The Central Role of the American National Standards Institute Healthcare Information Standards Board (ANSI HISB) and the National Committee on Vital and Health Statistics (NCVHS)

• HIPAA
• Privacy NPRM: Changes in rules affect consent, use of protected health information (PHI), business associate agreements; use of de-identified data
• Need to comply with standard transactions and code rules by Oct 2002 or apply for an extension
• WEDI-SNIP: Revised sequencing timeline for development and testing
• Outlook
• Leadership in standards initiatives: Coordination of standards, ANSI HISB to provide leadership and coordination to national standards initiatives; NCVHS as advisory board to the Secretary of HHS
• Players in HCIT and leadership discussion (some new, some old): Institute of Medicine, Leapfrog, American Hospital Association

Mar 2002   The HIMSS 2002 Annual Conference and Exhibition: A Perspective on the Market Environment (Special Edition)

• 2002 Annual HIMSS Conference and Exhibition
• Rethinking priorities: HIPAA, staffing shortages, reimbursement and terrorism preparedness
• HIPAA: Effort and costs to achieve “compliance”, security integration concerns
• Clinical Information Systems: CPOE integration in CIS
• The HIT Market: HIT market growing but HIT spending is directed towards infrastructure, enterprise vision and globalization of CIS

Feb 2002   HIMSS 2002 Annual Conference and Exhibition: A Perspective on Interoperability

• HIMSS 2002
• Bioterrorism/Homeland Security; IT priorities - alignment of business and IT plans; CPOE and CIS; Enterprise resource planning
• HIPAA “Compliance” Update
• Phoenix Health Systems/HIMSS Quarterly HIPAA Survey – Results
• Complying not leveraging: Decision to simply comply and remediate current systems instead of re-engineer processes
• Claims attachments: Draft claims rules yet to be published
• Privacy: “Minimum necessary” remains vague
• Security: Focus on threat analysis and risk assessment activities
• The Porter Report: Cynthia Porter of Porter Research presented at HIMSS 2002
• End-to-end security framework; access controls; authorization; electronic signature, digital signature, certificate authority, public key infrastructure; audit trails; network control - neutrality
• HL7: Winter Working Group, Version 3.0 update, clinical document architecture, security

 

2001

Dec 2001   Shift from standards developers to standards implementers

• Year End Review

• Various standards initiatives: Moving from purely voluntary consensus-driven process to one of regulatory mandate
• SNIP and IHE: WEDI-SNIP - HIPAA implementation; IHE - technical framework for implementing existing HL7 and DICOM standards
• Clinical Standards - ASTM
• IT-Business Alignment
• HIPAA: Delaying the compliance date for using the Standard Transactions and Codes one year to 16 October 2003.
• WEDI-SNIP
• Transactions and Codes Work Group - Delay; Savings/ROI
• Security and Privacy Workgroup - to coordinate local and regional experience implementing the Security and Privacy rules to develop national solutions; identified key security implementation issues
• Education and Awareness Work Group – September survey results
• IHE: Promote IHE compliance as a requirement during vendor selection
• ASTM E31: Clinical documents and records, Privacy and security
• Improving IT-Business alignment: Executive management decisions will be based on strategy and available resources and competing projects

Oct 2001   Priority on Security (post September 11)

• Priorities Revisited: Emergency preparedness and disaster response capabilities among healthcare providers

• Security
• Focus will be on emergency response, disaster recovery and contingency operations covering staff, supplies, facilities, communications and not just IT
• Digital Signature
• Proposed HIPAA electronic signature rules
• ISO X509 sets for the digital signature/PKI standard
• ASTM describes healthcare electronic record and signature requirements in its standards E1762 and E2084
• HL7
• Version 3 - to tightly define message usage, structure and content
• CCOW - maintains a common user (single sign-on) and patient context
• Clinical Document Architecture (CDA) Level One is now an ANSI certified standard
• Miscellaneous Notes – W3C; ebXML

Aug 2001   HIPAA’s Privacy Rule and Standards for Patient Medical Record Information

• HIPAA: general agreement that the Standard Transactions rules should go forward
• Privacy Rules: Minimum necessary use of PHI; mandating consents and disclosure
• Standards for Patient Medical Record Information
• Goal of PMRI standards is to enable the exchange of comparable, quality patient medical record data between systems; standards based PMR requires interoperability
• PMRI Strategy
• Three strategic paths
• Let the market develop the EMR
• Provide coordination of voluntary efforts
• Take over full direction and mandate standards

May 2001   HIPAA’s Effect on Interoperability Standards and SDOs

• HIPAA is setting the agenda: HIPAA displaces IT related initiatives away from other high priority initiatives (i.e. Medical errors)
• Standards Development Organizations: dynamics of the SDO world are changing from consensus advancement to one of supporting federal regulators agenda
• ASTM E31 Healthcare Informatics Committee: Two areas of focus - privacy and security, electronic health record
• HL7: Working on version 3
• Digital signature: Charter to produce an electronic signature standard

Mar 2001   HIPAA’s Administrative Simplification Rules and their Effect on HCIT Initiatives

• HIPAA at HIMSS: HIPAA is causing confusion and uncertainty among the customer base
• HIPAA Administrative Simplification: major points of contention -
• Costs of compliance
• HIPAA does not pre-empt state and other federal laws
• Difficult and wasteful to implement them in a piecemeal fashion
• Time frame is challenged
• Digital signature
• HIPAA Outlook: Gaps caused by the publication of interrelated rules at different times
• Bottom line: HIPAA will delay and redirect spending on HCIT

Jan 2001   How HIPAA Privacy, Security and Digital signatures will Redefine the Industry’s Priorities

• HIPAA
• Final Privacy Rules: Brief overview
• Proposed Security Rules: Diagram of impact of proposed security rules on HCIT
• Digital Signature: Background; Renewed urgency around required electronic signatures
• Joint SDO Meeting on Security: Agenda - securing HIPAA healthcare transactions, future cooperation between the SDOs on security.
• Background on electronic signature
• Meeting notes and bottom line: single digital signature standard
• HL7: January Working Group meetings - moving Version 3.0 standard forward
• HIMSS Preview: HL7 and IHE - two very different standards initiatives to be presented