Standards and Medical Informatics

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Standards and Medical Informatics

• W. Ed Hammond, Ph.D.
• President, AMIA
• Vice-chair, HL7 Technical Steering Committee
• Chair, Data Standards Working Group, Connecting
  for Health
• Convenor, ISO TC 215 WG2
• Professor-emeritus, School of Medicine
• Professor-emeritus, Pratt School of Engineering
• Adjunct Professor, Fuqua School of Business
• Duke University

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A scenario
Recently, at my exercise club, my blood glucose
measured 112 mg/dl. This elevated value was sent
to my composite record then to my PCP and to me.
When I logged onto my computer, a flag indicated
I had a message in my personal mail at my PCPs
web site. The message ask me to schedule an
appointment soon because of the elevated glucose,
as well as it was time for my annual physical
exam. I accessed the clinics web site and
scheduled an appointment with my PCP for the next
week. The system identified some additional
testing for me, and scheduled me 30 minutes
before seeing my PCP for the tests. I also looked
at my on record and noticed that my glucose had
been climbing over the past 12 years to its
current level.
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I arrived at the clinic, entered my health card
in to a kiosk registering my arrival. My
eligibility was automatically checked and my
health plan verified. I was directed to the lab
for the blood drawing. I was also assigned a
number which provided the linkage for me on this
visit. Within 2 minutes of my scheduled time, a
white board identifying me by number directed me
to Exam Room 10. Here the provider performed the
annual physical examination, sharing a terminal
between us, and discussing how she proposed to
deal with the elevated glucose with exercise and
weight reduction. Since my cholesterol was also
elevated, she decided to start me on Zocor. My
dentist had recently started me on an antibiotic
that intensifies the action of the
cholesterol-reducing drug. My PCP suggested that
I complete the antibiotic before I start the
Zocor. She also scheduled me to return in 3
weeks to test my liver function because of the
drug.
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This information was put into my personal web
page for download into my personal health record.
The exercise program was fed directly into my
exercise machine, and my daily progress was
monitored and recorded into my personal record.
I also gave permission for the data to be
uploaded to my PCP, since I thought the added
pressure of another eye watching me would
increase the incentive for my following the
program. I was also given, interactively, a
personal diet to help control my weight. I kept
an on-line log in my personal health record. I
also accessed information about the medication I
had been given to reduce my cholesterol. I read
about side effects and some of the controversy.
I knew about the side effects however, I decided
to continue the drug at least for the next month.
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The Holy Grail of Medical Informatics The
Electronic Health Record aka
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A changing world of health care

• Our world is expanding
• The tremendous expansion of diagnostic tests
  available,
• The almost individualization of treatment,
  particularly drugs
• a vastly expanding field of knowledge
• Solution demands use of information technology in
  health
• to contain costs
• to reduce medical errors
• and to increase quality
• Consumers are becoming more educated and want to
  be involved
• Integrated health systems are the trend

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A changing world of health care

• From a private, independent world to a combined
  and integrated community
• From unconnected, disparate heterogeneous systems
  to seamlessly connected interoperable systems
• From technologically constrained to
  technologically rich
• From hospital dominated to person-focused
  systems health vs illness
• From billing records to clinically enriched
  databases
• From concealing data to sharing data

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Patients the raison detre

• Patients are seen asynchronously in a variety of
  settings thus data must give a single,
  integrated view of the patient.
• Need complete, appropriate data for decision
  making, to reduce errors and improve care.
• The spectrum of patient care -- home, outpatient,
  inpatient, intensive care, emergency, nursing
  homes specialties.
• Patients are mobile -- data must be accessible
  internationally
• Patients move -- patient records follow and need
  to be understandable and useable in the new
  settings.

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Why standards in health care?

• There is an assumed and inherent need to share
  data in the health care setting. The data are of
  many types and form and will be used for multiple
  purposes.
• We must share both data and knowledge for both
  improved health care and for economic reasons.
• Sharing becomes economically possible only if
  interoperability exists.
• Interoperability occurs only if a full set of
  standards in health care exist.

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Standards are an everyday thing!

• VCRs, audio tapes, CDs, DVDs
• Bread size - to fit toasters
• ATM machines
• Air controllers use English language
• Distance between rails for trains
• 60 cycle, 110 volt electricity
• Shoe sizes, clothes, gloves
• Side of road we drive on
• Size of paper

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Too many standards .
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Steps to making a standard

• Awareness of need for standard
• Critical mass of technical expertise to create
  standard
• Must insure fairness and not competitive
  advantage to any single vendor
• Expertise must be both technical and domain
• MUST involve vendors, providers, consultants,
  government
• Global acceptance important in todays market
• Vendor implementation usually driven by consumer
  pressure to implement
• Visible reduction in cost and effort of
  interfaces using standard necessary for buy-in

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Different kinds of standards

• Company
• DOS
• Windows
• Consortium/Open Source
• Unix
• Linux
• JAVA
• M/Mumps
• Industry
• DICOM

• Government
• NIST
• CMS
• HIPAA/NCVHS
• Voluntary Consensus
• ASC X12
• HL7
• NCPDP
• ASTM
• IEEE

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Consensus Standards

• Volunteer-driven
• Not full-time commitment
• Uneven levels of participation
• Uneven levels of understanding
• Required resolutions of negatives
• Prone to compromise leads to ambiguity
• Funding constraints
• Meet only a few times per year
• Specialized balloting process (ANSI requires 90
  approval)

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How to get there from here why standards in
health care?

• There is an assumed and inherent need to share
  data in the health care setting. The data are of
  many types and form and will be used for multiple
  purposes. Traditionally, these uses have been
  addressed independently and redundantly.
• We must share both data and knowledge for both
  improved health care and for economic reasons.
• Sharing becomes economically possible only if
  interoperability exists.
• Interoperability occurs only if a full set of
  standards in health care exist.

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Why havent we done it?

• No accepted long term vision of what IT is.
• No proven value to those of make purchasing and
  financial decisions.
• No widespread stakeholder buy-in.
• Not considered a core component of health care.
• Resistance to change.
• Unwillingness to make decisions and take action
  on controversial issues.

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What are the building blocks?

• Data
• Patient-centered
• Comprehensive
• Aggregated
• Organized
• High data integrity
• Timely
• Structured, semantically understandable
• Sharable
• Accountable
• Secure and private

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How might we use it?

• Information for
• Patient care
• Prevention of medical errors
• Improved quality of care
• Consistency in care
• Cost effective care
• Shared understanding of health and health care
  among patient and provider
• Health surveillance and biodefense
• Workflow management
• Research
• Epidemiology
• Billing

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What and how can we learn?

• Knowledge
• Clinical trials
• Decision support
• Disease demographics
• Outcomes
• Quality indicators
• Evidence based medicine

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What do we get?

• Wisdom
• New models for health and health care
• More cost effective care
• Better understanding of disease and disease
  processes
• Better relationship among stakeholders
• A happier, healthier world

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Why data standards? (1)

• Patient-centric EHR
• Complete, aggregate data about patient
• Patient summary problem list
• Current medications list
• Allergies
• Base demographics
• Selected clinical elements
• Reimbursement data
• Insurance
• Health Plan

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Why data standards? (2)

• Population Health Record
• Outcomes data
• Utilization data
• Disease tracking
• Detection of disease outbreaks
• Detection of bioterrorism events
• General health surveillance
• Immunization

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Why data standards? (3)

• Reimbursement
• Reimbursement rules
• HIPAA transactions requirements
• Automation of process
• Easier audits for clinical justification
• Reduction of use of human resources in
  reimbursement process
• Analysis of treatment by multivariate parameters

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Why data standards? (4)

• Research
• Clinical Trials
• Drug Trials
• What diseases are prevalent
• By region
• By occupation
• By category
• Variation in outcomes
• Method of treatment
• Provider
• Region

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Classes of Standards

• External standards not unique to health care
• Examples include communication standards,
  Internet standards, LAN standards, XML/HTML
  standards, security standards, etc.
• Application level health data standards
  absolutely necessary for aggregating and sharing
  data
• Enhancement health-related standards that improve
  the process and extend the use of IT. This group
  includes clinical content and clinical knowledge
  standards.

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Classes of Standards - 1

• Basic communication standards that are not
  specific to health
• Communication standards
• Internet standards
• LAN standards
• Web Protocols
• XML
• Security standards
• Authentication standards
• Biometric standards
• Encryption standards
• Digital signature
• Groups producing or influencing these standards
• W3C, IETF, OMG, OASIS, others

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Classes of Standards - 2

• Standards that relate to the definition, style,
  and naming of the data itself
• Reference Information Model (RIM)
• Data types
• Terminology
• Clinical Documents
• Clinical Templates
• Data element master set
• Business Rules that identify what data elements
  are collected how, when and by whom
  implementation manuals, conformance documents,
  metadata dictionaries

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Classes of Standards - 3

• Process standard for message development
  framework
• Standards associated with data interchange
• HL7 V2.4, V2.4 (XML) and in ballot V2.5
• HL7 Version 3
• DICOM imaging domain
• IEEE/CEN/ISO medical devices
• Others

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Classes of Standards - 4

• Standards associated with the Electronic Health
  Record
• Architecture, content, format and form, purpose
• Privacy and confidentiality
• Access
• Persistence
• Control

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Standards Related to EHR - 5

• Decision Support Rules
• Arden Syntax, GLIF, GEM, Prodigy
• Clinical algorithms
• CPOE
• ePrescribing
• Reimbursement Rules

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Interoperability Standards (1)

• Personal data absolutely MUST be identified when
  it is sent from the source to the aggregating
  data base
• That is best (essentially error free)
  accomplished when there is a single, unique
  personal identifier
• Because of privacy concerns we have not yet
  accepted this solution

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Interoperability Standards (2)

• Reference Information Model
• Object Model that provides framework for the
  exchange and sharing of health data. EHR model
  must be based on this model
• HL7 has created such a model, accepted
  internationally, that is now becoming stable
• HL7 model is high level requiring subsequent
  refined models for communications and storage of
  data.

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Reference Information Model

• An information model needs to underpin all
  architecture and terminology developments to
  ensure consistency of approaches and a shared
  understanding.Liaw and Grain in a government
  report

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HL 7 RIM Core Classes
Entity
Participation
Act
Role
Referral Transportation Supply Procedure Condition
Node Consent Observation Medication Act
complex Financial act
Patient Employee Practitioner Assigned
PractitionerSpecimen
Organization Living Subject Material Place Health
Chart
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Data Element Definition Set

• Defines every data element that will be collected
  including when, how and in what form
• Data must be structured
• Links data elements to vocabulary sets as well as
  RIM
• Some work being done in this area by Health
  Informatics Standards Board (ANSI) and Australia

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Data Types

• Simple data types
• Numeric, strings, dates, currency, etc.
• Complex data types
• Addresses, names, coded data elements
• Tightly coupled with the RIM
• Must be consistent with terminology
• Must be used (stored) in the EHR as defined by
  data type

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Terminology

• Every data element that will be shared must be
  defined and coded in a terminology set (text
  modifiers may be permitted)
• Problem is the existence of too many
  terminologies, none of which is perfect
• Terminologies may be mapped but costs more money,
  creates errors and results in the loss of
  information
• Terminologies required for use must be free,
  controlled and maintained
• We must have a single, domain-model-based,
  constantly maintained, and freely distributed
  world-wide. terminology

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Drug Terminologies

• Significant progress has been made recently in
  creating a drug terminology standard. Effort
  includes starting with VA drug terminology set,
  adopted by FDA and assigned NDC codes, and mapped
  into UMLS. HL7 route, form and application
  device sets are included.
• NLM and SNOMED have apparently reached an
  agreement that will make SNOMED freely available
  for use in the U.S.

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Clinical Document Architecture

• XML-based definition of clinical documents such
  as discharge summaries, op notes, progress notes,
  radiology reports, etc.
• HL7 has ANSI approved standards. Work is based on
  3 levels (1) header (2) header plus body
  structure and section headings (3) element
  content specification and identification

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Conveying complex concepts

• Clinical Data Model or Clinical Templates
• Defines detail clinical object structures
• Permits constraints on objects
• Examples
• Clinical lab battery
• Heart Murmur
• Blood pressure measurement
• Physical exam for chest pain
• Protocol for sore throat
• Require registry

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Decision Support

• For defining knowledge and decision support
  algorithms
• HL7 brings together several existing efforts in
  this area
• Arden Syntax
• Prodigy (UK)
• Guideline Interchange Format (GLIF)
• GEM

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Implementation/Conformance

• Most frequently, ambiguity and options remain in
  standards at all levels. Total interoperability
  requires a precise definition of what will be
  sent to whom under what circumstances.
• One example of this approach is the Emergency
  Department implementation manual called DEEDS.
• The Centers for Disease Control has created a
  reporting system for health surveillance known as
  NEDSS will also provide this level of
  specification.

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Electronic Health Record

• Requires defining exactly what standards are
  required
• Issue is where does standard stop and vendor
  proprietary interests start.
• Includes some architecture and probably
  categorization of data elements stored.
• Several efforts underway including Good
  Electronic Health Record (Australia and Europe),
  HL7 and AMIA

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Reusable Components

• HL7 Clinical Components Object Working Group
  (CCOW)
• Defining standards for reusable component software

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Imaging Standards

• DICOM is international standard for images and
  pictures and similar media
• JTC1 defines standards for JPEG and MPEG
• DICOM also does structured reports similar to HL7
  clinical documents but for radiology and imaging
  reports. Efforts are being coordinated.

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Medical Devices

• IEEE provides leadership in this area.
• Includes bed-side devices and covers primitive
  layer of interface up to application.
• Standards include cable, wireless, infrared
  connectivity
• Standards become international through ISO

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Security Standards

• At communications level, mostly developed outside
  health industry but with influence. IETF playing
  major role.
• Digital Signature and PKI standards are being
  influenced by health-related participation.

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Other Standards

• Waveforms
• Data Integrity Standards
• Presentation Standards
• Icon Standards
• Functionality standards

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What is an EHR? my definition

• It is not a clinical repository.
• Its purpose is to enhance the health and enable
  the care of the individual. Its contents are
  solely justified for that purpose. When data
  ceases to contribute, it is removed.
• Much of the data in the inpatient setting has
  limited persistence - usually the more intense
  the care, the shorter the persistence.
• There are other repositories a data warehouse
  that does contain and retain everything.
• The EHR documents maintenance of care, diagnostic
  and treatment processes, health status.

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Population record

• A summary record from all sites and sources of
  care
• Linkage of data for new sites as care as well as
  population surveillance, research, quality,
  analysis
• Data arrives as identified data, available as
  disidentified

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The Personal Record

• Model to meet consumer needs and understanding
• Focus on functionality and work management, not
  clinical repository
• Information display should be driven by
  intelligent query and understanding of needs
• Couple with appropriate education
• Home entry of data - direct or sensors
• Person-controlled release
• Customizable

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Business Linkages
Hospital Intensive Care EmergencyDepartment
NursingHome
Ambulatory Care Clinic
Patient role in control?
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EHR Interoperability Diagram
Billing/Claims
Profile
EnterpriseData Warehouse
PersonalEHR
PersonalEHR
Profile
PatientEncounter
Provider EHRDatabase
Institution EHRDatabase
Disease Registry
Profile
LongitudinalEHR
ResearchDatabase
Profile
Profile
Profiles contain business rules
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Population or Composite Summary EHR
PatientEncounter
Provider EHRDatabase
Provider EHRDatabase
PopulationProfile
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Download Process
Sensitive DemographicData
DoubleEncryptionSiliconEncoder
ID
ID
HL7 Message
Identifying Data, name, address, etc.
Encrypted ID
Identifying Data, Translated (e.g. Zip).
Aggregated SummaryLongitudinalEHR
Summary Data
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Summary Longitudinal Record
Patient controlled access
Summary Longitudinal Record
Access log
Access list permitby provider group clinic othe
r
Feeds PH surveillance, patient
safety, epidemiology
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The future

• I am always a person a complete entity to the
  provider I am seeing.
• I dont have to worry that my known allergies
  will be missed.
• I have faith that all decisions will be made by
  someone who knows all about me, my preferences,
  and my health.
• My data will be interchangeable and
  understandable.
• My data will be secure and appropriately
  protected.