1. 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

2. 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 PCP’s 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 clinic’s 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.

3. 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.

4. 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.

5. The Holy Grail of Medical Informatics …
The Electronic Health Record
aka …

6. 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

7. 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

8. Patients – the raison d’etre
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.

9. 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.

10. 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

11. Too many standards ….

12. 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 today’s market
Vendor implementation usually driven by consumer pressure to implement
Visible reduction in cost and effort of interfaces using standard necessary for buy-in

13. 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

14. 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)

15. 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.

16. Why haven’t 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.

17. What are the building blocks?
Data
Patient-centered
Comprehensive
Aggregated
Organized
High data integrity
Timely
Structured, semantically understandable
Sharable
Accountable
Secure and private

18. 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

19. What and how can we learn?
Knowledge
Clinical trials
Decision support
Disease demographics
Outcomes
Quality indicators
Evidence based medicine

20. 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

21. 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

22. 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

23. 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

24. 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

25. 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.

26. 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

27. 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}

28. 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

29. Classes of Standards - 4
Standards associated with the Electronic Health Record
Architecture, content, format and form, purpose
Privacy and confidentiality
Access
Persistence
Control

30. Standards Related to EHR - 5
Decision Support Rules
Arden Syntax, GLIF, GEM, Prodigy
Clinical algorithms
CPOE
ePrescribing
Reimbursement Rules

31. 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

32. 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.

33. 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

34. HL 7 RIM Core Classes Relationship Link Act Relationship Entity Role
0..* 1
Act
Relationship 1
0..*
Entity
Role
Participation
Act 1
0..*
0..* 1
Organization
Living Subject
Material
Place
Health Chart
Patient
Employee
Practitioner
Assigned Practitioner Specimen
Referral
Transportation
Supply
Procedure
Condition Node
Consent
Observation
Medication
Act complex
Financial act

35. 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

36. Data Types Simple data types Complex 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

37. 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

38. 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.

39. 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

40. 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

41. 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

42. 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.

43. 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

44. Reusable Components
HL7 Clinical Components Object Working Group (CCOW)
Defining standards for reusable component software

45. 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.

46. 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

47. 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.

48. Other Standards Waveforms Data Integrity Standards
Presentation Standards
Icon Standards
Functionality standards

49. What is an EHR? … my definition
It is not a clinical repository.
It’s purpose is to enhance the health and enable the care of the individual. It’s 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.

50. 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

51. 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

52. Business Linkages Hospital Intensive Care Ambulatory Care Nursing Home
Emergency Department
Nursing Home
Ambulatory Care
Clinic
Patient role in control?

53. EHR Interoperability Diagram
Billing/Claims
Profile
Enterprise Data
Warehouse
Personal EHR
Personal EHR
Profile
Patient Encounter
Institution
EHR Database
Provider
EHR Database
Disease Registry
Profile
Longitudinal EHR
Research Database
Profile
Profile
Profiles contain business rules

54. Population or Composite Summary EHR
Patient Encounter
Provider
EHR Database
Population EHR
Population Profile
Patient Encounter
Provider
EHR Database
Provider
EHR Database
Population Profile

55. Download Process ID Double Encryption Silicon Encoder
Sensitive Demographic Data
Double Encryption Silicon Encoder ID ID
HL7 Message
Identifying Data, name, address, etc.
Encrypted ID
Identifying Data, Translated (e.g. Zip).
Aggregated
Summary Longitudinal EHR
Summary Data

56. Summary Longitudinal Record
Patient controlled access
Summary
Longitudinal
Record
Access log
Access list
permit by provider
group
clinic
other
Feeds PH
surveillance, patient safety,
epidemiology

57. The future
I am always a person – a complete entity to the provider I am seeing.
I don’t 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.