Presentation on theme: "Standards and Medical Informatics"— Presentation transcript:
1 Standards and Medical Informatics W. Ed Hammond, Ph.D.President, AMIAVice-chair, HL7 Technical Steering CommitteeChair, Data Standards Working Group, Connecting for HealthConvenor, ISO TC 215 WG2Professor-emeritus, School of MedicineProfessor-emeritus, Pratt School of EngineeringAdjunct Professor, Fuqua School of BusinessDuke 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 Recordaka …
6 A changing world of health care Our world is expandingThe tremendous expansion of diagnostic tests available,The almost individualization of treatment, particularly drugsa vastly expanding field of knowledgeSolution demands use of information technology in healthto contain coststo reduce medical errorsand to increase qualityConsumers are becoming more educated and want to be involvedIntegrated health systems are the trend
7 A changing world of health care From a private, independent world to a combined and integrated communityFrom unconnected, disparate heterogeneous systems to seamlessly connected interoperable systemsFrom technologically constrained to technologically richFrom hospital dominated to person-focused systems: health vs illnessFrom billing records to clinically enriched databasesFrom 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 internationallyPatients 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, DVDsBread size - to fit toastersATM machinesAir controllers use English languageDistance between rails for trains60 cycle, 110 volt electricityShoe sizes, clothes, glovesSide of road we drive onSize of paper
12 Steps to making a standard Awareness of need for standardCritical mass of technical expertise to create standardMust insure fairness and not competitive advantage to any single vendorExpertise must be both technical and domainMUST involve vendors, providers, consultants, governmentGlobal acceptance important in today’s marketVendor implementation usually driven by consumer pressure to implementVisible reduction in cost and effort of interfaces using standard necessary for buy-in
13 Different kinds of standards CompanyDOSWindowsConsortium/Open SourceUnixLinuxJAVAM/MumpsIndustryDICOMGovernmentNISTCMSHIPAA/NCVHSVoluntary ConsensusASC X12HL7NCPDPASTMIEEE
14 Consensus Standards Volunteer-driven Not full-time commitment Uneven levels of participationUneven levels of understandingRequired resolutions of negativesProne to compromise – leads to ambiguityFunding constraintsMeet only a few times per yearSpecialized 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? DataPatient-centeredComprehensiveAggregatedOrganizedHigh data integrityTimelyStructured, semantically understandableSharableAccountableSecure and private
18 How might we use it? Information for … Patient care Prevention of medical errorsImproved quality of careConsistency in careCost effective careShared understanding of health and health care among patient and providerHealth surveillance and biodefenseWorkflow managementResearchEpidemiologyBilling
19 What and how can we learn? KnowledgeClinical trialsDecision supportDisease demographicsOutcomesQuality indicatorsEvidence based medicine
20 What do we get? Wisdom New models for health and health care More cost effective careBetter understanding of disease and disease processesBetter relationship among stakeholdersA happier, healthier world
21 Why data standards? (1) Patient-centric EHR Complete, aggregate data about patientPatient summary problem listCurrent medications listAllergiesBase demographicsSelected clinical elementsReimbursement dataInsuranceHealth Plan
22 Why data standards? (2) Population Health Record Outcomes data Utilization dataDisease trackingDetection of disease outbreaksDetection of bioterrorism eventsGeneral health surveillanceImmunization
23 Why data standards? (3) Reimbursement Reimbursement rules HIPAA transactions requirementsAutomation of processEasier audits for clinical justificationReduction of use of human resources in reimbursement processAnalysis of treatment by multivariate parameters
24 Why data standards? (4) Research Clinical Trials Drug Trials What diseases are prevalentBy regionBy occupationBy categoryVariation in outcomesMethod of treatmentProviderRegion
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 dataEnhancement 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 - 1Basic communication standards that are not specific to healthCommunication standardsInternet standardsLAN standardsWeb ProtocolsXMLSecurity standardsAuthentication standardsBiometric standardsEncryption standardsDigital signatureGroups producing or influencing these standardsW3C, IETF, OMG, OASIS, others
27 Classes of Standards - 2Standards that relate to the definition, style, and naming of the data itselfReference Information Model (RIM)Data typesTerminologyClinical DocumentsClinical TemplatesData element master setBusiness Rules that identify what data elements are collected: how, when and by whom [implementation manuals, conformance documents, metadata dictionaries}
28 Classes of Standards - 3Process standard for message development frameworkStandards associated with data interchangeHL7 V2.4, V2.4 (XML) and in ballot V2.5HL7 Version 3DICOM – imaging domainIEEE/CEN/ISO – medical devicesOthers
29 Classes of Standards - 4Standards associated with the Electronic Health RecordArchitecture, content, format and form, purposePrivacy and confidentialityAccessPersistenceControl
30 Standards Related to EHR - 5 Decision Support RulesArden Syntax, GLIF, GEM, ProdigyClinical algorithmsCPOEePrescribingReimbursement Rules
31 Interoperability Standards (1) Personal data absolutely MUST be identified when it is sent from the source to the aggregating data baseThat is best (essentially error free) accomplished when there is a single, unique personal identifierBecause of privacy concerns we have not yet accepted this solution
32 Interoperability Standards (2) Reference Information ModelObject Model that provides framework for the exchange and sharing of health data. EHR model must be based on this modelHL7 has created such a model, accepted internationally, that is now becoming stableHL7 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..*1ActRelationship10..*EntityRoleParticipationAct10..*0..*1OrganizationLiving SubjectMaterialPlaceHealth ChartPatientEmployeePractitionerAssigned Practitioner SpecimenReferralTransportationSupplyProcedureCondition NodeConsentObservationMedicationAct complexFinancial act
35 Data Element Definition Set Defines every data element that will be collected including when, how and in what formData must be structuredLinks data elements to vocabulary sets as well as RIMSome 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 typesAddresses, names, coded data elementsTightly coupled with the RIMMust be consistent with terminologyMust be used (stored) in the EHR as defined by data type
37 TerminologyEvery 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 perfectTerminologies may be mapped but costs more money, creates errors and results in the loss of informationTerminologies required for use must be free, controlled and maintainedWe must have a single, domain-model-based, constantly maintained, and freely distributed world-wide. terminology
38 Drug TerminologiesSignificant 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 TemplatesDefines detail clinical object structuresPermits constraints on objectsExamplesClinical lab batteryHeart MurmurBlood pressure measurementPhysical exam for chest painProtocol for sore throatRequire registry
41 Decision SupportFor defining knowledge and decision support algorithmsHL7 brings together several existing efforts in this areaArden SyntaxProdigy (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 requiredIssue 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 ComponentsHL7 Clinical Components Object Working Group (CCOW)Defining standards for reusable component software
45 Imaging StandardsDICOM is international standard for images and pictures and similar mediaJTC1 defines standards for JPEG and MPEGDICOM 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 connectivityStandards become international through ISO
47 Security StandardsAt 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 StandardsIcon StandardsFunctionality 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, analysisData 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 repositoryInformation display should be driven by intelligent query and understanding of needsCouple with appropriate educationHome entry of data - direct or sensorsPerson-controlled releaseCustomizable
52 Business Linkages Hospital Intensive Care Ambulatory Care Nursing Home Emergency DepartmentNursing HomeAmbulatory CareClinicPatient role in control?
53 EHR Interoperability Diagram Billing/ClaimsProfileEnterprise DataWarehousePersonal EHRPersonal EHRProfilePatient EncounterInstitutionEHR DatabaseProviderEHR DatabaseDisease RegistryProfileLongitudinal EHRResearch DatabaseProfileProfileProfiles contain business rules
54 Population or Composite Summary EHR Patient EncounterProviderEHR DatabasePopulation EHRPopulation ProfilePatient EncounterProviderEHR DatabaseProviderEHR DatabasePopulation Profile
55 Download Process ID Double Encryption Silicon Encoder Sensitive Demographic DataDouble Encryption Silicon EncoderIDIDHL7 MessageIdentifying Data, name, address, etc.Encrypted IDIdentifying Data, Translated (e.g. Zip).AggregatedSummary Longitudinal EHRSummary Data
56 Summary Longitudinal Record Patient controlled accessSummaryLongitudinalRecordAccess logAccess listpermit by providergroupclinicotherFeeds PHsurveillance, patient safety,epidemiology
57 The futureI 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.