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Results of HITS Meeting of Friday, 5/15/09
Contents
Preface..............................
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SupportingA Patient-Centric Approach ....................................................
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Preface
 Author'sNote1
: Thisdocumentrepresentsasynthesisof the proceedingsof the ini...
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 HITS: isthe HIT StandardsCommittee: HHS43018 (bothHITP and HITS are organizedasFACA
...
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8 Areas of Focus forHITP & HITS
 The "startingpoints" - thatis: 8 areaswhere standard...
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HowDo We MeasureSuccess?
 SuccessinHIT deploymentisrealizedwhenwe have transparencyfo...
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CCHIT
 Question: regardingthe certificationcriteriaprocess:how doesthe CCHITfitin? Wh...
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OrganizingHITS for Feedback
 Committee MemberComment: Inourwork,HITS needstobe cogniz...
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 For example: the ICD-10code setallowsfor~170K diagnosescodes - ordersof magnitude mo...
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Meaningful Use
 MU drivesthe needforstandards. AlthoughMeaningful Use (MU) isHITP's ...
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wentintoeffectin2005 mightalreadyaddress/supportthe HITSstandardscomposedfor
"Secure ...
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 Below is a conceptual graphic. Think of several layers of standards supportingcerti...
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Movingto Machine-to-MachineDataExchange
 In the contextof standardssetting - the Com...
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Images
 Inclusionof Image dataisimportantfor EMR systems - andfor HIE exchange funct...
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 In the "quality"area we talked about going beyond what data needs to be collected -...
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HITS Project Plan & Next Steps
 HITS committed to a '90 day turnaround' to providere...
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Figure 1: HITECH Timeline
5/12/2009 12/31/2018
January 2014
All Americans have EHR
Ma...
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Transcript of "HITS Kickoff - 5/15/2009 - HealthCareReformForDummies.org"

  1. 1. perretta@ix.netcom.com Page 1 of 17 Results of HITS Meeting of Friday, 5/15/09 Contents Preface...........................................................................................................................................3 Revision History ..........................................................................................................................3 Abbreviations.................................................................................................................................3 Setting The Tone for the HITS Committee.........................................................................................4 HITS Mission...............................................................................................................................4 Timing........................................................................................................................................5 HITS Standards Includes Implementation......................................................................................5 How Do We Measure Success?.....................................................................................................6 Rule Making Process & ONCHIT's Role..........................................................................................6 Coordination With Other Organizations........................................................................................6 Allowing for Innovation ...............................................................................................................7 Organizing HITSfor Feedback.......................................................................................................8 Timeline Related Topics...................................................................................................................8 Beginning HITS' Work ..................................................................................................................8 Formulating An Implementation Roadmapin Light of Other Imperatives........................................8 Don't ForgetAdministrative Functions..........................................................................................9 Setting Standards............................................................................................................................9 Defining The Process...................................................................................................................9 Meaningful Use.........................................................................................................................10 Setting andAdjusting the Standards Bar .....................................................................................10 Standards Setting in an Asynchronous Standards World ..............................................................11 Candidate StandardsAreas............................................................................................................12 Secure Messaging......................................................................................................................12 Moving to Machine-to-Machine Data Exchange..........................................................................13 Fast Path to Medical Data..........................................................................................................13 Images......................................................................................................................................14 Implementation Standards.........................................................................................................14
  2. 2. perretta@ix.netcom.com Page 2 of 17 SupportingA Patient-Centric Approach ......................................................................................14 Setting Up HITS Workgroups..........................................................................................................14 Communications .......................................................................................................................15 HITS Project Plan & Next Steps ......................................................................................................16 Next Steps ................................................................................................................................16 Figure 1: HITECH Timeline .............................................................................................................17
  3. 3. perretta@ix.netcom.com Page 3 of 17 Preface  Author'sNote1 : Thisdocumentrepresentsasynthesisof the proceedingsof the initialHIT Standards Committee (HITS) chairedby JonathanPerlinandJohnHalamkaonFriday,5/18/09, at the US Departmentof Health&Human Services' Mary Switzerbuilding inWashington,DC. I was presentasa memberof the public;andnot as a memberof HITS nor HHS. Thus,pleasebe awarethatwhatI havecomposed below includemy own interpretation of the discussion. Ihave triedto expressmynotesincomplete thoughts - andorganize the discussioninlogical categories andnotspecificallyinthe orderof discussionduringthe meeting. Insome cases,I have extended mynotesto try to more accuratelyconveythe gistof a particularHITSdiscussion point.  Thisdocumentalsoincludes numerouscontextual hyperlinkstogermane references&citations on the Web.2  Partlyas a 'backgrounder'aid - Figure 1: HITECH Timeline onpage 17 isa simple graphicItried to pull togetherfromreadingthe HITECHsectionof the AmericanReinvestment&RecoveryAct. Such a "timeline"wasNOTa discussionpointinthe HITSmeeting- althoughsome aspectsof that schedule were alludedto. RevisionHistory Date Version Author Comment 5/16/09 1.0 H Perretta Createdprimarilyfromhandwrittennotes&secondaryresearch 5/18/09 1.01 H Perretta CorrectedabbreviationforHealthInformation Technology StandardsPanel toHITSP; Changedname of thisfile toHITS 05-15- 2009.docx Abbreviations  Belowisa simple listof abbreviationsusedinthissynthesis - withWebreferenceswhere applicable.  ARRA:AmericanReinvestment&RecoveryAct - aka "The StimulusPackage"(clickhere toget PDF of the legislation)  The Committee:Forpurposesof thisdocument:the HIT StandardsCommittee.  Coordinator: isDavidBlumenthal,MD, National CoordinatorforHealthInformationTechnology.  EHR & EMR & PHR: Perhapsunfortunate - butforpurposesof thisdocument - I usedthese termsinterchangeably - at leastasfar as thisdocumentgoes - theymeanthe same thing.  HIE: HealthInformationExchange  HITECH: TITLE XIIIof ARRA —HEALTH INFORMATION TECHNOLOGY(page 112 of ARRA).  HITP: isthe HIT Policy Committee:HHS43019. Alsoreferredtoas "the Committee"in discussionbelow. 1 Feel free to contact author: Henry Perretta -perretta@ix.netcom.com 2 Some links aretoother sections in this document as well.
  4. 4. perretta@ix.netcom.com Page 4 of 17  HITS: isthe HIT StandardsCommittee: HHS43018 (bothHITP and HITS are organizedasFACA committees (seeFederal AdvisoryCommittee Act(FACA)). The essential pointisthatFACA committeesmustbe opentothe public.  HITSP: The Healthcare InformationTechnologyStandardsPanel  "I": thisrefersto the authorof thisdocument: HenryPerretta. (Ijustwantedtomake clear in some caseswhere Iwas supposing the intentof variouscommitteecomments).  MU: Meaningful Use (asdefinedin ARRA)3 .  ONCHIT: Office of National Coordinatorof HealthInformationTechnology - headedbythe Coordinator;andreportingdirectlytothe Secretaryof Health& HumanServices. o ONCHITsupportsboththe HITP andHITS committees.  PHI: ProtectedHealthInformation  The Statute: ARRA and HITECH.  "We": thisisintendedtomeanthe HITS committee. Sorry,Iwaslazyand didn'twant to spell out "the Committee"eachtime thiscame up. Setting The Tone for the HITS Committee HITS Mission  HITS needstoget the standardsright - not forthe sake of the standardsthemselves - butfor "the largerpicture". Thisbiggerpicture can be framed aroundthese twoissues:  Providingaccesstocare  Organizingthe US healthcare system forefficientdeliveryof that care - forboth individuals and groupsof individuals.  So HITS needstokeepinmind:how will HITS'recommendationsleadto meaningfuluse (abbreviatedbelow as'MU') and to efficienthealthcare deliverytobothindividualsand groupsof individuals.  How we manage informationisthe singlebiggestconsiderationinaddressingthe above issues; and ONCHIThopesthe HITS committee ("HITS") canhelplaythe groundworkforthatmission. The ultimate goal of our workis to helpenable healthinformationtechnology(HIT) thatsupportsthe accessible,safe,efficient,effective andcompassionate deliveryof UShealthcare.  The central requirementwe face - isto make itpossible for"meaningfulusers"totake advantage of the incentives&assistance affordedthemviathe HITECHlegislation;beginning1/1/2011.  HITS responsibilitiesinclude  Recommendationsforrelevantstandards  Updatingof existingstandards  Guidelinesfortestingof standards(through NIST) 3 See -for example -this citation fromARRA(page356): MEANINGFULUSE OF CERTIFIED EHR TECHNOLOGY.—The eligible professional demonstrates to the satisfactionofthe Secretary, in accordance withsubparagraph (C)(i), thatduring such period the professionalis using certified EHR technology ina meaningful manner,whichshall include the use ofelectronicprescribing as determined tobe appropriate by the Secretary.
  5. 5. perretta@ix.netcom.com Page 5 of 17 8 Areas of Focus forHITP & HITS  The "startingpoints" - thatis: 8 areaswhere standardsare needed - stemfromHITECH (see page 117 inARRA). 1. Privacy & Securityprotections&safeguards 2. Requisite HITInfrastructure to allow forhealthinformationexchange 3. Utilizationof certifiedEHRsystems - sothat all Americansare representedinsuch systemsby 1/1/2014 4. Improve healthcare quality 5. Fosterpublicunderstandingof HIT 6. Processto coordinate policy amongstHITP,HITS, and otherhealthexchange bodies 7. Technologiesallowing authorization,authentication,andthe renderingof PHIto be unusable4 . 8. Supportof vulnerable populations Timing  We needtofigure outstandardsto getto true implementationof MU by1/1/2011. If we move backwardsfromthat date to today - itreallymeanswe have anacceleratedtimeline; whenwe take intoaccount HITS' work;HITS' parallel dependenciesonHITPactivities;the needforcontinual vettingandreview,andthe "harmonization"of HITSworkwithotherrelevantorganizations: in otherwords - the statutory"rule makingprocess".  LookAhead When Setting The StandardsBar:The HITS committee (abbreviated'HITS'throughout thisdocument) should"skate towhere the puck will be". This'principle'of HITS' activitieswas implicitlymentionedthroughoutthe day'sdiscussions.  Example: HITS couldmandate the use of prescriptiondrugdataexchange formatsasNCPDP specifiedinHIPAA. But the "puck"is moving: as e-Prescribinggainsmomentum,there will be feasibility(andmarketimpetus)tomovingtowardsmedicationhistorychecking, treatmentadherence,anddrug-druginteraction. HITSshouldbe cognizantof the latterin itsstandards-settingactivities. Conceptual graphicimmediatelybelow HITS StandardsIncludesImplementation  Unlike HITSP and othersimilarHITinitiatives, HITShas a charter to go beyond"certification standards/ specifications" - andestablish implementation &testing criteria as well.  In the past we have nothad an alignmentbetweenstandardssetting - andimplementation.There wasn'ta drive to "breakdownthose silo's". 4 Author's Note: I believe there are several purposes for this: a) de-identification of PHI for purposes of population based health studies/uses; b) safeguards in the event of a security breach; - and probably other reasons I'mnot thinkingof. Don't shoothere (NCPDP format) Shoot here (NCPDP format PLUS meds history -for example)
  6. 6. perretta@ix.netcom.com Page 6 of 17 HowDo We MeasureSuccess?  SuccessinHIT deploymentisrealizedwhenwe have transparencyforproviders(doctors,hospitals, etc.);payers;andpatients. RuleMakingProcess &ONCHIT'sRole  HITS recommendationswillinformthe Secretary'sdecisionsoncertificationandincentives. Note that HHS must make HIT standardsdecisionsconsistent/congruentwith the Federal Health InformationTechnologyStrategicPlan. A simplisticview of thisprocess: HITS Recommendations HHS Reviews HHS EstablishesRules consistent with IT Plan The Expedited Rule Process  There isan expeditedprocesstogetto the 12/31/09 rule makingdeadline. Inthisprocess,HHScan issue an"interimfinal rule". Inaddition,CongressallowsHHSto "looktoprior work"when developingthe interimfinalrule. Clickhere forfurtherdescriptionof the Federal expeditedrule process5 . The NormalRule Process  To illustrate thisapproach: HITSwouldsenditsrecommendationstothe Coordinator;andthen there wouldbe anopportunityforpubliccomment. Foran example of the "normal rule process"at work clickhere (example of ICD-10rule makingprocess). CoordinationWithOther Organizations  In general, "the statute"doesallowHITStohear fromanyone regardingdevelopmentof standards - includingcertificationcriteria. HITP  Obviouslythisisthe mostimportantbodyforHITSto coordinate with. HITPsetsthe prioritiesfor HITS focus. ONCHIT isthe "glue"coordinatingactivitiesof bothcommittees.  On 5/11/09, the HITP decidedthere wouldbe 3"workingsubgroups":  Meaningful Use (MU)  Note that there will be recommendationsfromHITP - but there will be a regulatoryprocessaroundHITPMU definitions.  Example MU areas (merelyillustrative,althoughlikelytobe addressedbyHITP):  MedicationsManagement  Care Coordination  Lab workflow  InformationExchange  Certification  NOTE: PrivacyandSecurityare a commonconsiderationforall 3 subgroups 5 From the text: A guide to federal agency rulemaking by Jeffrey S. Lubbers.
  7. 7. perretta@ix.netcom.com Page 7 of 17 CCHIT  Question: regardingthe certificationcriteriaprocess:how doesthe CCHITfitin? What does HITS do aboutcertificationcriteriathatdonotyet exist?  Answer:we are lookingatrecommendationsfor a) MU, and b) developmentof certification standardsthat do notexisttoday. LeveragingHITSP's Work  Question:howdoes HITSPDEFINITION_HITSBandthatbody'sworkwithinteroperability standardsplayintothe work HITS will take on?  Answer: InHITSP's approach - interoperabilitystandardswere drivenfromuse case scenarios. ARRA/HITECHhowever,have adifferentconstructforstandardsformulation. However,HITSB's interoperabilitystandardshave gone thruaharmonizationprocess;andmuchof the work that HITSP hasdone can be of use to HITS.  Author'sNote: BelowItriedto depictthe conceptI think JohnHalamkawasconveying:6 AllowingforInnovation  HITS needstobalance standardsettings:  On the one hand,the standardsneedto be prescriptive &constrainedenoughtoprotect the public;andto enable true healthinformationexchange capability.  For example:Whensettingstandards,we needtobalance between"leavingrural and small providerorganizationsbehind" - and- keepingthe statusquo.  On the otherhand,HITS doesnot wantto stifle innovationandcreativity. Inotherwords - by wayof example:When settingstandards,HITSshould tryto"stay aheadof the puck" - and allowEHR andHIE developerstoextend functionalityandperformance intheir products - while allowingthemtodelivercertifiableproducts.  The above considerationisone thatONCHITdealswith continuously.  One of the committee participantsofferedananalogy - the cell phone industry: standardsneedto allowforinnovationssuchasthe iPhone onone hand - butmakingsure innovationslikethe iPhone still can'talk' to any other cell phone andcell phone network. Bottom Line: in standardssetting: allow foran evolution inthe marketplace. 6 Author's note: I really only followed this discussion ata very rudimentary level. But the overall pointis: HITSB interoperability specificationscan bea very useful resource to inform the standards developed by HITS. HITSP Use Case (from a HITSP InteroperabilitySpec - click here for example) HITS transformsthe use case intoa dictionaryof sortsto helpdefine a particularmeaningfuluse (MU).
  8. 8. perretta@ix.netcom.com Page 8 of 17 OrganizingHITS for Feedback  Committee MemberComment: Inourwork,HITS needstobe cognizantof the fact that a 'waterfall approach' needstoallowfor"fastfeedback".  Author'sNote: I believethe commenterwastalkingaboutaway forHITS to quicklyreceive focusedandclearfeedbackonHITS recommendationsrapidly. Probablythisprinciple holds for a numberof "cycles" - such as: feedbackfromHITP;fromthe Coordinator;fromother standardsbodies;fromthe Secretary;from the public(e.g.thruthe publiccomments process). Timeline Related Topics BeginningHITS'Work  From a timelineperspective,atleastintheory,HITS'workisdependentonrecommendationsfrom HITP. However,overalltime constraintsdonotallow suchaclean'waterfall'sequenceof events. HITS needstocommence worknow - andthis isnot as badas itsounds: reasonable assumptions can be made rightnowon where HITPis likelytofall whereitcomestoareasof MU formulation; and certification priorities.  For example,the factthatHITP isorganizedinto3 sub-groupsisalreadyacue. See HITP on page 6. FormulatingAnImplementationRoadmap inLightof Other Imperatives  HITS (andONCHIT andHITP) needtobe cognizantof the fact that duringthe nextfew years,HIT vendorsandHIT 'meaningful users'willneedtograpple withotherstandardsmandatesaside from those stemmingfromHITECH;in particular:  The rolloutof new HIPAA Transaction& Code setstandards:  The X12 Version5010 and NCPDPVersionD.0standards  ICD-10 standards  We needtodevelopatimeline andfleshthattimeline outasa "roadmap"for all stakeholders - so that all relevantparties(vendors,policymakers,standardsbodies,providers,etc.) canunderstand theirresource needsandtriage appropriately. See below: 1/2012 - 5010 & NCPDPD5 10/2013 - ICD-10 1/2014 - NationwideEMR's HITS Standards Vetters,Reviewers,Users Feedback
  9. 9. perretta@ix.netcom.com Page 9 of 17  For example: the ICD-10code setallowsfor~170K diagnosescodes - ordersof magnitude more than the existingICD-9set. ObviouslyEHR'sand HIE facilitiesmustallow forthistosupport meaningful use;andimplementationspecificationsmusttake intoaccountthe impacton vendors and providers. Don'tForgetAdministrativeFunctions  As a corollarytothe discussion FormulatingAnImplementationRoadmap (see page 8), we donot wanta failure inmeetingthe 1/2014 milestonebecause providersare more concernedaboutbeing paidthan theyare about implementinganEHR. Atminimum, HITSneedstobe cognizantof health plan<-> providertransactionswhensettingstandards. HITECH incentivesandMU are not that attractive whenitcomesto providersmaintainingreliable cashflow.  Bottom line: the "HIT Roadmap"needstotake intoaccount providers'needstosupport"health planadministrative"transactions - particularlyeligibilityverification,claimssubmissionand payment. Setting Standards  General comment made duringthe discussion:the statute allows thatcan changeover time - you don't have to justthink about these standards (and Meaningful Use(MU) criteria) as "frozen for implementation" in 2011. Of course, some standards and MU criteria MUST be in placeby 1/1/2011. Defining TheProcess  Major inputsinformHITSstandardsrecommendationsactivities: HITP Guidance HITS Statute HITS subgroup work Work from other teams/orgs (e.g. HITSP)
  10. 10. perretta@ix.netcom.com Page 10 of 17 Meaningful Use  MU drivesthe needforstandards. AlthoughMeaningful Use (MU) isHITP's domain,the Committee discussedlikelyMUareas - to start a discourse onlikelystandardsareasthatHITS will needto address. Likely HITP MeaningfulUseAreas AlthoughHITPhas notissuedMU guidance; itis not a bad betthat MU areas will include(amongother topics): 1. ePrescribing:particularlygoingbeyondsimple electronicorderentry/dataexchange - and movingto"where the puck will be"- meaning:medicationmanagement; applicableuse information; drug-druginteraction;treatmentadherence;etc. 2. Lab 3. Clinical Summary - for purposesof care coordination.  The ideahere isto allowa providertocorrelate patientstatusat(forexample) the point of orderentry. A "Clinical Summary"inthiscontextwouldinclude thingslike aproblem list;allergylist;recenttreatmenthistory;summarieswhere relevantforradiology/ pathology/discharge summaries;etc.  Obviously"Clinical Summary"wouldneedtobe definedabitmore specificallythan above. 4. Quality Measuring Settingand AdjustingtheStandardsBar  The Committee discussedanother"property"of standards - notjust the standarditself;notjust WHEN a standard neededtobe implemented -buthow ambitious (or"difficult")the standardshould be to reach. The monikerusedhere was"settingthe bar". TradingOffBarHeight  If a standard'sbar is too high - itmay be too difficulttoreach - especiallyinlightof othermandates such as those discussedin FormulatingAnImplementationRoadmapinLightof OtherImperatives on page 8.  If the bar istoo low - the standardas implementedmaynottrulysupportthe meaningful use - and meaningful OUTCOME- that HITP (andultimatelyHHS) intends.  On the otherhand - we want the bar low enough(justright) sothat "meaningfulusers"can realisticallyobtainandimplementacertifiedEMRandget supportthruthe HITECH statute. Particularlyrelevantforsmall providergroupsandsmall hospitals(asalludedtoduringthe discussion - some hospitalshave 1to3 IT staff!).  The "bar height"all dependsonthe standardandhow thatstandard supportsthe Meaningful Use (MU) in question. The example discussed:  If an MU isrelatedtodramaticallyincreasingthe use of Secure Messaging(forsome meaningful outcomepurpose) - thenthe correspondingHITSstandardsrecommendations may be relativelylowin termsof "the bar". That's because HIPAA Securitystandardsthat
  11. 11. perretta@ix.netcom.com Page 11 of 17 wentintoeffectin2005 mightalreadyaddress/supportthe HITSstandardscomposedfor "Secure Messaging". AdjustingBarHeight Over Time  Call thisthe "Pole Vault"scenario. Thatis: the ideaisthat a standard's'bar' can be specifiedbyHITS to be raisedovertime.  For example - perhapsameaningfuluse (MU) isconcernedwithcoordinationof care. Perhapsone of the applicable supportingstandardsisforsecure messaging. The barmightbe set low initially - to allowperson-to-personmessaging(e.g.forsecure e-mail);butmightbe "raised"fora laterdate - to allowformachine-to-machine transmissions. StandardsSettingin an AsynchronousStandardsWorld  The gist of thisdiscussion wasallowingforthe factwhensettingstandardsinHIT; we mustallowfor the fact that "otherthingsare changingwithrespectto providers'use of technology - andthese are happeningindependentlyof eachother - and happeningatdifferenttimesrelativetostandard implementationdeadlines".  Thus,HITS needstofactor in the followingwhensettingstandards:  The existinginvestmentinIT- particularlyat providers. Tothe fullestextentpossible, standardsmustbe able tobe "retrofitted"toexistingsystemsandapplications.  The other considerationhereisthe needtoallow forthe learningcurve of providerusers; fromseveral angles:  Some providersmaybe usingapplicationstoday - butwe needto considertheir learningcurve astheybeginimplementingandusingcertifiedEMRsystems.  Some providers may be usingfew or no applications - and may have an even steeper learningcurvethan those above.  We need to avoid the "frozen interface syndrome".  For example: the Open Systems Interconnect (OSI) data communications standardsbecameobsolete - because they were stagnant and did not move ahead. Result: TCP/IP quickly replaced OSI as the de facto data networking standard.  The other (perhaps more relevant) example cited: is the situation with HL/7 Version 2.21. 7  We must allowfor standards to be "upgraded" and updated over time. HITS' standards' philosophy needs to accommodate the differingrates & timings of changes in application,system,sub-system, hardwareand networking technologies. 7 Author's Note: I think the Committee person who cited this example was alludingto the fact that perhaps interoperability standards wereproposed around HL/7 2.21 - however in the meantime HL/7 moved on to versions 2.3, 2.4, 2.5 and 3.0.
  12. 12. perretta@ix.netcom.com Page 12 of 17  Below is a conceptual graphic. Think of several layers of standards supportingcertified HITapplications. Each layer "moves forward"to the respective next levels (depicted as black diamonds) atdifferent rates and at different times.  The point is: the HIT standards fromHITS - needs to be relevant and support multiplelevels of standards "below" this top level. HIT Standards Sub System Software and Transaction Standards (e.g. HL/7, HIPAA, CORBA) Data Communication Standards (TCP/IP, PKI, etc.) Candidate Standards Areas SecureMessaging  One otherMU possibility: howaboutanarea centeredon Secure Messaging?  In otherwords: an area that dealswith:whatdowe replace FAXof 'free textinformation' with?  The concept here isstart withan MU area where we canset the bar relativelylow initially. Secure Messagingwouldneedarelativelylow level of technicaleffortintermsof formatted/codifieddataspecification. We'dbasicallybe tryingtoatleastenable further "digitization"&supportedelectroniccommunicationsmanagementcapabilitytodeal with free textcommunications - betweenandamongstproviders,patients,pharmacies,payers, etc.  Secure MessagingwouldnaturallyleadtoHITS standardsforauthentication,dataintegrity,and confidentiality. Overall,thissetsthe stage forfurtherstandardssettingfor Machine-to-Machine Data Exchange.  Note that HITSB developeduse casesforSecure Messaging - helpingHITSeffortsinthis"MU area".
  13. 13. perretta@ix.netcom.com Page 13 of 17 Movingto Machine-to-MachineDataExchange  In the contextof standardssetting - the Committee talkedabout anevolutioninstandards - thatis: goingfrom"humanto human viamachine"standards(example: secure messaginginsupportof personto personcommunicationsof free text) --- to --- machineto machinedataexchange.8  The ultimate goal are standardsto enable machine interoperabilityanddataexchange. Here again, the Committee needstoshootto where the puckwill be: Semanticand Syntactic Note:forboth the discussionof Secure MessagingandMovingtoMachine-to-Machine DataExchange the conceptof semanticandsyntacticdata exchange wasdiscussed.  Author'sNote: I believe the concepthere isthat"syntactic"dataspecificationsstipulate the allowable formatof data(allowable values;length;allowable charactersets;etc.);anda semanticspecificationspellsoutthe meaning of thatdata. Clickhere forfurtherinformation. I wouldguessthatone musthave agreementonSYNTACTICspec'sbefore one canimpose SEMANTICspec's ona givenstandard. Fast Path to Medical Data  The Committee talkedaboutanotherHITneed: a"fast path"to Medical Data. The problemtodayis that manyHIT / EMR systemswill supportavaluable function - butGETTING to that data varies enormously - andbecomesahindrance toproviderstaff tryingtocare for a patient.  So the "candidate standard"here wouldbe astandard presentation format(perhapswithsome guidelinesforstandardusernavigationtodataas well).  There isan analogyto thisproblem&solutiontoday:  For healthcare eligibilityinquiry&response, the HIPAA TCSrule mandatesthe use of the 270/271 transaction. Thisonlyspecifiesamachine - to- machine format. HoweverCAQH's CORE projectextendsthatstandardandattemptsto specifythe presentationof that informationinproviderapplications. 8 By way of illustration: "EDI"(electronic document interchange) is/arestandardsfor this purposeexpressly;as are HL/7 standards. Lab Other Sources/ Uses Problem Lists Rx Machine-Machine Info Exchange
  14. 14. perretta@ix.netcom.com Page 14 of 17 Images  Inclusionof Image dataisimportantfor EMR systems - andfor HIE exchange functionality. Most likely,imageinformationcanplayapart in a MU scenario. ImplementationStandards  The Committee needs to consider that implementing an EMR application(s) can takea lot longer than originally anticipated - especially sinceyou haveto deploy extremely carefully to maintain patient safety9 - in other words: "do no harm" while implementing.  James Walker cited an example from Geisinger; where they implemented an EMR application after 50 THOUSAND hours of testing. In spiteof that exhaustivetesting effort, the Geisinger team still had to address 4,192 issues AFTER deployment!  Bottom Line: implementation timelines need SupportingAPatient-CentricApproach  Here the discussionrevolvedaround information capturestandardsinsupportof 4 general areas: 1. Healthybehaviors 2. Managementof patientconditions(inotherwords:treatment) 3. Outcomes - beyondmortalityandbroadmorbiditymeasures 4. Patientengagementinhealthcare decisionmaking Setting Up HITS Workgroups  Like HITP; HITS figuresthe bestwayto focuson the taskat handwouldbe to organize intosub- groups - witheachsub-group(aka"workgroup") focusedonone aspect of HITS activities.  The firstideaproposed: whynotorganize HITS alongthe same linesasHITP's subgroups ('meaningfuluse'(MU),informationexchange,andcertification/adoption)?  One disadvantage of thatapproachdiscussedbythe group: HITP'ssubgroupsdo nothave an explicitprivacy&securityworkgroup. Goingback to the "8 areas"of focus - note that 2 of these areasare explicitlyrelatedtoprivacy/security (Privacy&Securityitself;and 'technologiesrelated toPHIprotection&renderingPHIunusable whenneeded).  Another workgroup "set" proposal was discussed:  AdministrativeTransactions  Clinical Care  Security constructs  Quality measurements (for patient status,and outcomes)  A final workgroup "set" was discussed and decided:  Clinical Operations (includinge-Prescribingand Clinical Summary)  Here we talked about standards thatgo beyond the current state - example: "Ok, you have implemented e-Prescribingwith NCPDP formats --- now here are standards to supporta Meaningful Use (MU) of checkingfor drug-drug interaction".  In other words: are we managing the patient - as opposed to simply collectingand moving data around electronically?  Clinical Quality 9 And, in fact, hopefully improve patient safety.
  15. 15. perretta@ix.netcom.com Page 15 of 17  In the "quality"area we talked about going beyond what data needs to be collected - and includingWHO collects itand WHEN they collectit.  We had a littlesidebar discussion hereas well - HITECH in this area should be informed by NQF (the National Quality Forum); evidence based medicine; and desirablepractice outcomes.  We also haveto allowfor the impactof ICD-10 and how that meshes with quality standards from HITS.10 The same is true for SNOMED.  Privacy and Security  Covering at leastdata transport- and user authentication. For all 3,we do need to keep an eye on the HIT administrativetransaction standards (meaning HIPAA 5010). Communications  We considered a fourth group - focused on communications: in other words; how are we going to communicate with all groups in near real time? By "groups" - we meant stakeholders likeproviders and the public. HITSB, by way of example, formed a communication committee early on for exactly this function.  The general concept is reflected below conceptually - from 2 perspectives:  What is "informing"the work of HIT  What stakeholders existfor communications for a variety of purposes. 10 Another example of "shootingwhere the puck will be". HITECH ARRA Other Standards bodies - NCVHS, NHIN, etc. Providers & IndustryStakeholders The Public at Large HITS
  16. 16. perretta@ix.netcom.com Page 16 of 17 HITS Project Plan & Next Steps  HITS committed to a '90 day turnaround' to providerecommendations. In other words: Next Steps  The nextitemsforHITS:  The HITS co/chairswill workwithcommitteeonwhowill leadeachsub-groupandwhat each subgroupwill do.  ONCHITwill give date guidance toHITSfor deliverables. HITS gets MU and/or standard guidancefrom HITP Applicable HITS workgroup(s) formulates standard(s) for MU 60 days Full HITS committee vets - and forwards to Coordinator as recommendation. 30 days Coordinatorapproves and forwards to Secretary
  17. 17. perretta@ix.netcom.com Page 17 of 17 Figure 1: HITECH Timeline 5/12/2009 12/31/2018 January 2014 All Americans have EHR March 2010 Budget for EMR Criteria National Coordinator a) submits requests for additional funding to Congress; b) appoints Chief Privacy Officer of the Office of the National Coordinator; c) Secretary reports on progress on grants for IT training embedded in clinical training (e.g. Medical Schools); d) Secretary issues guidance on the most effective and appropriate technical safeguards Jun-09 HIT Standards Plan a) HIT Standards Committee shall develop a schedule for the assessment of policy recommendations developed by the HIT Policy Committee b) Coordinator issues guidelines for Regional Extension Centers 12/2009 Certification Stds Not later than December 31, 2009, the Secretary shall, adopt an initial set of standards, implementation specifications, and certification criteria 3/1/2011 Report to Congress Secretary reports to Congress: a) actions taken, b) issues encountered; c) recommendations for full EMR adoption d) incentive ideas for FQHC & rural providers & free clinics; e) aging services technology. Secretary shall issue guidance on how best to implement the requirements for the de-identification of protected health information 9/1/2011 PHI Minimum Use Defined Not later than 18 months after the date of the enactment of HITECH,a) the Secretary shall issue guidance on what constitutes ‘‘minimum necessary’’ for purposes of subpart E of part 164 of title 45, Code of Federal Regulation; b) similar to (a) – but wrt payment for PHI disclosures 3/1/2014 Report on Impact Not later than 5 years after the date of enactment of this section, the Government Accountability Office shall submit to Congress and the Secretary of Health and Human Services a report on the impact of any of the provisions of this Act on health insurance premiums, overall health care costs, adoption of electronic health records by providers, and reduction in medical errors and other quality improvements. Important Milestones legislated in HITECH portion of ARRA 5/14/09

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