[RIN 0991-AB93] I. Introduction

Transcription

1 1 Summary f Prpsed Rule 2015 Editin Health Infrmatin Technlgy (Health IT) Certificatin Criteria, 2015 Editin Base Electrnic Health Recrd (EHR) Definitin, and ONC Health IT Certificatin Prgram Mdificatins I. Intrductin [RIN 0991-AB93] On March 30, 2015, the Office f the Natinal Crdinatr (ONC) fr Health Infrmatin Technlgy (HIT) caused t have published in the Federal Register a ntice f prpsed rulemaking (NPRM) t prpse 2015 Editin Health Infrmatin Technlgy (Health IT) certificatin criteria (2015 Editin) fr electrnic health recrd (EHR) technlgy fr meaningful use (MU) under the Medicare and Medicaid EHR Incentive Prgrams; t prpse a new 2015 Editin definitin f Base EHR, and t prpse changes t the ONC Health IT Certificatin Prgram t make that prgram mre pen and accessible t additinal types f health IT and health IT that supprts varius care and practice settings. The NPRM seeks cmment n a significant number f issues, and the deadline fr submissin f cmments is May 29, Cmments must be identified by RIN 0991-AB93 and may be submitted thrugh the Federal erulemaking Prtal ( thrugh the mail, 1 r by hand delivery r curier. 2 ONC fcuses n hw health IT certificatin may supprt an interperable natinwide health infrmatin infrastructure and the health care cntinuum thrugh the use f certified health IT. Specifically, ONC prpses the fllwing: Imprve interperability. T adpt new and updated vcabulary and cntent standards fr the structured recrding and exchange f health infrmatin, including a Cmmn Clinical Data Set cmpsed primarily f data expressed using adpted standards; and rigrusly testing an identified cntent exchange standard (Cnslidated Clinical Dcument Architecture (C-CDA)). Facilitate accessibility and exchange f data. T revise the 2015 Editin Base EHR definitin by including enhanced data prtability, transitins f care, and applicatin prgramming interface (API) capabilities. ONC Health IT Certificatin Prgram. T establish a framewrk that makes the prgram pen and accessible t mre types f health IT, health IT that supprts a variety f care and practice settings, varius HHS prgrams, and public and private interests. EHR Incentive Prgrams. T adpt a set f certificatin criteria t supprt the Stage 3 prpsals f the Medicare and Medicaid EHR Incentive Prgrams. 1 Address: Department f Health and Human Services, Office f the Natinal Crdinatr fr Health Infrmatin Technlgy, Attentin: 2015 Editin Health IT Certificatin Criteria Prpsed Rule, Hubert H. Humphrey Building, Suite 729D, 200 Independence Ave, S.W., Washingtn, D.C Submit ne riginal and tw cpies. 2 Address: Office f the Natinal Crdinatr fr Health Infrmatin Technlgy, Attentin: 2015 Editin Health IT Certificatin Criteria Prpsed Rule, Hubert H. Humphrey Building, Suite 729D, 200 Independence Ave, S.W., Washingtn, D.C Submit ne riginal and tw cpies.

2 2 Address health disparities. T prvide certificatin t standards fr the cllectin f scial, psychlgical, and behaviral data, fr the exchange f sensitive health infrmatin (Data Segmentatin fr Privacy), and fr the accessibility f health IT. Privacy and security. T ensure all health IT presented fr certificatin have the relevant capabilities. Patient safety. T imprve patient safety by applying enhanced user-centered design principles t health IT, enhancing patient matching, requiring relevant patient infrmatin t be exchanged, imprving the surveillance f certified health IT, and making mre infrmatin abut certified prducts publicly available and accessible. Reliability and transparency. T increase the reliability and transparency f certified health IT thrugh surveillance and disclsure requirements. Certificatin flexibility. Prvide health IT develpers with mre flexibility and pprtunities fr certificatin that supprt bth interperability and innvatin. ONC repeatedly ntes thrugh the prpsed rule that it intends t make the ONC Health IT Certificatin Prgram mre pen and accessible t ther types f health IT beynd EHR technlgy and fr health IT that supprts care and practice settings beynd the ambulatry and inpatient settings used fr purpses f the EHR Incentive Prgrams. ONC cnsiders the prpsed rule t be ecnmically significant (having an annual effect n the ecnmy f $100 millin r mre). II. Applicatin Access t Cmmn Clinical Data Set ONC prpses a new certificatin criterin fr applicatin prgramming interface (API) named the Applicatin Access t Cmmn Clinical Data Set. This criterin wuld require the demnstratin f an API that respnds t data requests fr any ne, and fr all, f the data referenced in the Cmmn Clinical Data Set (CCDS). ONC seeks t validate the cntinued interperability f certified health IT and the ability t exchange health infrmatin by prpsing a new certificatin criterin t rigrusly assess a prduct s C-CDA creatin perfrmance (fr bth C-CDA versin 1.1 and 2.0) when presented fr certificatin fr such capabilities. III. Revisins t Terms and t Definitins f Certain Terms ONC wuld make the fllwing name changes fr the 2015 Editin certificatin criteria: The term EHR Mdule wuld becme Health IT Mdule. The term EHR technlgy wuld becme health IT. Base EHR. Fr purpses f the 2015 Editin, ONC prpses several changes t the definitin f the term Base EHR as fllws: 1. The term wuld be named 2015 Editin Base EHR and the current term wuld be redesignated as 2014 Editin Base HER. 2. It wuld exclude privacy and security capabilities and certificatin criteria. Privacy and security capabilities wuld be addressed by requiring health IT develpers t meet privacy and security certificatin criteria rather than impsing the duty n eligible prfessinals (EPs) and eligible hspitals and eligible critical access hspitals

3 3 (cllectively EHs) t ensure that their technlgy is certified t the necessary privacy and security criteria. 3. It wuld nly require the capability t recrd and exprt clinical quality measure (CQM) data meaning that the definitin wuld n lnger include capabilities t imprt, calculate and reprt CQM data r any ther CQM-related requirements. 4. It wuld include the 2015 Editin smking status and implantable device list certificatin criteria as patient demgraphic and clinical health infrmatin data. 5. It wuld include the 2015 Editin applicatin access t Cmmn Clinical Data Set certificatin criterin t bth capture and query infrmatin relevant t health care quality and exchange electrnic health infrmatin with, and integrate such infrmatin frm ther surces. Thus, all EPs and EHs wuld have t adpt a Health IT Mdule certified t this criterin t meet the CEHRT definitin. 6. It wuld include the 2015 Editin Health IT certificatin criteria crrespnding t the remaining 2014 Editin referenced in the 2014 Editin Base EHR definitin (shwn in the table 5 f the prpsed rule and reprduced belw). Table 5. Certificatin Criteria Required t Satisfy 2015 Editin Base EHR Definitin Base EHR Capabilities Certificatin Criteria Patient demgraphic and Demgraphics (a)(5) clinical health infrmatin Prblem List (a)(7) Medicatin List (a)(8) Medicatin Allergy List (a)(9) Smking Status (a)(12) Implantable Device List (a)(20) Capacity t prvide clinical Clinical Decisin Supprt (a)(10) decisin supprt Capacity t supprt physician Cmputerized Prvider Order Entry (a)(1), (2) r (3) rder entry Capacity t capture and query Clinical Quality Measures (c)(1) infrmatin relevant t health care quality Capacity t exchange electrnic health infrmatin with, and integrate such infrmatin frm ther surces Transitins f Care (b)(1) Data Prtability (b)(6) Applicatin Access t Cmmn Clinical Data Set (g)(7) Direct Prject (h)(1) r Direct Prject, Edge Prtcl, and XDR/XDM (h)(2) ONC prpses t cntinue the same plicy n marketing; thus develpers may market their technlgy as meeting the 2015 Editin Base EHR definitin when their Health IT Mdules are certified t all the 2015 health IT certificatin criteria shwn abve. CEHRT. ONC prpses t discntinue use f the term CEHRT under its regulatins. ONC reasns that since the term is used t supprt the EHR Incentive Prgrams, it shuld nly be part f thse regulatins. ONC ntes that the Centers fr Medicare & Medicaid Services (CMS) prpses t adpt a CEHRT definitin (in 42 CFR 495.4) that cvers all the relevant cmpliance

4 4 timelines and wuld still refer t the relevant Base EHR definitins and certificatin criteria adpted by ONC. Cmmn Clinical Data Set (CCDS). ONC prpses t change the name f the Cmmn MU Data Set t the Cmmn Clinical Data Set; it als prpses additinal changes fr prpsed new and updated standards and cde sets as well as revisins t supprt patient safety thrugh clearly referenced data elements and new patient data; these prpsed changes wuld nly affect certificatin t the 2015 Editin. ONC prpses t include immunizatins 3 and Unique Device Identifiers f a patient s Implantable Devices in the CCDS fr 2015 Editin certificatin. Additinally, ONC wuld als include assessment and plan f treatment, gals, and health cncerns 4 fr 2015 Editin certificatin which are intended t replace care plan fields, including gals and instructins in the Cmmn MU Data Set fr in 2014 Editin certificatin. There was cnfusin amng stakehlders whether t interpret care plan fields, including gals and instructins as applying t a single patient encunter (r single inpatient stay) r as applying t a cmprehensive shared care plan (representing the synthesis and recnciliatin f multiple plans f care). ONC clarifies fr purpses f certificatin t the 2014 Editin that this is intended t be a single prvider s dcumentatin f their assessment, plan f treatment, gals, and health cncerns. ONC als seeks cmment n hw it may cntinue t engage the public t keep the CCDS relevant t clinical practice. ONC prpses t include the fllwing vcabulary standards fr the CCDS fr 2015 Editin certificatin: Health Level 7 (HL7) Versin 3 ( AdministrativeGender and a nullflavr value) fr sex, Race & Ethnicity Centers fr Disease Cntrl and Preventin (CDC) cde system in PHIN Vcabulary Access and Distributin System (VADS) and the Office f Management and Budget (OMB) standard fr race and ethnicity, Tags fr Identifying Languages Request fr Cmment (RFC) 5646 fr preferred language, The September 2014 Release f the U.S. Editin f Systemized Nmenclature f Medical Clinical Terms (SNOMED CT ) fr prblems and prcedures, The February 2, 2015 mnthly versin f RxNrm fr medicatins and medicatin allergies, Lgical Observatin Identifiers Names and Cdes (LOINC ) versin 2.50 fr labratry tests, and LOINC cdes, metadata, and relevant UCUM unit f measures specified fr vital signs. ONC ntes that fr race and ethnicity a Health IT Mdule must express bth detailed races and ethnicities accrding t the Race & Ethnicity CDC cde system and the aggregate OMB cde fr each race and ethnicity identified by the patient. 3 Immunizatins wuld have t be cded accrding t the CVX cde set (HL7 Standard Cde Set CVX Vaccines Administered, updates thrugh February 2, 2015) and the Natinal Drug Cde (NDC) cde set (NDC Vaccine Cdes, updates thrugh January 15, 2015) as part f the Cmmn Clinical Data Set. 4 Data wuld be included in accrdance with the C-CDA Release 2.0 Assessment and Plan Sectin (V2) r bth the Assessment Sectin (V2) and Plan f Treatment Sectin (V2); the Gals Sectin; and the Health Cncerns Sectin.

5 5 Use f FDA Definitins. ONC prpses t adpt the same definitins established by the Fd and Drug Administratin fr Implantable Device, Unique Device Identifier, Device Identifier, and Prductin Identifier. IV. ONC HIT Certificatin Prgram ONC prpses a number f changes t the certificatin prgram t reflect its gals f making the prgram mre pen and accessible t ther types f health IT beynd EHR technlgy and fr health IT that supprts care and practice settings beynd the ambulatry and inpatient settings used fr purpses f the EHR Incentive Prgrams. ONC prpses a significant number f terminlgy changes, including the fllwing: The name f the prgram wuld becme the ONC Health IT Certificatin Prgram (Prgram). References t HIT wuld all be changed t health IT (r Health IT in the case f its use as a prper nun). References t EHR Mdules wuld be changed t Health IT Mdules. ONC reassures readers that the prpsed name change f EHR Mdules is a change in name alne; it wuld nt affect the certificatin f previusly certified EHR Mdules, r the ability f EPs and EHs t use the technlgies t meet the CEHRT definitin. Of greater imprtance, ONC prpses t n lnger require ONC-ACBs t certify Health IT Mdules t the 2015 Editin meaningful use measurement certificatin criteria ( (g)(1) autmated numeratr recrding and (g)(2) autmated measure calculatin ). ONC ntes that develpers are welcme t seek certificatin t (g)(1) r (g)(2), especially since Stage 3 f the EHR Incentive Prgrams (as prpsed) wuld require EPs and EHs t have health IT certified t thse criteria t meet CEHRT requirements. Per the Health Infrmatin Technlgy Plicy Cmmittee (HITPC) recmmendatins, ONC develped prpsals t make the Prgram mre agnstic t care and practice settings. As nted abve, ONC prpses t remve meaningful use measurement certificatin requirements; it als prpses t add data segmentatin certificatin criteria t supprt settings fr patients with mre sensitive health issues, such as behaviral health, and t mdify 2014 Editin certificatin criteria by adding new r enhanced functinalities fr the 2015 Editin (e.g., transitins f care at (b)(1)). ONC anticipates issuing general interperability guidance fr the 2015 Editin, but it has n plan t independently develp r issue certificatin tracks by care r practice setting. It appears t be pen t wrking with ther agencies, prvider assciatins, etc., t identify functinality and certificatin criteria t supprt stakehlders. ONC als seeks cmment n future certificatin criteria t supprt lng-term pst-acute care, behaviral health, pediatrics, and ther care and settings. Its prpsal wuld als permit further referencing and use f certified health IT beynd the EHR Incentive prgrams. Health IT Mdule Certificatin Requirements. Privacy and Security. ONC prpses several changes t the privacy and security certificatin t the 2015 Editin. Under the new apprach, privacy and security (P&S) requirements will vary

6 6 based n the regulatry functinal area (i.e., Health IT Mdules with capabilities under ne r mre f the fllwing areas: clinical, care crdinatin, clinical quality measures, patient engagement, public health, transprt methds (and ther prtcls), and administrative functinal areas). The plicy wuld nt require each criterin t include all P&S functinalities but wuld include sufficient safeguards fr each criterin. Thus a Health IT Mdule presented fr any certificatin criteria that falls under a regulatry functinal area must be certified as either (i) technically demnstrating, thrugh system dcumentatin and certificatin testing, that it meets at least a minimal set f P&S certificatin criterin (referred t as Apprach 1 ) r (ii) demnstrating, thrugh system dcumentatin sufficiently detailed t enable integratin such that the Mdule has implemented service interfaces fr each applicable P&S criterin t enable access t external services t meet the P&S criterin (referred t as Apprach 2 ) as fllws: If the Health IT Mdule includes capabilities fr certificatin listed under: (a) Clinical (b) Care Crdinatin (c) Clinical Quality Measures (e) Patient Engagement (f) Public Health (h) Transprt Methds (and ther prtcls) (i) Administrative The Mdule must be certified t Apprach 1 r Apprach 2 fr each f the P&S certificatin criteria listed in the Apprach 1 clumn Apprach 1 Apprach (d)(1) (authenticatin, access cntrl, and authrizatin), (d)(2) (auditable events and tamper resistance), (d)(3) (audit reprts), (d)(4) (amendments), (d)(5) (autmatic lg-ff), (d)(6)(emergency access), and (d)(7) (end-user device encryptin) (d)(1) thrugh (d)(3) and (d)(5) thrugh (d)(8) (integrity) (d)(1) thrugh (d)(3) (d)(1) thrugh (d)(3), (d)(5), and (d)(7) (d)(1) thrugh (d)(3) and (d)(7) (d)(1) thrugh (d)(3) (d)(1) thrugh (d)(3) and (d)(5) thrugh (d)(8) Fr each applicable P&S certificatin criterin nt certified fr apprach 1, there must be system dcumentatin sufficiently detailed t enable integratin such that the Health IT Mdule has implemented service interfaces fr each applicable privacy and security certificatin criterin that enable the Health IT Mdule t access external services necessary t meet the privacy and security certificatin criterin. Appendix A f the prpsed rule includes a list f all P&S certificatin requirements fr each 2015 Editin criterin. ONC seeks cmment n the clarity and feasibility f this prpsal. Design and Perfrmance. Fr the 2015 Editin certificatin criteria, ONC-ACBs wuld have t certify a Health IT Mdule fr design and perfrmance as fllws: Certificatin Criteria Clinical: (a)(1) (10), (18), (20), (22), (23) Care Crdinatin: (b) (2), (3), and (4) All Criteria Clinical: (a) Care Crdinatin: (b) Patient Engagement: (e) Any criterin with C-CDA creatin capabilities Design and Perfrmance Criteria (g)(3) Safety-enhanced design (g)(4) Quality management system (g)(8) Accessibility-centered design (g)(5) Accessibility technlgy cmpatibility (g)(6) Cnslidated CDA creatin perfrmance (where multiple criteria require C-CDA creatin, (g)(6)

7 7 Certificatin Criteria Design and Perfrmance Criteria testing need nly be dne fr ne criterin) ONC-ACB Principles f Prper Cnduct: In-the-Field Surveillance. ONC prpses t require ONC-ACBs t initiate in-the-field surveillance f certified Cmplete EHRs and certified Health IT Mdules t assure that the technlgy cntinues t meet certificatin requirements when implemented and used in a prductin envirnment (i.e., in the field). ONC-ACBs wuld have t assess the capabilities in a prductin envirnment based n the use f the capability with prtected health infrmatin unless use f test data prvides an equivalent assessment. ONC ntes that in the field wuld nly ccasinally mean in-persn site visits; ONC-ACBs wuld cnduct mst assessments using remte methds. ONC seeks cmments n the prpsal, the methd fr cnducting the assessments, ways t minimize burden and csts, and apprpriate industry standards. ONC prpses bth reactive and randmized in-the-field surveillance as part f the ONC-ACB certificatin which wuld be enfrceable by the ONC-Apprved Accreditr (ONC-AA). Reactive surveillance wuld be a requirement fr ONC-ACBs t cnduct in-the-field surveillance when it becmes aware f facts r circumstances indicating questins regarding cntinued cmpliance f certificatin requirements (typically frm user feedback, including cmplaints). The ONC-ACB wuld als have t cnsider the impact and effect f disclsures by the develper n the prduct s cntinued cnfrmance t the relevant criteria (such as whether the develper substantially restricts r limits the capability s use r failed t disclse material infrmatin abut the implementatin r use f the capability) that culd substantially interfere with the use f capabilities. ONC ntes that an entire certified Cmplete EHR r certified Health IT Mdule culd be rendered nn-cnfrming; ONC expects the Natinal Crdinatr t priritize certain criteria fr surveillance fr which ONC-ACBs wuld give special scrutiny t cmplaints. ONC-ACBs wuld als have t verify the develper has met the mandatry disclsure requirements. ONC-ACBs wuld als cnduct randmized surveillance each year f 10 percent f certified Cmplete EHRs r certified Health IT Mdules it certified fr priritized criteria t detect patterns f nn-cnfrmance that culd give rise t a crrective actin plan. Randmized surveillance f certified Cmplete EHRs r certified Health IT Mdules may nt be dne mre frequently than annually, and in-the-field surveillance wuld be initiated at the lesser f (i) 10 lcatins r (ii) 5 percent f all lcatins at which the technlgy is implemented and in use. The lcatins wuld be selected at randm and reflect diversity f practice types, sizes, settings, and lcales. Where there is a pattern f nncnfrmity (defined as nncnfrmity with respect t any priritized criteria at 20 percent r mre f the lcatins), the develper wuld have t submit crrective actin plan within 30 days f a deficiency ntice. The plan wuld have t include, fr each certificatin criteria r disclsure deficiency, a descriptin f (i) the deficiency, (ii) the extent f the deficiency, (iii) the prpsed crrective actin (generally and at each surveilled lcatin), and (iv) the timeframe fr cmpletin f the crrective actin. The ONC-ACB may suspend (and later terminate) a certificatin if the develper fails t timely submit the crrective

8 8 actin plan; fails t cmply with ONC-ACB directins t address plan aspects that d nt meet applicable requirements; r fails t cmplete the plan within 6 mnths. ONC-ACBs wuld be required t reprt results f in-the-field surveillance t the Natinal Crdinatr at least quarterly (ONC ntes that currently there can be a 14-mnth lag between surveillance and reprting). Additinally, crrective actin plans wuld be reprted t the Certified Health IT Prduct List (CHPL) in a timely and effective manner (which means the data wuld be available t the public at least weekly). ONC ntes that these requirements are minimum requirement and d nt limit the ability r duty f ONC-ACBs t cnduct additinal surveillance. The requirements fr randmized surveillance wuld apply effective January 1, 2016; all ther requirements wuld be effective immediately. ONC seeks cmment n the timeline and ways t minimize disruptin. ONC-ACB Principles f Prper Cnduct: Transparency and Disclsure Requirements Citing myriad cncerns with the lack f transparency in the health IT marketplace, ONC prpses t strengthen its transparency and disclsure requirements under the Prgram. First, ONC prpses t mdify the requirement n develpers t cnspicuusly disclse any additinal types f csts a user may incur t implement r use the capabilities f certified health IT fr purpses f the EHR Incentive prgrams t expand disclsure fr all purpses within the certificatin nt just fr the EHR Incentive prgrams. Secnd, ONC prpses t expand the disclsure requirement t address mre than just additinal csts; ONC wuld have develpers disclse material infrmatin abut limitatins assciated with certified health IT prducts. Third, ONC prpses brader disclsure requirements and greater detail. Develpers wuld have t be mre practive in describing the types f limitatins and additinal csts that a user might pay (rather than the current standard wuld pay ) t achieve use within the prduct s certificatin, such as thse based n ptential cnditins applicable t a user r ptins available t a user. Develpers wuld have t prvide detailed descriptins f any material infrmatin n limitatins r additinal csts; the term material wuld mean that failure t disclse the infrmatin culd substantially interfere with a user s ability t implement the health IT cnsistent with the certificatin. Sme examples include the fllwing: Csts r fees t buy, license, implement, maintain, upgrade, use f supprt (r enable) the capabilities, r in cnnectin with data generated using the capabilities. Cntractual r ther limitatins n use fr any purpse within the technlgy s certificatin, r in cnnectin with data generated using the capabilities. Technical, practical r ther limitatins that culd prevent r impair successful implementatin, cnfiguratin, custmizatin, maintenance, supprt, r use f any capability, r prevent r limit use, exchange, r prtability f data generated using the capabilities. ONC seeks cmment n its examples abve; n whether it shuld revise r add types f infrmatin; and n whether it shuld require disclsure f mre specific cst structures.

9 9 ONC clarifies that develpers wuld nt have t disclse specific prices but wuld have t describe the nature and magnitude f additinal csts s a persn culd estimate thse csts, including infrmatin t help estimate cst t use the transitins f care capability. Develpers wuld nt have t disclse trade secrets r intellectual prperty r infrmatin f which they are unaware (such as csts/limitatins assciated with third party technlgies and services). ONC wuld expect develpers t prvide detailed descriptins f additinal cnsideratins a custmer wuld need t knw t reliably estimate csts and resurces required; hwever ONC wuld qualify this requirement based n the develper s knwledge f the custmer s circumstances and based n its range f experience (such as with ther custmers). Additinally, ONC-ACBs wuld have t get a vluntary public attestatin frm every health IT develper t which it issues (r has issued) a certificatin fr any editin f health IT. The attestatin wuld be a pledge t be transparent and wuld require the vluntary disclsure f the infrmatin described abve t (i) custmers befre prviding any certified health IT r related prduct r service, (ii) prspective custmers, and (iii) any ther persn n request. Only the attestatin wuld be required; cmpliance with the attestatin wuld be vluntary. ONC-ACB Principles f Prper Cnduct: Open Data Certified Health IT Prduct List (CHPL) In respnse t stakehlders wh believe that the links maintained by ONC-ACBs n the CHPL t test result summaries fr certificatin under the Prgram and the access t thse summaries as a PDF makes analysis difficult, ONC prpses t cnvert the CHPL t an pen data file represented in bth XML and JSON with accmpanying API functinality. ONC estimates this may take between 12 and 18 mnths. Fr the 2015 Editin and subsequent editins, ONC als prpses that ONC-ACBs reprt mre infrmatin t ONC in their weekly reprts n the current list f prducts n the CHPL. The infrmatin reprting requirements are apprximately duble what is required fr the 2014 Editin prducts included n the CHPL and are fund at (f)(1), as prpsed t be amended. ONC believes that the expanded list f data wuld subsume data included in the test result summaries; therefre, beginning with the 2015 Editin, ONC wuld strike the requirement fr ONC-ACBs t maintain hyperlinks t test result summaries. With respect t crrective actin plans under randmized in-the-field surveillance (described abve), the initiatin f such a plan wuld trigger the duty t reprt the surveillance-related data t be included in the pen data file this reprting is separate frm the quarterly reprting requirement fr all surveillance results. This reprting requirement applies t bth the 2014 and 2015 Editins certified health IT. Hwever, ONC-ACBs may nt reprt data that wuld identify any user r lcatin nr may they submit r disclse develper prprietary business infrmatin r trade secrets. ONC wuld prvide additinal guidance t ONC-ACBs regarding the reprting f this data. ONC seeks cmments n whether there are additinal data generated during testing that wuld be useful t the public t have disclsed. ONC-ACB Principles f Prper Cnduct: Recrds Retentin. ONC prpses t require ONC- ACBs t retain recrds related t certificatin f Cmplete EHRs and Health IT Mdules (including EHR Mdules) fr 6 years. ONC als prpses t make recrds f certificatins dne

10 10 under the Prgram available t ther agencies within HHS (such as CMS and the OIG) during the 6-year retentin perid. ONC-ACB Principles f Prper Cnduct: Cmplaints Reprting. ONC prpses t require ONC-ACBs t prvide the Natinal Crdinatr with quarterly lists f cmplaints received. The lists wuld specify the number f cmplaints, the nature f the cmplaints, and the type f cmplainant (i.e., prvider, develper etc.). ONC-ACB Principles f Prper Cnduct: Adaptatins and Updates f Health IT. ONC prpses t require ONC-ACBs t get reprts n a mnthly basis frm develpers f all adaptatins and updates (including changes t user-facing aspects) made t their certified health IT. ONC seeks cmments n whether mre frequently reprting is apprpriate. Even where a develper wuld have n adaptin r update t reprt, it wuld still have t prvide a recrd t the ONC- ACB indicating that there is n adaptin r update. ONC wuld nt require reprting f this infrmatin t ONC r t be included n the CHPL. The purpse f this reprting wuld appear t be t infrm ONC-ACBs in selecting certified health IT fr purpse f their surveillance duties. This wuld apply t health IT certified t the 2014 Editin and the 2015 Editin criteria, and wuld be effective beginning n the first calendar mnth that begins 30 days after the effective date f the final rule. Decertificatin f Health IT Request fr Cmment In the Cnslidated and Further Cntinuing Apprpriatins Act, 2015 (Public Law ), Cngress urged ONC (amng ther things) t use its authrity t decertify CEHRT that practively blcks infrmatin sharing. Nting that ONC-ACBs currently have the authrity t certify and terminate certificatins fr health IT, ONC seeks cmment frm all stakehlders n the circumstances, due prcess prcedures, remedies, and ther factrs it shuld cnsider in establishing new prgram requirements and prcesses fr ONC (r ONC-ACBs) t terminate certificatins. ONC encurages cmmenters t cnsider ptentially prfund asymmetric impacts that revking a certificatin culd create, including impacts n thse wh rely n the CEHRT fr the EHR Incentive prgrams and ther prgrams. V Editin Health IT Certificatin Criteria As in past prpsals fr new editins f certificatin criteria, the prpsed 2015 Editin criteria wuld retain sme f the 2014 Editin EHR certificatin criteria unchanged; mdify sme f the 2014 Editin criteria; prpse new criteria; update standards; and clarify regulatry text. One revisin is that the capabilities f each 2015 certificatin criterin apply t any health care setting unless therwise specified. Als, because Cmplete EHR certificatins will n lnger be issued beginning with the 2015 Editin, n criterin is labelled as ptinal [(thugh certain capabilities within a criterin may be s labelled)]. ONC ntes that all standards and implementatin specificatins have been develped r adpted by vluntary cnsensus standards bdies, except fr the fllwing where ONC was nt aware f any vluntary cnsensus standard that wuld serve as an apprpriate alternative: Transprt standards at

11 11 Electrnic submissin medical dcumentatin (esmd) at (a)(5)(iii) and (iv). Reprting syndrmic surveillance and immunizatin infrmatin t public health agencies at (d)(4) and (e)(4). Race and ethnicity at (f)(2). Prtectin f electrnic health infrmatin at ONC als includes in sectin VI f the prpsed rule a cmplete list the standards and implementatin specificatins it prpses t adpt, as well as a summary fr each and a unifrm resurce lcatr (URL). ONC als prpses t adpt the fllwing minimum standards cde sets (the first fur f which are newer versin f previusly adpted cde sets and the last tw are new): September 2014 Release f the U.S. Editin f SNOMED CT. LOINC versin February 2, 2015 mnthly versin f RxNrm. February 2, 2015 versin f the CVX cde set. Natinal Drug Cdes (NDC) Vaccine Cdes, updates thrugh January 15, Race & Ethnicity CDC cde system in the PHIN Vcabulary Access and Distributin System (VADS) Release (June 17, 2011)). ONC als prvides a table f bject identifiers (OIDs) fr certain cde systems fr develpers. ONC prpses t mdify definitins f new, revised, and unchanged as applied t the 2015 Editin criteria as cmpared t previus Editin criteria fr purpses f gap certificatin as fllws: New refers t criteria that as a whle nly include capabilities never referenced in previusly adpted editins and t which a Health IT Mdule presented fr certificatin t the 2015 Editin culd have never previusly been certified. Revised refers t criteria that include capabilities referenced in a previusly adpted editins as well as changed r additinal new capabilities; and t which a Health IT Mdule presented fr certificatin t the 2015 Editin culd nt have been previusly certified t all f the included capabilities. Unchanged refers t criteria that include the same capabilities as cmpared t prir editins; and t which a Health IT Mdule presented fr certificatin t the 2015 Editin culd have been previusly certified t all f the included capabilities. ONC ntes that all capabilities listed in a criterin are expected t be perfrmed electrnically unless therwise nted. The appendices t this summary cntain tables shwing the prpsed certificatin criteria fr 2015 Editin EHR in the rder listed under the prpsed regulatry text and prvide a clumn fr ther infrmatin and cmmentary relevant t each f the certificatin criteria. ONC prpses several new certificatin criteria; fr example:

12 12 Implantable device lists: T recrd, change, and access a list f unique device identifiers (UDIs); t parse certain data frm a UDI; t retrieve the Device Descriptin attribute assciated with a UDI in the Glbal Unique Device Infrmatin Database (GUDID) maintained by the FDA; and make bth the parsed data and retrieved data user accessible. Patient health infrmatin capture: A replacement fr the 2014 Editin advance directive certificatin criterin, t stre and permit access (thrugh links) t an advance directive and ther health infrmatin dcuments (e.g., a birth plan); als permit a user t recrd and access infrmatin directly frm a patient, such a thrugh a mbile device. Data segmentatin fr privacy send and receive: Tw new certificatin criteria (in prpsed (b)(7) and (8)) t separately track (i.e., segment) individually identifiable health infrmatin prtected by state r federal privacy laws mre restrictive than the HIPAA Privacy Rule (ne criterin each fr sending and receiving the data). Electrnic Submissin f Medical Dcumentatin (esmd): CMS and ONC established the esmd initiative t develp use cases and standards fr electrnic exchange f medical dcumentatin amng prviders and Medicare review cntractrs, including fr purpses f prir authrizatin and pre- and pst-payment review under the fee-fr-service prgram; esmd certificatin criterin at prpsed (i)(1) includes fur capabilities: create dcument templates; embed a digital signature in a CDA dcument; create and transmit external digital signatures fr dcuments; and create and transmit external digital signatures fr electrnic transactins fr purpse f data integrity and nn-repudiatin authenticity. Transprt methds and ther prtcls: Tw new criteria at prpsed (h)(4) and (5) related t prvider directry capabilities; health IT must be able t query a prvider using the Integrating the Healthcare Enterprise (IHE) Healthcare Prvider Directry (HPD) directry; respnd t such a query; r bth. Decisin Supprt Knwledge Artifact: T electrnically send and receive clinical decisin supprt knwledge artifacts in accrdance with a Health edecisins (HeD) standard. Decisin Supprt Service: T electrnically make an infrmatin request with patient data and receive electrnic clinical guidance in accrdance with a HeD standard. Care plan: T recrd, change, access, create, and receive care plan infrmatin using a Care Plan dcument template in C-CDA Release 2.0 Templates fr Clinical Ntes. CQM - Filter: Fr use in newer prgrams, such as Medicare Shared Savings Prgram, Pineer ACOs, the PQRS grup practice reprting ptin, and the Cmprehensive Primary Care Initiative which requires perfrmance measurement by eligible practice site rather than by individual practitiners; health IT must be able t filter by any cmbinatin f the required data elements (i.e., by any ne r a cmbinatin f any f the data elements (e.g., cmbinatin f TIN and NPI r cmbinatin f all data). Scial, psychlgical, and behaviral data: T recrd, change, and access a patient s scial, psychlgical, and behaviral data based n SNOMED CT and LOINC cdes. Transmissin t public health agencies Case reprting, Antimicrbial use and resistance reprting, and Health care surveys: Three new certificatin criteria t reprt data t public health agencies at prpsed (f)(5) thrugh (7)). Accessibility technlgy cmpatibility: Applicable t Health IT Mdules presented fr certificatin t clinical, care crdinatin, and patient engagement criteria; intended t ensure health IT is accessible t visually impaired and disabled individuals.

13 13 Applicatin access t cmmn clinical data set (CCDS): Fcus n ability f health IT t respnd t requests fr patient data frm ther applicatins fr any ne r mre (r all) f the CCDS data thrugh the demnstratin f an applicatin prgramming interface (API). Accessibility-centered design: Requires identificatin f user-centered design standards r laws fr accessibility applied (r cmplied with) in the develpment f specific capabilities included in a Health IT; wuld als require identificatin f failure t apply r cmply with such standards r laws. This applies t all certificatin criteria. Sme prpsed changes f nte t the 2014 Editin certificatin criteria include the fllwing: Cmputerized prvider rder entry (CPOE): T mandate that the criterin be split int 3 separate criteria by rder type (medicatins, labratry, and diagnstic imaging). ONC seeks cmment n whether a Health IT Mdule shuld (fr purpses f testing and certificatin) include the capability t include any r all f the fllwing in a transmitted rder: secndary diagnsis cdes, reasns fr rder, cmment fields fr the rdering prvider, and ther data elements. 5 Vital signs: T expand the types f vital signs fr recrding; 2) require each type f vital sign t have a specific LOINC cde attributed t it; 3) that The Unified Cde f Units f Measure, Revisin 1.9, Octber 23, 2013 ( UCUM Versin 1.9 ) be used t recrd vital sign measurements; and 4) that certain metadata accmpany each vital sign, including date, time, and measuring- r authring-type surce. Clinical decisin supprt (CDS): T adpt an updated Infbuttn standard and tw updated implementatin guides (IGs); t require certificatin nly t the Infbuttn standard (and assciated IG); and t require the ability t recrd users actins in respnse t CDS interventins. Electrnic ntes: ONC appears t mit this certificatin criterin. Family Health Histry: T adpt tw family health histry certificatin criteria (Family Health Histry and Family Health Histry-Pedigree), bth f which are revised. Patient-Specific Educatin Resurces: T remve the requirement t electrnically identify resurces based n labratry values/results, and t clarify resurces must be electrnically identified using Infbuttn and anther methd that des nt rely n Infbuttn. Transitins f care (TC): T expand n the 2014 Editin ptinal criterin by using updated C-CDA standard; t require capabilities t detect valid and invalid C-CDA dcuments, t require Health IT Mdule certified t SMTP-based edge t accept and prcess XDM packages it receives; t include a limited set f standardized data in the TC create element; and t seek cmment n C-CDA apprpriateness f tagging health infrmatin with prvenance metadata. Electrnic prescribing: T require receipt and respnse fr additinal transactins r segments (Change, Refill, and Cancel Prescriptin; Fill Status; and Medicatin Histry); t require directins fr medicatin use transmitted as e-prescriptins t be cdified in a structured frmat; and t limit e-prescriptins t the metric unit standard nly. 5 ONC clarifies that any specific data element requirements adpted in the final rule wuld nly apply in the absence f a standard fr testing and certificatin.

14 14 Clinical quality measures (CQMs): T require that a system user be able t exprt and imprt CQM at any time and withut subsequent develper assistance t perate (beynd nrmal rientatin/training); t recrd structured data t filter CQM results t create different patient ppulatin grupings by varius data elements, including practice site, TIN r NPI, diagnsis, and/r demgraphics; t seek cmment n the mst apprpriate standard (Quality Reprting Dcument Architecture (QRDA) r a QRDA-like standard); and t reserve the criterin fr CQM submissin fr the relevant Medicare payment system rulemaking in View, dwnlad, transmit t 3 rd party (VDT): T revise the text t clarify that this capability is patient-facing and fr patients t use; t include the Cmmn Clinical Data Set (CCDS) and diagnstic image reprts; t require the same API capabilities applicable t the CCDS apply t this criterin; t include the addressee f an ambulatry r inpatient summary; t prvide patient labratry test reprts; and fr the view capability, t be cmpliant with Web Cntent Accessibility Guidelines (WCAG) 2.0 Level A. ONC seeks cmments n a number f issues, including whether t require cmpliance with WCAG 2.0 Level AA. Clinical summary: ONC des nt prpse a 2015 Editin clinical summary certificatin criterin; it believes the capabilities under VDT criterin adequately supprt prpsals f the EHR Incentive Prgrams. Transmissin t Immunizatin Registries: T adpt an updated IG, require Natinal Drug Cdes (NDC) fr recrding administered vaccines, require CVX cdes fr histrical vaccines, and require a Health IT Mdule display an immunizatin histry and frecast frm an immunizatin registry Safety enhanced design: T add criteria fr errr preventin and t clarify cmpliance requirements fr data elements in Natinal Institute f Standards and Technlgy Interagency/Internal Reprt (NISTIR) Eligibility fr Gap Certificatin. Table 4 in the prpsed rule cntains a crsswalk f the unchanged 2015 Editin certificatin criteria t the crrespnding 2014 Editin fr purpses f gap certificatin; gap certificatin eligibility is als nted fr each f the certificatin criteria in the appendices t this summary. Pharmacgenmics Data Request fr Cmment ONC ntes that pharmacgenmics data identifies genetic variants in individuals that alter their metablism r ther interactins with medicatins and can lead t serius adverse events, and that in general health IT has nt captured genmic and genetic patient infrmatin in a structured manner as is the case fr ther clinical findings r lab-derived data. ONC als crrectly bserves that individually identifiable genetic infrmatin is subject t the HIPAA Privacy Rule and may als be subject t additinal federal and state privacy laws and regulatins. ONC signals an interest in establishing certificatin criteria fr this purpse and seeks input n factrs it shuld cnsider fr health IT that permits a user t disclse r use genetic infrmatin in a manner that cmplies with privacy laws. ONC and the Natinal Institutes f Health seek cmment n the fllwing questins:

15 15 Whether the 2015 Editin medicatin allergy list criterin shuld include the capability t integrate gentype-based drug metablizer rate infrmatin. Whether the 2015 Editin drug-drug, drug-allergy interactins checks fr CPOE criterin r as a separate certificatin criterin shuld include pharmacgenmic CDS fr drug-genme interactins. Whether a 2015 Editin criterin fr CDS shuld be ffered that incrprates a patient s pharmacgenmic gentype data int the CPOE prescribing prcess with the gal f aviding adverse prescribing utcmes fr knwn drug-gentype interactins. Whether there are certificatin appraches that culd enhance the end-user s (prvider s) adptin and cntinued use f health IT implementatins that guide prescribing thrugh CDS using pharmacgenmic data. Whether there are existing r develping standards applicable t the capture, strage, display, and exchange f ptentially clinically relevant genmic data, including the pharmacgenmic subset. Whether certificatin shuld be ffered fr health IT functinality that culd facilitate HIPAA-cmpliant sharing f discrete elements f a patient s genmic infrmatin frm their recrd t the family histry sectin f a relative s recrd. Whether the prpsed data segmentatin fr privacy criteria wuld prvide needed health IT functins with respect t the strage, use, transmissin, and disclsure f genetic, genmic, and pharmacgenmics infrmatin that is subject t prtectins under HIPAA and additinal state and federal privacy and prtectin laws such as the Genetic Infrmatin Nndiscriminatin Act (GINA).217 Whether the prpsed data segmentatin fr privacy criteria adequately balance cmplex genetic privacy issues, such as thse related t behaviral health, with the clinical value f cntext-apprpriate availability f a patient s actinable genetic and genmic infrmatin. Whether health IT shuld be required t apply different rules fr the use and exchange f genetic, genme, and pharmacgenmics data based n different grupings f diseases r cnditins based n the sensitivity f the infrmatin, such as thse related t behaviral health. Whether there are ther factrs ONC shuld cnsider fr health IT that allws the user t use r disclse genetic infrmatin subject t federal and state privacy laws. VI. Cllectin f Infrmatin Requirements; Regulatry Impact Analysis ONC believes that the Paperwrk Reductin Act cllectin f infrmatin requirements d nt apply t this prpsed rule because fewer than 10 annual respndents under the ONC Health IT Certificatin Prgram must cmply with cllectin and reprting requirements. ONC believes

16 16 the lnger recrds retentin requirement (frm 5 t 6 years) will nt impse a burden and that the requirement fr quarterly lists f cmplaints will pse a minimal burden. The change t the surveillance requirements fr 2014 Editin certificatins will pse a minimal burden (117 ttal hurs annually), and the new surveillance requirements fr 2015 Editin certificatins will require 234 ttal hurs annually. The estimated annual aggregate burden is 375 hurs. ONC determines that the rule is ecnmically significant because it estimates that csts t develp and prepare health IT fr testing and certificatin will exceed $100 millin per year. The ONC analysis fcuses n the technlgical and preparatin csts f EHR technlgy develpers t upgrade previusly certified technlgy r develp new health IT fr testing and certificatin; it des nt examine csts EPs, EHs and CAHs wuld incur t adpt and implement the technlgy. Additinally, ONC cnsiders these csts t be investment csts rather than cmpliance csts. ONC divides the certificatin criteria int Stage 3 Criteria (criteria assciated with the Stage 3 prpsed bjectives and measures fr the EHR Incentive prgrams) and Independent Criteria (all ther prpsed criteria). Tables 6 thrugh 9 f the prpsed rule set frth the estimated hurs and csts by criterin fr Stage 3 Criteria and fr Independent Criteria. ONC reduces its estimates fr the number f health IT develpers in part due t increases in interperability requirements and market share gains by certain develpers (including thrugh acquisitins f ther develpers). ONC estimates each develper will have 2.5 prducts per Stage 3 criterin and 1 prduct per each Independent criterin. ONC assumes $61 per hur fr a sftware develper. Table 10 f the prpsed rule (reprduced belw) shws estimated verall csts ver a fur-year perid (2015 thrugh 2018) ranging frm $ millin t $ millin with an uneven distributin ver that perid fr each year. Table 10. Distributed Ttal Develpment and Preparatin Csts (in Millins) fr Health IT Develpers (4 year perid) Ttals Runded Year Rati Ttal Lw Cst Estimate Ttal High Cst Estimate Ttal Average Cst Estimate % $49.36 $ $ % $59.23 $ $ % $59.23 $ $ % $29.61 $61.08 $ Year Ttals $ $ $ ONC believes the benefits f the prpsed rule include the new and updated standards and implementatin specificatins (especially fr interperability) that directly supprt the EHR Incentive prgrams. It als pints t certificatin criteria that supprt cllectin f patient data t supprt health disparities as well as enhanced requirements t supprt usability and patient safety. Finally in making the ONC Health IT Certificatin Prgram pen and accessible t mre types f health IT, including health IT fr a variety f care and practice settings, ONC believes this will help prviders, custmers, and develpers. As it has in the past, ONC struggles t calculate the number f develpers wh might qualify as small businesses fr purpses f the Regulatry Flexibility Act because it is unclear hw many

17 17 f thse entities will actually develp a health IT prduct fr certificatin t the 2015 Editin, but it ntes that mre than 60 percent f EHR develpers that have Cmplete EHRs r EHR Mdules certified t 2011 Editin EHR have fewer than 51 emplyees. ONC again asserts that its prpsals wuld result in the minimum amunt f requirements t accmplish its plicy gals and als believes that n alternative wuld lessen the burden. Further, as nted abve, ONC characterizes csts as investment rather than cmpliance csts, and thus believes the prpsed rule will nt significantly impact a substantial number f small businesses. ONC des request cmment n small entities they may nt have identified that may be affected in a significant way by the NPRM. ONC als believes that the NPRM des nt raise Federalism issues r issues under the Unfunded Mandates Act f 1995.

18 18 Appendix A Prpsed Clinical 2015 Editin EHR Certificatin Criteria Prpsed 2015 Editin EHR Certificatin Criteria: Observatins CLINICAL Health IT must be able t electrnically perfrm the fllwing capabilities under all applicable standards and implementatin specificatins: Prpsed (a) Clinical (1) COMPUTERIZED PROVIDER ORDER ENTRY (CPOE) MEDICATIONS Unchanged certificatin criterin Technlgy must enable a user t electrnically recrd, change, and access medicatin rders. Base EHR Included. T meet BASE EHR definitin, CPOE must be certified t ne f the three rder types medicatin, labratry, r diagnstic imaging under paragraphs (1), (2) r (3) f prpsed (a) (2) Cmputerized prvider rder entry (CPOE) Labratry (i) Technlgy must enable a user t recrd, change, and access labratry rders. (ii) Technlgy must be able t receive and incrprate a new r updated labratry rder cmpendium in accrdance with the cntent exchange standard specified in (l)(2) and, at a minimum, the versin f the vcabulary standard in (c)(3). (iii) Ambulatry setting nly. Technlgy must enable a user t create labratry rders fr electrnic transmissin in accrdance with the cntent exchange standard specified in (l)(1) and, at a minimum, the versin f the vcabulary standard in (c)(3). (3) COMPUTERIZED PROVIDER ORDER ENTRY (CPOE) DIAGNOSTIC IMAGING Technlgy must enable a user t recrd, change, and access diagnstic imaging rders. (4) DRUG-DRUG, DRUG-ALLERGY INTERACTION CHECKS FOR CPOE (i) INTERVENTIONS. Befre a medicatin rder is cmpleted and acted upn during CPOE, interventins must autmatically indicate t a user drug-drug and drug-allergy cntraindicatins based n a patient s medicatin list and medicatin allergy list. Gap certificatin status: Eligible Revised certificatin criterin Base EHR Included. T meet BASE EHR definitin, CPOE must be certified t ne f the three rder types medicatin, labratry, r diagnstic imaging under paragraphs (1), (2) r (3) f prpsed (a) Fr the ambulatry setting nly, prpses t adpt HL7 Versin Implementatin Guide: S&I Framewrk Labratry Orders (LOI) frm EHR, Draft Standard fr Trial Use, Release 2 US Realm ( Release 2 ) Fr all settings, prpses t adpt HL7 Versin Implementatin Guide: S&I Framewrk Labratry Test Cmpendium Framewrk, Release 2, ( electrnic Directry f Services (edos) IG ) LOINC versin 2.50 as the vcabulary standard (which includes CLIA test requisitin infrmatin (42 CFR (c)(1) (8)) included in the cntent message) Gap certificatin status: Nt Eligible Unchanged certificatin criterin (ther than name change) Base EHR Included. T meet BASE EHR definitin, CPOE must be certified t ne f the three rder types medicatin, labratry, r diagnstic imaging Gap certificatin status: Eligible Revised certificatin criterin Prpsed new requirements fr capabilities t recrd user actins fr interventins and enable users t view actins taken: Technlgy must be able t recrd at least ne actin taken in respnse t a DDI/DAI check and by whm the actin is taken; and

19 19 Prpsed 2015 Editin EHR Certificatin Criteria: CLINICAL (ii) ADJUSTMENTS. (A) Enable the severity level f interventins prvided fr drug-drug interactin checks t be adjusted. (B) Limit the ability t adjust severity levels t an identified set f users r available as a system administrative functin. (iii) INTERACTION CHECK RESPONSE DOCUMENTATION. (A) Technlgy must be able t recrd at least ne actin taken and by whm in respnse t drug-drug r drug-allergy interactin checks. (B) Technlgy must be able t generate either a human readable display r human readable reprt f actins taken and by whm in respnse t drug-drug r drug-allergy interactin checks. (5) DEMOGRAPHICS (i) Enable a user t recrd, change, and access patient demgraphic data including preferred language, sex, race, ethnicity, and date f birth. (A) RACE & ETHNICITY. (1) Enable each ne f a patient s races [ethnicities] t be recrded in accrdance, at a minimum, with the vcabulary standard, specified in (f)(2) (Race & Ethnicity CDC cde system), and whether a patient declines t specify race. (2) Enable each ne f a patient s ethnicities t be recrded in accrdance, at a minimum, with the vcabulary standard, specified in (f)(2) (Race & Ethnicity CDC cde system), and whether a patient declines t specify ethnicity. (3) Aggregate each ne f the patient s races and ethnicities recrded in accrdance with (1) and (2) abve t the categries in the vcabulary standard specified in (f)(1) (OMB cde fr each race and ethnicity). (B) Enable preferred language t be recrded in accrdance with the vcabulary standard in (g)(2) (RFC 5646), and whether a patient declines t specify a preferred language. (C) Enable sex t be recrded in accrdance with the vcabulary standard in (n)(1) (HL7 Versin 3). Observatins Technlgy must be able t generate either a human readable display r human readable reprt f actins taken and by whm ONC des nt specify the type f actins the technlgy must be able t recrd and seeks cmment n the requirement t recrd actins shuld be fr a subset f DDI/DAI interventins and what surces it shuld cnsider t define the subset ONC des nt seek t infer a specific wrkflw/user interface, nr des it prpse t establish uses fr the user actin, wh shuld be able t view the infrmatin, r wh culd adjust the capability ONC encurages develpers t build in functinality t infrm users f new r updated DDI/DAI when medicatin r medicatin allergy lists are updated; ONC seeks cmment n whether this shuld be a separate certificatin criterin r built int existing criteria, such as this criterin, clinical decisin supprt, etc. Gap certificatin status: Nt Eligible Revised certificatin criterin Base EHR Included New standards fr recrding race and ethnicities Minimum vcabulary standard Race & Ethnicity CDC cde system Must be able t recrd each f the patient s races & ethnicities (ONC des nt expect a drp dwn menu f 900 entries) Requirement t aggregate using OMB cde fr each race & ethnicity New standard fr recrding preferred language Request fr Cmments (RFC) 5646 Tags fr Identifying Languages, September 2009 (the certificatin test wuld be whether the Mdule can recrd preferred language using any f the cdes in RFC 5646) ONC envisins develper and prvider cllabratin n apprpriate implementatin New standard fr recrding sex HL7 Versin 3 (AdministrativeGender) and a nullflavr value as fllws: male (M), female (F), and unknwn (UNK) ONC ntes that fr the inpatient setting requirement, it prpses t require the capability that a user be able t recrd, change and access preliminary cause f death and date f death; the date f death capability was required as part f the 2011 Editin but mitted frm the 2014 Editin certificatin criterin Gap certificatin status: Nt Eligible

20 20 Prpsed 2015 Editin EHR Certificatin Criteria: CLINICAL (ii) Inpatient setting nly. Enable a user t recrd, change, and access the preliminary cause f death and date f death in the event f mrtality. (6) VITAL SIGNS, BODY MASS INDEX, AND GROWTH CHARTS (i) VITAL SIGNS. Enable a user t recrd, change, and access, at a minimum, a patient s vital signs including, at a minimum, patient's height, weight, diastlic bld pressure, systlic bld pressure, heart rate, respiratry rate, temperature, xygen saturatin in arterial bld by pulse ximetry, bdy mass index [rati], and mean bld pressure in accrdance with the fllwing (A)The vcabulary standard specified in (k)(1) and with the assciated applicable unit f measure fr the vital sign in the vcabulary standard specified in (m)(1); (B) METADATA. Fr each vital sign specified abve, the technlgy must als recrd the fllwing: (1) Date and time f vital sign measurement r end time f vital sign measurement; (2) The measuring- r authring-type surce f the vital sign measurement; and (3) Optinal. Date and time f vital sign measurement r end time f vital sign measurement in accrdance with the standard in (g); and (C) Metadata fr xygen saturatin in arterial bld by pulse ximetry. Fr the xygen saturatin in arterial bld by pulse ximetry, the technlgy must enable a user t recrd, change, and access the patient s inhaled xygen cncentratin identified, at a minimum, with the versin f the vcabulary standard adpt in (c)(3) and attributed with LOINC cde (ii) OPTIONAL Bdy mass index percentile per age and sex. Enable a user t recrd, change, and access a patient s bdy mass index [percentile] per age and sex fr patients tw t twenty years f age in accrdance with the fllwing (The patient s bdy mass index [percentile] per age and sex must be recrded in numerical values nly.): (A) Identified, at a minimum, with the versin f the standard adpt in (c)(3) and attributed with LOINC cde and with the assciated applicable unit f measure in the standard specified in (m)(1); and (B) METADATA. The technlgy must als recrd the fllwing: (1) Date and time f vital sign measurement r end time f vital sign Observatins Revised certificatin criterin Must be capable f recrding vital signs natively Must be capable f recrding diastlic and systlic bld pressure separately Must be able t attribute a specific LOINC cde t each type f vital sign as fllws: Systlic bld pressure with LOINC cde ; Diastlic bld pressure with LOINC cde ; Bdy height with LOINC cde ; Bdy weight measured with LOINC cde ; Heart rate with LOINC cde ; Respiratry rate with LOINC cde ; Bdy temperature with LOINC cde ; Oxygen saturatin in arterial bld by pulse ximetry with LOINC cde ; Bdy mass index (BMI) [Rati] with LOINC cde ; and Mean bld pressure with LOINC cde Vital signs must be able t be recrded with the fllwing metadata: Date and time f vital sign measurement, r end time f vital sign measurement, with ptinal certificatin in accrdance with the clck synchrnizatin standard ( (g)); The measuring- r authring-type surce f the vital sign measurement (e.g., user wh dcumented the vital sign r the medical device that was used t measure the vital sign); and Fr xygen saturatin, inhaled xygen cncentratin with LOINC cde All units f measures fr a vital sign value must be recrded with UCUM Versin 1.9. Optinal certificatin fr Pediatric vital signs: BMI per age and sex (with LOINC cde ) fr yuth 2-20 years f age; Weight fr length per age and sex (with a LOINC cde t be determined) and/r head ccipital-frntal circumference (with LOINC