,,ii #aad? ,,congress #a/ ,session ,s4 #bada ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,octob] #f1 #bjae ,mr4 ,cassidy 7= himself & ,mr4 ,:iteh\se7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,a ,,bill ,to am5d ! ,public ,heal? ,s]vice ,act ) respect to heal? in=mation te*nology4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,transp>5t ,rat+s on ,usability & ,security to ,trans=m ,in=mation ,te*nology ,act ( #bjae or ! ,,tru/ ,,x ,act4 #b4 ,def9itions ,section #cjjj ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;jj7 is am5d$-- 7#a7 by r$esignat+ p>agraphs 7#aj7 ?r\gh 7#ad7 z p>agraphs 7#ab7 ?r\gh 7#af71 respectively2 & 7#b7 by ins]t+ aft] p>agraph 7#i7 ! foll[+3 7#aj7 ,in=mation block+ ,! t]m in=mation block+ means1 ) respect to ! developm5t1 configuration1 implem5tation1 & use ( qualifi$ electronic heal? records & o!r heal? in=mation te*nology1 bus9ess1 te*nical1 & organizational practices t-- 7,a7 except z requir$ by law1 prev5t or mat]ially disc\rage ! access1 ex*ange1 or use ( electronic heal? in=mation2 & 7,b7 ! p]son kn[s or %\ld "k 7z def9$ 9 section #aabh;,a7i77#g7 ( ! ,social ,security ,act7 are likely to int]f]e ) ! access1 ex*ange1 or use ( electronic heal? in=mation4 7#aa7 ,int]op]ability ,! t]m int]op]ability means ! ability ( #b or m heal? in=mation sy/ems or compon5ts to ex*ange cl9ical & o!r in=mation & to use ! in=mation t has be5 ex*ang$ us+ common /&>ds to provide access to longitud9al or reque/$ in=mation to heal? c>e provid]s1 pati5ts1 & o!r au?oriz$ us]s :5 su* p]sons ne$ su* in=mation 9 ord] to facilitate coord9at$ c>e & improv$ pati5t outcomes4 4 #c4 ,enhancem5ts to te/+ & c]tification ,section #cjja7;c77#e7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;jj-#aa7 is am5d$-- 7#a7 9 subp>agraph 7,a7-- 7,a7 by /rik+ ,! ,national ,coord9ator & ins]t+ ! foll[+3 7i7 ,volunt>y c]tification program ,! ,national ,coord9ator 2 & 7,b7 by add+ at ! end ! foll[+3 7ii7 ,transp>5cy ( program 7,i7 ,9 g5]al ,to enhance transp>5cy 9 ! compliance ( heal? in=mation te*nology ) c]tification crit]ia adopt$ "u ?is subtitle1 ! ,national ,coord9ator1 9 coord9ation ) au?oriz$ c]tification bodies1 may make in=mation demon/rat+ h[ heal? in=mation te*nology meets su* c]tification crit]ia publicly available4 ,su* in=mation may include summ>ies1 scre5%ots1 video demon/rations1 or any o!r in=mation ! ,national ,coord9ator det]m9es appropriate4 7,,ii7 ,protection ( propriet>y in=mation ,no?+ 9 ?is p>agraph %all be con/ru$ to require ! release ( trade secrets or any o!r protect$ intellectual prop]ty4 2 7#b7 9 subp>agraph 7,b71 by add+ at ! end ! foll[+3 ,beg9n+ #ah mon?s aft] report+ crit]ia are f9aliz$ "u section #cjji;,a1 c]tification crit]ia %all include1 9 addition to crit]ia to e/abli% t ! te*nology meets su* /&>ds & implem5tation specifications1 crit]ia consi/5t ) section #cjji;,a7b7 to e/abli% t te*nology meets applicable security requirem5ts1 incorporates us]-c5t]$ design1 & a*ieves int]op]ability42 & 7#c7 by add+ at ! end ! foll[+3 7,c7 ,conditions ( c]tification ,beg9n+ #a ye> aft] ! date ( enactm5t ( ! ,,tru/ ,,x ,act1 ! ,secret>y %all require t ea* v5dor ( heal? in=mation te*nology & entity seek+ c]tification ( heal? in=mation te*nology1 z a condition ( c]tification & ma9t5ance ( c]tification ( su* te*nology1 provide to ! ,secret>y an atte/ation t-- 7i7 ! v5dor or entity1 unless = a legitimate purpose specifi$ by ! ,secret>y1 has n tak5 & w n take any action t con/itutes in=mation block+ ) respect to heal? in=mation te*nology2 7ii7 ! v5dor or entity w n engage 9 bus9ess practices or impose b9d+ bus9ess relation%ip obligations t seek to int5tionally limit communication betwe5 heal? in=mation te*nology us]s & an au?oriz$ c]tification body reg>d+ ! usability1 int]op]ability1 security1 bus9ess practices1 or o!r relevant in=mation ab\t ! heal? in=mation te*nology or us]s' exp]i5ce ) ! heal? in=mation te*nology2 & 7iii7 heal? in=mation f su* te*nology may be ex*ang$1 access$1 & us$ ?r\gh ! use ( application programm+ int]faces & o!r /&>ds )\t special ef=t1 z au?oriz$ "u applicable law4 7,d7 ,inspector g5]al au?ority 7i7 ,9 g5]al ,! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices may inve/igate any claim t-- 7,i7 a v5dor (1 or o!r entity (f]+1 c]tifi$ heal? in=mation te*nology-- 7aa7 violat$ an atte/ation made "u subp>agraph 7,c72 or 7bb7 engag$ 9 in=mation block+ ) respect to ! use ( su* heal? in=mation te*nology by a heal? c>e provid]1 unless = a legitimate purpose specifi$ by ! ,secret>y2 7,,ii7 a heal? c>e provid] engag$ 9 in=mation block+ ) respect to ! use ( c]tifi$ heal? in=mation te*nology1 unless = a legitimate purpose specifi$ by ! ,secret>y2 7,,iii7 a heal? in=mation sy/em provid] engag$ 9 in=mation block+ ) respect to ! use ( su* c]tifi$ heal? in=mation te*nology1 unless = a legitimate purpose specifi$ by ! ,secret>y4 7ii7 ,p5alty ,any p]son or entity det]m9$ by ! ,inspector ,g5]al to h committ$ an act describ$ 9 subclause 7,i71 7,,ii71 or 7,,iii7 ( clause 7i7 %all be subject to a civil monet>y p5alty ( n m ?an #aj1jjj = ea* su* act4 ,! provisions ( section #aabh;,a ( ! ,social ,security ,act 7o!r ?an subsections 7a7 & 7b77 %all apply to a civil money p5alty appli$ "u ?is subsection 9 ! same mann] z su* provisions apply to a civil money p5alty or proce$+ "u section #aabh;,a7a74 4 #d4 ,heal? in=mation te*nology rat+ program ,subtitle ,a ( title ,,xxx ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;jj-#aa et seq47 is am5d$ by add+ at ! end ! foll[+3 #cjji;,a4 ,heal? in=mation te*nology rat+ program 7a7 ,e/abli%m5t ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ! ,,tru/ ,,x ,act1 ! ,secret>y %all recognize a developm5t c\ncil made up ( "o repres5tative f ea* ( ! accr$it$ c]tify+ bodies accr$it$ by ! ,(fice & ! te/+ laboratories accr$it$ "u section #acbja7;b7 ( ! ,heal? ,in=mation ,te*nology = ,economic & ,cl9ical ,heal? ,act 7#db ,u4,s4,c4 #agiaa7;b771 & "o repres5tative f ! ,(fice ( ! ,national ,coord9ator1 = ! purpose ( e/abli%+ a heal? in=mation te*nology rat+ program to evaluate1 bas$ on ! me?odology e/abli%$ "u subsection 7d71 ! field p]=mance ( c]tifi$ heal? in=mation te*nology ) reg>d to int]op]ability1 usability1 & security1 9 accordance ) ! foll[+3 7#a7 #a /> rat+ ,c]tifi$ heal? in=mation te*nology %all receive a #a /> rat+ if an au?oriz$ c]tification body det]m9es t ! heal? in=mation te*nology is less ?an satisfactory4 7#b7 #b /> rat+ ,c]tifi$ heal? in=mation te*nology %all receive a #b /> rat+ if ! au?oriz$ c]tification body det]m9es t ! heal? in=mation te*nology is satisfactory4 7#c7 #c /> rat+ ,c]tifi$ heal? in=mation te*nology %all receive a #c /> rat+ if ! au?oriz$ c]tification body det]m9es t ! heal? in=mation te*nology is excell5t4 7b7 ,report+ crit]ia 7#a7 ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,,tru/ ,,x ,act1 ! ,secret>y1 9 consultation ) ! developm5t c\ncil describ$ 9 subsection 7a71 %all conv5e /akehold]s z describ$ 9 p>agraph 7#b7 = ! purpose ( develop+ ! report+ crit]ia 9 accordance ) p>agraph 7#c74 7#b7 ,developm5t ( report+ crit]ia ,! report+ crit]ia "u ?is subsection %all be develop$ ?r\gh a public1 transp>5t process t reflects input f relevant /akehold]s1 includ+-- 7,a7 prim>y c>e & specialty c>e heal? c>e pr(essionals2 7,b7 hospitals2 7,c7 heal? in=mation te*nology v5dors2 7,d7 advocates = pati5ts or consum]s2 7,e7 data %>+ networks1 su* z heal? in=mation ex*anges2 7,f7 au?oriz$ c]tification bodies & te/+ laboratories2 7,g7 security exp]ts2 & 7,h7 o!r entities or p]sons1 z ! ,secret>y1 9 consultation ) ! developm5t c\ncil1 det]m9es appropriate4 7#c7 ,consid]ations = report+ crit]ia ,! report+ crit]ia develop$ "u ?is subsection-- 7,a7 may include measures t reflect categories includ+1 ) respect to ! te*nology-- 7i7 security2 7ii7 usability & us]-c5t]$ design2 7iii7 int]op]ability2 7iv7 con=mance to c]tification te/+2 & 7v7 o!r categories z appropriate to measure ! p]=mance ( heal? in=mation te*nology2 7,b7 may include measures su* z-- 7i7 enabl+ ! us] to ord] & view ! results ( laboratory te/s1 imag+ te/s1 & o!r diagno/ic te/s2 7ii7 submitt+1 edit+1 & retriev+ data f regi/ries = quality ( c>e1 su* z physician regi/ries2 7iii7 access+ & ex*ang+ in=mation & data f m$ical devices2 7iv7 access+ & ex*ang+ in=mation & data held by ,f$]al1 ,/ate1 & local ag5cies & o!r applicable entities useful to a heal? c>e provid] or o!r applicable us] 9 ! fur!rance ( pati5t c>e2 7v7 access+ & ex*ang+ in=mation f o!r heal? c>e provid]s or applicable us]s2 7vi7 access+ & ex*ang+ pati5t g5]at$ in=mation2 7vii7 provid+ ! pati5t ) a complete copy ( _! electronic record 9 a computable =mat2 & 7viii7 o!r appropriate functionalities2 & 7,c7 %all be design$ to ensure t small & />t up v5dors ( heal? in=mation te*nology are n unduly disadvantag$ by ! report+ crit]ia or rat+ scale me?odology4 7#d7 ,public comm5t ,! ,secret>y %all conduct a #fj-;day public comm5t p]iod dur+ :i* any memb] ( ! public may provide comm5ts on ! propos$ report+ crit]ia & ! me?odology = au?oriz$ c]tification bodies to use 9 det]m9+ ! /> rat+s4 ,! ,secret>y %all provide timely responses to su* comm5ts be=e issu+ a f9al rule4 7#e7 ,modifications ,aft] ! report+ crit]ia h be5 e/abli%$1 ! ,secret>y1 9 consultation ) ! developm5t c\ncil1 may conv5e /akehold]s & conduct a public report+ p]iod = ! purpose ( modify+ ! report+ crit]ia develop$ 9 ?is subsection & me?odology = det]m9+ ! /> rat+s propos$ "u subsection 7d74 7#f7 ,consid]ation ( developm5t c\ncil recomm5dations ,9 promulgat+ f9al rules "u ?is subsection1 includ+ modifications to su* rules "u p>agraph 7#e71 ! ,secret>y may accept or reject ! recomm5dations ( ! developm5t c\ncil1 b may n promulgate a rule t does n repres5t a complete recomm5dation ( su* c\ncil4 7c7 ,collection ( fe$back ,! ,secret>y1 9 consultation ) ! developm5t c\ncil1 %all e/abli% a process = au?oriz$ c]tification bodies to collect & v]ify confid5tial fe$back f-- 7#a7 heal? c>e provid]s1 pati5ts1 & o!r us]s ( heal? in=mation te*nology on ! usability1 security1 & int]op]ability ( heal? in=mation te*nology products2 & 7#b7 v5dors or o!r entities (f]+ heal? in=mation te*nology on practices ( heal? in=mation te*nology us]s t may inhibit int]op]ability4 7d7 ,me?odology ,! ,secret>y1 9 consultation ) ! developm5t c\ncil1 %all develop a me?odology = au?oriz$ c]tification bodies to use to calculate ! /> rat+s = c]tifi$ heal? in=mation te*nology describ$ 9 subsection 7a74 ,! me?odology %all use ! report+ crit]ia develop$ 9 subsection 7b7 & confid5tial fe$back collect$ "u subsection 7c74 7e7 ,p>ticipation ,ea* v5dor (1 or entity (f]+1 heal? in=mation te*nology t is c]tifi$ "u section #cjja7;c77#e7 ( ! ,public ,heal? ,s]vice ,act aft] ! date ( enactm5t ( ! ,,tru/ ,,x ,act %all report on ! crit]ia develop$ "u subsection 7b7 on ! date t is #b ye>s aft] su* c]tification & e #b ye>s !reaft]4 7f7 ,"o /> rat+ ,ea* v5dor (1 or entity (f]+1 heal? in=mation te*nology t receives a #a /> rat+ %all take action1 ?r\gh a corrective action plan develop$ ) ! au?oriz$ c]tification body & approv$ by ! ,secret>y1 to improve ! heal? in=mation te*nology rat+ )9 a timeframe t ! ,secret>y det]m9es appropriate4 7g7 ,en=cem5t au?orities 7#a7 ,9 g5]al ,! ,secret>y may assess f9es on any v5dor (1 or entity (f]+1 c]tifi$ heal? in=mation te*nology & dec]tify heal? in=mation te*nology 9 accordance ) p>agraphs 7#b7 & 7#c74 7#b7 ,f9es 7,a7 ,9 g5]al ,! ,secret>y may assess f9es aga9/ su* a v5dor or entity if ! v5dor or entity-- 7i7 does n meet ! requirem5ts ( ! corrective action plan describ$ 9 subsection 7f72 7ii7 does n improve f a "o /> rat+ 9 accordance ) subsection 7f72 or 7iii7 does n report on crit]ia 9 accordance ) subsection 7e74 7,b7 ,f9e am\nts ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,,tru/ ,,x ,act1 ! ,secret>y %all e/abli% f9e am\nts = violations ( clauses 7i71 7ii71 & 7iii7 ( subp>agraph 7,a74 ,9 sett+ su* am\nts1 ! ,secret>y %all consid] ! am\nts necess>y to reimburse1 9 "p or 9 full1 ! us]s ( dec]tifi$ heal? in=mation te*nology = ! am\nts inve/$ 9 pur*as+ new c]tifi$ heal? in=mation te*nology1 z applicable4 7#c7 ,dec]tification ,! ,secret>y may dec]tify heal? in=mation te*nology if-- 7,a7 ! heal? in=mation te*nology does n improve f a "o /> rat+ )9 ! timeframe e/abli%$ "u subsection 7f72 7,b7 does n report on crit]ia 9 accordance ) subsection 7b72 or 7,c7 9 o!r circum/ances1 z ! ,secret>y det]m9es appropriate4 7h7 ,,gao reports ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ,congress a report e #d ye>s on ! rat+ scale me?odology develop$ pursuant to subsection 7b71 provid+ obs]vations on ! appropriat5ess ( ! curr5t me?odology & recomm5dations = *anges to ! me?odology4 7i7 ,int]net ,website ,! ,secret>y %all publi% ! /> rat+ = ea* c]tifi$ heal? in=mation te*nology & me?odology to det]m9e ! /> rat+ on ! ,int]net website ( ! ,(fice ( ! ,national ,coord9ator4 ,foll[+ ! biannual report+ describ$ 9 subsection 7e71 au?oriz$ c]tifi$ bodies %all h #cj days to calculate & submit updat$ rat+s to ! ,secret>y1 & updat$ rat+s %all be publi%$ on su* ,int]net website n lat] ?an #cj days foll[+ su* submission4 7j7 ,us] comp5sation fund ,! ,secret>y %all e/abli% a revolv+ us] comp5sation fund 9 :i* am\nts collect$ "u subsection 7g77#b7 %all be direct$ & us$ to assi/ us]s ( heal? in=mation te*nology t are dec]tifi$ "u subsection 7g77#c7 to reimburse us]s = ! co/s ( pur*as+ new c]tifi$ heal? in=mation te*nology products4 7k7 ,h>d%ip exemption ,! ,secret>y %all1 on a case-by-case basis1 exempt an eligible pr(essional1 eligible hospital1 or critical access hospital f ! application ( ! paym5t adju/m5t "u ! ,mean+ful ,use ( ,c]tifi$ ,,ehr ,te*nology program "u sections #ahdh7;a77#g77;,a71 #ahhf7;b77#c77;,b77ix77,i71 & #ahad7l77#d71 respectively1 ( ! ,social ,security ,act = #a ye> if ! eligible pr(essional1 eligible hospital1 or critical access hospital uses heal? in=mation te*nology t becomes dec]tifi$ "u subsection 7g77#c71 to help su* eligible pr(essional1 eligible hospital1 or critical access hospital transition to a new c]tifi$ electronic heal? record te*nology4 7l7 ,appeals ,! ,secret>y %all e/abli% a process :]eby any v5dor (1 or entity (f]+1 heal? in=mation te*nology c appeal-- 7#a7 ! heal? in=mation te*nology product's /> rat+2 or 7#b7 ! ,secret>y's decision to dec]tify a product1 z applicable4 4 #e4 ,updat+ in=mation on access+ p]sonal heal? in=mation ,subtitle ,a ( title ,,xxx ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;jj-#aa et seq471 z am5d$ by section #d1 is fur!r am5d$ by add+ at ! end ! foll[+3 #cjji;,b4 ,updat+ in=mation on access+ p]sonal heal? in=mation ,! ,national ,coord9ator1 9 consultation ) ! ,director ( ! ,(fice ( ,civil ,rights1 %all1 z appropriate1 update ! ,int]net website ( ! ,(fice ) in=mation to assi/ individuals 9 und]/&+ _! rights to access & protect _! p]sonal heal? in=mation "u ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif 7,public ,law #ajd-aia71 includ+ be/ practices = reque/+ _! p]sonal heal? in=mation 9 a computable =mat & us+ pati5t portals1 among o!r in=mation4 4