,,ii #aad? ,,congress #b;d ,session ,s4 #bgdd ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,april #e1 #bjaf ,ms4 ,w>r5 7= h]self & ,mr4 ,enzi7 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 to protect ! privacy ( individuals :o are rese>* subjects1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,g5etic ,rese>* ,privacy ,protection ,act4 #b4 ,protection ( privacy ( individuals :o are rese>* subjects 7a7 ,9 g5]al ,subsection 7d7 ( section #cja ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bda7 is am5d$ to read z foll[s3 7d7 ,protection ( privacy ( individuals :o are rese>* subjects 7#a7 ,issuance ( c]tificate 7,a7 ,9 g5]al ,if a p]son is engag$ 9 biom$ical1 behavioral1 cl9ical1 or o!r rese>*1 9 :i* id5tifiable1 s5sitive in=mation is collect$ 7includ+ rese>* on m5tal heal? & rese>* on ! use & effect ( alcohol & o!r psy*oactive drugs71 ! ,secret>y1 9 coord9ation ) o!r ,dep>tm5ts1 z applicable-- 7i7 %all issue to su* p]son a c]tificate ( confid5tiality to protect ! privacy ( individuals :o are ! subjects ( su* rese>* if ! rese>* is fund$ :olly or 9 "p by ! ,f$]al ,gov]nm5t2 & 7ii7 may1 ^u application by a p]son engag$ 9 rese>*1 issue to su* p]son a c]tificate ( confid5tiality to protect ! privacy ( su* individuals if ! rese>* is n s fund$4 7,b7 ,result ( c]tificate ,except z provid$ 9 subp>agraph 7,c71 any p]son to :om a c]tificate is issu$ "u subp>agraph 7,a7 to protect ! privacy ( individuals describ$ 9 su* subp>agraph %all n disclose or provide to any o!r p]son n connect$ ) ! rese>* ! "n ( su* an individual or any in=mation1 docum5t1 or biospecim5 t conta9s id5tifiable1 s5sitive in=mation ab\t su* an individual & t 0 creat$ or compil$ = purposes ( ! rese>*4 7,c7 ,exceptions ,! disclosure prohibition 9 subp>agraph 7,b7 %all n apply to disclosure or use t is-- 7i7 requir$ by ,f$]al1 ,/ate1 or local laws1 exclud+ in/ances describ$ 9 subp>agraph 7,d72 7ii7 necess>y = ! m$ical treatm5t ( ! individual to :om ! in=mation1 docum5t1 or biospecim5 p]ta9s2 7iii7 made ) ! cons5t ( ! individual to :om ! in=mation1 docum5t1 or biospecim5 p]ta9s2 or 7iv7 made = ! purposes ( o!r sci5tific rese>* t is 9 compliance ) applicable ,f$]al regulations gov]n+ ! protection ( human subjects 9 rese>*4 7,d7 ,prohibition on compell+ disclosure ,any p]son to :om a c]tificate is issu$ "u subp>agraph 7,a7 to protect ! privacy ( an individual describ$ 9 su* subp>agraph %all n1 9 any ,f$]al1 ,/ate1 or local civil1 crim9al1 adm9i/rative1 legislative1 or o!r proce$+1 disclose or provide ! "n ( su* individual or any su* in=mation1 docum5t1 or biospecim5 t conta9s id5tifiable1 s5sitive in=mation ab\t ! individual & t 0 creat$ or compil$ = purposes ( ! rese>*4 7,e7 ,immunity ,id5tifiable1 s5sitive in=mation protect$ "u subp>agraph 7,a71 & all copies !re(1 %all be immune f ! legal process1 & %all n1 )\t ! cons5t ( ! individual to :om ! in=mation p]ta9s1 be admissible z evid5ce or us$ = any purpose 9 any action1 suit1 or o!r judicial1 legislative1 or adm9i/rative proce$+4 7,f7 ,t]ms ( protection ,id5tifiable1 s5sitive in=mation collect$ by a p]son to :om a c]tificate has be5 issu$ "u subp>agraph 7,a71 & all copies !re(1 %all be subject to ! protections af=d$ by ?is section = p]petuity4 7,g7 ,m9imiz+ adm9i/rative burd5 ,! ,secret>y %all take /eps to m9imize ! burd5 to rese>*]s1 /reaml9e ! process1 & r$uce ! "t x takes to comply ) ! requirem5ts ( ?is subsection4 7#b7 ,rule ( con/ruction ,no?+ 9 ?is subsection %all be con/ru$ to limit ! access ( an individual :o is a subject ( rese>* to in=mation ab\t himself or h]self collect$ dur+ su* individual's p>ticipation 9 ! rese>*4 7#c7 ,def9itions ,= purposes ( ?is subsection1 ! t]m id5tifiable1 s5sitive in=mation means in=mation t is ab\t an individual & t is ga!r$ or us$ dur+ ! c\rse ( rese>* describ$ 9 p>agraph 7#a77;,a7 &-- 7,a7 ?r\gh :i* an individual is id5tifi$2 or 7,b7 = :i* !re is a risk1 z det]m9$ by curr5t sci5tific practices or /ati/ical me?ods1 t "s comb9ation ( ! in=mation1 ! reque/1 & o!r available data s\rces c\ld be us$ to d$uce ! id5tity ( an individual4 4 7b7 ,applicability ,beg9n+ on ! date ( enactm5t ( ?is ,act1 all p]sons engag$ 9 rese>* & au?oriz$ by ! ,secret>y ( ,heal? & ,human ,s]vices to protect in=mation "u section #cja7;d7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bda7;d77 prior to ! date ( enactm5t ( ?is ,act %all be subject to ! requirem5ts ( su* section 7z am5d$ by ?is ,act74 #c4 ,protection ( id5tifiable1 s5sitive in=mation ,section #cja ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bda7 is am5d$ by add+ at ! end ! foll[+3 7f7 7#a7 ,! ,secret>y may exempt f disclosure "u section #eeb7;b77#c7 ( title #e1 ,unit$ ,/ates ,code1 biom$ical in=mation t is ab\t an individual & t is ga!r$ or us$ dur+ ! c\rse ( biom$ical rese>* if-- 7,a7 an individual is id5tifi$2 or 7,b7 !re is a risk1 z det]m9$ by curr5t sci5tific practices or /ati/ical me?ods1 t "s comb9ation ( ! in=mation1 ! reque/1 & o!r available data s\rces c\ld be us$ to d$uce ! id5tity ( an individual4 7#b7 7,a7 ,ea* det]m9ation ( ! ,secret>y "u p>agraph 7#a7 to exempt in=mation f disclosure %all be made 9 writ+ & accompani$ by a /atem5t ( ! basis = ! det]m9ation4 7,b7 ,ea* su* det]m9ation & /atem5t ( basis %all be available to ! public1 ^u reque/1 ?r\gh ! ,(fice ( ! ,*ief ,,foia ,(fic] ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices4 7#c7 ,no?+ 9 ?is subsection %all be con/ru$ to limit a rese>* p>ticipant's access to in=mation ab\t su* p>ticipant collect$ dur+ ! p>ticipant's p>ticipation 9 ! rese>*4 4