,,ii #aah? ,,congress #b;d ,session ,s4 #cfba ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,janu>y #ah1 #bjbd,ms4 ,hassan 7= h]self & ,mr4 ,braun7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,a ,,bill ,to am5d ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act to e/abli% nonvisual accessibility /&>ds = c]ta9 devices ) digital int]faces1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,m$ical ,device ,nonvisual ,accessibility ,act ( #bjbd4 #b4 ,f9d+s ,congress f9ds ! foll[+3 7#a7 ,rapid advances 9 digital te*nology h l$ to increas+ly complex us] int]faces = ev]yday products1 su* z life-su/a9+ m$ical devices & te*nologies4 7#b7 ,_m ( ^! new devices utilize displays t c only be op]at$ visually & require us] int]action ) on-scre5 m5us & o!r int]faces t are inaccessible to consum]s :o are bl9d or h l[-vision4 7#c7 ,m$ical devices design$ = use 9 ! home are be+ increas+ly utiliz$ to less5 ! co/ ( inpati5t c>e = consum]s4 7#d7 ,devices su* z blood pressure monitors1 sleep apnea ma*9es1 9-home *emo!rapy treatm5ts1 & _m o!rs g5]ally lack nonvisual accessibility4 7#e7 ,if a m$ical device is n accessible 9 a nonvisual mann]1 a bl9d or l[-vision individual is unable to use x privately1 indep5d5tly1 & safely4 7#f7 ,_m te*nology companies h incorporat$ scre5 access te*nology functions1 su* z text to spee* s(tw>e1 into products develop$ & sold by su* companies4 7#g7 ,scre5 access te*nology is n ! only me*anism by :i* m$ical devices c be made accessible to bl9d or l[-vision consum]s4 7#h7 ,devices t utilize ^! me*anisms w be m us]-fri5dly 9 g5]al by includ+ multiple me?ods to confirm read+s & o!r data1 lead+ to less wa/e & few] mi/akes4 7#i7 ,devices c be design$ to "w ) nonvisual access te*nology us$ by individuals :o are bl9d or h l[-vision1 at little or no extra co/1 z long z su* compatibility is tak5 into consid]ation at ! beg9n+ ( ! design process4 7#aj7 ,consum]s :o are bl9d or h l[-vision mu/ be able to op]ate m$ical devices 9 an equally effective & equally integrat$ mann] & ) equival5t ease ( use z consum]s )\t disabilities4 #c4 ,nonvisual accessibility /&>ds = c]ta9 devices 7a7 ,9 g5]al ,section #eja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cea7 is am5d$ by add+ at ! end ! foll[+3 7k7 7#a7 ,beg9n+ on ! effective date specifi$ 9 section #eae;,d7d77#b71 if x is a cov]$ device1 unless ! device meets ! nonvisual accessibility /&>d specifi$ "u section #eae;,d or ! ,secret>y issues a waiv] ) respect to ! device "u subp>agraph 7#b74 7#b7 ,! ,secret>y may waive ! application ( subp>agraph 7#a7 ) respect to a cov]$ device if1 bas$ on cle> & conv9c+ evid5ce 7z det]m9$ by ! ,secret>y7 provid$ by ! manufactur] involv$1 ! ,secret>y det]m9es t ! application ( su* subp>agraph to ! device w\ld result 9 a fundam5tal alt]ation to ! nature ( ! product or an undue h>d%ip = ! manufactur]4 7#c7 ,9 ?is p>agraph3 7,a7 ,! t]m cov]$ device means a device t-- 7i7 is classifi$ "u section #eac into class ,,ii or ,,iii2 7ii7 is cle>$ "u section #eaj7k71 grant$ m>ket+ au?orization "u section #eac7;f77#b71 or approv$ "u section #eae aft] ! effective date specifi$ 9 section #eae;,d7d77#b72 7iii7 has a us] int]face2 & 7iv7 is n int5d$ solely = use by a heal? c>e provid] or 9 a sett+ outside ! home4 7,b7 ,! t]m fundam5tal alt]ation means an alt]ation to ! nature ( a cov]$ device t w\ld r5d] x unusable or incapable ( p]=m+ an ess5tial function4 7,c7 7i7 ,! t]m undue h>d%ip means an action requir+ significant difficulty or exp5se1 :5 consid]$ 9 light ( ! factors set =? 9 subclause 7ii74 7ii7 ,9 det]m9+ :e!r application ( subp>agraph 7#a7 w\ld impose an undue h>d%ip on a manufactur] ( a cov]$ device1 factors to be consid]$ may include-- 7,i7 ! nature & co/ ( compliance ) ! /&>d "u section #eae;,d2 & 7,,ii7 ! ov]all f9ancial res\rces ( ! manufactur] ( a cov]$ device4 7,d7 ,! t]m us] int]face means a scre5 or mobile application ?r\gh :i* a human us] int]acts or communicates ) ! device by inputt+ or receiv+ in=mation4 4 7b7 ,recognition ( /&>d ,! ,f$]al ,food1 ,drug1 & ,cosmetic ,act is am5d$ by ins]t+ aft] section #eae;,c 7#ba ,u4,s4,c4 #cfj;e-#d7 ! foll[+3 #eae;,d4 ,nonvisual accessibility /&>ds = c]ta9 devices 7a7 ,/&>d ,! nonvisual accessibility /&>d specifi$ 9 ?is section is1 ) respect to a us] int]face ( a device describ$ 9 section #eja7k71 t ! us] int]face is z effective 9 all[+ bl9d or l[-vision individuals to access in=mation1 engage 9 int]actions1 & enjoy s]vices ) ! same privacy1 indep5d5ce1 & ease ( use z ! us] int]face ( ! device enables individuals :o d n h l[-vision or are n bl9d4 7b7 ,tra9+ ,! ,secret>y %all conduct tra9+ to educate manufactur]s ( a us] int]face ( a device describ$ 9 section #eja7k7 or ( a device describ$ 9 su* section on ! /&>ds develop$ "u subsection 7a7 & h[ to comply ) su* /&>d4 7c7 ,/akehold]s ,9 develop+ ! /&>d "u subsection 7a7 & ! tra9+ to be conduct$ "u subsection 7b71 ! ,secret>y %all consult )-- 7#a7 ! ,ar*itectural & ,transportation ,b>ri]s ,compliance ,bo>d e/abli%$ "u section #ejb ( ! ,rehabilitation ,act ( #aigc2 & 7#b7 individuals :o are bl9d or :o h l[-vision4 7d7 ,regulations 7#a7 ,9 g5]al ,! ,secret>y %all1 9 consultation ) ! ,ar*itectural & ,transportation ,b>ri]s ,compliance ,bo>d ref]r$ to 9 subsection 7c77#a7-- 7,a7 n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is section1 issue propos$ regulations to implem5t ! /&>d specifi$ "u subsection 7a72 & 7,b7 n lat] ?an #b ye>s aft] ! date ( ! enactm5t ( ?is section1 publi% a f9al rule ) respect to su* propos$ regulations4 7#b7 ,effective date ,! f9al rule publi%$ "u p>agraph 7#a77;,b7 %all take effect on ! date t is #a ye> aft] ! date on :i* su* rule is publi%$4 4