SKY’S THE LIMIT

FCC’S ap­proval of wire­less spec­trum for health­care would un­chain pa­tients from hospi­tal beds, trans­form­ing care

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Ex­perts say the agency’s move will bol­ster provider-pa­tient data trans­mis­sion across all health­care set­tings /

The Fed­eral Com­mu­ni­ca­tions Com­mis­sion is on the cusp of un­leash­ing tech­nol­ogy that could re­lease pa­tients from the con­stel­la­tions of ma­chines that mon­i­tor them in the hospi­tal and revo­lu­tion­ize the level of mon­i­tor­ing pos­si­ble at home.

The FCC said it is likely to ap­prove a pro­posal that will al­lo­cate spec­trum for wire­less pa­tient mon­i­tor­ing tech­nol­ogy, po­ten­tially cre­at­ing a lu­cra­tive new mar­ket for com­pa­nies de­vel­op­ing the tech­nol­ogy and low­er­ing health­care costs by re­duc­ing hos­pi­ta­lac­quired in­fec­tions, pre­vent­ing un­planned emer­gency trans­fers and keep­ing el­derly and chron­i­cally ill pa­tients out of the hospi­tal.

The FCC chair­man and com­mis­sion­ers are sched­uled to vote this week on the pro­posed rules, which would in­crease spec­trum ca­paci- ty and re­li­a­bil­ity for med­i­cal body area net­works, or MBANS, in hos­pi­tals, clin­ics and physi­cians’ of­fices.

The pro­posed rule also rec­om­mends set­ting aside a por­tion of the spec­trum for pa­tient use out­side of a hospi­tal.

MBAN de­vices col­lect phys­i­o­log­i­cal data, such as a pa­tient’s tem­per­a­ture or blood pres- sure, us­ing a small wire­less sen­sor on a pa­tient’s body. The sen­sor would au­to­mat­i­cally trans­mit the data to a nearby “hub” de­vice and then on to a mon­i­tor­ing sys­tem.

The MBAN tech­nol­ogy, some of which may be dis­pos­able, will elim­i­nate the need for most wires that con­nect a pa­tient to mon­i­tor­ing equip­ment. An ex­am­ple of MBAN tech­nol­ogy is fe­tal teleme­try, which con­tin­u­ously mon­i­tors a baby’s health but does not limit a mother’s move­ment.

FCC Chair­man Julius Ge­na­chowski said dur­ing a May 17 news con­fer­ence at Ge­orge Washington Univer­sity Hospi­tal that the “real game-changer for MBAN tech­nol­ogy” will be health-mon­i­tor­ing de­vices that pa­tients can wear at home.

“This creative use of spec­trum also pro­vides wire­less health man­u­fac­tur­ers with the cer­tainty they need to stream­line their prod­uct de­vel­op­ment, which for many years op­er­ated on a va­ri­ety of fre­quen­cies,” Ge­na­chowski said in pre­pared re­marks. “I ex­pect it will even­tu­ally lead to tech­nolo­gies not just for health­care fa­cil­i­ties, but also for in-home use.”

GE Health­care, which man­u­fac­tures pa­tient mon­i­tor­ing sys­tems, iden­ti­fied the need for spec­trum to be set aside for this type of tech­nol­ogy in 2007. That year, the Waukesha, Wis.-based com­pany filed a pe­ti­tion with the FCC to re­quest the com­mis­sion al­lo­cate spec­trum and es­tab­lish ser­vice and tech­ni­cal rules for MBAN tech­nol­ogy.

Matt Grubis, chief en­gi­neer for GE Health­care’s mon­i­tor­ing so­lu­tions busi­ness, said what the FCC is propos­ing is sim­i­lar to what GE re­quested al­most five years ago.

Philips Health­care, Texas In­stru­ments and the Amer­i­can So­ci­ety for Health­care En­gi­neer­ing, whose mem­ber­ship in­cludes hospi­tal fa­cil­ity man­agers and clin­i­cal and bio­med­i­cal engineers, later joined GE Health­care in its push for the FCC to al­lo­cate MBAN spec­trum.

“GE Health­care is in­cred­i­bly pleased to see a rul­ing on med­i­cal body area net­works,” Michael Harsh, GE Health­care’s vice pres­i­dent and chief tech­nol­ogy of­fi­cer, said dur­ing the FCC news con­fer­ence. “By open­ing this new wire­less spec­trum for com­mu­ni­cat­ing health­care in­for­ma­tion through this promis­ing tech­nol­ogy of MBANS, pa­tient care and dis­ease mon­i­tor­ing will be rev­o­lu­tion­ized in the not-too-dis­tant fu­ture.”

It’s not the first time the FCC has set aside spec­trum for wire­less med­i­cal de­vices used in hospi­tal set­tings. In 2000, the agency al­lo­cated spec­trum for wire­less teleme­try de­vices, such

as heart mon­i­tors, to pro­tect the de­vices against the pos­si­bil­ity of in­ter­fer­ence from ra­dio and TV broad­casts.

The ASHE, a per­sonal mem­ber­ship group of the Amer­i­can Hospi­tal As­so­ci­a­tion, was ap­pointed as the fre­quency co­or­di­na­tor for the wire­less med­i­cal teleme­try ser­vice spec­trum in 2001 and said in a May 17 state­ment that it would ac­cept the role of fre­quency co­or­di­na­tor for MBANS.

The or­ga­ni­za­tion said both as­so­ci­a­tions be­lieve that MBANS will pro­vide nu­mer­ous clin­i­cal ben­e­fits for pa­tients.

“Tra­di­tional wire­less teleme­try sys­tems are of­ten re­stricted to cer­tain ar­eas or floors of a hospi­tal be­cause the sig­nals are limited,” the ASHE said. “MBANS would not have that is­sue, so pa­tients could be placed in the hospi­tal unit based on their spe­cific med­i­cal con­di­tion, rather than based on a unit’s wire­less mon­i­tor­ing ca­pa­bil­ity.”

Still, one con­cern is that the spec­trum that the FCC has pro­posed for use by MBAN tech­nol­ogy is also used by aero­nau­ti­cal teleme­try. It has been used al­most ex­clu­sively by com­mer­cial test pi­lots, ac­cord­ing to the FCC.

The ap­pointed MBAN fre­quency co­or­di­na­tor would need to “work with hos­pi­tals and MBANS man­u­fac­tur­ers to en­sure that med­i­cal teleme­try does not in­ter­fere with aero­nau­ti­cal teleme­try, such as data col­lected from test flights,” the ASHE said.

For de­vice man­u­fac­tur­ers, the pro­posed rule, which won’t pub­licly be avail­able un­til May 24, pro­vides clar­ity about the reg­u­la­tions be­hind the de­vel­op­ment of these kinds of de­vices.

It also presents mar­ket op­por­tu­ni­ties for the man­u­fac­tur­ers that would de­velop MBAN tech­nol­ogy.

“MBANS pro­vide a cost-ef­fec­tive way to mon­i­tor ev­ery pa­tient in a health­care in­sti­tu­tion, so they can pro­vide real-time and ac­cu­rate data, al­low­ing doc­tors and nurses to iden­tify life-threat­en­ing prob­lems or events be­fore they oc­cur,” Ge­na­chowski said in his re­marks.

He also said the FCC is con­sid­er­ing the adop­tion of new rules that would per­mit more in­ten­sive use of spec­trum for wire­less med­i­cal de­vices

Ge­na­chowski cited stud­ies find­ing that half of hospi­tal pa­tients are not mon­i­tored and that a mon­i­tored hospi­tal pa­tient has a 48% chance of sur­viv­ing car­diac ar­rest, while un­mon­i­tored pa­tients have only a 6% chance of sur­vival.

The de­vices can “pro­vide the best qual­ity mon­i­tor­ing at the low­est pos­si­ble cost,” GE Health­care’s Grubis said. “It brings our cus­tomers a new level of be­ing able to care for their pa­tients.”

GE Health­care and Philips Health­care said they have tech­nol­ogy in de­vel­op­ment that would use the newly al­lo­cated MBAN spec­trum if the pro­posal is ap­proved by the FCC.

A spokesman for Philips Health­care’s pa­tient care and clin­i­cal in­for­mat­ics busi­ness unit said the com­pany is de­vel­op­ing a res­pi­ra­tory mon­i­tor­ing sen­sor and plans to sub­mit the de­vice to the Food and Drug Ad­min­is­tra­tion for clear­ance this year.

The mar­ket for MBAN tech­nol­ogy could be in the hun­dreds of mil­lions of dol­lars, said An­thony Jones, chief mar­ket­ing of­fi­cer for Philips Health­care’s pa­tient care and clin­i­cal in­for­mat­ics unit.

Grubis con­firmed that GE Health­care is also de­vel­op­ing MBAN tech­nol­ogy, but de­clined to pro­vide ad­di­tional in­for­ma­tion. He said the com­pany’s avail­able wire­less pa­tient mon­i­tor­ing prod­ucts use the wire­less med­i­cal teleme­try ser­vice spec­trum, as well as a Wi-fi net­work.

Wire­less med­i­cal de­vices used on the WMTS and MBAN spec­trums must be ap­proved by the FDA and li­censed by the FCC. Two years ago, the FCC and the FDA an­nounced an ini­tia­tive to work to­gether to sup­port the de­vel­op­ment for wire­less med­i­cal de­vices.

How­ever, the FCC’S an­nounce­ment last week that it is propos­ing the al­lo­ca­tion of spec­trum specif­i­cally for MBAN tech­nol­ogy en­sures a path­way for de­vice­mak­ers to de­velop this type of tech­nol­ogy.

“It’s a fan­tas­tic idea,” said Dr. James Killeen, di­rec­tor of in­for­ma­tion tech­nol­ogy ser­vices for the emer­gency depart­ment at UC San Diego Health Sys­tem. “It opens up pri­vate in­dus­try to cer­tainly con­trib­ute more to med­i­cal de­vices.”

Con­cern about band­width also is of con­cern for hos­pi­tals. When the 531-bed San Diego hos- pital added new build­ings to its cam­pus a year ago, it also built sep­a­rate band­width for med­i­cal de­vices. Killeen said it’s not com­mon for hos­pi­tals to do this, but UCSD’S prox­im­ity to the lo­cal health IT in­dus­try in the San Diego re­gion was one fac­tor in the decision.

Killeen also said he agreed with the FCC’S pro­posal that MBAN de­vices would lead to lower costs, not­ing how care mod­els are chang­ing.

Dr. Joseph Smith, chief med­i­cal of­fi­cer and chief sci­ence of­fi­cer for the West Wire­less Health In­sti­tute, a med­i­cal re­search group that fo­cuses on low­er­ing health­care costs through tech­nol­ogy and in­no­va­tion, said the pro­posed rule clar­i­fies con­cerns and ques­tions for a num­ber of stake­hold­ers in­volved with wire­less med­i­cal de­vices.

Smith said man­u­fac­tur­ers will have a de­fined reg­u­la­tory path­way to fol­low when de­vel­op­ing tech­nol­ogy, the FDA will have ad­di­tional clar­ity about the spec­trum re­quire­ments when re­view­ing MBAN de­vices, and hos­pi­tals will have more in­for­ma­tion to con­sider when build­ing wire­less net­works.

It also sends a sig­nal to the ven­ture cap­i­tal com­mu­nity that there is an es­tab­lished path­way for man­u­fac­tur­ers that de­velop MBAN tech­nol­ogy, Smith said. “It pro­vides clar­ity about the kinds of so­lu­tions that will work.”

Ge­na­chowski said the “game-changer” would be health-mon­i­tor­ing de­vices that pa­tients can wear at home.

FCC ap­proval would pro­vide mar­ket op­por­tu­ni­ties for de­vice man­u­fac­tur­ers.

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