EASY ON THOSE APPS

MO­BILE MED­I­CAL APPS GAIN SUP­PORT, BUT MANY LACK CLIN­I­CAL EV­I­DENCE

Modern Healthcare - - NEWS - By Joseph Conn

Mo­bile med­i­cal ap­pli­ca­tions in­creas­ingly are be­ing used by pa­tients and con­sumers. Now health­care providers are eval­u­at­ing whether and how to work with their pa­tients in tap­ping th­ese apps. But they’re pro­ceed­ing cau­tiously be­cause of the dearth of clin­i­cal ev­i­dence for many con­sumer apps, and be­cause some de­vel­op­ers may be mis­lead­ing con­sumers by over­stat­ing their prod­ucts’ ca­pa­bil­i­ties.

In Septem­ber, de­vel­op­ers of a con­sumer-mar­keted mo­bile app, Ul­timEyes, agreed to pay $150,000 to set­tle an en­force­ment ac­tion by the Fed­eral Trade Com­mis­sion based on the claim that the app was “sci­en­tif­i­cally shown to im­prove vi­sion.” The pro­mot­ers “did not have the sci­en­tific ev­i­dence to sup­port their claims,” the FTC said.

Ear­lier this year, the fed­eral agency went af­ter mar­keters of two mo­bile apps, Mole De­tec­tive and MelApp, “for deceptively claim­ing their mo­bile apps could de­tect symp­toms of melanoma even in its early stages.” The apps’ mar­keters reached set­tle­ments that bar them from con­tin­u­ing to make such un­sup­ported claims, the FTC said.

The FTC ac­tion on the melanoma apps fol­lowed re­search led by Dr. Laura Fer­ris, an as­sis­tant pro­fes­sor at the Univer­sity of Pitts­burgh, that was pub­lished in JAMA Der­ma­tol­ogy in 2013. Her team looked at four such apps. “We saw that they didn’t work all that well,” Fer­ris said in an in­ter­view. “You can’t just put th­ese out there with no val­i­da­tion or no data to back them up, be­cause the stakes are too high.”

That’s a par­tic­u­lar is­sue for the poor, the unin­sured, and the un­der­in­sured who might buy an app for a few dol­lars and di­ag­nose them­selves, rather than pay for a doc­tor’s visit, she said.

Given the grow­ing use of mo­bile med­i­cal apps, “I think we will be see­ing an in­crease in scru­tiny and en­force­ment by the FDA and the FTC,” said Monica Ch­mielewski, a part­ner at Fo­ley & Lardner. She doubted that more “in­nocu­ous” apps like weight track­ers would be sub­ject to scru­tiny. “But when you have th­ese mo­bile med­i­cal de­vices tread­ing in the ar­eas of di­ag­no­sis and treat­ment, for those I

think we’ll see in­creased en­force­ment.”

Only 16% of health­care pro­fes­sion­als cur­rently use mo­bile ap­pli­ca­tions with their pa­tients, but 46% plan to do so in the next five years, ac­cord­ing to a 2015 sur­vey of 500 pro­fes­sion­als by Re­search Now, a Plano, Texas-based mar­ket re­search firm. Even so, 86% of the pro­fes­sion­als sur­veyed said they be­lieve mo­bile apps will in­crease their knowl­edge of their pa­tients’ con­di­tions, while 46% said the apps will im­prove their re­la­tion­ships with pa­tients.

Re­search Now also sur­veyed con­sumers who use med­i­cal apps and found that 96% said they be­lieve the de­vices help them im­prove the qual­ity of their lives. Sixty per­cent use them to mon­i­tor their ac­tiv­ity and their work­outs, 49% to count their calo­ries and 42% to mon­i­tor weight loss.

“I have pa­tients ask­ing me all the time about healthre­lated apps,” said Dr. Mike Sevilla, a fam­ily physi­cian who be­longs to a six-physi­cian group prac­tice in Salem, Ohio. “It’s really a great way for me to talk to my pa­tients and make them ac­count­able” for man­ag­ing their own health.

He rec­om­mends apps from the Mayo Clinic and We­bMD to pa­tients. “We’re com­ing into the hol­i­days and peo­ple are al­ready think­ing about weight loss and low­er­ing their choles­terol and count­ing their steps.” Sevilla said. He be­lieves home blood-pres­sure read­ings via apps of­ten are more ac­cu­rate be­cause pa­tients’ blood pres­sure can rise when they come to the doc­tor’s of­fice.

Es­ti­mates of the size of the U.S. mo­bile health mar­ket vary widely. Manu Varma, head of strat­egy for Philips’ Hos­pi­tal to Home busi­ness unit, which sells de­vices and con­sults with providers set­ting up mo­bile health pro­grams, said the mar­ket is grow­ing 20% a year. For health­care providers, a ma­jor fac­tor driv­ing that adop­tion is the shift to val­ue­based pay­ment, which creates a pow­er­ful in­cen­tive to keep pa­tients health­ier and re­duce costs by avoid­ing un­nec­es­sary hos­pi­tal­iza­tions and emer­gency depart­ment use.

Ban­ner Health in Phoenix has im­ple­mented a project called In­ten­sive Am­bu­la­tory Care, which uses an ar­ray of mo­bile de­vices for home health mon­i­tor­ing of about 600 pa­tients with mul­ti­ple chronic con­di­tions.

The pro­gram, which is free to pa­tients, in­volves sev­eral am­bu­la­tory teams each con­sist­ing of two physi­cians, two nurses, two so­cial work­ers, a phar­ma­cist and a health coach who serve up to 40 pa­tients. The de­vices, sup­plied by Philips, in­clude a wire­less scale and mon­i­tors for blood pres­sure, pulse rate, blood oxy­gen and glu­cose, plus video com­mu­ni­ca­tion.

Re­sults from the ini­tial 135pa­tient pi­lot pro­gram in­di­cated a 27% re­duc­tion in en­rolled pa­tients’ cost of care, pri­mar­ily be­cause of fewer hos­pi­tal ad­mis­sions and shorter lengths of stay, as well as lower out­pa­tient health­care costs, said Dr. Har­gob­ind Khu­rana, Ban­ner’s se­nior med­i­cal di­rec­tor of health man­age­ment. “Pa­tients like it a lot,” he said. “They adopted the tech­nol­ogy more eas­ily than we thought.”

As with the in­tro­duc­tion of any new clin­i­cal-care process, there are safety is­sues with mo­bile health. “We’re go­ing from a sit­u­a­tion where we had no data to one where we prob­a­bly have more data than we need,” Khu­rana said. “You have to have pro­cesses in place where we don’t re­spond to data that’s flawed. You val­i­date by talk­ing with the pa­tient. You understand that data is just one part of the de­ci­sion tree.”

Re­search shows that mo­bile apps can of­fer clin­i­cal ben­e­fits, par­tic­u­larly when used in a struc­tured health­care pro­gram. A lit­er­a­ture sur­vey pub­lished in PLOS Medicine in 2013 by re­searchers at the Lon­don School of Hy­giene & Trop­i­cal Medicine con­cluded that text mes­sages to pa­tients’ mo­bile phones were ef­fec­tive with smok­ing ces­sa­tion and in boost­ing pa­tient com­pli­ance with an­tiretro­vi­ral med­i­ca­tion regimes.

In Septem­ber, the Amer­i­can Heart As­so­ci­a­tion con­cluded that the ev­i­dence gen­er­ally sup­ports us­ing mo­bile med­i­cal apps to ad­dress smok­ing, weight, health­ful eat­ing, reg­u­lar phys­i­cal ac­tiv­ity, blood glu­cose, blood pres­sure and choles­terol lev­els. The as­so­ci­a­tion said heart re­searchers have found that con­sumer health-in­for­mat­ics tools have a pos­i­tive im­pact on knowl­edge, ad­her­ence, self-man­age­ment and be­hav­ior changes re­lated to health­ful eat­ing, ex­er­cise and phys­i­cal ac­tiv­ity—but not on obe­sity.

Smart­phone apps also were deemed “use­ful tools at the point of care and in mo­bile clin­i­cal com­mu­ni­ca­tion, as well as in re­mote pa­tient mon­i­tor­ing and self-man­age­ment of dis­ease.” But the as­so­ci­a­tion noted con­cerns that the apps gen­er­ally “fail to in­cor­po­rate ev­i­dence-based con­tent” and lack “rig­or­ous test­ing” for ef­fi­cacy.

In an­other lit­er­a­ture re­view, Spy­ros Kit­siou, an as­sis­tant pro­fes­sor in bio­med­i­cal and health in­for­ma­tion sci­ences at the Univer­sity of Illi­nois at Chicago, and his Cana­dian col­leagues con­cluded that hard-wired tele­mon­i­tor­ing and mo­bile tele­mon­i­tor­ing were ef­fec­tive in re­duc­ing the risk of all-cause mor­tal­ity and heart fail­ure-

“WE’RE GO­ING FROM A SIT­U­A­TION WHERE WE HAD NO DATA TO ONE WHERE WE PROB­A­BLY HAVE MORE DATA THAN WE NEED.”

Dr. Har­gob­ind Khu­rana Se­nior med­i­cal di­rec­tor of health man­age­ment, Ban­ner Health

re­lated hos­pi­tal­iza­tions in in­ter­ven­tion pro­grams for pa­tients with chronic heart fail­ure.

The qual­ity of the ev­i­dence is only “mod­er­ate,” Kit­siou said in an in­ter­view. But he ar­gued that it’s good enough to sup­port us­ing the de­vices and ap­pli­ca­tions in clin­i­cal prac­tice. “In the next five to 10 years we’ll have even more ev­i­dence col­lected and be able to con­duct more rig­or­ous clin­i­cal tri­als,” he said.

Kit­siou and his co-au­thors wrote that “the key to the suc­cess of th­ese pro­grams is not the tech­nol­ogy it­self, but the co­or­di­na­tion of care that needs to be in place along the con­tin­uum of health ser­vices de­liv­ered for (heart fail­ure) pa­tients within a health­care sys­tem.”

He noted, how­ever, that the dig­i­tal in­ter­ven­tions he and his col­leagues eval­u­ated were not the “run-of-the mill” mo­bile apps for con­sumers avail­able from Ap­ple or Google. The vast ma­jor­ity of con­sumer med­i­cal apps “have not been for­mally eval­u­ated, so we know next to noth­ing about their ef­fec­tive­ness and whether they can ac­tu­ally harm the pa­tient,” he said. “As the num­ber of health apps is rapidly grow­ing, there is an ur­gent need for greater reg­u­la­tion and over­sight of th­ese med­i­cal/health apps by FDA and other gov­ern­ment en­ti­ties.”

Health­care lawyers cau­tion that providers run a va­ri­ety of le­gal risks in us­ing mo­bile apps with pa­tients. “If the pa­tient brings in a bunch of stuff, if you rely on it and it’s wrong, it’s a prob­lem,” said Kirk Nahra, pri­vacy prac­tice chair­man at Wi­ley Rein in Wash­ing­ton. “But if you ig­nore it and it’s right, it’s a prob­lem. You’re damned if you do and damned if you don’t.”

Robin Di­a­mond, se­nior vice pres­i­dent at the Doc­tors Co., a med­i­cal li­a­bil­ity in­surer, said, “The physi­cian needs to make sure pa­tients know the lim­i­ta­tions of the app” and how the provider or­ga­ni­za­tion han­dles the data pro­duced by the app. “The pa­tient may think, ‘I don’t have to worry about telling my physi­cian my blood pres­sure is a lit­tle high this week,’ ” she said. “But pa­tients with mo­bile mon­i­tors need to be told, ‘You still need to call me if you have this level.’ ”

There is also a risk that the read­ings pro­duced by a mo­bile de­vice may be in­ac­cu­rate. “There are a lot of untested apps on the mar­ket that may be un­re­li­able or even dan­ger­ous,” Di­a­mond said. If treat­ment is pre­scribed based on the wrong data, the provider could be found li­able, though she knows of no such cases so far.

Dr. Art Pa­pier, CEO and chief med­i­cal of­fi­cer at Rochester, N.Y.-based Visu­alDX, which of­fers com­put­er­ized di­ag­no­sis-sup­port tools for med­i­cal pro­fes­sion­als, noted that it’s im­por­tant to dis­tin­guish be­tween med­i­cal apps for con­sumers and those for pro­fes­sion­als.

“They’re two dif­fer­ent worlds,” he said. “You do want pa­tients en­gaged in fol­low­ing their (skin) moles, and they can cer­tainly track them by pho­tograph­ing them. But you need to be cau­tious about apps that give peo­ple mis­taken in­for­ma­tion that the mole is OK.”

“THE PHYSI­CIAN NEEDS TO MAKE SURE PA­TIENTS KNOW THE LIM­I­TA­TIONS OF THE APP.”

Robin Di­a­mond Se­nior vice pres­i­dent, Doc­tors Co.

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