Health IT Regulators Face Challenges as Medical Apps Proliferate

An iHealth rep offers a man a blood pressure checkup from a blood pressure monitoring system for iPod touch, iPhone and iPad during a demonstration of various health-related products on the opening day of the International Consumer Electronics Show on January 10, 2012 in Las Vegas, Nevada. The show kicked off with a dazzling array of high-tech gadgetry including ultra-thin laptops, snazzy smartphones, iPad rivals and flat-screen and 3D TVs with a record 3,100 companies from around the world displaying their goods over a space equivalent to more than 35 football fields in the cavernous Las Vegas Convention Center for the four-day event.
National Journal
Darius Tahir
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Darius Tahir
Oct. 17, 2013, 6:39 a.m.

The reg­u­la­tion of health IT was al­ways bound to un­spool slowly, giv­en the in­volve­ment of mul­tiple agen­cies with over­lap­ping jur­is­dic­tion and a rap­idly chan­ging and im­port­ant in­dustry. The first piece of fi­nal­ized health IT reg­u­la­tion, which laid out rules for mo­bile ap­plic­a­tions, was re­leased Sept. 23 fol­low­ing two years of de­bate. The gov­ern­ment is re­quired to out­line its plans for the rest of the sec­tor by Janu­ary.

Health IT has the po­ten­tial to lower costs and im­prove pro­ductiv­ity in the health care sec­tor, which has re­cently stag­nated. New de­vel­op­ments in health IT could make doc­tors’ tasks more ef­fi­cient or re­place them en­tirely, a shift that would square with Obama­care’s in­cent­ives for pro­viders to de­liv­er qual­ity care at a lower cost.

Three agen­cies are charged with reg­u­lat­ing the sec­tor: the Food and Drug Ad­min­is­tra­tion, which will ap­prove some apps and soft­ware and over­see the use of IT in clin­ic­al prac­tice; the Fed­er­al Com­mu­nic­a­tions Com­mis­sion, which man­ages wire­less spec­trum; and the Of­fice of the Na­tion­al Co­ordin­at­or for Health In­form­a­tion Tech­no­logy, which over­sees elec­tron­ic med­ic­al re­cords. The agen­cies have in­dic­ated they will take a flex­ible ap­proach to health IT reg­u­la­tion in the hopes of en­cour­aging in­nov­a­tion.

The FDA said on Sept. 23 that it will largely waive en­force­ment for apps with non-dan­ger­ous func­tions: those that trans­mit in­form­a­tion from a pa­tient’s elec­tron­ic health re­cord; help man­age a health con­di­tion without of­fer­ing pa­tient-spe­cif­ic ad­vice, such as of­fer­ing gen­er­al diet tips for a dia­bet­ic; or provide simple cal­cu­la­tions, like body-mass in­dex.

The agency will be more strict with apps that con­trol or mim­ic reg­u­lated med­ic­al devices, such as an app that can show elec­tro­car­di­o­grams, and apps that provide pa­tient-spe­cif­ic ana­lyses or dia­gnoses — for ex­ample, an app that takes pic­tures of skin moles and de­term­ines wheth­er they are likely be­nign or ma­lig­nant. The FDA may re­quire pre­market clear­ance or ap­prov­al for these.

The reg­u­la­tions is­sued in Septem­ber left the some ques­tions un­answered; the agency still hasn’t de­cided how to reg­u­late soft­ware that helps doc­tors make treat­ment choices. And the de­cisions it has made don’t cov­er the en­tire sec­tor, which also in­cludes soft­ware that con­trols med­ic­al devices or elec­tron­ic health re­cords. That’s where the oth­er agen­cies come in.

A 2011 law, the FDA Safety and In­nov­a­tion Act, man­dated that the FDA, FCC, and ONC de­liv­er a re­port to Con­gress by Janu­ary 2014 out­lining their frame­work for reg­u­lat­ing health IT. The agen­cies con­vened a work group com­prised of ex­perts and in­dustry rep­res­ent­at­ives, which de­livered a re­port in Septem­ber re­com­mend­ing how the agen­cies should con­struct their fi­nal re­port (bur­eau­cracy at its finest).

The work group’s re­com­mend­a­tions echo the FDA’s mo­bile med­ic­al app guid­ance. Mem­bers think the agen­cies should ex­er­cise light over­sight over simple soft­ware and more closely mon­it­or com­plic­ated, risky tech­no­logy, the soft­ware that sub­sti­tutes its judg­ment for hu­mans’ in med­ic­al situ­ations.

They have a lot of snake oil to look out for. A Janu­ary study in the journ­al JAMA Der­ma­to­logy ex­amined four apps pur­port­ing to dia­gnose skin can­cer based on a pic­ture of a mole. The res­ults were poor; the odds of a pos­it­ive dia­gnos­is be­ing cor­rect ranged from 6.8 per­cent to 98.1 per­cent; neg­at­ive dia­gnoses sim­il­arly var­ied in ac­cur­acy. The au­thors blamed a “lack of reg­u­lat­ory over­sight” for the wide range in qual­ity.

Earli­er this year, FDA cracked down on the mo­bile app uChek, which uses an al­gorithm and the iPhone’s cam­era to per­form ur­inalys­is. The app’s makers lacked the agency’s clear­ance to mar­ket those cap­ab­il­it­ies, and the tech­nic­al spe­cific­a­tions on their web­site re­vealed that the com­pany’s data fell short of typ­ic­al FDA stand­ards. FDA sent them a let­ter re­quest­ing it come in­to com­pli­ance.

Sim­il­ar cases are likely to pro­lif­er­ate now that FDA has an­nounced its ap­proach to reg­u­lat­ing this mar­ket. The agency said in Septem­ber that it will al­low of­fend­ers “reas­on­able time” to com­ply be­fore fa­cing the con­sequences. The agency de­clined to an­swer in a Sept. 26 Twit­ter chat ex­actly how it would con­duct en­force­ment against mo­bile apps.

The Fed­er­al Trade Com­mis­sion is ex­pec­ted to join the FDA in en­for­cing rules for mo­bile apps and health IT gen­er­ally. The FTC has cracked down on false mar­ket­ing claims by mo­bile med­ic­al apps in the past; in 2011, the agency pur­sued ac­tion against sev­er­al “acne cure” apps that led to set­tle­ments. Of­fi­cials from the agency have sug­ges­ted it may re­quire ran­dom­ized con­trolled tri­als to back up cer­tain med­ic­al claims.

FDA’s guid­ance on mo­bile med­ic­al apps spe­cific­ally ex­empts phys­i­cians who tweak apps for their own use from man­u­fac­turer re­quire­ments, and that sep­ar­a­tion of de­veloper and prac­ti­tion­er is con­sist­ent with the work group’s re­com­mend­a­tions for health IT. But that un­der­scores part of the dif­fi­culty with over­see­ing the sec­tor: Small, loc­al changes may res­ult in er­rors — or mis­use — that have noth­ing to do with the de­veloper.

That’s where loc­al reg­u­lat­ors, who are closer to the ac­tion, are likely to come in and help de­term­ine where something went wrong. Health IT of­ten in­volves chained-to­geth­er func­tions; a piece of soft­ware might con­trol a med­ic­al device, which feeds data in­to an elec­tron­ic health re­cord, which is mon­itored by an­oth­er med­ic­al device’s soft­ware, which could af­fect how a pa­tient is treated. It isn’t known how many er­rors or ad­verse events are at­trib­ut­able to health IT for the same reas­on, the agen­cies’ work group said.

It’s something that needs to change if health IT is to work well. Reg­u­lat­ors, even as they re­cog­nize the po­ten­tial in the sec­tor’s fu­ture, will have to pay close at­ten­tion to the pit­falls of the present.

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