AMIA seeks to fo­ment se­ri­ous con­sid­er­a­tion of topic

Modern Healthcare - - Front Page - Joseph Conn

AMIA wants to spark de­bate on reg­u­lat­ing health IT

The Amer­i­can Med­i­cal In­for­mat­ics As­so­ci­a­tion has called for a na­tional dis­cus­sion about whether fed­eral reg­u­la­tion of health in­for­ma­tion technology sys­tems could help pro­mote pa­tient safety.

The as­so­ci­a­tion stopped short of call­ing for fed­eral reg­u­la­tion of the health IT in­dus­try in a five-page re­port that was re­leased Nov. 11 and en­dorsed by the AMIA’s board of di­rec­tors. The re­port, Chal­lenges in Ethics, Safety, Best Prac­tices and Over­sight Re­gard­ing HIT Ven­dors, Their Cus­tomers and Pa­tients: A Re­port of an AMIA Spe­cial Task Force, was the prod­uct of an eight-mem­ber task force im­pan­eled by the AMIA board in Septem­ber 2009.

Task force mem­bers were mind­ful of the con­tro­versy sur­round­ing pos­si­ble govern­ment reg­u­la­tion of med­i­cal-and health-re­lated soft­ware but con­cluded that “some sys­tem of govern­ment over­sight or reg­u­la­tion of health in­for­ma­tion technology needs to be given se­ri­ous con­sid­er­a­tion,” ac­cord­ing to the re­port.

The dec­la­ra­tion is al­most an about-face from a 1997 rec­om­men­da­tion that the AMIA made in con­junc­tion with other health­care or­ga­ni­za­tions. The groups urged the FDA to ex­empt most clin­i­cal soft­ware sys­tems from reg­u­la­tion and in­stead fo­cus reg­u­la­tory ef­forts on those sys­tems pos­ing the high­est clin­i­cal risk.

In the new re­port the task force also noted that Sen. Chuck Grass­ley (R-Iowa), the rank­ing mem­ber of the Se­nate Fi­nance Com­mit­tee, has re­quested in­for­ma­tion from hos­pi­tals and IT ven­dors. Specif­i­cally, Grass­ley asked hos­pi­tals about gag clauses in their IT con­tracts that might bar them from talk­ing about sys­tem glitches and about providers’ fi­nan­cial ties to IT ven­dors.

The re­port au­thors con­cluded that be­cause there has been “ex­traor­di­nar­ily rapid growth” in IT adop­tion since 1997—in­clud­ing the adop­tion of di­rect dig­i­tal links be­tween reg­u­lated pa­tient-mon­i­tor­ing de­vices and un­reg­u­lated health IT sys­tems—the AMIA should “join with other stake­hold­ers to re­visit the role of gov­ern­men­tal and other for­mal reg­u­la­tion.” The or­ga­ni­za­tion pro­poses do­ing that through the ex­ist­ing task force or a new one.

The task force also rec­om­mended re-ex­am­in­ing “gov­er­nance of in­sti­tu­tions that man­u­fac­ture and use health in­for­ma­tion sys­tems— in­clud­ing, but not limited to, elec­tronic health records, per­sonal health records, com­put­er­ized provider-or­der-en­try sys­tems, elec­tronic med­i­ca­tion-ad­min­is­tra­tion record sys­tems and lab­o­ra­tory sys­tems.”

Task force Chair­man Ken­neth Good­man said the group also made rec­om­men­da­tions to elim­i­nate the “hold harm­less” clauses ven­dors of­ten in­sert in con­tracts with providers and the gag clauses that pre­vent providers from dis­cussing sys­temic er­rors with other providers.

“The lat­ter was the source of some pretty in­tense de­bate,” said Good­man, a pro­fes­sor of medicine and the di­rec­tor of the bioethics pro­gram at the Uni­ver­sity of Mi­ami.

Good­man: There was “in­tense de­bate” over end­ing gag clauses.

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