Health­care IT pro­posal keeps over­sight light

Modern Healthcare - - NEWS - By Joseph Conn

Rec­om­men­da­tions re­gard­ing a draft plan for health­care in­for­ma­tion tech­nol­ogy reg­u­la­tion that calls for a fairly light reg­u­la­tory touch go­ing for­ward were ap­proved last week by the fed­er­ally char­tered Health In­for­ma­tion Tech­nol­ogy Pol­icy Com­mit­tee.

The plan in­cludes a three-tiered, risk-based reg­u­la­tory frame­work for health­care IT sys­tems and soft­ware.

The Food and Drug Ad­min­is­tra­tion would re­tain con­trol over med­i­cal-de­vice soft­ware it al­ready reg­u­lates that could pose pa­tient safety risks if glitches oc­cur. Most health IT prod­ucts, how­ever, in­clud­ing com­plex sys­tems such as com­put­er­ized physi­cian-or­der en­try and med­i­ca­tion man­age­ment soft­ware, would fall un­der a lower-risk cat­e­gory, which, ac­cord­ing to the pro­posed frame­work, would not be reg­u­lated by the FDA.

A cen­tral com­po­nent of the plan is the es­tab­lish­ment of a Health IT Safety Cen­ter, a clear­ing­house for health­care IT pa­tient safety re­ports.

“We be­lieve that the safety cen­ter has the po­ten­tial to bring sub­stan­tial value to the coun­try,” said the HITPC work group’s chair­man, Dr. David Bates. He added that the safety cen­ter should be a govern­ment-sup­ported, pub­lic-pri- vate part­ner­ship “out­side of govern­ment.” Bates is the med­i­cal di­rec­tor of clin­i­cal and qual­ity anal­y­sis, in­for­ma­tion sys­tems at Part­ners Health­Care Sys­tem, Bos­ton. A fi­nal ver­sion of the federal reg­u­la­tory frame­work isn’t due un­til win­ter.

Amer­i­can Med­i­cal As­so­ci­a­tion Ex­ec­u­tive Vice Pres­i­dent and CEO Dr. James Madara said in a let­ter to the FDA that the AMA backs the plan’s “risk-based frame­work for over­sight and reg­u­la­tion.” The AMA also “strongly sup­ports” the safety cen­ter, he wrote.

But some key groups are “ex­tremely con­cerned with the fea­si­bil­ity of a three-cat­e­gory sys­tem un­der which all health IT will be reg­u­lated,” call­ing it, “a sim­plis­tic ap­proach,” ac­cord­ing to the mHealth Reg­u­la­tory Coali­tion, whose mem­bers in­clude med­i­cal de­vice­mak­ers and ap­pli­ca­tion de­vel­op­ers.

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