FDA calls for risk-rat­ing health IT

Modern Healthcare - - NEWS - By Jaimy Lee

The Food and Drug Ad­min­is­tra­tion has pro­posed that health in­for­ma­tion tech­nol­ogy prod­ucts should be clas­si­fied into three cat­e­gories based on their po­ten­tial risks to pa­tient safety, rather than by their tech­nol­ogy plat­form.

The federal agency re­leased its pro­posal in a re­port that of­fers rec­om­men­da­tions for how health IT prod­ucts should be reg­u­lated.

“We be­lieve a limited, nar­rowly tai­lored ap­proach that pri­mar­ily re­lies on (Of­fice of the Na­tional Co­or­di­na­tor for Health In­for­ma­tion Tech­nol­ogy)-co­or­di­nated ac­tiv­i­ties and pri­vate sec­tor ca­pa­bil­i­ties is pru­dent,” the re­port stated. “We also rec­om­mend that no new or additional ar­eas of FDA over­sight are needed.”

Ad­min­is­tra­tive HIT prod­ucts such as billing and claims soft­ware and in­ven­tory man­age­ment sys­tems would fall into a low-risk cat­e­gory.

Med­i­ca­tion man­age­ment, provider or­der en­try, most clin­i­cal-de­ci­sion sup­port soft­ware and other health man­age­ment IT prod­ucts would go into a sec­ond low-risk cat­e­gory.

Med­i­cal-de­vice sys­tems, in­clud­ing soft­ware for bed­side mon­i­tor alarms and ra­di­a­tion treat­ment that pose risks to pa­tient safety, would be put into a third cat­e­gory. The FDA would con­tinue to reg­u­late these prod­ucts.

The pro­posed frame­work seeks to pro­tect pa­tient safety and avoid reg­u­la­tory du­pli­ca­tion and is re­quired by a pro­vi­sion in the FDA Safety and In­no­va­tion Act of 2012, HHS said in a news re­lease. The ONC and the Federal Com­mu­ni­ca­tions Com­mis­sion also helped de­velop the re­port.

“This pro­posed strat­egy will fa­cili- tate in­no­va­tion, pro­tect pa­tients and sup­port FDA’s fo­cused over­sight on higher risk tech­nol­ogy, sim­i­lar to med­i­cal de­vices that are cur­rently reg­u­lated,” said Dr. Jef­frey Shuren, di­rec­tor of the FDA’s Cen­ter for De­vices and Ra­di­o­log­i­cal Health.

The re­port is avail­able for pub­lic com­ment and HHS plans to hold a pub­lic meet­ing on it in May.

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