ONC fi­nal­izes rule giv­ing it more over­sight of EHRs

Modern Healthcare - - LATE NEWS - —Vir­gil Dick­son

In a fi­nal rule re­leased last week, the Of­fice of the Na­tional Co­or­di­na­tor for Health In­for­ma­tion Tech­nol­ogy will have more over­sight of elec­tronic health records and other tech­nolo­gies that store, share and an­a­lyze pa­tient in­for­ma­tion.

The rule also gives the ONC the author­ity to ask de­vel­op­ers to pull non­com­pli­ant prod­ucts from the mar­ket.

The ONC now has the power to de­cer­tify health IT prod­ucts that don’t com­ply with reg­u­la­tions or are found to pose a risk to pub­lic health or safety by caus­ing med­i­cal er­rors, for ex­am­ple.

If the ONC de­cer­ti­fies a prod­uct, its de­vel­oper will be re­quired to no­tify af­fected cus­tomers and providers who pur­chased the prod­ucts. The ONC could also is­sue a cease-and-de­sist no­tice to pre­vent the fu­ture sale or mar­ket­ing of the prod­uct.

The Amer­i­can Med­i­cal As­so­ci­a­tion sup­ported the ONC’s idea to use cor­rec­tive ac­tions to re­solve pa­tient safety and se­cu­rity is­sues in­volv­ing an IT prod­uct. How­ever, the group was con­cerned about the sus­pen­sion or ter­mi­na­tion of an IT prod­uct’s cer­ti­fi­ca­tion.

That ac­tion “may have se­ri­ous reper­cus­sions for physi­cians and pa­tients” since both rely on the prod­ucts to co­or­di­nate care. The agency em­pha­sized ter­mi­na­tion is a last re­sort. It also added a new step that gives health IT de­vel­op­ers a chance to re­solve is­sues prior to de­cer­ti­fi­ca­tion.

The Col­lege of Health­care In­for­ma­tion Man­age­ment Ex­ec­u­tives, a pro­fes­sional as­so­ci­a­tion that rep­re­sents chief in­for­ma­tion of­fi­cers at hos­pi­tals, praised the rule. Its mem­bers worry that some sys­tems fail to cal­cu­late qual­ity mea­sure­ment data cor­rectly, jeop­ar­diz­ing the accuracy of in­for­ma­tion that is in­creas­ingly tied to pay­ment and penal­ties for providers.

The Elec­tronic Health Record As­so­ci­a­tion felt the ONC was over­step­ping its author­ity in its abil­ity to de­cer­tify prod­ucts. The po­ten­tial cost of this rule for health IT de­vel­op­ers, the ONC and health­care providers could range as high as $650 mil­lion, the rule said, but it pegged the av­er­age an­nual cost at $6.6 mil­lion.

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