ONC surveillance guidance a message to more than certifiers

The Office of the National Coordinator for Health IT 's first surveillance guidance, issued earlier this month to help the ONC-Authorized Certification Bodies (ONC-ACBs) monitor the electronic health record products they have certified, covers a lot of ground. It identifies ONC's current surveillance priorities: exchange capabilities, safety related capabilities, security capabilities and population management capabilities. The guidance also flags that the ONC-ACBs should focus on how EHR developers handle complaints about their products.

So why do I have the feeling that ONC has a different agenda than simply giving the ONC-ACBs a new tool?

The final rule establishing the permanent certification program, published in the Federal Register January 2011, stated that ONC expected to issue annual guidance outlining its surveillance priorities. That was two-and-a-half years ago. And while the five priorities identified in this month's guidance are important ones, ONC's really stating the obvious in listing those issues as top priorities.

Wouldn't it have been a little more helpful to have had these priorities identified two years ago, before so many products were certified and sold? Even three months ago, before HHS decertified two EHRMagic products, leaving providers--who thought they were working with a certified product that would enable them to meaningfully use their EHRs--stranded?

Listing these priorities now seems like Monday morning quarterbacking.

So what's really going on here? I don't have a crystal ball, but I believe that the guidance is being used to send a message much broader than to the five ONC-ACBs.

First, the guidance provides an opportunity for ONC to remind the ONC-ACBs that they are accountable for proper certification and surveillance of certified products, especially as the industry moves toward Stage 2 of the Meaningful Use program. Granted, it does provide a few more details regarding surveillance than the final rule, but the final rule had already outlined what ONC-ACBs were supposed to do regarding surveillance, which ONC takes pains to point out.

Second, this may be a signal to providers and vendors that more products will be losing their certifications. Now that the ONC-ACBs have guidance to follow and have been reminded to conduct surveillance, they'll be more diligent and harsher on violators. Otherwise, they may lose their own accreditation. Both providers and vendors are hereby put on notice. The next decertification announcement may apply to you. I wouldn't be surprised if new certification announcements are already in the works.

Finally, the guidance serves as a reminder to critics that ONC takes its role seriously. If unqualified products are becoming or staying certified, and thus keeping providers from meeting the Meaningful Use requirements, then the program itself is no longer credible; that provides naysayers who want to "reboot" or jettison the program with a lot of ammunition. - Marla (@MarlaHirsch)

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