EHR decertification strategy will require a careful balancing act

There's a new buzzword in the electronic health record world beginning to gain traction: decertification.  

So far, only two EHR products, both developed by Santa Fe Springs, California vendor EHRMagic, have had their certification revoked in 2013 for failing to meet the standards of the Meaningful Use program.

But now, a number of EHR products may be at risk of decertification, if more momentum builds to decertify those that "proactively" block the sharing of electronic information. Congress specifically addressed decertification last month in its 2015 omnibus appropriations bill, urging ONC to use its authority to certify only products that meet the Meaningful Use standards and don't block data sharing, and to decertify any products that do. It has asked ONC for a report on the extent of the problem and ONC's strategy to address it. The report is due in March.

ONC, for its part, related in a Health IT Standards Committee work group meeting last week that it takes this task "very seriously." ONC policy analyst Karson Mahler told the workgroup that decertification is "on the table" and that the agency is looking at the problem in a "deliberate and systematic way," as well as looking hard at the "implications of more aggressive action."

Fair enough.

But decertification is a Draconian move, and as acknowledged back in 2013 and again by Mahler, it can have tremendous long term collateral consequences on providers who are using targeted systems. Moreover, it is likely that decertification for blocking interoperability will affect more stakeholders.  

In addition to hapless providers who are using decertified EHR, decertification also would affect entities that are sharing data with those providers in order to meet the interoperability requirements of Meaningful Use, the health information exchanges that are trying to facilitate data sharing and patients whose data may no longer be shared by a product taken out of commission.  

And we're still in murky waters. Here are just a few issues that concern me:

  • How will "proactively block the sharing of information"--Congress's phrase for determining what should be decertified--be interpreted? 
  • Is "proactively" the same as "intentionally" or "for competitive advantage?"
  • Will providers have to return any incentive payments they had earned with the newly decertified EHRs? Or would application be non-retroactive?
  • Would vendors be given the opportunity to mend their ways and avoid decertification?
  • Would providers be given support in transitioning to a new certified EHR product, and/or exempt from the Meaningful Use requirements for a period of time in order to make the transition?
  • Congress also asked ONC to report on the extent to which providers are engaged in information blocking. Would they be punished, and if so, how?
  • ONC already has a proposed rule under review at OMB to update its certification processes. Will that rule now need to be pulled, reviewed and modified?

Interoperability is a priority for health IT, and products should not be--or remain--part of the Meaningful Use program if they can't or won't meet the requisite interoperability standards. But decertification has a much further reach than merely imposing a penalty on an individual provider who doesn't meet the Meaningful Use requirements.

I'm gratified to hear that ONC is "very concerned" at how this "blunt instrument" could impact the industry. This is an area where clarity and balancing of interests are very much needed. - Marla (@MarlaHirsch and @FierceHealthIT)