DirectTrust responds to ONC’s Final Rule

Oct. 19, 2016
The National Coordinator for Health Information Technology (ONC) recently announced its final rule for the Health IT Certification Program.  The final rule includes ONC’s direct review, consistent authorization and oversight, and increased transparency and accountability of healthcare certified health IT.
In response, DirectTrust CEO/President David C. Kibbe, MD, MBA said, “In general, and not speaking for all of our very diverse members, I am in favor of the new final rule, the so-called Oversight Rule, in part because it has maintained the oversight function I feel is of value, and also scaled back from the proposal in March. Specifically:
“If you’re going to be regulated, it’s natural that you’d like the carrot without the stick.  The carrot for Meaningful Use (MU) has been pretty large, almost $40 billion of tax payers’ dollars, much of which went to EHR vendors whose products have to be certified by ONC as having the ‘right stuff.’ To date, there hasn’t been much stick. That is, there have been few penalties for those who don’t continue to have the right stuff or make it work the right way for customers after purchase.  ONC has taken note of EHR customers’ complaints regarding information blocking, but to my knowledge has not acted on any of these.  Although I understand why the EHR vendors want to push back on this final rule, I also think they have to be pretty happy with what they’ve achieved for themselves in terms of federal subsidies and federal oversight over the past six years.  $40 billion is a lot of carrot! 
“In my opinion, there truly needs to be continuing oversight by ONC’s certification program to protect against the very few but potentially very damaging instances in which vendor conduct turns out to be improper after initial certification, or when vendors fail to perform their responsibilities as agreed to as part of the certification process.  We don’t get our cars and trucks inspected just once; we’re required to get inspections annually.  The same notion of keeping the technology healthy, capable and safe for patients and users ought to apply to these increasingly very complicated software systems known as EHRs.
“But there is a larger issue here. The key idea is that we want a national program of health IT in which all of the participants stay up-to-date with such things as security standards, new vocabularies for clinical diagnoses and treatments, and new features and function sets that promote safe use.  We want ALL of the certified EHR vendors’ products to stay in step with the natural evolution that is occurring in the national health IT infrastructure, not just some of them.  
“In no area of health IT is it more important for vendors and their EHRs to stay in step than in conformity with the infrastructure that allows for electronic exchanges of health information.  This is because it is through the interoperable exchange of health information—across different organizations using different EHR vendors’ products—that we can eventually make the most progress in closing the gap between our health care system’s potential for quality improvements and the recognizably disappointing results to date.  So, this ongoing program of oversight and accountability by ONC for the nation’s EHRs is a good thing; it balances the protections we want with the minimum amount of regulatory hassles possible—in other words, it’s a balanced carrot and stick approach.
“An aside:  People interested in the broad subject of healthcare interoperability have to acknowledge that significant progress has been made in assuring that a patient’s health information can follow him or her across the diverse IT ecosystem of the health care delivery landscape.  Standards and protocols are now firmly in place that permit real time health information exchange, and this capability is growing every day. They also have to acknowledge that interoperable health information exchange is a ‘team sport,’ requiring collaboration, cooperation, and coordinated workflows and information exchange processes. Like any network, the strength of the whole is determined by the weakest link.  Each EHR is effectively a node on a network of health information exchange; each node a vital component of the whole fabric or infrastructure. In an increasingly stark and transparent way, every EHR that has problems with interoperability is a non-conformance problem for the whole network. In such a connected world, referees are needed.”