- The US government shutdown, which is in its fourth week, is likely to further delay an ONC health IT rule being reviewed by the Office of Management and Budget (OMB), observed AMIA Vice President of Public Policy Jeffery Smith.
OMB is reviewing an ONC health IT rule implementing the 21st Century Cures Act, which is expected to have a major impact on the healthcare industry, Smith noted.
“Without question, the shutdown is affecting the OMB timetable. OMB has been reviewing this ONC rule for an inordinate amount of time. This shutdown exacerbates that,” Smith said.
The ONC rulemaking before OMB includes conditions and maintenance of certification requirements for health IT developers under the ONC Health IT Certification Program, voluntary certification of health IT for use by pediatric healthcare providers, and reasonable and necessary activities that do not constitute information blocking, which is prohibited by the act.
“21st Century Cures was pretty all encompassing in terms of laying out the blueprint for what ONC needed to accomplish over a two- to three-year period. One of the things that happened as a result of a transition in administrations, and I think is more pronounced when it's a transition among parties, is that a lot of forward momentum and progress got stalled,” he said.
According to an AMIA slide show provided to HITInfrastructure.com, the 21st Century Cures Act requires that ONC develop rules so that the following communications are not restricted or prohibited: the usability, interoperability, and security of health IT; relevant information regarding users’ experience when using health IT; business practices of developers of health IT related to exchange of electronic health information, and the manner in which a health IT user employs such technology.
In addition, the act directs ONC to establish processes and standards for publishing application programming interfaces (APIs) so that such APIs allow health information to be accessed, exchanged, and used “without special effort,” including access to all data elements of a patient’s electronic health record.
“OMB has been looking at this for a really long time. That indicates that they have a lot of questions about what the policy would do, and they have some concerns with how the policy is written … Because the government is shut down, whoever is assigned to reviewing this from the OMB perspective, they can't work,” Smith noted.
The rulemaking notice explained that it would also modify the 2015 Edition health IT certification criteria and program to advance interoperability, enhance health IT certification, and reduce burden and costs.
“The ONC certification program has been around for a while now, and for the most part industry and stakeholders understand what it means. 21st Century Cures came in and said, ‘We're going to add to this program. We're going to create conditions and maintenance of certification,’” Smith said.
“These are going to be things that certified health IT vendors have to do after they're certified and as a condition of maintaining their certification. Another discrete piece that we anticipate being in this rule is a voluntary certification for pediatric healthcare providers. Then there is this nebulous piece, which is certification modification to advance interoperability and reduce burden and cost,” he added.
Smith said that OMB may have asked before the Christmas break for an extension on approving the ONC rule.
“It's really not clear to me how long we can expect OMB to continue to review even once the government gets funded again. I think it's an open question … If the rumor about OMB having asked for another extension is true, that might push it down the road another two months,” Smith concluded.