Karen DeSalvo called on the private sector on March 1 to aid in Office of the National Coordinator for Health Information Technology mission to open up the nation’s health IT systems, announcing rules changes that would move the industry to greater standardization.
“The private sector has a major role to play in this, just like they did with payment reform,” she said. “We’re leveraging the same kind of pathway that we did with payment reform to this effort around interoperability.
“So we would say that we are going to set goals, we’re going to move forward, we’re going to put all of our weight in one direction as the federal government and we’ve asked the private sector to come along. They said they would.”
To drive home that point, HHS released a proposed rule on March 1 that opens the door for ONC to certify that health IT products are meeting the agency’s interoperability standards.
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The proposed rule, called the “ONC Health IT Certification Program: Enhanced Oversight and Accountability” would give HHS and ONC powers to certify health IT technologies in three key areas:
- Direct review: It allows ONC to review certified health IT products and electronic health records systems to assess risks to public health and safety, working with its Authorized Certification Bodies to conduct the reviews
- Enhanced oversight: Giving ONC greater purview over health IT testing bodies to address issues that arise in the testing process
- Greater transparency and accountability: Makes information on performance and compliance of certified health IT available to the public
The focus of interoperability at the HIMSS conference in largely revolved around encouraging the private sector to streamline and standardize the way it shares data in the health IT realm.
The push was highlighted by HHS secretary Sylvia Burwell’s Feb. 29 announcement that several industry stakeholders would make interoperability, and data sharing, a priority.
But to fully make data sharing a possibility, HHS is calling on the private sector to open up information that some developers may consider proprietary, like application programming interfaces used to create healthcare IT apps.
Another issue is standardizing the way information is shared, with some in the private sector interpreting HIPPA regulations to protect patient data differently from company to company.
A day after Burwell’s announcement, though, DeSalvo was again calling on the private sector to support efforts to make interoperability a possibility.
“There’s no doubt that there’s plenty that we can and are doing to advance interoperability, but we cannot and will not do this alone,” she said. “There’s got to be a partnership with the private sector.”
Elise Sweeney Anthony, ONC’s acting director of policy, said the proposed rule is not meant to chill developer innovation, but instead ensure that operates in conjunction with the rest of the health IT sphere.
“Our goal is to partner with developers. Our goal is not to jump to decertification,” she said. “There’s a process in the rule that focuses on corrective action and identifying a follow-up should we see if a problem exists with nonconformity, that we would start with corrective action and would work with the developer to address it.”
The comment period for the new rule will be open until May 2.
Date: March 2, 2016