On Tuesday, March 1, in the Sands Expo Center in Las Vegas, Karen DeSalvo, M.D., National Coordinator for Health IT, and other senior leaders from the Office of the National Coordinator for Health Information Technology (ONC) gave the HIMSS16 assembled press a federal health IT update which included various new policy announcements.
On March 1, the U.S. Department of Health and Human Services (HHS) and ONC proposed a new rule that would aim to further enhance the safety, reliability, transparency, and accountability of certified health IT for users. The “ONC Health IT Certification Program: Enhanced Oversight and Accountability” proposed rulemaking would modify the ONC Health IT Certification Program to reflect the widespread adoption of certified electronic health records (EHRs) and the rapid pace of innovation in the health IT market, according to an HHS press release.
"Today’s proposed rule will help us ensure that health IT products and the health IT marketplace are continuing to meet the needs of the healthcare system,” said DeSalvo. “We look forward to comments on the proposed rule from health IT developers and other stakeholders as we continue to work together to make health information available where and when it is needed safely and reliably.” The proposed rule would focus on three key areas:
- Direct Review: Enabling ONC to directly review certified health IT products, including certified EHR systems, and take necessary action to address circumstances such as potential risks to public health and safety. This will complement existing ONC-Authorized Certification Bodies (ONC-ACBs) responsibilities.
- Enhanced Oversight: Increasing ONC oversight of health IT testing bodies to align with ONC’s existing oversight of ONC-ACBs and provide the means for ONC to quickly, directly, and precisely address testing issues.
- Greater Transparency and Accountability: Making identifiable surveillance results of certified health IT publicly available to provide customers and users with valuable information about the overall performance of certified health IT, including illuminating good performance and continued compliance.
Speaking to the HIMSS gathered media live on the morning of March 1, DeSalvo said that ONC is aiming to leverage not just the certification of EHRs and technology, but to create a marketplace in which products that are purchased allow for more transparency in which developers will have to disclose more information to consumers. There has been a lot of work to see how the products in the field are working and ONC wants to hear feedback from the users, DeSalvo said.
DeSalvo also touched on HHS' announcement at HIMSS16 on Feb. 29 of a major federal initiative that has gathered together industry leaders to advance data-sharing, consumer access to healthcare data, and interoperability, in which the five largest private health systems in the U.S and the companies that provide 90 percent of EHRs hospitals nationwide have signed on a pledge to engage in these actions. On March 1, DeSalvo reinforced that sentiment. "Last night's commitment is a way forward for an open health system. [The private sector] will not block data, will give access, and will work with us on privacy and security. We do feel that the manifestation of these commitments is a world in which there are apps—FHIR-based apps—that are platform-agnostic so providers can push or pull information in a way that gives users a new kind of interface," she said. DeSalvo added, "You have to have shared standards and no data blocking in order for that to work. We would like to see this change happen as rapidly as possible, and also as safely and securely as possible," she said, further noting that the president of the United States "has a keen interest in seeing data move."
Since the announcement from HHS Secretary Sylvia Mathews Burwell yesterday evening, there has been whispering among those at HIMSS on if this pledge from major health IT stakeholders is something that looks nice on paper but lacks real substance. If the stakeholders involved break their promise on not blocking the flow of data and using agreed-upon standards for interoperability, will they be held accountable? These points were brought up to DeSalvo on Tuesday morning, who reiterated that this collaboration is a shared partnership with with the private sector. "We have made a commitment to work together to pull in the same direction, and the private sector has a major role to play in this, just like they do in payment reform," she said, offering that as a parallel to draw upon. "In that world, we know we are one of three, but that's not the majority. The private sector has come along with that, and made public commitments with the advancement towards alternative payment models," she said.
As such, the same concept can be applied in the health IT world, DeSalvo noted. "We cannot do this alone; it has to be a partnership," DeSalvo stressed, pointing to the fact that the vendors which provide 90 percent of EHRs to hospitals nationwide have signed on to this pledge. "They want to be in this new world, and the list will keep growing," DeSalvo said. "When we released the information blocking report a year ago, a bunch of organizations denied that blocking was happening. To move to this place where something like this can happen in the marketplace is a cultural shift," she said, pointing to the Argonaut Project as an example of a public-private partnership that can accelerate rapidly. Nonetheless, when pressed about a specific timeframe for when technology systems can "talk" to each other, thus relieving doctors of major pain points, DeSalvo said "It won't be in the very near term. You are looking at two or three years, or more."
What's more, when asked about if payers will be included in the pledge, DeSalvo said there is strong interest in having every entity weigh in and contribute to the pledge. "Coming off the work we have done with payers and with delivery system reform, we were quite focused on bringing developers to the table, as well as providers. You need to have conversations in which developers and providers can sit across the table and discuss challenges. So we are still welcoming all organization's to sign on to the pledge," she said, pointing to UnitedHealth Group/Optum as being part of the commitment, in addition to CMS, which of course "is the biggest payer out there," DeSalvo said.
Furthermore, ONC also announced on March 1 a strategy to spur the development of market-ready, user-friendly software applications, which includes two software app challenges with award prizes totaling $175,000 each: one focused on consumer use and one focused on provider use. Additionally, a competitive funding opportunity of up to $275,000 will support the development of an open resource to make it easier for developers to publish their apps and for providers to discover and compare them. The strategy will leverage the Health Level 7 – Fast Healthcare Interoperability Resources (FHIR) standard and the use of open, standardized application programming interfaces (APIs). Notably, ONC’s 2015 Edition Health IT Certification final rule includes API-related certification criteria, according to an HHS press release.