Hospitals need to start preparing to share and use unstructured patient data as the next phase of information-blocking regulations from HHS' Office of the National Coordinator for Health Information Technology go into effect next year, the Biden administration's top health information-technology official said at an event Monday.
The first phase of requirements from a landmark data-sharing rule from ONC went into effect April 5, under which healthcare providers, health information exchanges and certain software developers must share patient data with one another and with patients as requested, unless they meet an exception outlined in the rule.
For now, organizations are only required to exchange data included in ONC's U.S. Core Data for Interoperability—a standardized, but limited, set of data elements. But starting in October 2022, that requirement will encompass all of a patient's electronic health data, including data that isn't standardized.
"How are we going to start to leverage the unstructured data in all the various ways, shapes, forms, formats?" said ONC chief Micky Tripathi at an event hosted by Health Level Seven, the standards organization best known for creating Fast Healthcare Interoperability Resources, on Monday. "I don't think that 18 months is too far ahead to be thinking about that, given how complex that is."
Fast Healthcare Interoperability Resources, better known as FHIR, is a popular data-sharing standard used in healthcare. Under ONC's rule, health IT software developers must make APIs that meet specific FHIR standards available to customers by December 2022 to earn approval from ONC's health IT certification program.
As the industry works to figure out how to best use this data, Tripathi urged provider organizations and software companies to consider applications that improve processes for healthcare organizations, as well as for patients. That could include tools that make clinician workflows more efficient or that streamline how payers share data with providers.
Those B2B—or "business-to-business"—uses for health data may be where there's a greater need, according to Tripathi. While much of the focus on the information-blocking regulations to date has been on ensuring patients' right to access their own data, Tripathi called on healthcare organizations to "double-down" on developing B2B data uses, as well as B2C—or "business-to-consumer"—patient uses.
"We know (B2B) is value-enhancing," Tripathi said. "That doesn't mean for a second that we should back off from (B2C), because it's our obligation, as an industry, to make all of that information available to patients," he stressed. "I just want to strike that note of balance."
Sharing data more freely, particularly through standard APIs, could inform value-based care, make it possible to more easily exchange patient data between healthcare providers and payers, automate administrative work that's often completed by physicians manually, and add transparency to processes like prior authorization and payment, according to Tripathi.
The ONC's rule is a companion to an interoperability rule CMS finalized at the same time in March 2020. CMS is set to begin enforcing requirements that payers implement APIs for patient access and provider directories as part of the rule in July, following a period of enforcement discretion due to the COVID-19 pandemic.
That July deadline is "firm," said Alexandra Mugge, deputy chief health informatics officer at CMS, at HL7's event. She also highlighted a separate regulation that would require payers to build APIs that support data exchange and streamline prior authorization, which was released during the Trump administration and is currently on hold as it's reviewed by the Biden administration.
"FHIR allows all of us to move data as resources in a way that can truly modernize healthcare," she said. "It helps us achieve the kind of data exchange that consumers are used to in almost every other industry."