By Meghan Franklin
March 2, 2021
When Genevieve Morris was appointed in 2017 as the Principal Deputy National Coordinator for the Office of the National Coordinator for Health Information Technology (ONC), President Obama had already signed the Cures Act into law. ONC had been charged with writing a rule to address the interoperability and patient access provisions of the Act, which later became known as the “ONC Final Rule” or the “info blocking rule.”
Throughout an almost three-year process, Morris said the info blocking rule went through countless rounds of development and review to ensure it both stayed within the authority it had been given in the legislative text of the Cures Act and accomplished its intended policy goals.
When ONC was charged with writing the info blocking rule, Morris said that policy makers started with a couple of important questions:
When she came to ONC, Morris was well versed in well-meaning policy, she said. “It’s easy to have an overarching goal of what you want your policy to accomplish. It’s really hard to write a policy that actually gets you to that goal vs. shortcuts that people take to comply with a policy by a certain date.”
It was important to Morris and others working on the info blocking rule that their policy framework achieved the goal—to make data sharing the rule, instead of the exception—while ensuring it didn’t kill innovation.
Starting with that goal in mind, the team at ONC held weeks of policy sessions to talk through and draft the details of the rule.
After months of policy sessions and internal reviews, ONC provided a draft of the rule to federal agencies for review and comment.
Centers for Medicare and Medicaid Services, Centers for Disease Control and Prevention, Social Security Administration, Federal Trade Commission, the offices of the Deputy Secretary and Secretary of the Department of Health and Human Services, Office of the General Counsel, and the Office of Management and Budget were among the agencies that reviewed and provided comments on the rule.
After receiving feedback from federal agencies, the policy writers at ONC made revisions to the policy draft until it was ready to enter “proposed rule” status.
Once the rule entered “proposed” status, it entered into a 90-day public comment period, Morris said.
“It was definitely the largest set of public comments ONC had ever received,” Morris said. Each public comment was read by ONC, and the public comments were incredibly helpful, she said.
“This (the info blocking rule) was an incredibly tricky regulation,” Morris said. “It is impactful to the market from a revenue and technology perspective. Historically, under HIPAA, you’re permitted to share data. The rule flips that on its head and turns permitted purposes into required purposes. It’s a huge change in thinking for the industry.”
Perhaps most helpful about the public comments were that they highlighted for ONC where they needed to clarify the info blocking exceptions, Morris said.
“The proposed rule made it seem like you could not profit from data sharing. That wasn’t ONC’s intention; the public comments helped ONC see that the expansiveness of some of their definitions needed to be narrowed. ONC wanted to ensure there could still be profitability in data sharing and innovative uses of data,” Morris said.
After the 90-day public comment period, ONC made further revisions to the proposed rule, keeping their overarching policy goals in mind.
In March 2021, the rule was finalized.
Morris said the info blocking rule is needed because “The market was broken, and it wasn’t fixing itself. Unless my provider is in a value-based model, there’s no business case for them to share data with each other,” Morris said. “Patients and their health are at stake.”
While Morris noted that she tends to think that less government regulation is better, info blocking is a case where she feels government intervention is necessary.
“Because safety and better care for the patient is not a business case, it’s the government’s job to step in to ensure data is shared because it’s the right thing for all of us,” Morris said.
Ultimately, at ONC, Morris said there was a shared motivation among those working on the info blocking rule to write policy that would encourage innovation in the right direction for patient safety and care.
“We wanted those in the industry to ask: How can I innovate with data and generate revenue in that way rather than hoarding data?” Morris said.
Morris said she is hopeful that with easier and more abundant access to data, innovation will happen in ways that benefit patients and the entire healthcare system.
Since she had an integral seat at the table when the info blocking rule was drafted, Morris is intimately familiar with the intricacies of the rule.
She recognizes that the rule represents a big shift in the industry and said she hopes healthcare organizations see that it will have impacts similar to when HIPAA was rolled out.
“There were massive training programs when HIPAA was rolled out,” Morris said. “Healthcare organizations should view info blocking as a similar magnitude to HIPAA.”
Like for HIPAA training, Morris said organizations need to adopt not only initial training materials and programs, but also consider how anyone who touches patient data will need to be trained on an ongoing basis.
“Part of the info blocking rule says that you not only need to demonstrate that you have policies and procedures in place to promote appropriate data sharing, but also that you’ve educated your staff on those policies and procedures. If you don’t train your staff on a certain policy, you can’t claim an exception,” Morris said.
Ultimately, Morris said, time will tell where organizations struggle to comply with info blocking. “Once you put policies into the wild, you’re not exactly sure how things will go."
About the expert: Genevieve Morris served as Principal Deputy National Coordinator for the Office of the National Coordinator for Health Information Technology (ONC) when the “ONC Final Rule” was drafted and is considered a leading expert in health information technology and interoperability. In her current role as Senior Director, Clinical Interoperability Strategy for Change Healthcare, Morris and her team are working to serve as catalysts for greater collaboration between payers and providers on the path to value-based and consumer-centric care.
About the writer: Meghan Franklin is a writer and strategic communicator with an M.A. in Rhetoric and a deep background in healthcare. As a former healthcare IT project manager and communications specialist at one of the nation’s leading children’s hospitals, she loves delving into healthcare topics. She values working with individuals and organizations on a mission to do something good.