In a strongly worded letter to National Coordinator Donald Rucker, M.D., several healthcare and health IT industry groups expressed frustration with the Office of the National Coordinator for Health IT’s lack of progress in publishing information blocking regulations, as required in the 21st Century Cures Act.
“It has been 601 days since the 21st Century Cures Act was signed into law. Every day that the administration delays implementation of these critical provisions places patients at risk of harm,” the letter states. Stakeholders including Health IT Now, Research!America, Oracle, the American Medical Informatics Association (AMIA), the American Academy of Family Physicians, Cambia Health Solutions and Claim Your Health Data Coalition signed the letter dated August 6.
In the letter, addressed to both Dr. Rucker and Daniel Levinson, inspector general of the Department of Health and Human Services (HHS), the stakeholder groups note that the 21st Century Cures Act, which was enacted in December 2016, requires the HHS Secretary to “issue regulations to prevent information blocking and to also identify reasonable and necessary activities that do not constitute information blocking.” Further, the law requires ONC to implement a standardized process for the public to submit reports on claims of health information technology products or developers of such products not being interoperable or resulting in information blocking and actions that result in information blocking. “The Office of the Inspector General (OIG) has enforcement authority over vendors and providers who are found to engage in information blocking,” the letter states.
The stakeholder groups also contend that “information blocking poses a significant risk to patient safety and greatly contributes to increased costs and waste in the health care system.”
According to reporting from Politico, during ONC’s 2nd Interoperability Forum this week in Washington, D.C., Rucker told the form audience that ONC is still working on the rule. The rule’s release has been delayed several times and is not expected to be released in September.
“Rucker emphasized Monday that his goal is to make protocols and standards that would let large amounts of health data flow easily between health providers, not just individual patient charts. He and other officials emphasized that ONC’s work is all being done within the confines of HIPAA,” the Politico article stated. Rucker also noted that properly defining which behaviors do and don’t constitute information blocking is “hard to sort out,” and the rule is a “work in progress,” Politico reported.
In a separate statement regarding ONC's delay in issuing an information blocking proposed rule, Douglas Fridsma, M.D., Ph.D., AMIA president and CEO, said, "Information blocking is the absence of interoperability, and there are numerous reasons why information may not flow as intended. Some of these reasons are technical, others for business or policy reasons. The socio-technical interoperability stack is complex and so too is the task of identifying which among its layers is responsible for information blocking. This rule must be critically calibrated to account for these layers, and it must be part of a larger conversation about how we will address other aspects of the socio-technical interpretability stack. Now is the time to initiate this broad conversation through release of the proposed information blocking rule."
In the letter, the industry groups also cautioned that “information blocking impedes provider access to the most current, accurate or complete information on their patients. As the administration proposes and implements new rules related to open APIs and interoperability in Medicare’s payment rules for hospitals and doctors, the lack of clear rules of the road needlessly creates uncertainty for vendors and providers alike.”
“We understand the nuance required but feel that it is past time for a proposal to be made,” the stakeholder groups wrote in the letter.
