Providers, vendors and other healthcare stakeholders are split on whether the Office of the National Coordinator for Health Information Technology's proposed rule will effectively tackle information-blocking, or whether its mandates will unintentionally curtail innovation.
The ONC in February released its long-awaited information-blocking proposal, a companion to the CMS' proposed interoperability rule. The ONC's rule outlines how regulators will require providers to share medical data with patients, as well as steps to discourage healthcare organizations from creating barriers that stand in the way of health data exchange.
The public comment period for the ONC's rule closed Monday, a 30-day extension from the original May 3 deadline. Now, the office is tasked with sifting through nearly 1,300 comments from providers, vendors and trade groups.
A key point of contention relates to whether health IT developers should be allowed to charge fees for access to certain data and services. Under the ONC's rule, suppliers of API technology—such as electronic health record vendors—would be able to charge fees to recover expenses related to data access, but not beyond that unless expressly permitted. For example, suppliers would be able to charge fees for "value-added services," such as advanced training or premium development tools, according to the ONC.
But this system might prevent startups from being able to generate enough profit to sustain themselves, patient-matching startup Verato argued. The company urged the ONC to get rid of the prohibition on fees.
"In its effort to stop the large EHR vendors from charging exorbitant fees through their monopoly power with their customers, the ONC's proposed fee restrictions could ultimately destroy the health IT market by preventing innovative, best-of-breed technology vendors from participating in the market," Verato wrote in a letter to the agency.
The Electronic Health Record Association also argued that the emphasis on reducing fees would "have a chilling effect on investment in innovation," raising concerns about whether EHR vendors would be required to share their intellectual property in exchange for limited fees under the ONC's rule.
"The proposed requirement to limit companies' ability to charge fees beyond cost recovery devalues the work of software developers, increases recordkeeping burden and disincentivizes efforts to improve efficiency," the association wrote in a letter to the agency.
Providers had a more positive view of the ONC's proposed crackdown on data-sharing fees.
The UCSF Center for Digital Health Innovation in San Francisco wrote that it agrees with the ONC's proposal as a way to prevent health IT developers from applying "discriminatory terms or prohibitive costs" that stand in the way of innovation and interoperability.
To balance between these concerns, some groups like the American Hospital Association and the federal Health Information Technology Advisory Committee encouraged the ONC to reevaluate how it defines the basic data that all patients would have a right to access with limited fees, in contrast to the value-added services that merit an exception. The AHA suggested the ONC focus fee limitations on observational clinical data held in a patient's medical record, while allowing higher fees for advanced services that transform or analyze data, such as risk scores.
Another area of concern is the definition of information-blocking itself, which many organizations found too vague.
The ONC's rule outlines seven exceptions where information-blocking, or participating in activities that inhibit data exchange, is acceptable for providers, such as if they're engaged in practices to prevent patient harm or to protect patient privacy.
But many organizations asked for clarification on these exceptions.
Spectrum Health in Grand Rapids, Mich., recommended the ONC defer specifying any information-blocking exceptions at all and instead align with existing regulations. The health system emphasized that it opposed the exception for protecting patient privacy, which it argued is not consistent with HIPAA.
The exception would create a "gray area for providers regarding what must—or what may—be shared," Spectrum Health wrote. "Providers currently have the ability to leverage HIPAA rules that say they 'may share' a patient's information. With this proposed exception it appears ONC is stating that if it is permissive under HIPAA, it is now mandated."
That uncertainty is part of why the Health Innovation Alliance, a coalition of insurers, patient groups, trade organizations and technology vendors, has called on the ONC to rescind its information-blocking rule, arguing the exceptions are too broad and leave room for organizations to unnecessarily claim exception. The group wants the ONC to reissue a proposal that better defines what is and is not information-blocking.
"ONC and CMS ought to go back to the drawing board to clarify with specificity how this is going to work," Joel White, the group's executive director, said on a media call last week.
