ONC proposed rule aims to provide clarity on information blocking

The healthcare industry is getting closer to a clearer definition of what the blocking of electronic health information is and what it is not, according to the Department of Health and Human Services.

Section 4004 of the 21st Century Cures Act authorizes HHS to identify reasonable and necessary activities that do not constitute information blocking.

Toward that end, the Office of the National Coordinator for Health IT last week made public its long-awaited proposed rule implementing the information blocking provisions of the Cures Act, while including seven exceptions to the definition of information blocking.

The seven exceptions cover preventing harm; promoting the privacy of electronic health information; promoting the security of EHI; recovering costs reasonably incurred; responding to requests that are infeasible; licensing of interoperability elements on reasonable and non-discriminatory terms; and maintaining and improving health IT performance.

“ONC proposes seven categories of practices that would be considered reasonable and necessary that, provided certain conditions are met, would not constitute information blocking,” according to the agency. “If the actions of a regulated actor (healthcare provider, health IT developer, or health information exchange or network) satisfy an exception, the actions would not be treated as information blocking and the actor would not be, as applicable, subject to civil penalties or other disincentives under the law.”

Also See: Proposed ONC rule requires FHIR interoperability standard

Rucker-speaker-CROP.jpg
Donald Rucker, MD

“By supporting secure access of electronic health information and strongly discouraging information blocking, the proposed rule supports the bipartisan 21st Century Cures Act,” says Don Rucker, MD, National Coordinator for HIT.

“At first glance, we are pleased that ONC’s information blocking rule acknowledges in its exceptions the importance of promoting the privacy and security of electronic health information, which is a core tenet of the HIM profession,” says Wylecia Wiggs Harris, CEO of the American Health Information Management Association.

A separate proposed rule issued by the Centers for Medicare and Medicaid Services attempts to shame “bad actors” with a proposal to publicly report providers or hospitals that participate in information blocking practices that unreasonably limit the availability, disclosure and use of electronic health information.

“The days of holding patient data hostage are over,” declares CMS Administrator Seema Verma. “Our proposed rule includes a policy to publicly identify doctors, hospitals and other healthcare providers who engage in information blocking. Simply put, we’re going to expose the bad actors who are purposely trying to keep patients from their own information.”

“Information blocking is a thing of the past,” Verma adds, emphasizing that there is no more room for excuses. “We won’t tolerate it anymore, and those of you that continue down this road will see less opportunities to engage in this practice in the future.”

Under the Cures Act, the HHS Office of the Inspector General has the authority to investigate claims of information blocking and assign financial penalties of as much as $1 million per violation for practices found to be interfering with the lawful sharing of electronic health records. When finalized, the ONC rule will be used by HHS OIG to take enforcement action against those that impede the electronic flow of health data.

According to Rucker, there are four classes of entities that “come under the issue of information blocking”—electronic health record vendors, health information exchanges and networks and healthcare providers.

“In the Cures law, the first three—EHR vendors, networks and exchanges—are subject to similar monetary penalties,” Rucker says. “That is a process where people would report to ONC—we have a reporting mechanism—and then we would refer to the Office of the Inspector General, who provides the enforcement.”

At the same time, Rucker notes that “the provider penalties in Cures are to be determined by the Secretary, and that is something we’re still working on collectively within Health and Human Services.”

Joel White, executive director of the Health Innovation Alliance (formerly Health IT Now), a coalition of patient groups, provider organizations, employers and payers, contends that the proposed rules from HHS are a first step to ending the “shameful business practices” of bad actors blocking information.

“We will review them to ensure they are an honest attempt to end the business practices and technology issues confounding interoperability—but end they must,” White says. “If these rules do not achieve this end, we will be back. The future of healthcare depends on it.”

For reprint and licensing requests for this article, click here.