Azar defends patient access to EHR data under ONC rule, but pushback resumes

Health and Human Services Secretary Alex Azar lashed out on Monday at healthcare stakeholders critical of a proposed rule from the Office of the National Coordinator for Health IT meant to enable patient access to their electronic medical records.

Speaking at ONC’s annual meeting on Monday, Azar charged that EHR systems today are “balkanized” and “segmented,” creating data silos that prevent patients from accessing their health information. “Unfortunately, some industry stakeholders are defending the balkanized, outdated status quo," he said.


Last week, CNBC reported that health IT vendor Epic Systems emailed the heads of some of the largest U.S. hospital organizations, urging them to oppose the proposed ONC rule because of concerns that “healthcare costs will rise, that care will suffer, and that patients and their family members will lose control of their confidential health information.”

Azar did not cite Epic by name, but he insisted that “scare tactics are not going to stop the reforms we need” and that “defending the current balkanized state and status quo is a highly unpopular position to take.”

Last March, ONC issued a proposed rule requiring healthcare providers to offer patients access to their electronic health information through secure, standards-based application programming interfaces. Specifically, the agency’s proposed rule—for the first time—requires HL7’s Fast Healthcare Interoperability Resources as the standard to which health IT developers must certify their APIs.

The ONC rule is “about access and choice,” Azar told the ONC meeting. He emphasized that “patients should be able to access their health records at no cost—this is about ensuring patients have access to information about their own health, and interoperability is the first step.”

On this issue, Epic issued a “rare public statement on the pending ONC rule” on Monday, noting that it “does not typically comment publicly on national policy issues.” While the EHR vendor said it “strongly agrees” with ONC’s support for patients' ability to access their own data, it also made the case that changes must be made to the agency’s rule to prevent serious risks to patient privacy.

“By requiring health systems to send patient data to any app requested by the patient, the ONC rule inadvertently creates new privacy risks,” Epic contends in its statement. “The data sent to the apps might include family member data, without the patient realizing it and without the family members' knowledge or permission.”

In addition, the vendor warned that “there are no transparency requirements to make it very clear to the patient what data the app is taking and what the app will do with that data.”

To address these patient privacy risks, Epic recommended that transparency requirements and privacy protections are established for apps gathering patient data before the ONC rule is finalized.

It’s a sentiment shared by the American Medical Association, which charges that ONC is making a policy decision to “not prioritize patient privacy” and that—if the rule is finalized as proposed by the agency—patients’ health information will be vulnerable to inappropriate secondary uses and disclosures from third-party apps.

AMA contends that ONC has not indicated that it will create policy to help ensure patient privacy protections through the API. “In other words, it is promoting API usage, but not requiring that the API technology include privacy and security controls,” according to an AMA briefing document on the subject.

In September, ONC’s proposed rule was sent to the Office of Management and Budget for OMB’s review. ONC is expected to release its final regulations early this year.

Steve Posnack, deputy national coordinator for health IT, told Monday’s ONC meeting that “there will be no rule release today or tomorrow” during the second day of the conference. “It’s still going through the clearance process,” he explained. “There is a golden hue that is attributed to rules once they’ve finished baking in the oven—and we’re just close to getting there.”