'Open Notes' Patient Access to Data Rule Delayed Until April

Implementation of the federal "Open Notes" rule granting patients immediate access to their clinical notes, originally slated for Monday, has been postponed until next spring, a Department of Health and Human Services official said.

The deadline has been extended to April 5, 2021, to give providers who are busy with the demands of COVID-19 and the move to telehealth more time to comply with the rule, Don Rucker, MD, National Coordinator for Health Information Technology, said on a press call.

"This was really based on priorities that providers have set with their limited healthcare information technology resources," Rucker said. "That was the gating activity."

Susan Bailey, MD, president of the American Medical Association, said that her organization wrote to the Office of the National Coordinator for Health Information Technology to request additional time for physicians to comply with the rule.

"Given the widespread impact these rules will have, it is crucial that physicians are given both time and additional guidance," Bailey said in a statement. "The AMA will continue working with ONC to provide clear and usable resources to help physicians and their medical practices understand and implement these requirements."

The "Information Blocking" rule of the 21st Century Cures Act, passed in 2016, was supposed to go into effect on Nov. 2. Referred to as "Open Notes," it states that eight types of clinical notes can't be blocked and must be made immediately available to patients. These include:

• Consultation notes
• Discharge summary notes
• History and physical
• Imaging narratives
• Lab report narratives
• Pathology report narratives
• Procedure notes
• Progress notes

Psychotherapy notes, and information compiled in anticipation of a lawsuit, are exempt from the rule.

"Patients have had the right to see their medical record, but it hasn't been easy, in general, for them to do that," said Catherine DesRoches, DrPH, executive director of OpenNotes, a study group that launched early trials of the practice. "This gives patients easy and convenient access to all of their medical information through a patient portal."

In 2010, the OpenNotes program began as a collaboration between Beth Israel Deaconess Medical Center in Boston, Geisinger Health System in Pennsylvania, and Harborview Medical Center in Seattle. With funding from the Robert Wood Johnson Foundation, they launched an exploratory study of 105 primary care doctors who invited 20,000 of their patients to read their notes via a secure online portal.

The results, published in the Annals of Internal Medicine in 2012, found that doctors reported little change in workload, and "few turned off access to notes after the pilot was over," DesRoches said. Patients were happy with the ability to see the notes and few reported being worried or confused by them.

Since that study, numerous hospitals and health systems have implemented an open-note policy, DesRoches said. Today, more than 250 healthcare organizations grant such access to more than 53 million patients, she said.

Among those organizations are the U.S. Department of Veterans Affairs, the Mayo Clinic, the MD Anderson Cancer Center, and Sanford Health. "These were all early innovators who can serve as examples for other organizations," DesRoches said.

UCHealth in Colorado has used Open Notes since 2016. CT Lin, MD, chief medical information officer of UCHealth, said the new rule requires additional reporting, even for his institution. While UCHealth already provides many types of notes immediately, it delays several types of results, including reports like neonatal screens, cytology results, and mammograms for a range of 4 to 14 days.

Despite the high number of early adopters, providing immediate access to notes will be uncharted territory for many healthcare organizations and physicians who have raised several concerns, such as notes being misinterpreted or second-guessed by patients.

It could also mean taking more time to write notes differently so that patients can understand them, which could mean more work for already overstretched clinicians, some have argued.

Still, more physicians have seen the upside. Ziad Gellad, MD, MPH, of Duke University in Durham, North Carolina, tweeted, "My patient care is better because of the feedback patients have given on my notes -- forgotten allergies, missed exposures, and clarity on our plan to name a few."

"I think this is going to force health professionals to help patients think about information and what they do with it," Bryan Vartabedian, MD, of Baylor College of Medicine/Texas Children's Hospital in Houston, wrote on his blog 33 Charts. "It will force patients to recognize the difference between information and knowledge and wisdom. I suspect that the most critical ultimate change will be transparent conversations and more timely physician follow-up on high stakes studies."

https://www.medpagetoday.com/publichealthpolicy/generalprofessionalissues/89384