OpenNotes Proposes That HHS Create ‘National Transparency Advisory Group’

April 24, 2019
Initiative also recommends that EHR vendors should be required to provide functionality to measure how many patients read clinical notes

In its response to a proposed rule from the U.S. Department of Health and Human Services, the OpenNotes initiative has recommended that HHS establish a “National Transparency Advisory Group” charged with advising HHS and monitoring the nation’s progress toward a fully transparent healthcare system.

In an April 24 interview with Healthcare Innovation, Cait DesRoches, executive director of the nonprofit Open Notes initiative, explained that making clinical notes available to patients is a vehicle for improving transparency in healthcare. The HHS rule proposes that clinical notes be included in an expanded set of data that must be exchanged electronically and made easily accessible to patients in the U.S. Core Data for Interoperability.

“Our concern is that including clinical notes in the things that have to be exchanged and available to patients is great,” said DesRoches, an associate professor of medicine at Harvard Medical School. “But if we think about it only in a checkbox way – yes we can do this or no we can’t — then we lose the opportunity to think more broadly about how transparency can improve care.”

OpenNotes’ research has found that patients who read their notes feel more in control of their care and say they do a better job of taking their medications. They understand and follow their care plans and they can find clinically important mistakes in their notes. “We want to reap those benefits more broadly across the health system,” DesRoches said. “The advisory group would be charged with pushing forward this idea that it is not just a checkbox. Organizations need to embed transparency into the culture of the care they provide. That might be linked to the measurement system or linked to figuring out how to really pair health information and price transparency together.”

In its comments to HHS, OpenNotes suggests that the advisory group should be comprised of clinicians, policy makers, patients, experts in health information technology, patient safety, and healthcare organization leaders. In contrast to a focus on health information technologies, the prime concern of the Office of the National Coordinator (ONC) and its advisory groups, the mission of this new group should be to ensure that the goal of bringing more transparency to clinical care is implemented successfully. In particular, it would focus on information sharing designed to increase patient safety and health care value.

I asked DesRoches if OpenNotes was surprised that HHS included clinical notes in the U.S. Core Data Set proposal. She said the organization had been talking with people at ONC for a few years about the benefits of making notes available to patients. “We also had some initial conversations with the Argonaut Project group, so we knew they were working on the FHIR programming recommendations for including notes in that data set,” she added. “Their recommendations are often picked up by ONC. We were pleasantly surprised that it carried through into this proposed rule, but we knew it was something in the works.”

The NPRM says that the notes have to be included in the core data set that is exchanged between providers. When you couple that with ONC and CMS’ interpretation of the 21st Century Cures Act, it looks like that data has to be also be made available to patients with no special effort, DesRoches said. The Cures Act says patients should have access to all their data in the record. “It is kind of a three-legged stool,” she explained. “The Cures Act, this new proposed rule, and the third piece around Meaningful Use, which says that EHR vendors have to have an open API to allow third-party developers, after being authorized by a patient, to access data in the medical record and pull it into a third-party app. Those three things come together in a way that strongly suggests that patients will have access to their clinical notes.”

In its comments to HHS, OpenNotes made several other proposals that I asked DesRoches to elaborate on:

• EHR/patient portal vendors should be required to provide an option in all EHR products/portals that enables access to notes by patients via secure electronic patient portals and on mobile/cellular devices. She said the current portal environment is a mixed bag. At health systems that use a Cerner portal, it is relatively straightforward to find your notes, she said. There is a link on the landing page. With Epic portals, there are more clicks involved and it is not all that intuitive, and it is hard to find them. “On the flip side, however, Epic allows an organization to monitor how many notes are being read. With Cerner portals, an organization can’t get a measure of how many of their notes are being read.”  

• OpenNotes also is recommending to HHS that EHR vendors should be required to provide functionality in all their products that allows practices to calculate: a) the number of patients with active portal accounts opening notes or downloading them to a mobile device; and b) the proportion of all available notes opened or downloaded by patients. “You are never going to get any improvement if you can’t accurately measure where you start from,” DesRoches said.

• To ensure privacy in special circumstances, information blocking provisions should be implemented to allow health systems and clinicians flexibility to put in place additional privacy protections for patients such as adolescents, patients with mental illness, and victims or potential victims of abuse, including child, elder, sexual, and domestic abuse. DesRoches explained that pediatricians sometimes worry about their adolescent patients. There are both organizational policies and state laws around the type of adolescent notes that have to be kept confidential. Sometimes providers worry about domestic violence, where perhaps the patient’s abuser might have their log-in information, she added. With planned information blocking regulations, organizations could be fined for not sharing information. “What we would like is some explicit guidance and regulations around these situations. We wouldn’t want an organization to be punished because they have legitimate concerns about sharing data.”

• In order to track the degree to which note sharing is implemented by practitioners, HHS should collaborate on or develop a robust measurement system and scorecard that tracks implementation metrics and the number of patients reading notes and the proportion of available notes read or downloaded at the practice level. HHS should set robust baselines for these measures and include and modify them in future measurement program requirements. DesRoches said this could be a quality measure or it could be included in MIPS. It could substitute for other types of patient engagement measures. “It could be included in a Meaningful Use measurement system as a real metric of patient engagement with the record,” she said.

• HHS should support learning networks of providers and patients that work to increase the number of providers actively offering shared notes and the number of patients reading their notes. These efforts could focus on: a) regional initiatives; b) vulnerable populations requiring safety net care and/or experiencing literacy or language challenges; and c) patients with a specific or high burden of illness. This is something AHRQ or PCORI could help with, DesRoches noted. “We have started doing it in our own initiative. We have several regional collaboratives and are working toward national collaboratives focused on particular types of providers such as safety net providers or pediatric providers,” she said. “But giving that real heft and putting some money behind it and the power of HHS behind it could speed the development.

• HHS should explore the effects of notes co-produced by patients and clinicians together and interventions that incorporate transparent quality and price considerations into individual treatment plans to improve quality and value. OpenNotes is piloting co-produced notes where patients are sent an e-mail a few days before their office visit and asked to write the subjective portion of the note: how they have been doing since their last visit and why are they coming in and they are asked to set the agenda for the upcoming visit. “What we have been learning is that patients are willing and able to do it. Some clinicians are reporting that they are able to diagnose problems more quickly.”

• Finally, HHS should include and amplify the voice of patients in building and improving electronic health records and apps enabled by open APIs (application programing interfaces) designed to enable patient and clinician access, management, and sharing of health information. I asked how HHS could do that. DesRoches noted that committees such as the ONC HITAC committee have very little patient representation. “EHR companies don’t see patients as one of their end-users when they design their systems,” she added. “In the end, we want patients to be using this information. If we are expecting that patients are going to take on a higher burden in choosing different types of treatment and assessing price information, if we are not giving them access to the data in a format that is useful for them, then they are at a real disadvantage. We need to be actively inviting patients to join in conversations about what data is important and what it should look like in order to ensure that we move closer to a system where the walls between providers and patients come down.”

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