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CASE STUDY: OPENNOTES

Interviewees: Catherine M. DesRoches, DrPH, Executive Director; and John Santa, MD, MPH, Director of Dissemination

ABSTRACT

Trust and communication are the cornerstones of the patient-provider relationship. OpenNotes is a vendor-agnostic, international movement that strives to enhance this patient-provider dynamic by encouraging clinicians to provide patients electronic access to their clinical notes. The program pursues its goals through demonstration projects, research, and patient awareness and advocacy. One of its focus areas is bidirectional data sharing through the “OurNotes” project, which creates a shared space for patients to not only view their physician’s clinical notes, but contribute their personal health data to them. Since its founding in 2010, OpenNotes has attained a wide reach, with 266 participating health systems across the U.S. and Canada (OpenNotes, 2020). Despite growing evidence of the value of patient data sharing, OpenNotes faces concerns from pockets of the health care community related to issues of workflow, liability risk, and market competition. The program has tried to overcome these barriers by relying on influential voices in the health care community to champion the effort and by generating demand among patients. The OpenNotes movement is one of several campaigns aimed at enhancing patient data access that has amounted to several new federal efforts, notably Patient Access Rules with origins in the Centers for Medicare & Medicaid Services (CMS) and Office of the National Coordinator for Health Information Technology (ONC) (CMS, 2000). Implemen-

tation, compliance, and enforcement of these new rules are being observed closely throughout the health care industry. However, OpenNotes suggests that financial incentives for organizations and providers could help to advance patient data access.

BACKGROUND

OpenNotes is a movement that encourages clinicians to routinely share clinical notes with their patients. While the Health Information Portability and Accountability Act (HIPAA) Privacy Rule of 1996 guarantees patients the right to obtain copies of their medi-

cal records, access by and large has been limited and cumbersome for patients, improving moderately over the last decade due to ONC Meaningful Use requirements (HHS, 2015). Nevertheless, some health care entities continue to invoke HIPAA privacy rules as rationale to constrain access to medical records, claiming that this access might overwhelm patients with information and, thus, providers with patient inquiries. There is an added concern that possible documentation errors could lead to increased liability risk for providers. However, studies have not supported these fears. In fact, opening access to medical records has shown to give patients a sense of agency in their care, with the possible benefits of bolstering patient engagement, improving health outcomes, and reducing medical errors (Bell et al., 2020; DesRoches et al., 2019; UIC, 2018).

OpenNotes began as an exploration of these benefits and an effort to correct the imbalance in data sharing. OpenNotes’ co-founders were troubled by the observation that, despite the ubiquity of data sharing in the industry, patients themselves had limited access to their own records. Drawing from the co-founders’ early work in patient engagement, a pilot study was launched in 2010. The study, which was funded by the Robert Wood Johnson Foundation, involved 105 providers from Beth Israel Deaconess Medical Center, Geisinger Health System, and Harborview Medical Center inviting 20,000 of their patients to view their notes electronically. The study’s results validated much of the prior research and contradicted provider assumptions that the practice of sharing notes is burdensome and unduly causes worry or confusion among patients.

Since this initial demonstration, OpenNotes has diversified into the mental health space in a push for the sharing of all notes with exceptions when safety/harm or privacy are an issue. Psychotherapy notes are unique in that they often contain information about the practitioner’s reactions and process during therapy sessions (e.g., countertransference) and often exist outside of the medical record. For this reason, they are afforded special protections under HIPAA and are not required to be shared under the 2000 federal information blocking rule (45 Code of Federal Regulations §164.501 Final Rule, 2003) (HHS, 2000). However, OpenNotes has made strides with the sharing of other mental health notes, finding that

patients who read their mental health notes report significant benefits and there are few drawbacks for clinicians. As a result, many health care networks have begun opening access to their mental health notes (Sun, 2014; OpenNotes, 2020; OpenNotes, 2021). In addition, OpenNotes has been championing the notion that holding back mental health notes may contribute to stigma and health care disparities.

These successes have propelled the OpenNotes movement into at least 266 health systems that, as of December 2020, offer 54.3 million patients across the U.S. and Canada electronic access to their clinical notes (OpenNotes, 2020). However, the percentage and demographic characteristics of patients who avail themselves of this opportunity is incompletely known as this is a dynamic and changing group whose characteristics differ from one health system to another. As an extension of its mission, OpenNotes pursues research with collaborators around the world, assessing the benefits of transparency in medical care. It also has launched several related initiatives, including one focused on fostering a culture of bidirectional information exchange between patients and providers called OurNotes, and another on an investigation of the utility of and challenges related to inclusion of social determinants of health data in the clinical notes exchange. A third principal area of work focuses on the potential of increased transparency to improve care safety.

Altogether, the initiatives are supported by 13 personnel. The Division of General Medicine at Beth Israel Deaconess Medical Center is the organizational home for OpenNotes. Over the last decade, OpenNotes has acquired additional funding from federal grants and foundations, namely the John A. Hartford Foundation, Agency for Healthcare Research and Quality, ONC, the Gordon and Betty Moore Foundation, the Peterson Center on Healthcare, and the Cambia Health Foundation.

DESCRIPTION

The blueprint for an OpenNotes implementation consists first of understanding the organizational culture of a health system and gathering information about the system’s electronic health record

(EHR) vendor. A critical step is to determine staff attitudes toward the EHR system (e.g., to what degree do providers experience EHR burnout) and the extent to which note- sharing occurs. Next, the Open Notes team meets collectively with the system’s technical and strategic leadership (chief technical officers, chief medical informatics officers, and chief medical officers) to determine the best approach for garnering support across the enterprise. This consists of understanding which groups are opposed to the idea and their motivations for their opposition, and then crafting an approach that is responsive to their reservations. In some cases, a research-driven, fact-based approach is preferred, and in other cases, a campaign focused on the cultural issues is more appropriate for attaining stakeholder buy-in. Interviewees for this case study remarked that the hurdle of making the case for clinical note sharing to health system leadership diminished whenever representatives from patient and family advisory committees were present in these discussions. The internal culture of a service line is another influential factor of uptake.

BARRIERS

Despite the demonstrated value of patient data sharing, risk management and workflow issues remain a concern among health care decision makers. The interviewees shared details from their encounters with malpractice insurers and providers who, despite being impressed with the evidence on the reduction in medical errors, expressed concerns about the vulnerabilities of poor note-takers. In one example shared with the NAM, a provider voiced concern that the need to correct documentation errors could increase his already strained workload.

Lack of awareness of the OpenNotes movement among the patient and caregiver communities poses an obstacle to gathering support given the role these groups play in elevating the demand for data sharing. Ongoing dissemination efforts are aimed at increasing awareness and have been boosted in light of the information blocking regulations taking effect.

Navigating the variability in state laws and cultural notions about the sharing of sensitive data such as adolescent and mental health

notes is another important barrier. Despite the advances OpenNotes has made in the sharing of mental health notes—much of it credited to the Veterans Administration (VA) Health System’s research—convincing organizations to share these types of notes requires significant effort (VA, 2017). Most participating health systems choose not to share behavioral and mental health notes. Most care delivery organizations begin by sharing ambulatory notes and then opt to begin sharing other types of notes, basing it either on individual or organizational preference. Interviewees suggested that decreasing the stigma of mental illness and broader awareness about the benefits of mental health data access could increase successful efforts toward note sharing.

VALUE PROPOSITION AND FACILITATORS OF SUCCESS

Response from the health care community has been equally positive and advantageous to the growth of OpenNotes. A subset of chief medical informatics officers sees the movement as empowering, helping them regain a sense of autonomy as physicians and reconnect with patients in a shared decision making capacity. OpenNotes relies on champions who are well-respected in their communities to help penetrate a market. It should be noted that, at times, it takes just one person with sufficient political capital to counter the resistance and compel others into action.

OpenNotes interviewees acknowledge that EHRs have served as a catalytic force for the movement. Although health care decision makers often cite the technical cost of data sharing and usability issues related to EHRs as the reasons for not engaging in clinical note sharing, the surge in recent conversations about the ownership of health data helped solidify the value proposition for opening up EHRs to patients, ushering in a favorable cultural change to which OpenNotes is well-positioned to respond and support.

FUTURE DIRECTIONS

One of the most consequential indicators of this culture change is the federal rule, effective on April 5, 2021, mandating that U.S. health care providers furnish patients with access to their EHR

notes free of charge (OpenNotes, 2021). The rule stems from the 21st Century Cures Act of 2016, which requires the sharing of most types of notes, including consultation notes, medication lists, and imaging and pathology report narratives (U.S Congress, 2016). Although the current regulation requires organizations to share a more limited set of information with patients, by the end of 2022, all information in the EHR will have to be shared with patients, and organizations will have to allow patients to access this information through any third-party application of their choosing. While optimistic about the anticipated effects of the rule, the OpenNotes team remains circumspect, given the exceptions that could create latitude for interpretation and enforcement. As health systems address the rule, they confront challenges with aggregating and presenting data in a patient-friendly way while balancing the liability concerns of the organization.

OpenNotes interviewees commented that along with policy levers, there is a crucial need for financial incentives, such as transparency performance metrics tied to payment or reimbursement to clinicians for time spent responding to patient emails as part of the global move to value-based care. However, until this shift occurs, the program endeavors to generate demand for data sharing through research and dissemination, which requires a steady infusion of capital. Their advice to others aiming to solve a similar problem is to focus on patient awareness and highlight issues though measurement. The body of research showing that OpenNotes does not disrupt or add to clinician workload is another important ingredient that can be applied to many other substantive changes related to health care data, dispelling one of the key concerns about health data sharing raised in the progenitor publication (Whicher et al., 2020). Although efforts to develop metrics around data sharing have gained minimal traction over the years, spotlighting the paucity of metrics and consequent inability to describe the extent of sharing could help to draw attention and curiosity to the issue.

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