OpenNotes submitted comments and recommendations to the U.S. Office for Civil Rights (OCR) to assist in modernizing Health Insurance Portability and Accountability Act (HIPAA) regulations. The deadline to submit recommendations is February 12, 2019.
In December 2018, OCR asked members of the public for help in identifying provisions in HIPAA that impede or limit coordinated care among individuals and covered entities (including hospitals, physicians, and other providers, payors, and insurers), without meaningfully contributing to the protection of the privacy or security of individuals’ protected health information.
OpenNotes (www.opennotes.org) provides these comments to help inform decisions regarding the modernization of HIPAA regulations.
We believe HIPAA should reflect the many opportunities for patients that can accompany health information technologies now employed by U.S. health systems and medical groups. In addition, offering practices flexibility in responding as new technologies are adopted will increase the ability of OCR to work even more effectively on behalf of patients and their families.
While patients currently have a legal right under HIPAA to review their clinical notes, requesting and obtaining this information can be lengthy, cumbersome, and costly for patients, and where appropriate, their families. Current and future technologies facilitate faster and less expensive data flow to patients. Building upon our findings concerning the effectiveness of sharing clinical notes with patients (see: summary of “OpenNotes” research findings below) and changes in technology since the passage of HIPAA in 1996, we suggest the following to OCR as it works to evaluate and update HIPAA:
- Electronic medical records (EMR)/patient portal vendors should be required to provide an option in all EMR products/portals that enables easy access to notes by patients via patient portals.
- Electronic medical records (EMR) vendors should be required to enable mobile phone and other cellular device access to notes and other health information.
- Providers offering access to clinical notes should be required to inform patients on a regular and recurrent basis of their availability.
- Those offering open notes should be required to inform individual patients requesting medical records that the information they desire may: a) be available via their patient portal at no cost, and b) such information can be accessed more readily than via traditional medical record requests and procedures.
- To ensure privacy in special circumstances, health systems and medical groups should have some 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. Other conditions may also require specified exceptions, depending on individual or group circumstances.
SUMMARY OF OPENNOTES EXPERIENCE AND RESEARCH
OpenNotes is an advocacy, policy, and research initiative, based at Beth Israel Deaconess Medical Center in Boston, MA, with collaborators around the US. OpenNotes urges the spread and effective implementation of shared clinical notes. In addition, it evaluates the effect of shared clinical notes on patients, care partners, and clinicians (colloquially known as “open notes”) and works to disseminate research findings. This effort began with philanthropic support in 2010. Since that time, all financial support has continued to come from philanthropies. OpenNotes is not involved in any product development, consulting services or any other commercial activity. OpenNotes and its collaborators have conducted multiple studies, leading to more than 80 publications in peer-reviewed journals and considerable interest in print, broadcast, and social media.
Clinical notes differ from other types of information in the record. They document interactions and conversations patients have with their doctors, nurses or other health care professionals and ordinarily contain a summary of the most important information discussed. Notes are “the story” of a person’s health care, connecting the other elements of the medical record. Our research and implementation experience show that easy access to ambulatory notes brings substantial benefits that far outweigh risks for patients and clinicians.
Once introduced to the concept of OpenNotes, well over 90 percent of patients want easy access to notes to continue. Patients, parents and care partners report many benefits from reading clinical notes, including:
- Better understanding their health conditions
- Feeling more in control of their health
- Improved adherence to medications and their health care plans
- Improved communication with clinicians and care partners
- Increased trust of doctors
- Being reminded of the next steps, such as diagnostic and screening tests, referrals and immunizations
- Finding and reporting potential errors in the record
These benefits cross all populations and clinical specialties. And strikingly, lower income patients, African Americans and other racial minorities, and those with less than high school education are more likely than white patients or those with higher incomes to report improved trust in their clinician and health care organization when access to notes is offered.
Patients report few risks associated with reading clinical notes. Fewer than 8% of patients report feeling confused, offended, or worried when reading notes, and 85-90% of report they can read and understand notes. But confusion also presents an opportunity for clarification, resolution of an error, and other positive outcomes. While privacy concerns are often mentioned by clinicians, patients do not report similar worries when it comes to their notes. In fact, they often emphasize it is their right to have easy access to them.
Clinicians are anxious about workflow, time spent in documentation, and litigation risks. Clinicians who share notes however report workflows are not significantly changed. A majority eventually acknowledge that sharing notes is a good idea. Some documentation changes are needed—fewer acronyms, fewer pejoratives, reduced copy and paste—but these are quickly integrated into workflows. And evidence suggests that easy access to notes may decrease litigation risk because of diagnostic error detection and subsequent correct, improved communication and trust. Furthermore, we are piloting interventions that suggest that many patients will want to contribute to the formulation of notes by submitting text and their priorities, thereby creating notes that are truly shared between patients and clinicians.
Five of the largest EMR vendors in the US support note sharing in one or more of their EMR/patient portal products. We have documented the implementation of OpenNotes in almost 200 organizations. More than 37 million people are registered on portals that share notes with patients. Real world implementation supports our research findings:
- No significant workflow problems have been reported in any implementation. Some documentation issues have required attention—acronyms, pejoratives, copy and paste.
- Patient and family advisory committees have consistently supported OpenNotes. Patients often describe access to notes as a “right.”
- Multiple surveys by implementers have produced results consistent with OpenNotes research studies
- Most medical record staff report no change in medical record requests, such as changes in documentation, although we know of no formal study of the impact of OpenNotes on medical record activity.
Some individual patients and patient populations may require special attention:
- As suggested above, clinicians may appropriately wish to “hide” notes in some individual and group special circumstances. OpenNotes efforts may therefore not include all notes.
- Access to notes by adolescents varies across the country, primarily due to privacy concerns especially related to parent access. State regulations vary. OpenNotes may therefore not include all adolescent notes.
- Currently, the majority of OpenNotes implementers do not include notes written by clinicians who focus their practice on patients with mental illness. However, a growing number of psychiatrists and psychotherapists are sharing notes.
In summary, reflecting extensive experience and research findings, we believe there is sufficient evidence to conclude that the benefits of making notes easily accessible to patients are much greater than the risks. This practice is feasible across the delivery system, with minimal risks of disruption to clinical practice. It can be facilitated by EMR vendors, with modest changes to existing products. The privacy risks to patients appear small. And overwhelming majorities of patients with easy access to notes want such access to continue.