Financial/Legal

Open notes: Legal issues


 

In July, I had my annual physical with my primary care physician, whose practice is based out of a large urban academic medical center. As she concluded my visit and directed me to the lab to have my blood work done, she said, “You’ll be receiving an automatic notice from MyChart by 9 am tomorrow that your medical records from today’s visit are available. I apologize if I have not yet had the opportunity to review them and enter my note, but you’ll get access to all of that, as well, as soon as it is in the system.”

Ms. Koch is codirector of health law & policy institute and assistant professor at the University of Houston Law Center, as well as director of law and ethics at the MacLean Center for Clinical Medical Ethics at the University of Chicago

Valerie Gutmann Koch

This sort of interaction is increasingly common across the United States as health care institutions implement policies and procedures to comply with new regulations promulgated by the Office of the National Coordinator for Health Information Technology (ONC), which went into effect on April 5, 2021. These rules were promulgated in accordance with the 21st Century Cures Act of 2016 (Cures Act).1 The regulations, known as the Interoperability, Information Blocking, and the ONC Health IT Certification Program, implement provisions of the Cures Act intended to “support the access, exchange, and use of electronic health information.” The rule is considered a significant step in the “open notes” movement, which is intended to make health care more transparent by enabling patients to access their medical records. The drafters of the ONC regulations have carved out certain exceptions to the information blocking rule. For example, one exception allows some patient information to be withheld where making that information available might cause physical harm to the patient or another person.

Thus far, few patients have been informed about the new regulation.2 By forbidding “information blocking,” the rule enables patients to more easily access and control their health information. Currently, the rule requires that physicians allow automatic access, without charge, to a patient’s own personal health information, including clinical notes, medication lists, laboratory results, and other diagnostic reports. Records must be provided “without delay,” or at least as soon as the physician’s office receives an electronic copy. In 2022, it will be required that access to even more of a patient’s personal electronic health record be provided in real-time through a patient portal and that electronic health information be shareable across third-party apps.

The Cures Act and the regulations governing its implementation highlight the inherent tension between two core principles of bioethical inquiry: autonomy and beneficence. The first principle, autonomy, champions allowing patient access and control over their own personal information. Beneficence, which is often expressed as paternalism, ensures that the experts are able to analyze and interpret data so that patients are in the best position to then make informed decisions.

With these principles in mind, arguments against open notes have generally fallen into three related categories. First, critics worry that immediate access to one’s medical record will increase patient anxiety caused by feelings of being inundated with complex medical information that patients may be ill-equipped to analyze and understand. This is a common refrain any time policies are implemented to improve medical information sharing. For example, critics of direct-to-consumer genetic testing caution that permitting unfettered access to complex information, particularly without an intermediary to interpret the data, could lead to confusion and poor medical choices.

There may be validity to this claim. One study found that 3% of patients reported feeling very confused when granted access to their medical notes.3 Another study concluded that direct release of medical test results “sometimes leads to unnecessary anxiety.”4 While the drafters of the ONC regulations have carved out certain exceptions to the information blocking rule, those exceptions do not allow for withholding of information because of concerns about patient anxiety or psychological harms.

The second common critique of open notes is that requiring release of all clinical notes will lead to clinician self-censorship, effectively muzzling or silencing the experts whose responsibility it is to objectively interpret results in order to provide the best care for their patients. Some have expressed concern that clinicians will be forced to “code” their records to avoid addressing “sensitive” subjects that might make patients feel offended or judged. This, in turn, might lead to less complete, reliable, or useful clinician communication.3

In fact, open notes has led to changes in the documentation process for some clinicians. They have reported modifying the way they document patient visits by changing their use of critical language and sensitive information.5 One study found that open notes led physicians to adjust “their language to avoid being perceived as critical of patients; omitting certain terms, such as ‘noncompliant’ and ‘patient denies’; and modifying how they document sensitive information.”3

In response, experts recommend focusing on precise and empathetic patient notes; in other words, the clinician should not write something in the note that they would not say directly to the patient. For example, they recommend that clinicians use precise language (for example, identifying the patient’s BMI) rather than using terms that could be offensive (for example, labeling the patient as “obese”).6 The shift to more empathetic note-taking could be seen less as a burden and more as a valuable tool in the shared decision-making endeavor: It could allow physicians to document both their clinical judgments and the patient’s values and preferences, which could lead to better medical decision-making.

Third, critics of open notes point to concerns about the burden it places on clinicians’ already limited time. The ONC rule requires automatic release of test results regardless of whether the clinician has had the opportunity to review them and offer their interpretation and insight. Because physician interpretation of results has known benefits,4 this puts additional pressure on clinicians to review results and enter notes in a timely manner. But physicians have reported that often open notes necessitates that they spend more time on documentation than they would otherwise.5

Despite critiques of open notes, the benefits of allowing patients access to their medical records have been repeatedly demonstrated. And research has shown that patients benefit from accessing open notes by allowing them to access and control their own personal medical information.5 Patients report that they understand and value the information provided to them in their medical records,7 and they feel empowered to participate in their medical decision-making. In surveys, patients report that reading their doctors’ notes is useful for taking care of their health and for remembering their care plans, understanding why a medication was prescribed, and reinforcing the need to take their medications and adhere to treatment plans.8

Importantly, open notes can increase patient engagement and patients’ trust in their physicians,9 thereby improving the doctor-patient relationship.3 And allowing patients to share their medical records with care partners enables supported decision-making, particularly for older and chronically ill individuals.3 Additionally, it is predicted that open notes may, in fact, decrease legal liability.9 By improving both trust in the doctor-patient relationship and safety, some experts expect that legal claims against clinicians will, in turn, decrease.10

The modern practice of medicine necessitates a more empathetic approach to clinical note-taking, even in the absence of regulation requiring it. As the regulations implementing the Cures Act roll out, patients will have easier, and more immediate, access to their medical records. Despite earlier hesitancy, clinicians are steadily beginning to support sharing access to notes with patients.5 Change can be hard. But the change expected of clinicians because of these new regulations appears to be less onerous than originally anticipated.

Prof. Koch is codirector of Health Law & Policy Institute and assistant professor at the University of Houston Law Center, as well as director of law and ethics at the MacLean Center for Clinical Medical Ethics at the University of Chicago. She has no disclosures.

This article was updated Sept. 9, 2021.

References

1. Fed Regist. 2020 May;85(85):25642-961.

2. The Petrie-Flom Center Staff. “New Rule Puts Medical Data in Patients’ Hands.” Bill of Health. July 12, 2021. Accessed August 30, 2021. https://blog.petrieflom.law.harvard.edu/2021/07/12/new-rule-puts-medical-data-in-patients-hands/.

3. Blease C et al. Ann Intern Med. 2021 Jan;174(1):101-2.

4. Pillemer F et al. PLoS One. 2016 Jun. doi: 10.1371/journal.pone.0154743.

5. DesRoches CM et al. JAMA Netw Open. 2020 Mar. doi: 10.1001/jamanetworkopen.2020.1753.

6. Heath S. “Most Patients Understand Clinical Notes, Patient Data Access.” Patient Engagement HIT. July 29, 2020. Accessed August 30, 2021. https://patientengagementhit.com/news/most-patients-understand-clinical-notes-patient-data-access

7. Leveille SG et al. J Gen Intern Med. 2020 Dec;35(12):3510-6.

8. Walker J et al. J Med Internet Res. 2019 May. doi: 10.2196/13876.

9. Bell SK et al. BMJ Qual Saf. 2017 Apr;26(4):262-70.

10. Kachalia A, Mello MM. N Engl J Med. 2011 Apr;364(16):1564-72.

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