Monday, April 5 is the official start of a US law requiring healthcare organizations to provide patients with free, full, and immediate electronic access to their doctor’s clinical notes as well as test results and reports from pathology and imaging.

The mandate, called “open notes” by many, is part of the 21st Century Cures Act, a wide-ranging piece of federal healthcare legislation. The previous deadline of November 2, 2020 for enacting open notes was extended last year because of the exigencies of the COVID-19 pandemic.

Organizations must provide access via patient portals to the following types of notes: consultations, discharge summaries, histories, physical examination findings, imaging narratives, laboratory and pathology report narratives, and procedure and progress notes. Noncompliant organizations will eventually be subject to fines from the US Department of Health and Human Services for “information blocking.”

Medscape Medical News reported on the mandate last year and some readers said it was an unwelcome intrusion into practice. Since then Medscape has run additional open notes stories about physician concerns, a perspective essay addressing those fears, and a reader poll about the phenomenon.

Now, as the legislation turns into a practical clinical matter, we offer five key points for clinicians to consider.

1 – Clinicians Don’t Have to Change Writing Style. The new law mandates timely patient access to notes and test results, but doesn’t require that clinicians alter their writing, says Scott MacDonald, MD, an internist and electronic health record medical director at UC Davis Health in Sacramento, California. “You don’t have to change your notes,” he says. However, patients are now part of the note audience and some healthcare systems are directing clinicians to make patient-friendly style changes.

Everyday experience should guide clinicians when writing notes, says one expert.

“When you’re not sure [of how to write a note], just mirror the way you would speak in the office — that’s going to get you right, including for mental health issues,” advises Leonor Fernandez, MD, an internist at Beth Deaconess Israel Medical Center, Boston, Massachusetts, in her “take-away” comments in the online video, How to Write an Open Note.

According to a 2020 Medscape poll of 1050 physicians, a majority (56%) anticipate that they will write notes differently, knowing that patients can read them via open notes. Nearly two thirds (64%) believe that this new wrinkle in medical records will increase their workload. However, actual practice suggests that this is true for a minority of practitioners, according to the results from a recent study of more than 1000 physicians in Boston, Seattle and rural Pennsylvania, who already work in open notes settings. Only about one third (37%) reported “spending more time on documentation.”

Note writing is going to change because of the addition of the patient reader — and something will be lost, argues Steven Reidbord, MD, a psychiatrist in private practice in San Francisco. By watering down the language for patients, “you are trading away the technical precision and other advantages of having a professional language,” comments Reidbord, who blogs for Psychology Today and has criticized the open notes movement in the past.

However, years of investigation from OpenNotes, the Boston-based advocacy and research organization, indicates that there are many gains with patient-accessible notes, including improved medical record accuracy, greater medication adherence, and potentially improved healthcare disparities among a range of patient types. In a 2019 study, researchers said that worry and confusion among note-reading patients are uncommon (5% and 3%, respectively), which addresses two criticisms voiced by multiple Medscape readers last year.

2 – Some Clinical Notes Can Be Withheld. The new rules from the federal government permit information blocking if there is clear evidence that doing so “…will substantially reduce the risk of harm” to patients or to other third parties, wrote Tom Delbanco, MD, and Charlotte Blease, PhD, of OpenNotes in Boston in a Medscape commentary in February.

There are also state-level laws that can supersede the new US law and block access to notes, points out UC Davis’ MacDonald. For example, California law dictates that providers cannot post cancer test results without talking with the patient first.

The OpenNotes organization also points out that, with regard to sensitive psychotherapy notes that are separated from the rest of a medical record, those notes “can be kept from patients without their permission, and such rules vary state by state.”

3 – Some Patients Are More Likely Readers. Some patients are more likely to peer into their files than other, says Liz Salmi, senior strategist at OpenNotes, who is also a brain cancer patient. “Those patients who have more serious or chronic conditions…are more likely to read their notes,” she commented to Medscape Medical News.

A new study of nearly 6000 medical oncology patients at the University of Wisconsin confirms that opinion. Patients with incurable metastatic disease were much more likely than those with early-stage, curable disease to read notes. Notably, younger patients were more likely than older ones to access notes, likely the result of generational tech savvy.

Despite the unpredictability of serious disease such as cancer, oncology patients find satisfaction in reading their notes, say experts. “We’ve overwhelmingly heard that patients like it,” Thomas LeBlanc, MD, medical oncologist at Duke University, Durham, North Carolina, where all patients already have access to clinicians’ notes, told Medscape Medical News in 2018.

4 – You Are Part of the Avant Garde. The United States and Scandinavian countries are the world leaders in implementing open notes in clinical practice, OpenNotes’ Blease told Medscape Medical News.

“It’s a phenomenal achievement” to have enacted open notes nationally, she said. For example, there are no open notes in Northern Ireland, Blease’s home country, or most of Europe, she points out.

In the US, there are more than 200 medical organizations, including at least one in every state, that were voluntarily providing open notes before April 5, including interstate giants such as Banner Health and big-name medical centers such as Cleveland Clinic.

It may be hard for the US to top Sweden’s embrace of the practice. The national open notes program now has 7.2 million patient accounts in a country of 10 million people, noted Maria Häggland, PhD, of Sweden’s Uppsala MedTech Science Innovation Center during a webinar last year.

5 – The Start Day Will Come and You Won’t Notice. “When April 5 happens, something brand new is going to happen symbolically,” says Salmi of OpenNotes. Its importance is hard to measure, she explains. “Patients say they trust their doctor more because they understand their thinking with open notes. How do you value that? We don’t have metrics for that.”

UC Davis’ MacDonald suggested that open notes are both new and not new. Last fall, he predicted that the launch day would come and few clinicians would notice, in part because many patients already access truncated information via patient portals.

However, there are “sensitive issues,” such as with adolescents and reproductive health, where “we know that some parents have sign-in information for their teen’s portal,” he commented. With clinical notes now on full display, potential problems “may be out of our control,” MacDonald acknowledged.

Still, the Sacramento-based physician and IT officer acknowledged that concerns about open notes may be a bit inflated. “I’ve been more worried about reassuring physicians that everything will be ok than what’s actually going to happen [as the law takes effect],” MacDonald said.

The OpenNotes organization is grant-funded and staff have disclosed no relevant financial relationships.

Nick Mulcahy is an  award-winning  senior journalist for Medscape, focusing on oncology, and can be reached at  [email protected] and on Twitter:   @MulcahyNick

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