Patients gained instant and broader access to their health information, starting April 5, 2021. What will be the impact on patient safety and medical professional liability (MPL)?

The information blocking (aka “open notes”) rule of the federal 21st Century Cures Act dictates that eight categories of clinical notes created in an electronic health record (EHR) must be immediately available to patients through a secure online portal. Individual or organizational health care providers may not block, or delay patients’ access to, any eligible information (including test and studies results) entered and stored in their EHR.

Patients’ right to access their records were codified, under HIPAA, in 1996; the 2016 passing of the Cures Act legislation aimed to make access easier and virtually unrestricted. Specifically, the final rules of the Act require that patients have immediate access to the following eight categories of clinical notes:

  • Consultation notes
  • Discharge summary notes
  • History and physicals
  • Imaging narratives
  • Lab report narratives
  • Pathology report narratives
  • Procedure notes
  • Progress notes

Exempt from unrestricted access are notes “compiled in reasonable anticipation of, or use in a civil, criminal or administrative action or proceeding” and psychotherapy session notes. However, other components of psychiatric care (e.g., diagnoses, medications, appointment times, etc.) may not be blocked.

Impact on Safety and Liability

Opening your notes offers the potential to enhance patient safety by linking clinicians and patients between visits–times when ambulatory vulnerabilities often compound. Such a link may help detect and prevent errors by mitigating missed follow-up appointments and referrals, uncompleted diagnostic tests, delayed notification of abnormal test results, and persistent but undiagnosed symptoms. It may also provide a new platform for patients to report possible errors in their notes.

What was or was not documented is rarely the primary reason a patient files a claim or suit alleging malpractice, but the medical record is, essentially, the “key witness” in such proceedings. Any issues with that record (gaps, ambiguity, insensitivity) serves to undermine the defense of standard and appropriate medical care and has the potential to create an impression of negligence.

CRICO’s 2020 Report, The Power to Predict (based on data from CRICO’s national Comparative Benchmarking System), notes that the odds of an MPL case closing with an indemnity payment increase 76% when there are indications that documentation of patient encounters and care was inadequate to ensure appropriate care by subsequent caregivers, or to guide the patient’s involvement in his or her care decisions. From 2014–18, 56% of 5,410 cases with insufficient documentation closed with indemnity (compared with 30% for all MPL cases). Average payment in those cases was $432,000; five percent of cases closed with $1M+ payments.

Power to Predict Open Notes SPS Image

In general, clinicians should avoid “defensive” documentation, but there are steps in the documentation process that benefit both the patient’s care and the defensibility of that care if it is later questioned via malpractice claim or lawsuit. Expanded patient access doesn’t mean you have to dramatically alter how and what you chart, but you will want to be sensitive to terminology and descriptive language that may be unnecessarily hurtful or confounding to a lay reader. When unsure, a good rule of thumb is to mirror in your notes the way that you would speak with a patient in person. Specific language that is required for billing and coding should not be altered.

On its website, CRICO has published answers to frequently asked questions about how these new rules and regulations impact patient safety and provider liability. This page also offers the opportunity to pose questions to our MPL and Patient Safety experts.

Many other organizations—in particular, the OpenNotes movement—have developed advice and recommendations for writing “open” notes and managing patient questions and concerns. These include:

  1. How to write an open note (OpenNotes)
  2. Information Blocking Resource Center (ACP | AHIMA | AMA | AMIA | APA | CHIME | MGMA | Premier Inc.)
  3. How do I comply with info blocking (AMA)

Additional Material


Latest News from CRICO

Get all your medmal and patient safety news here.
    1x1_auto_0135

    Utilization of Electronic Health Record Sex and Gender Demographic Fields: A Metadata and Mixed Methods Analysis

    News
    CRICO Grants
    This CRICO co-funded retroactive study published in the Journal of the American Medical Informatics Association analyzed the records of patients 18 years of age or older in the Mass General Brigham health system with a first Legal Sex entry (registration requirement) between 2018 and 2022. The study was important because “Sex and gender demographic data are widely viewed as essential to providing culturally responsive gender affirming care and facilitating research and public health interventions.”

    Establishing a Regional Registry for Neonatal Encephalopathy: Impact on Identification of Gaps in Practice

    News
    CRICO Grants
    Neonatal encephalopathy continues to be a significant risk for death and disability. To address this risk, regional guidelines were developed with the support of CRICO. A neonatal encephalopathy registry was also established. The aim of this study was to identify areas of variation in practice that could benefit from quality improvement projects.
    safety first radiology 1x1

    The Safety of Outpatient Health Care

    News
    Although most care occurs in the outpatient setting, knowledge of outpatient adverse events (AEs) remains limited. This study looks at adverse events in outpatient settings.
X
Cookies help us improve your website experience.
By using our website, you agree to our use of cookies.
Confirm