Documentation in the Age of Open Notes: 21st Century Cures Act

On December 13, 2016, President Obama signed into law the 21st Century Cures Act. This sweeping healthcare legislation provided funding for numerous healthcare initiatives and streamlined the process for drug and medical device approval, delivery of mental health services, and telehealth. The Act also included numerous provisions related to electronic health records, in particular, it increased interoperability and improved patient access to their electronic health information (EHI). Section 4002 of the Cures Act requires that healthcare practitioners, health information networks/exchanges, and health information technology (IT) developers refrain from “information blocking” or activities that are likely to interfere with access, exchange, or use of EHI unless one of the exceptions applies.
 
The information blocking provision of the Cures Act goes into effect on April 5, 2021. After that date, healthcare practitioners, health information networks/exchanges, and health IT developers will be subject to penalties if they are found to have committed information blocking. While largely an information technology issue, beginning in April, patients will have open, free access to eight types of electronic clinical notes: 

• Consultation notes.
• Discharge summary notes.
• History and physical.
• Imaging narratives.
• Laboratory report narratives.
• Pathology report narratives.
• Procedure notes.
• Progress notes.

Clinical notes to which the new rules do NOT apply are: 

• Psychotherapy notes that are maintained apart from the rest of the electronic heath record.
• Information compiled for use in a civil, criminal, or administrative proceeding.

Many organizations have already implemented these provisions. Other organizations and practitioners are concerned that without context, providing unrestricted access to clinical notes and test data to patients will lead to confusion, dissatisfaction, and potential liability. Education, as well as staff and patient preparation, are essential in order to make the transition seamless. Consider the following when implementing an "open notes" policy at your facility:

Know the law regarding minors' rights. Laws regarding minors' rights to privacy of healthcare information differs. In some states, for example, adolescents who are 13 may seek treatment for some services, such as sexually transmitted disease (STD) treatment, without parental consent. For other services, such as treatment for a sports injury, they may need the parental consent. Consider working with IT developers to create a system to designate or flag certain notes or portions of notes as confidential to maintain the minor’s privacy. Teach minors and their families how to navigate the system and set expectations as to what information will remain confidential and what information will be shared with the minor’s parents.

Engage the healthcare team. Practitioner commitment to the concept of note transparency is fundamental. Research shows that providing open access to clinical notes improves practitioner and patient satisfaction. When patients are engaged in their own healthcare, patient safety increases and outcomes are improved. Despite concern to the contrary, once practitioners are accustomed to documenting notes that are accessible to patients, their workflows are not impacted. For additional resources and information on communicating with practitioners regarding notes transparency, see OpenNotes. 

Provide documentation training for practitioners. Complex medical jargon, acronyms, abbreviations, and disparaging patient descriptors can confuse and anger patients. Resolving misunderstandings and confusion about note entries can consume practitioner and staff time. Providing refresher training on documentation fundamentals can prevent documentation issues before they occur. Consider specific documentation training. Place emphasis on avoiding:

• Extraneous or biased statements. Subjective, derogatory, or flippant remarks about the patient, family, or healthcare team members give an unfavorable impression about the healthcare team and the care the patient received. In addition, these kinds of remarks can result in using professional and staff time responding to patient requests for a medical record amendment. 
• Professional feuding. Professionals who fight battles or snipe at other healthcare practitioners in the medical record create the impression of unprofessional behavior and poor care. 
• Non-conventional abbreviations/acronyms. Develop a list of approved abbreviations/acronyms that are universally understood by the healthcare team. Using unapproved or non-conventional terms can create confusion and misunderstanding in the minds of patients and can result in inefficiently using practitioner and staff time. For example, use the phrase “short of breath” rather than “SOB” when describing a dyspneic patient. 
• Complex medical jargon. Whenever possible, avoid medical jargon that can be misinterpreted by the patients. For example, consider using the phrase “enlarged heart” versus “cardiomyopathy.” Utilizing plain language principles may increase note readability, patient health literacy, and patient engagement. 

Develop a process for amendment requests. As clinical notes become available to patients, patients will inevitably disagree with the contents of the notes. The HIPAA Privacy Rule allows patients to request a medical record amendment if the patient feels the information contained in it is inaccurate. The Privacy Rule specifies the processes organizations must follow in receiving, processing, and responding to these requests. Review your policies regarding the processing of patient requests for medical record amendments to be sure that they are compliant with state and federal law, streamlined, consistently followed, and minimize the use of practitioner time. 
 
Communicate key details about open notes with patients. Engage patients intentionally and systematically. Invite patients to read the notes and give you feedback. Key considerations when communicating include:

• Discuss timing. Inform the patient about when a note or results will be available. Let them know results may be viewable to them before the ordering practitioner reviews the results. It is essential to set the expectation of when findings will be reviewed and educate that incidental findings do occur. Practitioners have found it helpful to proactively educate the patient and/or family about correlating symptoms to possible diagnoses and educate about the planned communication and next steps. 
• Utilize supportive language. Labeling the patient is a common pitfall but can be overcome by changing the practitioner’s perspective. Instead of saying “a schizophrenic,” consider stating “a patient with schizophrenia.” An alternative to saying “the patient refused treatment” could be “the patient chose not to pursue treatment.” Describe behaviors such as “she typically takes her medicine twice a week” versus “non-compliant.” Include the patient perspective respectfully and include the patient’s efforts, strengths, and resources. Document goals and progress.
• Explain professional requirements. If a patient understands the professional requirements to assess for lethality, such as homicidal and suicidal ideation, it will not be a surprise when reading the note. If there are safety concerns, consider blocking the note. Specific situations where a note can be blocked are defined as exceptions. Use exceptions sparingly.    

The 21st Century Cures Act seeks to promote transparent communication in healthcare and interoperability of patients’ records. Many facilities and practitioners that have already implemented an “open notes” system have found that patients and practitioners alike have experienced an improvement in patient safety and quality of care. Understanding the law and engaging the team and patients while providing training about processes and communication will aid organizations in successfully implementing Cures Act regulations.
 
 

Copyrighted. No legal or medical advice intended. This post includes general risk management guidelines. Such materials are for informational purposes only and may not reflect the most current legal or medical developments. These informational materials are not intended, and must not be taken, as legal or medical advice on any particular set of facts or circumstances.