OpenNotes: A Practice Compliance Requirement Affecting Group Practices, VAPs and Hospitals in Spring 2021


Group practices, Voluntary Attending Physicians, and hospitals of all sizes should take note of a fast-approaching federal regulatory compliance requirement: OpenNotes, a program from the HHS that will require practices to “unblock” various categories of patient notes and make them available to patients by Monday, April 5, 2021

Philosophically, OpenNotes is a simple concept – making a patient’s practitioner notes (including SOAP Notes) available to the patient at any time, with no charge. 

History of OpenNotes

The OpenNotes concept began in the early 1970s, when articles on the idea began being circulated. The OpenNotes concept truly became a healthcare industry initiative in 2010, with the founding of the OpenNotes non-profit advocacy organization. The 2016 US congressional “21st Century Cures Act” wrote OpenNotes into law, with an implementation date that is now set for April 5, 2021. 

Purpose and Proof of Concept of OpenNotes

In numerous academic studies, the increased transparency delivered by OpenNotes has shown improvement in care, patient outcomes, and a reduction in costs to the healthcare system. The main goal of OpenNotes is an improvement of outcomes and care quality – and it also brings a bonus of reducing liability for hospitals and physician groups by involving patients more in their medical records, thereby decreasing the chance for mistakes and errors. 

Studies have found that more involved patients are more motivated to follow their care plan, have higher rates of health literacy, and are more engaged.One study found that after one year, 99% of patients wished to continue.

Coming into Compliance with OpenNotes

So, what must hospitals, VAPs, and medical practices do to be compliant with The Cures Act and OpenNotes when it goes into effect on April 5, 2021? 

The key term and intent of the 21st Century Cures Act is “unblocking.” To comply with the 21st Century Cures Act, medical practices must make available new categories of their patients’ healthcare information to them. These categories include consultation notes, discharge and summary notes, history and physical information, imaging narratives, lab report narratives, pathology report narratives, procedure notes, and progress notes. 

Psychotherapy notes and information compiled in anticipation of a lawsuit are exempt from the rule. 

What is the risk for non-compliance with the OpenNotes? Or the 21st Century Cures Act?

While the details are still being determined in Washington – as well as any incentives for compliance with OpenNotes, it should be noted that the 2016 legislation authorizes a penalty “which may not exceed $1,000,000 per violation.”

Although there is still much to be determined as to what the enforcement of these penalties will look like, getting ahead of the curve and coming into compliance as soon as possible is a best practice to avoid being noncompliant down the road. 

How Can I Develop and Launch an OpenNotes Program?

First, make sure to communicate the benefits of OpenNotes to your relative stakeholders. Then, during the planning process, think about questions like: how will you manage your patients’ requests? How will patients (and proxies) access the notes? How will patient requests to change notes be managed? Who on the team will be responsible for educating and enrolling patients – and introducing them to OpenNotes? 

Generally, raising awareness among stakeholders and promoting understanding of the benefits of OpenNotes will ease its rollout. 

As you would imagine, there are many best practices in implementing and maintaining compliance with OpenNotes. It will impact everything from how practices record notes, to IT network security, and beyond.