September 30, 2021

The Office of the National Coordinator Provides Important Clarifications on Data Sharing Requirements

A couple weeks ago, the Office of the National Coordinator (ONC) for Health Information Technology within the U.S. Department of Health and Human Services (HHS) hosted a webinar that provided important clarifications regarding the data sharing and “information-blocking” requirements. As a reminder, these new rules, which were mandated by the 21st Century Cures Act, require that patient notes, lab results, and other information be shared with patients—with some limited exceptions.

ONC issued a regulation implementing these requirements last year, but due to the COVID-19 pandemic, delayed the effective date until April 5 of this year. ACEP has tried to be proactive to help you as emergency physicians understand the requirements and to assess whether any regulatory changes are necessary. In May, we polled our members to gather emergency physicians’ overall input on the data sharing requirements.

Although respondents generally supported sharing data with patients, the biggest issue flagged repeatedly in the poll was around the timing of the data sharing. Specifically, there appear to be significant unintended consequences associated with sharing notes and lab results immediately—before emergency physicians are able to discuss the results with their patients. Over two-thirds of respondents in the poll stated that lab results are shared immediately with patients once they are available (also interestingly, over 20 percent didn’t know when the results are shared with patients). According to these respondents, this policy of sharing notes immediately has caused patient confusion, anger, and sadness—with some extremely compelling examples, including patients who have found out they had cancer or a miscarriage without first being able to discuss their diagnosis with a physician. Further, there are numerous examples of patients misreading or misinterpreting clinical notes and lab results, causing physicians to have to spend significant time correcting those misconceptions and consoling patients.

We had the opportunity to share these results directly with ONC in June. In a conversation with ONC’s leadership, including its chief medical officer, we specifically requested that ONC alter regulations to allow for emergency departments (ED) to delay sharing lab results and clinical notes with patients for a 24-hour period or at least until the patient was discharged from the ED.

Unfortunately, ONC did not accept our recommendation, and during the webinar last week, clarified that such a delay is unacceptable in most cases. Specifically, ONC stated that having an organizational-wide policy of delaying the release of lab results or clinical notes is considered “interfering” with data sharing.

Under the current regulations, not all cases of interference necessarily constitute information blocking violations. To be an information blocking violation, you as a physician would have to know that a practice you are conducting is unreasonable and is likely to interfere with the access, exchange, or use of electronic health information. Towards the end of the webinar, ONC said that a potential strategy that hospitals (or EDs) could use to avoid violating the information blocking regulations is to give patients the choice of receiving results right away or waiting until they had a chance to review them with their doctor. However, that clearly is not a feasible option. How are EDs supposed to operationalize a process that would enable them to tailor the release of lab results and clinical notes based on the preferences of each patient?

ONC also unfortunately stated that you cannot claim that sharing results immediately with a patient will cause the patient to experience “harm”—which is one of the regulatory exceptions that ONC has granted for the data sharing requirements. ACEP disagrees with this decision, as we believe that instituting a delay in data sharing in the ED does protect patients from emotional harm and should be appropriate use of the harm exception.

We are not alone in our disappointment over various aspects of this policy. In a recent article in Medpage, the American Medical Association (AMA) and AMGA (formerly the American Medical Group Association) both stated that implementing the data sharing requirements in this way will harm patients and will cause emotional stress to already overburdened clinicians. The AMGA has also specifically requested that ONC allow clinicians to delay sharing results with patients for a 24 to 72 hours so that they could deliver them in a “more compassionate way.”

ACEP will continue to push for regulatory changes to the data sharing requirements and will also work with the AMA and others to coordinate our advocacy efforts. Again, while we strongly believe that patients deserve to have access to their health care data, we also feel that is critical to protect the physician-patient relationship and preserve the opportunity for you all to have meaningful conversations with your patients about their diagnosis and treatment options.

Before concluding, I would note that at this time, there are no penalties for health care providers who do not comply with the information blocking requirements. However, the Office of the Inspector General (OIG) with HHS is working on regulations that would create “appropriate disincentives” for providers who violate the requirements. There is no timetable for when these regulations will be released.

Until next week, this is Jeffrey saying, enjoy reading regs with your eggs.

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