Scope of information blocking rule expands; compliance still a struggle

Many providers still have questions regarding how to implement the sharing requirements and specific cases that might pose challenges.

Medicar records on mobile phone
Under the expanded rule, patients now can get electronic access to nearly everything in their health records.

The scope of the rule that bans blocking the sharing of electronic health information has been expanded, and many providers remain confused about how to comply with the regulation that’s designed to improve patients’ access to their information.

Providers can be found liable for information blocking if they know that their action or omission is “unreasonable” and likely to interfere with access, exchange or use of electronic health information (EHI).

When the information blocking rule, mandated by the 21st Century Cures Act, went into effect on April 5, 2021, it applied only to a limited set of data found in the first version of the U.S. Core Data for Interoperability (USCDI). But as of October 6, providers and other entities, known as “IB Actors,” who are subject to the rule must share almost all EHI when requested by patients and certain others.

“We have to remember that this is a learning experience for patients. Many do not know that providers write notes or that it might be helpful for them to access and read them.”

“The expanded rule means that patients can now get electronic access to essentially everything in their records without extra charge,” says Catherine DesRoches, executive director of OpenNotes, an international movement advocating for greater transparency in healthcare.

The Office of the National Coordinator for Health IT (ONC) anticipates that this access will enable patients to have more control of and be more direct participants in their care.

Many questions remain

But many providers still have questions regarding how to implement the information sharing requirements.

Ten provider organizations, including the American Hospital Association and American Medical Association, sent a letter on September 26 to Health and Human Services Secretary Xavier Becerra asking the agency to delay the effective date for the rule another year.

However, HHS has opted not to extend the deadline.

Among the problems cited in the letter are a lack of technical infrastructure to support the secure exchange of EHI, the lack of guidance regarding protecting sensitive health records, a lack of vendor compliance support readiness upon which provider readiness is dependent, and the need for HHS to provide more education, especially to smaller and lesser-resourced providers.

“Providers want to be information sharers. But they want to do it correctly and get it right the first time.”

“Providers want to be information sharers. But they want to do it correctly and get it right the first time,” says Chelsea Arnone, Director of Federal Affairs for College of Health Information Management Executives, one of the signatories of the letter.

For instance, if a provider has reported an issue to Child Protective Services, and the parent requests the child’s EHI, it’s unclear how the provider should proceed, Arnone says. There are also questions regarding how the rule dovetails with state laws, she points out.

Patient safety concerns could arise if patients do not understand the information being shared, Arnone adds.

“Many clinicians don’t want patients to find out they have a life-changing diagnosis, such as ALS or Huntington’s Disease, in a patient portal on a weekend and then can’t contact their clinician for three days,” she notes.

Commenting on the request for a deadline extension, an ONC spokesman says: “While we understand that for many, information sharing is a cultural change, these regulations have been a long time coming, and the information blocking regulation has been effective for 18 months. We don’t believe patients or providers can afford to wait any longer for the benefits of improved information sharing.”

ONC issued a blog post on September 30 reminding stakeholders how the information blocking rule works.

A bigger burden?

ONC says the widened scope of the rule is a “clear step” to empower providers with the best available information and tools to improve their ability to deliver high-value care.

But some providers are worried about the bigger burden now that more data must be shared, especially while they are still reeling from the pandemic and struggling with both clinician burnout and a depleted workforce, Arnone says.

They also fear that the lack of guidance may cause them to violate the rule despite their own best efforts, she says. For instance, there is no direction on best use practices, and the FAQs on ONC’s website haven’t been updated in months, she points out.

Providers were struggling to comply even before the Oct. 6 expansion. Of the 452 complaints ONC has received of possible incidents of information blocking, more than 80 percent have been against providers.

Some outside organizations, such as the non-profit Sequoia Project, have stepped in to develop resources to help IB actors comply with the rule.

Another uncertainty is how ONC will handle situations where an IB actor contends that an instance of information blocking fits within an allowable exception to the general prohibition. ONC has stated that this will be reviewed on a case-by-case basis.

And enforcement of the rule is still uncharted territory. HHS’ Office of Inspector General has not yet finalized a rule regarding enforcement, and it’s not clear whether that rule would be applied retroactively. OIG declined to comment because the agency has a general policy not to discuss active rulemaking, according to a spokesperson.

Meanwhile, the Biden administration recently asked Congress to enact legislation that would give the Department of Health and Human Services the authority to provide organizations with “binding advisory opinions” about what constitutes information blocking.

Are patients prepared?

It remains to be seen whether consumers will have a strong interest in obtaining and sharing their EHI.

“We have to remember that this is a learning experience for patients,” says DesRoches of OpenNotes. “Many do not know that providers write notes or that it might be helpful for them to access and read them. I expect that this will evolve over time as patients learn more about this new access.”

This could be a good opportunity for providers to connect with their patients.

“I encourage providers to view this new access as a way to help patients engage in their care,” DesRoches says. “Understanding that patients report significant benefits [from seeing their records], the advice that I would give to clinicians is to think about how we can implement this in a robust way that helps to increase the likelihood that patients will know their information is available and know how and why they might want to access it.”

CHIME’s Arnone says providers “want to partner with patients. It’s their health data for their own care coordination.”

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