Non-profit organization The Sequoia Project has published a new document that provides actionable implementation guidance and feedback in anticipation of the new information blocking rules, expected soon from the Office of the National Coordinator for Health IT.

Section 4004 of the 21st Century Cures Act prohibits "information blocking" and authorizes the U.S. Department of Health and Human Services to identify activities that could hinder patient access to healthcare data.

The rule could transform the way in which patient data is shared among providers and with patients. It's expected to outline permissible business practices that will not be considered information blocking, but also will generally require healthcare providers and their service providers to share data much more broadly.

Because compliance is often siloed in different parts of an organization, information blocking, which cuts across different parts of the organization, is likely to make compliance a challenge for healthcare organizations, according to the new report drawn up by Sequoia's information blocking workgroup, which was launched in early 2019.

Forthcoming rules to have a 'broad and significant impact'

Among the recommendations of the new report, Information Blocking Guidance to the Health IT Community, are the designation of a corporate compliance officer and other bodies that report directly to the CEO and governing body, alongside "regular and effective" education and training for staff.

"It will be essential to monitor the compliance program for effectiveness and needed enhancements," one comment contained in the report noted.

Sequoia's workgroup warns that it will be challenging to ensure that smaller clinician practices obtain needed compliance expertise and resources, while some organizations may face high volume of requests for information and will have challenges in handling volume.

In addition, the workgroup concluded there is a "great need" for clarity on scope of the interoperability elements, including APIs and electronic health records, predicting three months would be the "best case" scenario for a "very narrowly defined" scope of interoperability elements.

Developed by a multi-stakeholder Information Blocking Workgroup, which included representatives from diverse sectors of health information technology, the 105-page paper, publically accessible via The Sequoia Project's website, broadly addresses implementation-related aspects of priority components of the information blocking regulation.

"Given the broad and significant impact the rules would have to the health information sharing community, we formed the workgroup," Mariann Yeager, CEO of The Sequoia Project, said in a statement. "Working collaboratively to interpret and apply the rules will be important to fostering cooperation as the community prepares for ONC and OIG enforcement."

The organization argues that the healthcare community will need implementation guidance to meet legislative and regulatory intent and reduce compliance uncertainty and costs.

"This report aims to be a guide for the community," said Yeager. "Implementation guidance is essential to reduce uncertainty and prepare for compliance.

The workgroup will continue with a deeper dive early this year, considering the ONC Final Rule. Sequoia officials say it will also review the Final Rule and identify and address priority implementation topics and approaches.