Perpetual Progression: ONC Proposals To Enhance the Information Sharing Rules

By Lauren Riplinger , Melissa A Soliz and Chantal Worzala

The Sequoia Project’s Information Sharing Workgroup (ISWG) recently took a close look at proposals from the Office of the National Coordinator for Health IT (ONC) to enhance federal information sharing requirements. Although ONC’s proposed changes in HTI-1 offer some clarification, actors will still need robust compliance programs to address information blocking and advance a culture of information sharing.

The Information Blocking Rule (IBR) prohibits healthcare providers, developers (and offerors) of certified health IT, and health information networks/exchanges (HIN/HIEs) (collectively, “actors”) from engaging in practices that are likely to interfere with the access, exchange, or use of electronic health information (EHI), unless the practice is required by law. The IBR has rolled out incrementally:

• Compliance was required in April 2021.
• The scope of EHI to be shared expanded in October 2022.
• Enforcement for developers and HIN/HIEs began on Sept. 1, 2023.
• HHS will continue to delay enforcement against healthcare providers until it has finalized rules on provider disincentives (proposed rule expected this fall).

Key Changes Proposed?

ONC proposed the following changes to the IBR:

• Add a definition of “offer health IT” to clarify when an individual or entity may be considered a developer through these activities. ONC proposes to exclude certain arrangements, such as technology donations, subsidized supply arrangements, and other health IT implementation and use activities when certain conditions are met.
• Add a new condition to the manner exception that would allow an actor to meet obligations under the IBR when responding to certain EHI requests by offering to fulfill the request via a technical manner specified by the Trusted Exchange Framework and Common Agreement (TEFCA).
• Expand the infeasibility exception, which recognizes that legitimate practical challenges may limit an actor’s ability to comply with EHI requests, by adding: 1) A new “manner exception exhausted” condition, whereby it will not be information blocking if an actor offers, but ultimately fails, to fulfill an EHI request using all the alternative technical manners listed under the manner exception, under most circumstances. 2) A “third party seeking modification of use” condition that would allow an actor to deny a request by a third party to modify (e.g., create or delete) EHI maintained by the actor. However, this would not be an option when the request is coming from a healthcare provider to allow such use by the provider’s business associate.

Impact on the Field

The ISWG discussed how these proposals may impact each actor type, resulting in the following views from the field:

Providers

Clarifying that certain arrangements related to health IT--such as providing subsidies or consulting and legal services--do not fall under the definition of “offering” health IT may be a big win for health systems, hospitals, and managed service organizations (MSO) that support access to critical health IT infrastructure by smaller providers. If finalized, the proposal would remove the existing disincentives from health IT resale/donation activities by providers concerned that they could be classified as both a provider and a developer under the IBR. Developers face a higher knowledge standard than providers and significant civil money penalties.

Likewise, MSOs and similar organizations that provide administrative and consulting services will be unlikely to be classified as developers. Oftentimes, smaller providers lack the resources and staff to deploy, and monitor, and update systems and enter partnerships with larger health systems, MSOs, and others to operate and maintain their health IT. ONC’s proposal to exclude these types of beneficial arrangements will further information sharing and support smaller providers.

The proposed third-party modification use condition will help providers by ensuring that they remain in control of what goes into the medical record and how that medical record “talks” to the provider’s other systems when EHI is involved. The proposed modification reduces the administrative burden and uncertainty by decreasing the documentation requirements for use of this exception.

Developers and HIN/HIEs

All actor types will benefit from the proposed infeasibility condition for “manner exhausted,” if finalized. Actors will have more certainty that if they tried but failed to reach agreement with the requestor to fulfill an EHI request using the technical manners prioritized by ONC, they did not engage information blocking. ONC’s “manner exhausted” proposal will enable HIN/HIEs and developers to focus their resources on developing standardized, scalable solutions for access, exchange, and use, rather than building custom solutions. It also lowers administrative and documentation burdens.

The proposed TEFCA condition could significantly impact actors and requestors. TEFCA will create the minimum requirements to support nationwide data exchange for six permitted purposes, including treatment and individual access. If finalized as proposed, this exception would give actors that participate in TEFCA “safe harbor protection” against any IBR complaint when they receive a request for a TEFCA permitted purpose from an entity that also participates in TEFCA, and they offer to fulfill the request using any technical service provided under TEFCA. Agreement by the requestor would not be required, and the actor holding the data would not be required to meet the IBR fees and licensing exceptions. As proposed, the TEFCA condition could create a powerful tool for actors to deny EHI requests from others who also participate in TEFCA.

Bottom Line

HTI-1 contains many proposals intended to support interoperability by protecting beneficial health IT arrangements, investing in standardized technologies, and reducing the administrative burden. The healthcare community will need to continue to work together to define good practices for compliance.

Note: The co-authors serve on The Sequoia Project ISWG. Although they strived to reflect group discussions, their perspectives are their own and do not necessarily reflect the views, opinions, or positions of The Sequoia Project, the ISWG, their employers, or affiliated organizations. More information about the ISWG, including a suite of deliverables on the real-world implications of the information blocking rules, can be found here.