Health information networks must understand the guidelines and exceptions to comply with information blocking rules and maintain access to electronic health information for patients and providers. Here’s what you should know.
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Federal authorities are ramping up efforts to crack down on information blocking practices to enhance patient care and facilitate seamless information exchange. They recently unveiled stringent statutory penalties targeting individuals and organizations that engage in information blocking by deliberately hindering access to electronic health information (EHI) or obstructing their sharing with patients and healthcare providers.
Indeed, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released long-awaited guidelines for exceptions and statutory penalties under the 21st Century Cures Act (Cures Act). The Final Rule, announced on June 27, 2023, states that any entity guilty of information blocking may face penalties of up to $1 million per violation. Healthcare providers could also be subject to disincentives, fines, or other disciplinary actions if found non-compliant.
Organizations that facilitate the exchange of electronic health records may find that effectively navigating the new regulations is critical yet complex. Luckily, healthcare IT experts and partners can provide valuable support to prepare organizations to meet these regulatory requirements and avoid penalties that took effect on September 1, 2023.
Until now, information blocking has represented a significant barrier to achieving true interoperability — at times, even perpetrated by bad actors that purposefully impede the exchange or use of electronic health information. The motivations behind information blocking may vary – from financial gain to concerns about maintaining competitiveness or control over data.
Federal regulators’ clear guidelines and enforcement actions are meant to address these issues and ensure individuals and their providers can easily access accurate and timely medical records to minimize errors or gaps in care delivery.
The rules are also intended to increase interoperability in the healthcare sector to allow more seamless coordination of information-sharing between hospitals, clinics, labs, pharmacies, and other
stakeholders involved in the delivery of patient care. To that end, some provisions in the regulation include specific language to support healthcare IT initiatives in facilitating pediatric medical treatment “across the care continuum” and preventing inappropriate access to prescription opioids.
Stakeholders contend that the obstruction of interoperability, whether deliberate or unintentional, can hinder the sharing of crucial data in the medical field and impede innovation, resulting in various adverse effects, such as:
Federal legislators signed the Cures Act in 2016, introducing sweeping changes to improve patient access to healthcare, including requiring healthcare organizations to share medical records, or electronic health information (EHI), with patients or healthcare providers at their request and without delays or costs.
Building upon this statutory direction is The Office of the National Coordinator for Health Information Technology (ONC) Cures Act Final Rule, which defines information blocking as any practice that prevents or discourages authorized access, exchange, or use of electronic health records for reasons not explicitly permitted under applicable law.
ONC also outlines interoperability requirements, which lay the foundation for how organizations access, exchange, and use EHI with the following objectives in mind:
Following the introduction of proposed rulemaking in 2020, ONC defined eight exceptions that provide entities managing healthcare information with the assurance that their EHI practices will not be deemed information blocking as long as they meet specific conditions. These exceptions fall under two categories:
The final ruling of the Cures Act is a significant stride towards enhancing interoperability and curbing information blocking practices. If enforced to the letter, the regulations will encourage vendors to develop new and improved solutions that meet the evolving needs of healthcare providers, facilitate seamless exchange of information between various operating systems and applications, and set the stage for increased patient empowerment.
To ensure compliance with the Final Rule, healthcare leaders and IT providers must assess and address information blocking at the system, organization, and community levels.
Consider these five general practices with your advisors to help support compliance:
This material is for general information purposes only and should not be construed as legal advice or any other advice on any specific facts or circumstances. No one should act or refrain from acting based upon any information herein without seeking professional legal advice. Health Catalyst, Inc. (HCAT) makes no warranties, representations, or claims of any kind concerning the content herein. HCAT and the contributing author expressly disclaim all liability to any person in respect of the consequences of anything done or not done in reliance upon the use of contents included herein.
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