June 29, 2022

Volume XII, Number 180

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HHS Information Blocking Rule: The 8 Exceptions

Two years ago, the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) issued regulations under the 21st Century Cures Act advancing the interoperability of electronic health information (EHI) and access to EHI by patients and interested stakeholders. These regulations (known as the ONC Cures Act “Information Blocking Rule”) established conditions under which providers, developers of certified health IT, and health information networks and exchanges cannot knowingly engage in practices likely to interfere with the access, exchange, or use of electronic health information.

ONC will evaluate information blocking claims by reviewing the unique circumstances surrounding the practice and evaluating the following elements to determine whether information blocking has occurred:

  • The information involved meets the definition of EHI;

  • The Individual or entity engaged in the practice is a regulated Actor;

  • The Actor meets the applicable knowledge standard required for that type of Actor;

  • The practice is likely to prevent, materially discourage, or inhibit the access, exchange or use of EHI;

  • The practice is required by law; and

  • An Information Blocking Rule exception covers the practice.

In the Information Blocking Rule, ONC established eight categories of reasonable and necessary practices that will not be considered information blocking. Failure to meet an exception does not necessarily mean a practice is information blocking. Outside these exceptions, HHS will consider the facts and circumstances surrounding information blocking claims on a case-by-case basis to determine whether the practice rises to the level of an interference and whether the Actor acted with the requisite intent. ONC encouraged Actors to voluntarily comply with an exception so that their practices are not subject to information blocking claims.

The document linked here includes a checklist that is excerpted from portions of the Information Blocking Rule, but in no way should be a substitute for an attorney, the regulatory references (e.g., the statute, the Information Blocking Rule, and HHS interpretive guidance), or an analysis of the practice and the Actor’s intent.

© 2022 Bradley Arant Boult Cummings LLPNational Law Review, Volume XII, Number 172
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About this Author

Amy S. Leopard Healthcare IT Attorney Bradley Arant Boult Cummings Nashville
Partner

Amy Leopard advises a diverse array of clients in the healthcare and technology industries.

Amy is a valued business advisor at the intersection of healthcare and information technology law. She provides trusted counsel to healthcare providers, entrepreneurs, and service providers on licensing, payment, regulatory compliance, privacy and technology issues. As a former hospital executive, Amy has in-depth knowledge from over 25 years in the healthcare industry as a vice president in both academic medical center and community hospital settings and...

615-252-2309
Russell E. Barnwell Healthcare litigation and compliance lawyer Bradley Arant Boult Cummings law firm Alabama
Associate

Russ Barnwell is an associate in the Healthcare Practice Group. His areas of focus include healthcare regulatory compliance; government enforcement actions and investigations; mergers and acquisitions; and matters of corporate governance. He assists clients spanning the healthcare industry, including hospitals, health systems and other healthcare provider entities; digital health companies; and pharmaceutical and medical device manufacturers. Russ regularly helps clients navigate unchartered regulatory waters, and he has significant experience guiding clients through the...

205.521.8324
Eric Setterlund Healthcare and Cybersecurity lawyer Bradley Arant Boult Cummings law Firm Tennessee
Counsel

Eric Setterlund serves as counsel in Bradley’s Healthcare and Cybersecurity and Privacy practice groups. He has extensive experience with matters related to healthcare privacy, security protections and regulatory compliance. Prior to joining the firm, Eric served as chief privacy officer and privacy and data counsel for BlueCross BlueShield of Tennessee. He draws upon his real-world business and program management experience to provide his clients practical advice for complex regulatory and transactional matters.

Eric has a strong understanding...

615.252.3509
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