Navigating Compliance Challenges with the Information Blocking Rule: A Collection of Case Studies

HITEQ Center and Feldesman Tucker Leifer Fidell LLP, September 2023

The Office of the National Coordinator for Health Information Technology’s (ONC) 21st Century Cures Act Information Blocking Rule (Info Blocking Rule) prohibits covered actors – including health care providers, health IT developers of certified health IT, and health information exchanges/health information networks– from engaging in practices likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information (EHI). The Info Blocking Rule includes eight exceptions that provide actors with certainty that, when their practice interferes with the access, exchange, or use of EHI and meets the conditions of one or more exception, such practice will not be considered information blocking.¹ An actor’s practice that does not meet all the conditions of an exception will be evaluated on a case-by-case basis to determine whether information blocking has occurred.²

Since the Info Blocking Rule went into effect in 2021, EHI has become more available than ever as it is posted to portals, sent through health information exchanges, and available via health-related apps upon request by patients.3 As the availability of EHI has increased, so too have concerns about the privacy of EHI. Like other actors, health centers are faced with new compliance challenges, including how to best protect sensitive EHI, how to respond to patient requests to restrict access to their EHI, and how to respond when patients request changes to their EHI. Health centers must navigate complex and, at times, conflicting federal and state laws and regulations.

The case studies in this Issue Brief demonstrate recent compliance challenges faced by health centers. Each includes a review of the applicable federal, legal, and regulatory requirements and recommendations for navigating conflicting requirements.

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1 45 CFR 171.200; 45 CFR 171.300.
2 “Frequently Asked Questions,” HealthIT.gov, The Office of the National Coordinator for Health Information Technology (ONC), April 2023, https://www.healthit.gov/faq/would-it-be-information-blocking-if-actor-does-not-fulfill-request-access-exchange-or-use-ehi.