The American College of Radiology provides the following only as general information. Readers should not construe this educational resource to provide specific legal advice on their individual practice matters. This information is subject to change depending on future rules and/or clarifications.
The 21st Century Cures Act Section 4004 expanded the authority of the Department of Health and Human Services (HHS) Office of Inspector General (OIG) to investigate and penalize information blocking practices that impede legally permissible requests for certain health care data. The provision is relevant to three types of actors —providers, developers of certified health information technology, and health information networks/exchanges. Information blocking by a provider necessitates that the provider knows the practice is unreasonable and likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information (EHI).
The EHI definition was previously limited on a temporary basis to the data elements represented by the U.S. Core Data for Interoperability (USCDI) , including imaging narrative data. However, beginning Oct. 6, 2022, the EHI definition includes virtually all electronic protected health information (ePHI) that is part of the Health Insurance Portability and Accountability Act (HIPAA)-designated record set, with certain limitations. Therefore, EHI includes non-deidentified medical images, reports, device/algorithm outputs containing ePHI, and many other data types used in medical decision-making.
Providers that engage in practices implicating the provision can be reported to HHS and investigated on a case-by-case basis. If a given practice is found to be in violation, the provider will then be subject to disincentives under existing HHS authorities. Provider-specific disincentives have yet to be defined by HHS agencies, and regulatory implementation by HHS agencies is currently incomplete.
HHS defined eight exceptions —i.e., activities that would otherwise implicate the provision, but are exempt from penalization because they are deemed reasonable and necessary. Practices that meet the conditions of at least one exception have additional assurance they will not be penalized.
Providers that engage in practices that implicate the provision, but do not meet the conditions of an exception, will not be automatically penalized. HHS will evaluate such practices to determine, based on circumstances and the provider’s knowledge, whether information blocking has occurred.
Information Blocking regulations were effective beginning April 5, 2021. The EHI definition expanded on Oct. 6, 2022.
HHS has yet to promulgate disincentives for providers through rulemaking. HHS has not specified whether providers will be retrospectively penalized for any information blocking that occurs in the gap before that rulemaking has come to fruition.
When enacted in 2016, Congress intended the information blocking provision to discourage anticompetitive, anti-exchange behaviors involving data-sharing not already addressed by existing regulations. If well-implemented and appropriately enforced, the information blocking provision should help broadly advance data-sharing and interoperability, including in many ways that help radiology providers connect with referring providers and networks. It is relevant to any legally permissible request for EHI, including from patients and/or other providers.
Radiology providers must comply by not engaging in information blocking practices. It is generally advisable for all actors, including radiology providers, to work closely with their legal teams on regulatory compliance strategies that correspond with their technological capabilities. Such strategies should account for the EHI definition expansion in Oct. 2022.
It is generally recommended that actors use first-party information provided by relevant HHS agencies due to the continually evolving state of implementation and enforcement.
- HHS information blocking resources – This website provides guidance documents, answers to frequently asked questions, and other links. This is a good starting place to learn about the information blocking provision.
- HHS ONC final rule on exceptions (May 1, 2020) – This final rule covers many topics related to the HHS Office of the National Coordinator for Health IT’s purview with respect to the 21st Century Cures Act. This includes, but is not limited to, areas of relevance to ONC in the information blocking provision, particularly defining the eight exceptions. It does not address enforcement considerations, disincentives/penalties, and other information blocking topics that are in the purview of other HHS agencies.
- HHS ONC interim final rule on timeline extensions (Nov. 4, 2020) – This interim final rule extended the compliance timeframes related to ONC’s May 1, 2020 rule, including with respect to key information blocking timelines like the applicability and EHI definition expansion dates.
- 21st Century Cures Act – The “Cures Act” was a legislative package in 2016 that addressed numerous healthcare policy topics, including establishing the information blocking provision (Sec. 4004).