Information Blocking

Section 4004 of the 21st Century Cures Act (2016) expanded the authority of the U.S. Department of Health and Human Services (HHS) to investigate and penalize information blocking practices that impede legally permissible requests for certain healthcare data. The information blocking 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 means that provider knows a given practice is unreasonable and likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information (EHI).

The EHI definition includes nearly all electronic protected health information (ePHI) that is part of the Health Insurance Portability and Accountability Act (HIPAA)-designated record set (DRS), with certain limitations. This is generally inclusive of most imaging data or other clinical data used by radiologists in medical decisionmaking, including images. It is not limited to radiology reports.

Providers and other actors that engage in practices implicating the provision can be reported to HHS and investigated on a case-by-case basis. HHS enforcement priorities will inform whether the allegation is investigated. If a given practice is investigated and found to be in violation, the provider is then subject to disincentives. These disincentives negatively affect the provider’s scoring in the Merit-based Incentive Payment System, Medicare Shared Savings Program or the hospital Medicare Promoting Interoperability Program. Additionally, data about the violation will be posted publicly online. Non-provider actors — which can include providers serving as networks or developers — are instead subject to civil monetary penalties. 

HHS defined several exceptions and corresponding criteria as an optional method of compliance certainty for practices deemed reasonable and necessary that could otherwise implicate the provision. When an actor’s practice meets the condition(s) of an exception, it will generally not be considered information blocking.

Information blocking regulations were effective beginning April 5, 2021. Periodic HHS rulemakings have added and/or revised components of the relevant regulations over time. Actors are encouraged to stay up to date with their compliance strategies.  Learn more

Information blocking includes, but is not limited to, provider-to-patient exchange scenarios. It also includes exchange between providers, and between providers and vendors or networks. The purpose is to advance data-sharing and interoperability, including in ways that deter anti-competitive behaviors sometimes experienced by radiology providers. For example, radiology providers can report other actors for unresponsiveness to requests, unfair exchange policies, or unreasonable fees that could interfere with their own legally permissible access, exchange, or use of EHI.

Radiology providers must proactively comply by not engaging in information blocking practices, which can be inclusive of internal policies that delay access by patients or other providers, including via the third-party apps/software they use. It is generally advisable for all actors, including radiology providers, to work closely with qualified legal teams on regulatory compliance strategies that correspond with their technological capabilities. It is important to understand what data is generated, maintained or accessed by the radiology provider that would meet the EHI definition, and to factor this into relevant decisionmaking. Importantly, HHS information blocking rules do not mandate new technology/product purchases.

Frequently Asked Questions (FAQ): ACR has received numerous information blocking-related questions. Many of these questions are difficult to address without further clarity from HHS; however, this document compiles our understanding.

ACR Bulletin Dispatches Article: This July 2022 ACR Bulletin Dispatches article (see page 5) discusses HHS’ February 2022 flexibilities for enabling patient access while avoiding surprise.

RadiologyInfo.org: Radiology information for patients and families, including suggestions or understanding radiology data and more.

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 
• HHS investigation information and priorities