Information Blocking
The Information Blocking provision discourages interference by relevant providers, developers and networks of legally permissible access, exchange and use of electronic health information.
Background
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.
Timeline
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
