What Is Information Blocking and to Whom Does It Apply?
Information blocking is a practice by an "actor" that is likely to interfere with the access, exchange, or use of electronic health information (EHI), except as required by law or specified in an information blocking exception. The Cures Act applied the law to healthcare providers, health IT developers of certified health IT, and health information exchanges (HIEs)/health information networks (HINs).
It is also important to note that the Cures Act established two different "knowledge" standards for actors' practices within the statute's definition of "information blocking." In particular, for health IT developers of certified health IT, as well as HIEs/HINs, the law applies the standard of whether they know, or should know, that a practice is likely to interfere with the access, exchange, or use of EHI. For healthcare providers, the law applies the standard of whether they know that the practice is unreasonable and is likely to interfere with the access, exchange, or use of EHI.
The exact regulatory definition of Information Blocking can be found in the Code of Federal Regulations in 45 CFR 171.103.
Information Blocking Exceptions
Eight information blocking exceptions were established in the 2020 Cures Act Final Rule. When an actor’s practice meets the condition(s) of an exception, it will not be considered information blocking. Importantly, the information blocking exceptions are voluntary and offer actors certainty, but it is also worth noting that even in cases where a practice does not meet any of the exceptions it does not automatically mean that information blocking has occurred. Instead, such practices will be evaluated on a case-by-case basis to determine whether information blocking has occurred. Learn more about elements of whether information blocking occurred in cases where no exception has been met.
The exceptions are divided into two categories:
How Do I Submit an Information Blocking Claim and What Happens to a Claim Once It Is Submitted?
Information blocking claims can be submitted online through ONC’s Report Information Blocking Portal.
As specified by the Cures Act, information blocking claims and information received by ONC in connection with a claim or suggestion of possible information blocking are generally protected from disclosure under the Freedom of Information Act.
ONC has authority to review claims of possible information blocking against health IT developers of certified health IT that may constitute a non-conformity under the ONC Health IT Certification Program. Separately, the HHS OIG has authority to investigate claims of possible information blocking across all types of actors: health care providers, health information networks and health information exchanges, and health IT developers of certified health IT.
Information Blocking Provider Disincentives
A new proposed rule released on October 30, 2023, by the U.S. Department of Health and Human Services (HHS) details HHS’ first steps for holding health care providers accountable for information blocking under the 21st Century Cures Act (Cures Act). Specifically, the “21st Century Cures Act: Establishment of Disincentives for Health Care Providers That Have Committed Information Blocking” proposed rule proposes a set of appropriate disincentives in Centers for Medicare & Medicaid Services (CMS) programs. If finalized, the set of disincentives would apply to certain health care providers that have been found to have committed information blocking by the HHS Office of Inspector General (OIG) and for which OIG refers its determination to CMS.
What proposals are included?
The proposals would establish disincentives for certain health care providers through several existing CMS programs, consistent with the Cures Act’s requirement for the secretary to establish disincentives using applicable Federal law. OIG enforcement, already in place for other actors as of September 1, 2023, would begin for providers upon finalization of this proposed rule.
Information Blocking Resources
ONC publishes blogs, journal articles, and data briefs on a regular basis to ensure everyone can easily stay current with the latest findings and learnings from our work across the health IT ecosystem.
The Cures Act requires ONC to establish certain Conditions and Maintenance of Certification requirements for health IT developers under the ONC Health IT Certification Program. Per these Conditions and Maintenance of Certification, a health IT developer who participates in the ONC Health IT Certification Program may not take any actions that constitutes “information blocking” as defined in Section 3022(a) of the Public Health Service Act (PHSA) and 45 CFR 171.103.
The materials contained on this webpage are based on the provisions contained in 45 C.F.R. Parts 170 and 171. While every effort has been made to ensure the accuracy of this restatement of those provisions, this webpage is not a legal document. The official program requirements are contained in the relevant laws and regulations. Please note that other Federal, state and local laws may also apply.