Frequently Asked Questions
Yes, but only to the extent that the fees for the EHI export comply with the “Fees Exception” (45 CFR 171.302). For example, if the fees to export or convert data from the technology were not agreed to in writing at the time the technology was acquired, then the “Fees Exception” would not be available and such fees could implicate the information blocking definition unless another exception applies (45 CFR 171.302(b)(4)).
Note that if the EHI export would be performed using health IT certified under the ONC Health IT Certification Program (45 CFR Part 170) to the “EHI Export” certification criterion (45 CFR 170.315(b)(10)), a fee that is charged to perform such export for purposes of switching health IT or to provide patients their electronic health information (45 CFR 171.302(b)(3)) would not qualify for the “Fees Exception”.
The facts and circumstances of each situation or allegation would need to be evaluated. Whether a practice constitutes information blocking depends on the unique facts and circumstances of the practice. More specifically, information blocking occurs when: an individual or entity engaging in a practice is an actor as defined in 45 CFR 171.102; the practice involves EHI as defined in 45 CFR 171.102; the actor meets the requisite knowledge standard applicable to the type of actor; the practice is likely to prevent, materially discourage, or otherwise inhibit the access, exchange, or use of EHI; the practice is not one that is required by law; and the practice is not covered by an exception under 45 CFR Part 171.
Yes. On and after April 5, 2021, any actor’s agreements, arrangements, or contracts are subject to and may implicate the information blocking regulations in 45 CFR part 171.
No. The information blocking regulations do not require actors to have or use health IT certified under the ONC Health IT Certification Program. Actors subject to the information blocking regulations are not required to immediately upgrade their certified health IT (as of the applicability date (i.e., April 5, 2021)) if they also happen to participate in a separate regulatory program that requires the use of certified health IT, such as CMS’ Promoting Interoperability Programs.
Please review the questions under the "Electronic Health Information" heading for more information.
The applicability date for the information blocking regulations in 45 CFR part 171 was established in the ONC Cures Act Final Rule, and was subsequently adjusted in the ONC Interim Final Rule. The Interim Final Rule moved the applicability date from November 2, 2020 to April 5, 2021.
The Interim Final Rule also revised the information blocking definition in 45 CFR 171.103 to adjust the timeframe for the “USCDI limitation.” Before October 6, 2022, electronic health information (EHI) for the purposes of the information blocking definition is limited to the EHI identified by the data elements represented in the United States Core Data for Interoperability (USCDI) standard.
Enforcement of the information blocking regulations depends upon the individual or entity that is subject of an enforcement action or "actor." For health IT developers and health information networks/HIEs, the HHS Office of the Inspector General is currently engaged in rulemaking to establish enforcement dates. For health care providers, HHS must engage in future rulemaking to establish appropriate disincentives as directed by the 21st Century Cures Act.
Yes, an individual’s request for a copy of their EHI in some form of physical media, such as where the EHI is printed to paper or copied onto a CD or USB drive, could implicate the information blocking regulations. The definition of information blocking includes any practice (act or omission by an actor, as defined at 45 CFR 171.102) that is not required by law or covered by an exception and that is likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information (EHI) (as defined at 45 CFR 171.102). Importantly, however, any fee charged for providing this type of access to EHI that does not meet the Fees Exception (45 CFR 171.302) potentially could be considered information blocking.
We have consistently interpreted the broad definition of information blocking in section 3022(a) of the Public Health Service Act to encompass potentially any fee that is likely to interfere with, prevent, or materially discourage the access, exchange, or use of EHI (84 FR 7521, 85 FR 25880). This would include any fees charged to individuals for copies of their EHI furnished on paper or on electronic media (such as CDs or USB drives). To be covered by the Fees Exception, any fee(s) charged for copies of EHI on electronic media or printed to paper must meet all of its conditions, including that fees(s) are not among the list of excluded fees at 45 CFR 171.302(b). Of note, one of the exception’s conditions ensures alignment with HIPAA in that any fee prohibited by the HIPAA Privacy Rule for an individual’s right of access (45 CFR 164.524(c)(4)) is not covered by the Fees Exception. (84 FR 7540, 85 FR 25886).