Frequently Asked Questions
It depends. The Manner Exception, in particular the last provision of the “alternative manner” (45 CFR 171.301(b)(1)(iii)), does not specify the particular file extensions or outputs that must be supported. Instead, as a last alternative to make electronic health information (EHI) accessible, exchangeable, or useable, this specific provision within the exception requires actors to produce EHI in a “machine-readable format, including the means to interpret the electronic health information, agreed upon with the requestor.” If it is necessary to produce a PDF for the purpose of meeting this provision, the PDF should be an interpretable, machine-readable output. While this may be possible for some PDFs, other PDFs, such as those that include EHI as images, generally might not be an interpretable, machine-readable output.
One way a PDF could be a machine-readable format would be if it was structured so that the data it conveyed could be consumed by another software program using consistent processing logic, consistent with the National Institute of Standards and Technology’s definition of “machine-readable.” If a data output format is structured so that the EHI it conveys is machine readable, then that output format is a machine-readable format, regardless of the file extension.
Updated:
This FAQ has been updated to reflect the effective date of the HTI-1 Final Rule.
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 posted its final rule implementing information blocking penalties. For health care providers, HHS has posted its proposed rule to establish appropriate disincentives as directed by the 21st Century Cures Act. For additional information, see the Disincentives Proposed Rule Overview fact sheet and the Disincentives Common Questions fact sheet.
Updated:
This FAQ has been updated to reflect the effective date of the HTI-1 Final Rule.
Under section 4004 of the 21st Century Cures Act (Cures Act), the HHS OIG has authority to investigate any claim that health care providers, health information networks (HINs) and health information exchanges (HIEs), and health IT developers of certified health IT (collectively defined as “actors” in 45 CFR 171.102) have engaged in information blocking.
For actors HHS OIG determines have committed information blocking, enforcement consequences depend upon the actor involved.
- For health IT developers of certified health IT and HINs/HIEs (as defined in 45 CFR 171.102), the Cures Act subjects these entities to civil monetary penalties if HHS OIG determines they committed information blocking. Under the Cures Act, these penalties could be up to $1 million per violation. The HHS OIG has issued a final rule on this enforcement authority.
- For health care providers (as defined in 45 CFR 171.102) the Cures Act authorizes the Secretary of Health and Human Services to establish appropriate disincentives through notice and comment rulemaking. HHS has posted its proposed rule to establish appropriate disincentives as directed by the 21st Century Cures Act. For additional information, see the Disincentives Proposed Rule Overview fact sheet and the Disincentives Common Questions fact sheet. Until the appropriate disincentives are established, HHS OIG will not prioritize investigation of information blocking conduct by health care providers.
Updated:
This FAQ has been updated to reflect the effective date of the HTI-1 Final Rule.