Information Blocking Claims: By the Numbers
Rachel Nelson and Cassie Weaver | February 28, 2022
The 21st Century Cures Act (Cures Act), signed into law by President Obama in 2016, directed ONC to implement a standardized process for the public to report claims of possible information blocking. The information blocking claims reporting process welcomes claims of possible information blocking from anyone who believes they may have experienced or observed information blocking. Any information received by ONC in connection with a claim or suggestion of possible information blocking and that could reasonably be expected to facilitate identification of the source of the information (claimant) is protected from disclosure under the Cures Act. The Cures Act authorizes the HHS Office of Inspector General (OIG) to investigate any claim of information blocking.
Today, we posted a Quick Stat visualization of data on the information blocking claims we have received through the Report Information Blocking Portal since April 5, 2021—the applicability date of the information blocking regulations. Moving forward, we generally plan to update these resources on a monthly basis and provide our data in two formats—a web page showing cumulative numbers to date and a downloadable file [XLSX – 92 KB] that shows what the cumulative counts were each month dating back to April 5, 2021. This is our first release of information blocking claims data, and we intend to evolve our reporting in the future as we get more data and public feedback. Our goal is to create transparency and help the industry prevent information blocking before it happens.
What the Quick Stat visualizes
The first visualization shows the total number of Report Information Blocking Portal submissions received (299), the number of these submissions that present claims of possible information blocking (274), and the number of submissions (25) that do not appear to present a claim of information blocking—such as those that pose a general policy question. In addition, two charts visualize the number of claims by type of claimant and by the types of potential actor (as defined in the information blocking regulations) alleged to have engaged in information blocking.
In considering the number of claims in total, and by types of claimants and potential actors, it is important to know what is tabulated as a claim. If what someone describes in a submission to the Report Information Blocking Portal appears to have any potential to involve conduct implicating the regulatory definition of information blocking, then it is counted as a claim. Unless the submission is obviously, on its face, not an information blocking claim, we share the submission with OIG. A submission is counted as “not a claim” if the answer to both of the questions below is “no”:
- Is the submission about an individual or entity who could potentially be an information blocking “actor”? Only health care providers, health IT developers of certified health information technology, and health information networks/exchanges are subject to the information blocking regulations.
- Does the submission appear to be about electronic health information (EHI) as defined for purposes of the information blocking regulations? Only information included in the definition of EHI falls within the definition of information blocking, and until October 6, 2022, the information blocking definition is further limited to EHI that is identified by the data elements represented in the USCDI v1. Certain EHI, like image files that otherwise meet the definition of EHI, will not fall within the definition of information blocking until October 6, 2022.
The second visualization looks at the 274 claims of possible information blocking we received since April 5, 2021, by type of claimant: 176 appear to come from patients (and/or their attorneys) and 32 on behalf of patients by third parties (such as patients’ parents or personal representatives); 32 appear to come from health care providers; and 20 appear to come from developers of health IT—this category includes both developers with health IT certified under the ONC Health IT Certification Program, as well as developers who do not have certified health IT. Because we will accept a claim from anyone, and because we don’t ask people to self-identify their role in the circumstances giving rise to their claim, in some cases we are unable to identify the perspective from which the claimant is reporting a particular claim of possible information blocking—that is the case in 16 of the 274 claims.
The third and final visualization shows the number of claims against various types of individuals or organizations (potential information blocking “actors”) that the claimant indicates may have engaged in information blocking. Where claimants provide enough information to identify a specific type of potential actor that the claimant suspects may have engaged in information blocking, we believe it is likely that 211 claims are against health care providers and two are against health information networks/health information exchanges. Of a total of 46 claims that seem likely to allege information blocking specifically by a health IT developer, 42 are against health IT developers who participate in the ONC Health IT Certification Program. (Because the definition of “health IT developer of certified health IT” includes individuals or entities that offer certified health IT, an investigation would be needed to determine whether an alleged developer/vendor that does not clearly participate in the Certification Program is in fact an information blocking actor under the regulations.)
The breakouts of claims by types of potential actor reflect that our ability to parse claims of possible information blocking is limited to who, on the face of the claim, it appears the claimant is suggesting may have engaged in information blocking. For example, if a claim indicates involvement of potential actors who appear to fit in more than one category, we count these claims as naming a combination of the types of potential actors it describes. To determine if information blocking occurred in any of these cases—and if so, which actor committed information blocking—an investigation would be needed. Ultimately, whether information blocking occurred would depend on the full facts and circumstances of a specific case, and would be based on whether the individual or entity engaging in the practice is an “actor” and had the requisite knowledge standard, whether the practice rose to the level of an interference, whether the claim involves electronic health information, and whether the practice was required by law or was covered by an exception to the definition of information blocking.
What have we observed in claims received since April 2021?
Bearing in mind that there are several factors to consider regarding a claim of possible information blocking, we can still make some general observations based on the information claimants have provided.
Because the claims reflect what people and entities are encountering as they seek to access, exchange, and use EHI, the circumstances described in the claims may offer insight into potential impediments to EHI access, exchange, or use. The claims also suggest we have had some success in fostering awareness of the Report Information Blocking Portal beyond the health IT community, because the claims are coming not only from health IT developers but from a variety of people—including patients and their representatives, and health care providers. Though we cannot tell through simple triage whether a particular claim represents information blocking as defined in the regulations, some of the concerns described in the claims we have received appear on their face consistent with examples of practices likely to interfere with access, exchange, or use of EHI that we described in ONC’s Cures Act proposed and final rules. For example, health care providers have reported being charged what they assert are excessive fees to access EHI or to export EHI to a new EHR system, and unnecessary delays in receiving EHI they have requested for their patients. Claimants representing the patient perspective have described being charged fees for electronic access to their health information, experiencing unnecessary delays in receiving access to their EHI, or both.
What happens when we receive a claim?
Some claims we’ve received have alleged that a health IT developer of certified health IT has committed information blocking. Due to the ONC Health IT Certification Program’s requirement that participants refrain from information blocking, we can also review those claims within ONC, in addition to sharing the claim with OIG. ONC’s authority to review developers’ compliance with Certification Program requirements, and to take certain actions under the Certification Program where a developer is found to be out of compliance, is separate from OIG’s authority to investigate claims of information blocking and issue civil monetary penalties. Once ONC has reviewed and investigated a claim, we can issue notices of non-conformity to the developer, or even certification terminations and bans if appropriate.
HHS prioritizes communication, transparency, and ongoing engagement with all our stakeholders. To that end, ONC acknowledges each portal submission we receive and informs the claimant when we’ve shared their claim with OIG. We also provide feedback, where applicable, to let people know if the information in their claim, on its face and as presented, appears to have no potential to involve conduct implicating the regulatory definition of information blocking. When the claim is not against a health IT developer who participates in the Program, we inform the claimant that the claim is outside the scope of ONC’s authority—at that point, OIG will still have discretion to investigate the claim or not. Of course, ONC and OIG continuously coordinate and work together to address and deter information blocking.
More information about what happens to a claim after it is submitted is available in the Information Blocking Portal Process fact sheet, and three frequently asked questions also provide more detail about reporting claims of information blocking through the Report Information Blocking Portal on ONC’s website, HealthIT.gov.
Outreach, Stakeholder Feedback, and Resources
As we continue to conduct outreach on the information blocking regulations and the process for reporting claims of information blocking, we’re heartened by the robust public participation we’ve seen to date and hope that any individual or organization who believes that they may have seen information blocking will consider filing a report through the Report Information Blocking Portal.
In addition, we also welcome questions, comments, or general feedback about information blocking through the Health IT Feedback and Inquiry Portal. We use the feedback we receive to help guide our outreach programs.
For more on information blocking, including fact sheets, webinars, and FAQs, check out the rest of the resources on our website.