Nearly 300 complaints of healthcare organizations allegedly blocking access to patient data have been logged since major interoperability regulations went into effect last year.
A healthcare regulation went into effect last April that gives patients easier access to their digital health records through their smartphones. the regulation requires health IT vendors, providers and health information exchanges to enable patients to access and download their health records with third-party apps. Under the rule, providers can't inhibit the access, exchange or use of health information unless the data fall within eight exceptions.
Micky Tripathi, the national coordinator for health IT under the Biden administration, said the information blocking rules, along with other interoperability rules mandated by the 21st Century Cures Act, represent a "paradigm shift for the industry" by putting patients in control of their health data.
Healthcare experts believe the regulation could finally be a major step in achieving a meaningful level of data sharing far beyond what's been seen before in the healthcare sector.
According to data released by the Office of the National Coordinator for Health IT (ONC), there have been 274 possible claims of information blocking submitted to the agency's Report Information Blocking Portal since April 5, 2021.
The bulk of the complaints accuses healthcare providers of alleged information blocking, as providers account for more than three-quarters of the complaints at 211.
"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," ONC executives Rachel Nelson and Cassie Weaver wrote in a blog post.
Healthcare providers have reported being charged what they assert are excessive fees to access electronic health information or to export that information to a new electronic health record system, and unnecessary delays in receiving electronic health information they have requested for their patients, Nelson and Weaver wrote.
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 information, or both.
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. Two claims are against health information networks/health information exchanges.
The claims of information blocking are only allegations and are investigated either by ONC or HHS' Office of the Inspector General, according to ONC officials in a blog post.
ONC can investigate claims that a health IT developer, such as an EHR company, has committed information blocking, due to the ONC Health IT Certification Program’s requirement that participants refrain from it. ONC also shares those claims with OIG.
ONC is responsible for defining the policies related to information blocking and establishing a complaint process, and the HHS' OIG is responsible for investigating complaints and assessing any necessary penalties on certified health IT developers or health information networks/exchanges, Tripathi wrote in Health Affairs this month.
The information blocking ban lacks teeth, for now.
In 2020, HHS' OIG released a proposed rule outlining civil monetary penalties related to information blocking. In the rule, OIG proposes a maximum fine of $1 million per violation. A final rule from OIG is expected in March to begin enforcement of the information blocking policies, Tripathi wrote.
Nelson and Weaver wrote that the data released Monday represents the first release of information blocking claims data. "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," they wrote in the blog post.
The ONC data also shows that 176 of the information blocking claims 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.
The claims suggest that ONC has had some success in fostering awareness of the agency's public reporting 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, Nelson and Weaver wrote.