- HHS has received 299 claims of information blocking since April last year, when sweeping interoperability regulations came into effect, its health IT agency said Monday.
- Of that tranche, 274 present claims of possible information blocking, while 25 do not, regulators said. The majority — 211 — have been filed against healthcare providers, while 46 allege information blocking specifically by a health IT developer. Just two are against health information networks or exchanges.
- It's unclear what percentage of the claims are substantiated, though ONC has sent all 274 possible claims to HHS' Office of the Inspector General for investigation. That doesn't necessarily mean all will be investigated, as OIG has discretion as to whether it looks into a given claim or not, an ONC spokesperson said.
The Office of the National Coordinator's first release of information blocking claims was much anticipated, given the free flow of health information across different entities is a perennial problem in the U.S.
The 21st Century Cures Act passed in 2016 directed ONC to create a process for the public to report claims of possible information blocking. In early 2020, the Trump administration finalized interoperability rules requiring providers, health information exchanges and health IT developers certified by ONC to share data with patients and with each other.
The rules set up a portal where claims can be filed against such actors for blocking the exchange of health data. The claims can be investigated by HHS' Office of the Inspector General if they appear to involve conduct implicating the regulatory definition of information blocking.
Valid claims have to be about an actor that's subject to the information blocking regulations, and have to be regarding electronic health information as defined in the regulations. That definition is somewhat narrow until October of this year, when it will expand beyond just electronic health data that's included in the U.S. Core Data for Interoperability dataset.
The ONC data found the brunt of information blocking allegations are being lobbied against healthcare providers.
ONC noted that breaking out claims by type of actor is limited to who the claimant is suggesting might have engaged in information blocking. For example, if a potential information blocker fits more than one category, ONC counts that claim as a combination of the types of potential actors it describes.
To determine if information blocking occurred, an investigation would be needed, regulators said. Ultimately, determining whether information blocking occurred would depend on the circumstances of each case, such as whether the entity counts as an actor, whether their actions rose to the level of interference, whether it involves electronic health information and whether the practice was required by law, or was covered by one of the eight exceptions to information blocking.
But the concerns raised by the claims appear "on their face consistent" with practices that would interfere with access, exchange of use of electronic health information as set out by the rules, regulators said in a blog post on the data.
For example, providers reported being charged excessive fees to access health data, or to export it to a new EHR system, along with unnecessary delays in receiving electronic health information that they requested for patients.
And patients — which have filed the large majority of claims, followed by attorneys and healthcare providers — described being charged fees to access their health information electronically, along with experiencing unnecessary delays in getting access to their data.
After an investigation, if actors are found guilty of information blocking they can be subject to harsh fines from ONC or OIG. In 2020, OIG proposed a rule outlining the financial penalties for health information exchanges and health IT developers that are found information blocking. That rule is expected to be finalized in March.
HHS has yet to propose appropriate disincentives on providers, though 21st Century Cures said regulators could fine up to $1 million per information-blocking incident.
ONC plans to update the data on a monthly basis moving forward.