Implementation of the HHS Information Blocking and Interoperability Regulations

The new information blocking and interoperability rules created by the Department of Health and Human Services included in the 21st Century Cures Act became effective starting April 12, 2021. It’s been more than one year since the release of the final rule, and at this point, the advantages of the information blocking and interoperability conditions can already be attained.

The final rule describes information blocking and specifies the penalties for companies that participate in activities that hinder access, sharing, and usage of electronic health information (EHI). The final rule additionally allows patients to enjoy new rights with regards to their healthcare information and permits them to ask for it to be delivered to the application they choose.

The set compliance date was April 5, 2021, then healthcare companies, health information exchanges, and licensed health IT developers need to adhere to the terms of the final rule. Within 18 months starting from April 5, 2021, the information blocking provision is only applicable to a part of EHI specified in the US Core Data for Interoperability (v1). Core EHI consists of immunization records, clinical notes, laboratory test data, prescription drugs, and other EHI. The first 18-months is supposed to assist the regulated community to become accustomed to the information blocking rules prior to the effectivity of the full extent of the regulation’s EHI definition on October 5, 2022. Covered entities and business associates are urged to disclose all EHI when possible, and not limit sharing to the information represented by the USCDI before the final compliance date 18 months after.

According to the final rule, the due date for data sharing was modified from 30 days of receiving the request to “without unnecessary delay.” It is expected to make EHI readily available through the platform of the linked covered entity to enable the download of that information. It is essential for policies and procedures to be evaluated and kept up to date to make sure that EHI is accessible immediately, and not to go on with the 30-day due date, which may now be seen as information blocking.

The final rule likewise offers patients more rights over their healthcare information and calls for covered entities and business associates to give patients their EHI, as requested, to an application he/she chooses. Clinicians can deliver patient health information to these applications without a lot of manual work via safe, standardized application programming interfaces (APIs). Just like the requests from other healthcare companies, it isn’t required to give complete records to patients’ chosen applications for the initial 18 months, just the information represented by the USCDI.

With regards to the HHS HIPAA Right of Access enforcement initiative, there are already 18 penalties imposed by HHS for failing to give patients a copy of their required health records promptly. The HHS may well begin implementing compliance with the prerequisites of the final rule so that patients can get their EHI delivered to a health application with comparable vigor. The HHS Office for the National Coordinator for Health IT (ONC) is going to work with the HHS Office of Inspector General to impose information blocking provisions compliance, even though the final enforcement rule remains pending.