HHS Information Blocking and Interoperability Regulations Now Effective

The Department of Health and Human Services created the new information blocking and interoperability rules which were included in the 21st Century Cures Act. It took effect on April 12, 2021 and so people can now enjoy the benefits of the information blocking and interoperability conditions.

The final rule defines information blocking and prescribes the penalties for firms that take part in activities that restrict access, disclosure, and use of electronic health information (EHI). The final rule also makes it possible for patients to enjoy the privileges of accessing their healthcare data and allows them to request its delivery to the application they decide on.

The fixed effective date was April 5, 2021. Healthcare organizations, health information exchanges, and certified health IT creators must comply with the conditions of the final rule. In a period of 18 months beginning April 5, 2021, the information blocking provision is simply applied to a section of EHI described in the US Core Data for Interoperability (v1). Core EHI is made up of immunization information, clinical records, lab test results, prescription medications, and other EHI. The initial 18-months are expected to help the regulated community to be acquainted with the information blocking rules before the implementation of the entire scope of the regulation’s EHI definition come October 5, 2022. As much as possible, covered entities and business associates are advised to share all EHI, and not only the data made available by the USCDI prior to the final compliance day after 18 months.

The final rule now requires the sharing of data “without unnecessary delay” instead of within 30 days from receiving the request. The provider must make the EHI quickly available through the platform the covered entity chooses to download the information. It is important for guidelines and procedures to be re-evaluated and kept updated to ensure that EHI is available right away, and not within 30-days as this may now be considered as information blocking.

The final rule similarly gives patients a lot more privileges when it comes to their healthcare data. It requires covered entities and business associates to provide patients their EHI, as needed, through a program he/she chooses. Clinicians will be able to deliver the patient health data to these applications without needing manual work using secure, standardized application programming interfaces (APIs). Just as when healthcare companies address the requests, it isn’t necessary to provide the entire records to patients’ preferred platform for the first 18 months, only the data listed by the USCDI.

In terms of the HHS HIPAA Right of Access enforcement initiative, the HHD already imposed 18 penalties on entities that failed to provide the patients’ copy promptly. The HHS could start implementing compliance with the requirements of the final rule in order for patients to obtain their EHI sent to a health program with comparable energy. The HHS Office for the National Coordinator for Health IT (ONC) will work together with the HHS Office of Inspector General to enforce compliance with the information blocking provisions, though the final enforcement rule is still imminent.