As of September 1, 2023, the U.S Office of Inspector General (OIG) at the Department of Health and Human Services (HHS) has been given the green light to start enforcement against Certified Health Information Technology (HIT) developers, health information exchanges (HIEs), and health information networks (HINs) for practices that infringe the information blocking provisions of the 21st Century Cures Act (Cures Act). Quarles & Brady LLP details these developments.
The Cures Act is a significant legislative shift intended to promote the interoperability of health information. Its information blocking provisions are embodied in its intent to prevent organizations from creating undue obstacles to the access, exchange, or use of electronic health information (EHI). Health tech developers, HIEs, and HINs who fail to comply with these provisions risk facing severe penalties from the OIG.
The initiation of enforcement introduces new potential liabilities for those dealing with EHI. Noteworthy is the fact that penalties can reach up to $1 million per violation, thus signaling the critical importance and commitment of the U.S. government to ensuring free and unfettered access to EHI under the Cures Act.
The precise scope of the enforcement, however, remains to be seen, creating an air of uncertainty for those in the health technology sector. As the enforcement date has arrived, close examination of the Act’s requirements, the risk of potential infractions, and the development of robust compliance programs are more important than ever for HIT developers, HIEs, and HINs.