The U.S. Department of Health and Human Services (HHS) recently unveiled a proposed rule which introduces punishments for healthcare providers who infringe upon the Information Blocking Rule (IBR) under the 21st Century Cures Act (“Cures Act”). With the intent to enhance transparency and data exchange, the Cures Act extends the IBR to a wide array of “actors” within the healthcare domain. These include not only healthcare providers but also health information exchanges (HIE), health information networks (HIN), and developers of certified health information technology (Health IT developers). Violations may occur when the aforementioned actors knowingly and intentionally inhibit the access, exchange or use of electronic health information.
This proposed amendment by the HHS could have a significant bearing on the conduct of entities subjected to the IBR. This could spark a review of their compliance protocols to avoid the regulatory penalties introduced by the proposed rule.
Under the proposed punitive measures, healthcare providers who infrally and persistently bar the access or use of electronic health information could face significant disincentives. In their current form, the penalties range from corrective action plans to monetary fines and even program exclusion. However, the exact nature and extent of these disincentives remain ambiguous and the HHS is expected to further clarify the specifics through future rulemaking.
In conclusion, while the proposed rule underscores the U.S. government’s commitment to facilitating electronic data exchange in the healthcare sector, it significantly amplifies the consequences for noncompliance with the IBR. Reflective of the growing emphasis on transparency and interoperability in healthcare, these actions by the HHS could pave the way for increased scrutiny and potential legal actions against noncompliant entities in the future.