On July 3, the Department of Health and Human Services’ Office of Inspector General (OIG) established a final rule regarding the statutory civil money penalties for information blocking requirements, as part of the 21st Century Cures Act – a law designed to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficientlyFDA.
This rule has been established to standardize the penalties and ensure compliance with the Cures Act, which aims to promote health data interoperability and discourage behaviors contravening information sharing. Detailed in a legal update on JD Supra, the OIG will commence enforcing the information blocking penalties, as outlined in the final rule, starting from September 1.
Information blocking can pose a substantial challenge to the appropriate and efficient sharing of health data. By elucidating the penalties for non-compliance, the OIG provides a layer of deterrent against such practices thereby promoting transparency, efficiency, and improved patient care.
For legal professionals working in healthcare, understanding this final rule and the implications of non-compliance is essential to maintain the transparency and integrity of information sharing in their respective organizations.
The implementation of defined penalties for such contraventions of the law marks a significant stride towards promoting interoperable access, exchange, and use of electronic health information.