On Oct. 29, 2020, the United States (U.S.) Department of Health and Human Services (HHS) Office of the National Coordinator for Health IT (ONC) released an anticipated interim final rule with comment period officially delaying the compliance start date for the “information blocking provision” mandated by Section 4004 of the 21st Century Cures Act, among other initiatives. Of note:
- The information blocking compliance timeframe for all actors has been delayed until April 5, 2021, due to the ongoing COVID-19 public health emergency.
- The previously scheduled expansion of the “electronic health information (EHI)” definition has been delayed until Oct. 6, 2022. For the first 18 months of the information blocking provision, the scope of the EHI definition would be limited the U.S. Core Data for Interoperability (USCDI) dataset, which includes the imaging narrative content of clinical notes. After Oct. 6, 2022, it would expand to include any electronic protected health information included in the designated record set per HIPAA access requirements, with certain limitations.
While all actors “are subject to” the information blocking provision (45 CFR Part 171) on and after April 5, 2021, the enforcement component of Cures Section 4004 continues to be incomplete. It is possible that the HHS Office of Inspector General could complete and promulgate its final rule on civil monetary penalties for non-provider-actors before April 5. However, HHS agencies have yet to propose provider-specific disincentives, which are required by the law to be implemented via notice-and-comment rule-making.
For more information, please see the following resources:
- Cures Act Sec. 4004 Information Blocking Implementation Likely Delayed (Oct.1, 2020).
- CMS and ONC Interoperability Rules to be Published May 1 (April 23, 2020).
- ONC and CMS Release Final Rules on Interoperability, Info-Blocking (March 12, 2020).
- ONC Cures Act Website (links to rules).