Just two business days before the first of many critical components of the new 21st Century Cures Act Interoperability, Information Blocking, and ONC Health IT Certification Program Final Rule (the “Final Rule”) were set to take effect, the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health IT (ONC) issued an advanced copy of an interim final rule with comment period (the “Interim Final Rule”) extending the compliance dates and timeframes necessary to comply with the Final Rule. In doing so, ONC sought to provide additional flexibility for health care providers and developers of certified health IT in particular, given the sustained and unprecedented strain on the health care system due to the COVID-19 pandemic.
This is the second compliance extension since the ONC announced the Final Rule in March, also due to the pandemic. Now, in addition to extending the compliance dates relating to information blocking, the 2015 Edition Cures Update certification criteria, and the Conditions and Maintenance of Certification requirements, ONC’s Interim Final Rule offers some technical corrections and clarifications of certain points in the Final Rule. To the relief of many regulated actors, for instance, ONC clarifies that the information blocking provisions do not explicitly require regulated actors to purchase or update certified health IT. Instead, regulated actors must leverage their existing health IT, certified or not, in a manner that does not interfere with appropriate requests to access, exchange, or use electronic health information. By contrast, the 2015 Edition Cures Update certification criteria do establish new functional requirements intended to facilitate interoperability and deadlines for when such functionalities must be present for a health IT product to maintain its certification.
ONC considered several factors in determining the appropriate extension length for each requirement, establishing shorter extensions for requirements that do not require the implementation of new technology, such as the information blocking provisions. Other requirements, such as the 2015 Edition Cures Update certification criteria, do require technological updates and, accordingly, received longer extensions.
We have outlined certain key changes to the ONC Final Rule compliance timeline below.
- General Prohibition – Information Blocking: April 5, 2021
- Condition of Certification – Information Blocking: April 5, 2021
- Assurances Condition of Certification – Information Blocking: April 5, 2021
Application Program Interfaces (APIs)
- Condition of Certification – Existing API Technology: April 5, 2021
- New Standard API Certification Criterion: December 31, 2022
- Condition of Certification – New Standardized API: December 31, 2022
- Assurances Condition of Certification – Existing Data Export Certification Criterion: April 5, 2021
- New EHI Export Certification Criterion: December 31, 2023
- Assurances Condition of Certification – New EHI Export Certification Criterion: December 31, 2023