Responding to public health threats posed by the coronavirus pandemic, today the U.S. Department of Health and Human Services’ (HHS) Office of the National Coordinator for Health IT (ONC) released an interim final rule with comment period that extends the compliance dates and timeframes necessary to meet certain requirements related to information blocking and Conditions and Maintenance of Certification (CoC/MoC) requirements.
Released to the public on March 9, 2020, ONC’s Cures Act Final Rule established exceptions to the 21st Century Cures Act’s information blocking provision and adopted new health information technology (health IT) certification requirements to enhance patients’ smartphone access to their health information at no cost through the use of application programming interfaces (APIs).
“We are hearing that while there is strong support for advancing patient access and clinician coordination through the provisions in the final rule, stakeholders also must manage the needs being experienced during the current pandemic,” said Don Rucker, MD, national coordinator for health IT. “To be clear, ONC is not removing the requirements advancing patient access to their health information that are outlined in the Cures Act Final Rule. Rather, we are providing additional time to allow everyone in the health care ecosystem to focus on COVID-19 response.”
In the Cures Act Final Rule, ONC set compliance dates and timeframes to meet certain requirements related to the information blocking and Conditions and Maintenance of Certification (CoC/MoC) requirements. In April 2020, ONC first responded to health IT stakeholders’ concerns about the COVID-19 pandemic by exercising its enforcement discretion and providing three months after each initial date or timeline for all new requirements under the ONC Health IT Certification Program (Program).
The interim final rule issued today provides the health care ecosystem additional flexibility and time to effectively respond to the public health threats posed by the spread of COVID-19. It extends the Program compliance dates beyond those identified in the April 21, 2020, enforcement discretion announcement and establishes new future applicability dates for information blocking provisions. The interim final rule also adopts updated standards and makes technical corrections and clarifications to the ONC Cures Act Final Rule.
|New Applicability and Compliance Dates/Timeframes & Corresponding Provisions|
|April 5, 2021||December 31, 2022||One Calendar Year Extension|
- Information blocking provisions (45 CFR Part 171)
- Information Blocking CoC/MoC requirements (§ 170.401)
- Assurances CoC/MoC requirements (§ 170.402, except for § 170.402(b)(2) as it relates to § 170.315(b)(10))
- API CoC/MoC requirement (§ 170.404(b)(4)) - compliance for current API criteria
- Communications CoC/MoC requirements (§ 170.403) (except for § 170.403(b)(1) – where we removed the notice requirement for 2020)
- 2015 Edition health IT certification criteria updates (except for § 170.315(b)(10) – EHI export, which is extended until December 31, 2023)
- New standardized API functionality (§ 170.315(g)(10))
- Submission of initial attestations (§ 170.406)
- Submission of initial plans and results of real world testing (§ 170.405(b)(1) and (2))