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Office of the National Coordinator for Health IT Extends Compliance Deadlines under Interoperability Final Rule

In an effort to provide additional relief to a health care system strained by the COVID-19 pandemic, the Office of the National Coordinator for Health IT (“ONC”) released an Interim Final Rule with Comment Period (“IFC”) on October 29, 2020 that extends the compliance dates under the 21st Century Cures Act Interoperability, Information Blocking, and ONC Health IT Certification Program Final Rule (the “Final Rule”) and offers some technical corrections and clarifications.

https-www-sheppardhealthlaw-com-wp-content-uploads-sites-25-2020-11-new-applicability-and-compliance-dates-1-pngOf particular interest to health care providers, health IT developers and health information networks and exchanges, the IFC extends for five months (from November 2, 2020 to April 5, 2020) the deadline to comply with the Final Rule’s information blocking provisions. The Final Rule also extends the compliance timeframes to meet the updated 2015 Edition Health IT certification criteria, and the Conditions and Maintenance of Certification requirements under ONC’s Health IT Certification Program.

ONC first responded to concerns about the COVID-19 pandemic in April 2020 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. Unlike ONC’s prior enforcement discretion, the IFC codifies new compliance dates in federal regulations.

ONC clarified in the IFC that it “ is not removing the requirements advancing patient access to their health information that are outlined in the Final Rule”  Rather, it is “providing additional time to allow everyone in the health care ecosystem to focus on COVID-19 response.”

Actors that are subject to the Information Blocking and other requirements under the 21st Century Cures Act, including health care providers, IT developers and health information exchanges / health information networks, should view this extension as a boon.  Many actors have scrambled to get into compliance by the former November 2nd deadline but still had gaps in their programs and efforts.  If actors move quickly now, they will be able to further build out and cement their compliance before the April 5, 2020 dates and significantly reduce their compliance risk.

Here is a summary of the new Final Rule compliance timeline.

This article is not an unequivocal statement of the law, but instead represents our best interpretation of where things currently stand.  This article does not address the potential impacts of the numerous other local, state and federal orders that have been issued in response to the COVID-19 pandemic, but which are not referenced in this article.

Copyright © 2021, Sheppard Mullin Richter & Hampton LLP.National Law Review, Volume X, Number 311
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About this Author

Associate

Vinay Bhupathy’s health care practice bridges the gap between regulatory and transaction law and he represents all manner of healthcare entities from providers such as hospitals and physician groups to payors and health information technology companies. 

310.228.3735
Associate

Susan Ingargiola is an associate in the Corporate Practice Group in the firm's New York office.

Areas of Practice

Susan advises healthcare organizations, including hospitals, health systems, insurers, community health centers, health information exchange organizations, pharmaceutical and biotechnology companies, and mobile app developers on health information privacy issues, including compliance with HIPAA and state medical record confidentiality laws, as well as other compliance- related matters. She conducts regulatory diligence in connection with...

212-896-0624
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