Dec 29, 2020

ONC Extends Deadlines for Applicability of Information Blocking Rules

By Divya Srivastav-Seth, Esq.

Due to the ongoing pandemic, the Office of the National Coordinator for Health Information Technology (“ONC”) has issued an interim final rule and extended the deadline for applicability of its earlier final rule related to electronic health information blocking from November 2, 2020 until April 5, 2021. See 85 Fed. Reg. 70,064 (Nov. 4, 2020). The ONC’s Final Rule, 85 Fed. Reg. 25,642, May 1, 2020, (“Final Rule”), implemented the 21st Century Cures Act’s, Public Law No:114-255 (December 13, 2016), prohibition against information blocking which broadly includes any practice of a covered actor i.e. a health care provider, health IT developer of certified health IT, health information network or health information exchange, that is known or could be reasonably understood to likely interfere with the access, exchange, or use of electronic health information (“EHI”) unless required by law or covered by an ONC regulatory exception.

ONC has included regulatory exceptions in the Final Rule for reasonable and necessary activities that subject to certain conditions will not constitute information blocking. These exceptions include practices that are reasonable and necessary to prevent harm, protect privacy and security of EHI, involve the inability of an actor to fulfill a request due to infeasibility or the temporary unavailability of EHI access. Other exceptions include procedures involving limitations as to content and manner or charging of fees or license requirements. The content and manner exception would allow the definition of EHI to be narrower in scope for the eighteen months after the applicability of the Final Rule so that actors could respond with a minimum of EHI identified by the data elements represented in the United States Core Data for Interoperability (“USCDI”) standard. After these eighteen months expired, the EHI would revert to the broader definition found in the rule which references the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations (“HIPAA”) Privacy Rule (45 CFR §160.103) subject to exceptions for psychotherapy notes or information compiled in reasonable anticipation of, or for use in, a civil, criminal, or administrative action or proceeding), regardless of whether the group of records are used or maintained by or for a covered entity as defined under HIPAA. The interim final rule extends this use of the USCDI standard to October 6, 2022.

A practice that does not meet the conditions of an exception would not automatically constitute information blocking and would be evaluated on a case-by-case basis to determine whether information blocking has occurred. The Office of the Inspector General has issued a proposed rule regarding the applicability of the civil monetary penalty framework for violations of the information blocking rules but these rules have not become final yet and further rulemaking is anticipated.

For more information, contact Divya Srivastav-Seth, Esq. at dss@spsk.com or (973) 631-7855.