Regulation

ONC Announces Additional Flexibilities Around Interoperability Final Regulation Implementation

On Thursday, October 29, the Office of the National Coordinator for Health Information Technology (ONC) published an Interim Final Regulation that extends the applicability date for the information blocking provisions and some compliance dates in the ONC Health IT Certification Program, including dates for certain updated 2015 Edition health IT certification criteria and Conditions and Maintenance of Certification requirements.

This announcement builds on ONC’s enforcement discretion announcement from April 2020 (along with the Centers for Medicare & Medicaid Services), and enables our health care system to focus on addressing the COVID-19 Public Health Emergency (PHE), while still maintaining a trajectory that will advance patients’ access to their health information. Today’s announcement from ONC can be divided up into three pieces: information blocking, certification, and enforcement.

Information Blocking Provisions

The applicability of most of the Final Regulation’s information blocking provisions are extended to April 5, 2021. ONC is striving to balance its commitment to advance interoperability and support the access, exchange, and use of electronic health information (EHI) through implementation and enforcement of the information blocking provisions with the work underway to address COVID-19. In addition, ONC observes that the information blocking provisions (unlike some of the 2015 Edition Cures Update certification criteria) do not explicitly require regulated actors (health care providers, health IT developers of certified health IT, health information exchanges, and health information networks) to purchase or update certified health IT, so ONC has less of a concern about technology resource allocations in the near term.

ONC also highlighted that it established the six-month-delayed applicability date to provide regulated actors with additional time to thoroughly read and understand the final rule and educate their workforces in order to apply the exceptions in an appropriate manner. It is important to note that the EHI definition includes only the EHI identified by the data elements represented in the United States Core Data for Interoperability (USCDI) for the first 18 months after the applicability date. Therefore, for the 18-month period on and after the April 5, 2021, and before October 6, 2022, the EHI required for the information blocking provisions will be limited to the data represented in USCDI. As a result, actors will have additional time to gain experience applying the exceptions with the narrower definition of EHI, as compared to the full scope of EHI, which will apply on October 6, 2022.

Certification-Related Requirements

ONC is also extending the required compliance date for health IT developers of certified health IT to comply with the Information Blocking Condition of Certification requirement and the Assurances Condition of Certification requirement to April 5, 2021.

In addition, the compliance date for the 2015 Edition Cures Update certification criteria is extended until December 31, 2022. The updated certification criteria require health IT developers to upgrade their current technology in order to maintain or earn their certified status. ONC is cognizant that certified health IT serves an important public good that is relied upon by hospitals, patients, and public health networks. If ONC did not grant an appropriate extension for developers to comply with the 2015 Edition Cures Update, some health IT developers may decide not to seek re-certification, or forego certification altogether.

In terms of application programming interfaces (APIs), ONC is extending to April 5, 2021, compliance with its requirements for when Certified API Developers with Health IT Module(s) must comply with API Condition of Certification requirements. ONC previously stated in its Final Regulation that Certified API Developers must provide their API technology to all API Information Sources that meet the certification requirements by May 1, 2022. In this announcement, ONC extends the compliance timeline for that rollout of the new standardized API functionality to December 31, 2022.

ONC is also seeking to ensure that when establishing policies for health IT developers that may also affect healthcare providers participating in CMS programs, its certification timelines complement the schedules inherent in the CMS programs. In the interest of clarity and cohesion among HHS components, ONC aligned some of its compliance dates to the calendar year for instances that may impact CMS program participants.

Enforcement of Information Blocking Provisions

It is also important to emphasize that the community is waiting for a couple of additional regulatory measures that provide a more complete enforcement picture around ONC’s Final Regulation. The Department of Health and Human Services Office of Inspector General (OIG) has noted that enforcement of information blocking civil monetary penalties for health IT developers of certified health IT, health information exchanges, and health information networks would not begin until 60 days after it issues a final rule, which has not occurred.

For healthcare providers subject to information blocking provisions, any provider determined to have committed information blocking would, per the 21st Century Cures Act, be referred to federal agencies to be subject to “appropriate disincentives”—a proposed regulation, with a comment period, is currently pending with further clarification on this piece.

Facts sheets and additional resources from ONC on today’s announcement are available here.

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