May 9, 2021

Volume XI, Number 129

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Can We Expect to See ONC’s Final Rule on Information Blocking Soon?

A recent update to the Office of Management and Budget (OMB) website suggests that the answer is “yes”—though that depends on how one defines “soon.” According to its website, OMB received the Office of the National Coordinator for Health Information Technology’s (ONC’s) final rule, entitled 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program, for review on October 28, 2019.

Based on the rule title, it appears that ONC is ready to finalize its proposals concerning information blocking and related exceptions. Earlier this year, ONC issued a proposed rule that, among other things, proposed to define information blocking and establish seven exceptions to the broad prohibition for reasonable and necessary activities that should not be considered information blocking. For more information about the information blocking provisions of ONC’s proposed rule, see our On the Subjecthere and here.

OMB review is one of the final steps in the process before a rule is published in the Federal Register. OMB did not identify a deadline for completing its review. The agency generally has up to 90 days to complete its review and while it can take less time, OMB took longer with ONC’s proposed rule.

ONC received more than 2,000 public comments on its proposed rule, many of which related to information blocking topics such as the broad scope of the proposed definitions for certain covered actors—e.g., health information exchanges and health information networks—as well as the scope of the definition of “electronic health information.” Several large industry stakeholders recently wrote a letter to Chairman Lamar Alexander and Ranking Member Patty Murray of the Senate Committee on Health, Education, Labor and Pensions raising concerns about ONC’s rulemaking efforts to date and recommending, among other things, that ONC issue a Supplemental Notice of Proposed Rulemaking (SNPRM) to seek further input from stakeholders on various information-blocking-related issues. While we do not know the ultimate contents of ONC’s final rule, it does not appear that ONC has pursued the SNPRM path to gain additional public input.

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© 2021 McDermott Will & EmeryNational Law Review, Volume IX, Number 303
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About this Author

James A. Cannatti III* practices at the intersection of today's most pertinent health care issues, including digital health, health IT policy, and fraud and abuse, including Anti-Kickback Statute/Stark Law matters. With more than 10 years of experience in the US Department of Health & Human Services’ (HHS) Office of Inspector General (OIG), most recently as Senior Counselor for Health Information Technology, James is well-attuned to the regulatory issues impacting the rapidly evolving digital health landscape, including:

  • Information...

202-756-8866
Daniel F. Gottlieb, Health Care Industry Attorney, McDermott Will Emery Law firm
Partner

Daniel Gottlieb is a partner in the law firm of McDermott Will & Emery LLP and is based in the Firm’s Chicago office.  Daniel represents a wide range of health care industry clients, including health care providers, health information technology vendors, pharmaceutical companies, medical device companies, and health plans.  He has extensive experience in advising clients on compliance with federal and state health care laws as well as representing health care industry clients in mergers, acquisitions, joint ventures, and...

312 984 6471
Karen Sealander, Partner, McDermott Law FIrm
Partner

Karen S. Sealander is a Partner in the law firm of McDermott Will & Emery LLP and is based in the Firm’s Washington, D.C. office.   A member of the Firm’s Government Strategies practice, Karen focuses her practice exclusively in the health sector  Karen has more than two decades of experience representing and counseling health care providers, health insurance plans, integrated health care delivery systems, professional associations of health care providers and others in the health sector on legislative, regulatory and legal matters.  She worked extensively on the Patient Protection and...

202 756 8024
Scott Weinstein, Attorney, Health Law, McDermott Will & Emery Law Firm
Associate

Scott Weinstein is an associate in the law firm of McDermott Will & Emery LLP and is based in the Firm’s Washington, D.C., office.  He focuses his practice on general health matters.

Prior to joining McDermott, Scott served as a Presidential Management Fellow in both the United States Department of Health and Human Services, Office of the National Coordinator for Health Information Technology and the Executive Office of the President, Office of National Drug Control Policy.  In these roles, he focused on issues related to health information privacy and security, electronic...

202-756-8671
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