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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 Subjects here 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.

While we wait for ONC to publish its final rule on key policy decisions that will shape the information blocking enforcement landscape moving forward, please do not hesitate to contact your regular McDermott lawyer or any one of the authors of this blog post if you have questions or need assistance related to information blocking.




ONC Sends Information Blocking Proposed Rule to OMB

The Office of the National Coordinator for Health Information Technology (ONC) is one step closer to issuing its long-awaited proposed rule to implement various provisions of the 21st Century Cures Act, including proposed regulations distinguishing between prohibited health information blocking among health care providers and health information technology vendors and other permissible restrictions on access to health information. According to its website, the Office of Management and Budget (OMB) received ONC’s proposed rule for review on September 17, 2018. OMB review is one of the final steps in the process before a proposed rule is published in the Federal Register for public comments. OMB did not identify a deadline for completing its review. The agency generally has up to 90 days to complete its review, but can take less time than that.

In addition to defining the scope of prohibited information blocking conduct, the proposed rule is likely to address other issues of interest to health industry stakeholders. According to OMB, the proposed rule “would update the ONC Health IT Certification Program (Program) by implementing certain provisions of the 21st Century Cures Act, including conditions and maintenance of certification requirements for health information technology (IT) developers, the voluntary certification of health IT for use by pediatric healthcare providers, health information network voluntary attestation to the adoption of a trusted exchange framework and common agreement in support of network-to-network exchange, and reasonable and necessary activities that do not constitute information blocking. The rulemaking would also modify the Program through other complementary means to advance health IT certification and interoperability.”

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HHS Finalizes Overhaul of Federal Human Subjects Research Protections

On January 18, 2017, the Department of Health and Human Services (HHS) and 15 other federal agencies issued a final rule overhauling the federal human subjects research regulations known as the “Common Rule.” These are the first revisions to the Common Rule since its original enactment in 1991, and have been in progress since HHS first published an Advanced Notice of Proposed Rulemaking in July 2011. According to the press release accompanying the final rule, HHS made “significant changes” to its most recent proposals (published in September 2015) in response to the 2,100+ public comments they received.

The majority of the Common Rule’s changes and new provisions will go into effect in 2018. We are reviewing the final rule in detail, and a summary of changes and new provisions is forthcoming.




OMB Reviewing Common Rule Overhaul

On January 4, 2017, the Department of Health and Human Services (HHS) submitted a draft final rule to amend the federal human research regulations to the Office of Management and Budget (OMB). These regulations, often referred to as the Common Rule, were originally developed in 1991 and have been adopted by multiple federal departments and agencies. OMB review is the last step before final publication and suggests that HHS is trying to release a final rule before President Obama leaves office on January 20, 2017.

Through its Office for Human Research Protections (OHRP), HHS initially published an Advanced Notice of Proposed Rulemaking in July 2011. The Advanced Notice generated significant controversy and OHRP did not publish a notice of proposed rulemaking (Proposed Rule) for over four years, ultimately doing so on September 8, 2015. The Proposed Rule, like its earlier Advanced Notice counterpart, suggested major changes to the Common Rule, including changes to its overall jurisdictional scope, requirements relating to secondary use of biospecimens and individually identifiable information, and the general research review and oversight process.

Since the Proposed Rule’s publication, OHRP has received significant feedback from both industry and expert advisory groups about the proposed changes and their overall impact. While certain proposed changes have been applauded, the Proposed Rule has also generated considerable concern and uncertainty among stakeholders.

The current status of OMB’s review is pending.




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