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ONC’s New Information Blocking Prohibition Affects Health Care Providers, Health IT Developers, Health Information Exchanges, and Health Information Networks

On March 9, 2020, the Office of the National Coordinator for Health Information Technology (“ONC”) and the Center for Medicare and Medicaid Services (“CMS”) published their long-awaited final rules that seeks to promote interoperability. Market participants waited longer than usual for this rule due to the Department of Health and Human Services (“HHS”) extending the comment period at the request of a variety of stakeholders.

The ONC’s rule (the “Final Rule”) supports interoperability by prohibiting “information blocking”.  Affected organizations (see below) will want to be considering the impact on contracts and developing compliance policies that reflect the requirements of the Final Rule. One aspect of needed compliance relates to the Final Rule’s exceptions to information blocking including a newly-added “content and manner” exception.

Generally, information blocking is defined as an action by an actor interfering with, preventing, or materially discouraging access, exchange, or use of electronic health information[1]  (“EHI”). Actors include health care providers, health IT developers, health information exchanges, or health information network. In the proposed rule, the ONC proposed seven exceptions to conduct that might otherwise be deemed information blocking. However, in the Final Rule, ONC created eight exceptions. Further, the ONC defined two categories of exceptions: (1) Exceptions that involve not fulfilling requests to access, exchange, or use EHI and (2) Exceptions that involve procedures for fulfilling requests to access, exchange, or use EHI. Each of the eight enumerated exceptions are categorized as follows:

Exceptions that involve not fulfilling requests to access, exchange, or use EHI include the following: (1) preventing harm to a patient or another person; (2) protecting an individual’s privacy; (3) protecting the security of EHI; (4) not fulfilling a request due to infeasibility; and (5) to make health IT temporarily unavailable or to scale down the health IT’s performance for the benefit of the overall performance of the health IT. All exceptions include enumerated conditions that must be met in order to qualify for the exception.

Exceptions that involve procedures for fulfilling requests to access, exchange, or use EHI include the following: (6) limiting the content of its response to a request to access, exchange, or use EHI or the manner in which it fulfills a request to access, exchange, or use EHI; (7) charging fees, including fees that result in a reasonable profit margin; and (8) licensing interoperability elements for EHI to be accessed, exchanged, or used. The “content and manner” exception was added as the eighth exception in the Final Rule to accommodate stakeholder comments expressing concern regarding flexibility in the implementation of the information blocking prohibition, as well as comments requesting clarification regarding reasonable alternatives to provide access. As above, all exceptions include enumerated conditions that must be met in order to qualify for the exception.

It is important to note that a failure to fall within an exception does not necessarily mean that a practice constitutes information blocking. Each practice that may violate the information blocking prohibition will be analyzed on a case-by-case basis through investigation by the Office of Inspector General and/or ONC.


[1] EHI is finalized in the final rule to mean electronic protected health information (ePHI) as the term is defined for HIPAA in 45 CFR 160.103. Until 24 months after the publication date of the final rule, EHI for purposes of the information blocking definition is limited to the EHI identified by the data elements represented in the USCDI standard adopted in § 170.213.

©2020 Epstein Becker & Green, P.C. All rights reserved.National Law Review, Volume X, Number 85

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About this Author

Patricia M. Wagner, Epstein becker green, health care, life sciences
Member

PATRICIA M. WAGNER is a Member of the Firm in the Health Care and Life Sciences and Litigation practices, in the firm's Washington, DC, office. In 2014, Ms. Wagner was selected to the Washington DC Super Lawyers list in the area of Health Care.

Ms. Wagner's experience includes the following:

Advising clients on a variety of matters related to federal and state antitrust issues 

Representing clients in antitrust matters in front of the Federal Trade Commission and the United States Department of...

202-861-4182
Ebunola Aniyikaiye, Epstein Becker Law Firm, Washington DC, Health Care Law Attorney
Associate

Ebunola Aniyikaiye is an Associate in the Health Care and Life Sciences practice, in the Washington, DC, office of Epstein Becker Green. She will be focusing her practice on such areas as fraud and abuse, health care legislation and policy developments, value-based purchasing and accountable care, and government investigations. 

Ms. Aniyikaiye received her J.D., with a concentration in Health Law, from American University Washington College of Law (AUWCL), where she was an Articles Editor of the Administrative Law Review and graduated with Exceptional Service Honors for her commitment to pro bono work.

While attending AUWCL, Ms. Aniyikaiye served as a Health Law Clerk for the U.S. Senate Committee on Health, Education, Labor, and Pensions (HELP), in the Office of the Ranking Member. Prior to that, she was a Legal Intern for the Marketplace Appeals Group at the Centers for Medicare & Medicaid Services’ Offices of Hearings and Inquiries and for the Administrative Conference of the United States. Earlier in her legal career, she served as a Judicial Intern for the Honorable Gerald Bruce Lee of the U.S. District Court for the Eastern District of Virginia.

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