On September 17, 2018, the federal Office of the National Coordinator for Health Information Technology (ONC) submitted proposed new rules to the Office of Management and Budget (OMB), entitled, “21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program.” https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201804&RIN=0955-AA01 [View related post].

The 21st Century Cures Act was signed into law in December 2016, and a critical requirement of the Act was to publish regulations that will ultimately set forth the framework for regulatory investigations by the Office of the Inspector General. The new rules set forth provisions that provide guidance on what measures can and can’t be taken to block information sharing.

From a Health IT standpoint, protecting health data and prohibiting information blocking are critical steps in the transformation to a patient centered health care system. What is information blocking?

Information blocking means a practice that:

(A) except as required by law or specified by the Secretary pursuant to rulemaking under paragraph (3), is likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information; and

(B) (i) if conducted by a health information technology developer, exchange, or network, such developer, exchange, or network knows, or should know, that such practice is likely to interfere with, prevent, or materially discourage the access, exchange, or use of electronic health information; or (ii) if conducted by a health care provider, such provider knows that such practice is unreasonable and is likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information. 42 U.S.C. §300jj-52(a)(1).

The ONC states that information blocking ”occurs when a person or entity- typically a health care provider, IT developer, or EHR vendor – knowingly and unreasonably interferes with the exchange and use of electronic health information…” See https://www.healthit.gov/topic/information-blocking. The ONC further cites examples of information blocking that include fees that make data exchange cost prohibitive or organizational policies or contract terms that prevent sharing information with patients or health care providers. Id.

These regulations will be important in defining the practices, parameters and regulatory enforcement framework that will allow the “trusted exchange” of data, while prohibiting practices that inappropriately restrict or inhibit that data exchange, and set forth a regulatory framework if entities do engage in data blocking.

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