Definition of information blocking, from the 21st Century Cures Act – H.R. 6, 114th Congress, 1st Session (see related post on interoperability).

Title II, Subtitle A, Section 3010A, subsec. (d):

‘‘(d) INFORMATION BLOCKING.—

‘‘(1) IN GENERAL.—For purposes of this section and section 3010, subject to paragraph (3), the term ‘information blocking’ means, with respect to the access, use, and exchange of qualified electronic health records and other health information technology, business, technical, and organizational practices, including practices described in paragraph (2), that—

‘‘(A) prevent or materially discourage the access, exchange, or use of electronic health information; and

‘‘(B) the actor knows or should know (as defined in section 1128A(i)(7) of the Social Security Act) are likely to interfere with the access, exchange, or use of electronic health information.

‘‘(2) PRACTICES DESCRIBED.—For purposes of paragraph (1), the practices described in this paragraph shall include the following:

‘‘(A) Contract terms, policies, or business or organizational practices that restrict authorized use under applicable State or Federal law of electronic health information or restrict the authorized exchange under applicable State or Federal law of such information for treatment and other permitted purposes under such applicable law, including transitions between certified EHR technologies.

‘‘(B) Charging unreasonable prices or fees (such as for health information exchange, portability, interfaces, and full export of health information) that make accessing, exchanging, or using electronic health information cost prohibitive.

‘‘(C) Developing or implementing health information technology in nonstandard ways that are likely to substantially increase the costs, complexity, or burden of sharing electronic health information, especially in cases in which relevant interoperability standards or methods to measure interoperability have been adopted by the Secretary.

‘‘(D) Developing or implementing health information technology in ways that are likely to lock in users or electronic health information such as not allowing for the full export of health information; lead to fraud, waste, or abuse; or impede innovations and advancements in health information access, exchange, and use, including health information technology-enabled care delivery.

‘‘(3) EXCEPTIONS.—

‘‘(A) IN GENERAL.—The term ‘information blocking’ shall not include practices that-

‘‘(i) are required by applicable law; or

‘‘(ii) that the Secretary, through regulation, identifies as necessary to protect patient safety, to maintain the privacy or security of individuals’ health information, or to promote competition and consumer welfare.

‘‘(B) PROCESS.—For purposes of subparagraph (A)(ii), not later than 12 months after the date of the enactment of this section, the Secretary shall issue regulations following the notice and comment procedures of section 553 of title 5, United States Code, except that the Secretary may issue the first such regulation as an interim final regulation.

‘‘(C) NO ENFORCEMENT BEFORE EXCEPTIONS IDENTIFIED.—The term ‘information blocking’ shall not include any practice or conduct occurring before the date that is 30 days after the date on which the first regulation (as described in subparagraph (B)) is issued under such subparagraph.

‘‘(D) CONSULTATION.—To the extent that regulations issued under this paragraph define practices that are necessary to promote competition and consumer welfare, the Secretary may consult with the Federal Trade Commission in issuing such regulations.

‘‘(E) APPLICATION.—The term ‘information blocking’, with respect to an individual or entity, shall not include an act or practice other than an act or practice committed by such individual or entity.

Leave a comment

Your email address will not be published. Required fields are marked *