An actor's practice that is implemented to reduce potential exposure to legal action will not be considered information blocking when the practice satisfies the condition in paragraph (a) of this section and also satisfies the requirements of at least one of the conditions in paragraphs (b) or (c) of this section.

(a) Threshold condition. To satisfy this condition, a practice must meet each of the following requirements:

(1) Belief. The practice is undertaken based on the actor's good faith belief that:

(i) Persons seeking, obtaining, providing, or facilitating reproductive health care are at risk of being potentially exposed to legal action that could arise as a consequence of particular access, exchange, or use of specific electronic health information; and

(ii) Specific practices likely to interfere with such access, exchange, or use of such electronic health information could reduce that risk.

(2) Tailoring. The practice is no broader than necessary to reduce the risk of potential exposure to legal action that the actor in good faith believes could arise from the particular access, exchange, or use of the specific electronic health information.

(3) Implementation. The practice is implemented either consistent with an organizational policy that meets paragraph (a)(3)(i) of this section or pursuant to a case-by-case determination that meets paragraph (a)(3)(ii) of this section.

(i) An organizational policy must:

(A) Be in writing;

(B) Be based on relevant clinical, technical, and other appropriate expertise;

(C) Identify the connection or relationship between the interference with particular access, exchange, or use of specific electronic health information and the risk of potential exposure to legal action that the actor believes the interference could reduce;

(D) Be implemented in a consistent and non-discriminatory manner; and

(E) Conform to the requirements in paragraphs (a)(1) and (2) of this section and to the requirements of at least one of the conditions in paragraphs (b) or (c) of this section that are applicable to the prohibition of the access, exchange, or use of the electronic health information.

(ii) A case-by-case determination:

(A) Is made by the actor in the absence of an organizational policy applicable to the particular situation;

(B) Is based on facts and circumstances known to, or believed in good faith by, the actor at the time of the determination;

(C) Conforms to the conditions in paragraphs (a)(1) and (2) of this section; and

(D) Is documented either before or contemporaneous with engaging in any practice based on the determination. Documentation of the determination must identify the connection or relationship between the interference with particular access, exchange, or use of specific electronic health information and the risk of potential exposure to legal action.

(4) Another actor's reliance on good faith belief. For purposes of this section, an actor who is a business associate of, or otherwise maintains EHI on behalf of, another actor may rely on the good faith belief consistent with paragraph (a)(1) of the section and organizational policy or case-by-case determinations consistent with paragraph (a)(3) of this section of the actor on whose behalf relevant EHI is maintained.

(b) Patient protection condition. When implemented for the purpose of reducing the patient's risk of potential exposure to legal action, the practice must:

(1) Affect only the access, exchange, or use of specific electronic health information the actor in good faith believes could expose the patient to legal action because the electronic health information shows, or would carry a substantial risk of supporting a reasonable inference, that the patient:

(i) Obtained reproductive health care;

(ii) Inquired about or expressed an interest in seeking reproductive health care; or

(iii) Has any health condition(s) or history for which reproductive health care is often sought, obtained, or medically indicated.

(2) Be subject to nullification by an explicit request or directive from the patient that the access, exchange, or use of the specific electronic health information occur despite the risk(s) to the patient that the actor has identified.

(3) For purposes of paragraph (b)(1) and (2) of this section, “patient” means the natural person who is the subject of the electronic health information or another natural person referenced in, or identifiable from, the EHI as a person who has sought or obtained reproductive health care.

(c) Care access condition. When implemented for the purpose of reducing the risk of potential exposure to legal action for one or more licensed health care professionals, other health care providers, or other persons involved in providing or facilitating reproductive health care that is lawful under the circumstances in which such health care is provided, the practice must affect only access, exchange, or use of specific electronic health information that the actor believes could expose a care provider(s) and facilitator(s) to legal action because the information shows, or would carry a substantial risk of supporting a reasonable inference, that they provide or facilitate, or have provided or have facilitated, reproductive health care.

(d) Presumption. For purposes of determining whether an actor's practice meets paragraph (b)(1)(i) or (c) of this section, care provided by someone other than the actor is presumed to have been lawful unless the actor has actual knowledge that the care was not lawful under the circumstances in which such care is provided.

(e) Definition of legal action. As used in this section, legal action means any one or more of the following—

(1) A criminal, civil, or administrative investigation into any person for the mere act of seeking, obtaining, providing, or facilitating reproductive health care;

(2) A civil or criminal action brought in a court to impose liability on any person for the mere act of seeking, obtaining, providing, or facilitating reproductive health care; or

(3) An administrative action or proceeding against any person for the mere act of seeking, obtaining, providing, or facilitating reproductive health care.

[89 FR 102564, Dec. 17, 2024]