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e-CFR data is current as of February 25, 2021

Title 45Subtitle ASubchapter DPart 171Subpart B → §171.202


Title 45: Public Welfare
PART 171—INFORMATION BLOCKING
Subpart B—Exceptions That Involve Not Fulfilling Requests to Access, Exchange, or Use Electronic Health Information


§171.202   Privacy exception—When will an actor's practice of not fulfilling a request to access, exchange, or use electronic health information in order to protect an individual's privacy not be considered information blocking?

An actor's practice of not fulfilling a request to access, exchange, or use electronic health information in order to protect an individual's privacy will not be considered information blocking when the practice meets all of the requirements of at least one of the sub-exceptions in paragraphs (b) through (e) of this section.

(a) Definitions in this section. (1) The term HIPAA Privacy Rule as used in this section means 45 CFR parts 160 and 164.

(2) The term individual as used in this section means one or more of the following—

(i) An individual as defined by 45 CFR 160.103.

(ii) Any other natural person who is the subject of the electronic health information being accessed, exchanged, or used.

(iii) A person who legally acts on behalf of a person described in paragraph (a)(1) or (2) of this section in making decisions related to health care as a personal representative, in accordance with 45 CFR 164.502(g).

(iv) A person who is a legal representative of and can make health care decisions on behalf of any person described in paragraph (a)(1) or (2) of this section.

(v) An executor, administrator, or other person having authority to act on behalf of a deceased person described in paragraph (a)(1) or (2) of this section or the individual's estate under State or other law.

(b) Sub-exception—precondition not satisfied. To qualify for the exception on the basis that State or Federal law requires one or more preconditions for providing access, exchange, or use of electronic health information that have not been satisfied, the following requirements must be met—

(1) The actor's practice is tailored to the applicable precondition not satisfied, is implemented in a consistent and non-discriminatory manner, and either:

(i) Conforms to the actor's organizational policies and procedures that:

(A) Are in writing;

(B) Specify the criteria to be used by the actor to determine when the precondition would be satisfied and, as applicable, the steps that the actor will take to satisfy the precondition; and

(C) Are implemented by the actor, including by providing training on the policies and procedures; or

(ii) Are documented by the actor, on a case-by-case basis, identifying the criteria used by the actor to determine when the precondition would be satisfied, any criteria that were not met, and the reason why the criteria were not met.

(2) If the precondition relies on the provision of a consent or authorization from an individual and the actor has received a version of such a consent or authorization that does not satisfy all elements of the precondition required under applicable law, the actor must:

(i) Use reasonable efforts within its control to provide the individual with a consent or authorization form that satisfies all required elements of the precondition or provide other reasonable assistance to the individual to satisfy all required elements of the precondition; and

(ii) Not improperly encourage or induce the individual to withhold the consent or authorization.

(3) For purposes of determining whether the actor's privacy policies and procedures and actions satisfy the requirements of paragraphs (b)(1)(i) and (b)(2) above when the actor's operations are subject to multiple laws which have inconsistent preconditions, they shall be deemed to satisfy the requirements of the paragraphs if the actor has adopted uniform privacy policies and procedures to address the more restrictive preconditions.

(c) Sub-exception—health IT developer of certified health IT not covered by HIPAA. If the actor is a health IT developer of certified health IT that is not required to comply with the HIPAA Privacy Rule, when engaging in a practice that promotes the privacy interests of an individual, the actor's organizational privacy policies must have been disclosed to the individuals and entities that use the actor's product or service before they agreed to use them, and must implement the practice according to a process described in the organizational privacy policies. The actor's organizational privacy policies must:

(1) Comply with State and Federal laws, as applicable;

(2) Be tailored to the specific privacy risk or interest being addressed; and

(3) Be implemented in a consistent and non-discriminatory manner.

(d) Sub-exceptiondenial of an individual's request for their electronic health information consistent with 45 CFR 164.524(a)(1) and (2). If an individual requests electronic health information under the right of access provision under 45 CFR 164.524(a)(1) from an actor that must comply with 45 CFR 164.524(a)(1), the actor's practice must be consistent with 45 CFR 164.524(a)(2).

(e) Sub-exception—respecting an individual's request not to share information. Unless otherwise required by law, an actor may elect not to provide access, exchange, or use of an individual's electronic health information if the following requirements are met—

(1) The individual requests that the actor not provide such access, exchange, or use of electronic health information without any improper encouragement or inducement of the request by the actor;

(2) The actor documents the request within a reasonable time period;

(3) The actor's practice is implemented in a consistent and non-discriminatory manner; and

(4) An actor may terminate an individual's request for a restriction to not provide such access, exchange, or use of the individual's electronic health information only if:

(i) The individual agrees to the termination in writing or requests the termination in writing;

(ii) The individual orally agrees to the termination and the oral agreement is documented by the actor; or

(iii) The actor informs the individual that it is terminating its agreement to not provide such access, exchange, or use of the individual's electronic health information except that such termination is:

(A) Not effective to the extent prohibited by applicable Federal or State law; and

(B) Only applicable to electronic health information created or received after the actor has so informed the individual of the termination.

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