Cal. Code Regs. tit. 22 § 126055

Current through Register 2024 Notice Reg. No. 52, December 27, 2024

Section 126055 - Informing Requirements; Affirmative Consent; Revocation of Consent

(a) Informing Requirements

(1) Prior to requesting consent from an individual or the individual's legally authorized personal representative to permit the electronic exchange of health information among separate, unaffiliated entities, Demonstration Project Participant shall provide notice to the individual or the individual's legally authorized personal representative, which at a minimum shall contain statements describing:

(A) Electronic exchange of health information.

(B) Uses of IHI, which may incorporate the Demonstration Project Participant's Notice of Privacy Practices created in accordance with 45 C.F.R. § 164.520, if appropriate.

(C) Benefits and risks associated with disclosing IHI through a HIO or independent directed exchange, including the exchange of sensitive health information, such as HIV status, mental health records, reproductive health records, drug and alcohol treatment records, and genetic information which could be inferred or embedded in information that is made available through a HIO or independent directed exchange.

(D) Consent requirements.

(E) Specific exceptions to the consent requirements for electronic exchange of health information for mandated public health reporting and for transmitting mandated HIPAA transactions and code sets.

(F) Specific exceptions to the consent requirements in emergency situations.

(G) Process for revoking consent, including a contact name, phone number, email address, and website.

(H) When the revocation of consent is effective.

(b) Affirmative Consent

(1) Before an individual's individual health information is electronically disclosed through a HIO or independent directed exchange, Demonstration Project Participant shall obtain written affirmative consent documenting the individual's or the individual's legally authorized personal representative's choice to electronically disclose the individual's individual health information or verify the individual's consent in a centralized consent registry.

(2) Obtaining affirmative consent documenting the individual's or the individual's legally authorized personal representative's choice to electronically exchange their individual health information under this regulation does not necessarily relieve the Demonstration Project Participant from obtaining other legally required authorizations to disclose health information if other laws impose additional or different requirements that are not satisfied in the consent obtained pursuant to this regulation.

(3) Emergency situations

(A) A Demonstration Project Participant may disclose to a CMIA provider an individuals' health information through a HIO or independent directed exchange when:

i. The individual requires emergent care;

ii. The individual or the individual's legally authorized personal representative is incapable of consenting;

iii. The individual or the individual's legally authorized personal representative has not explicitly denied or withdrawn consent on a previous occasion; and

iv. It is in the best interest of the individual, as determined by the treating health care provider.

(4) Mandated public health reporting. Affirmative consent is not required for mandated public health reporting disclosures.

(5) Mandated HIPAA transactions and code sets. Affirmative consent is not required for mandated HIPAA transactions and code sets.

(c) Revocation of consent

(1) An individual or the individual's legally authorized personal representative may revoke their previously granted consent to the electronic exchange of health information among separate, unaffiliated entities by contacting the designated contact person or Demonstration Project Participant as described in the informing requirements in section (a).

(2) After the effective date of the revocation of consent, the Demonstration Project Participant shall not allow the individual's health information to be disclosed through a HIO or independent directed exchange unless and until the individual or the individual's legally authorized personal representative reinstates consent.

(d) An individual may re-establish consent at any time by providing written affirmative consent to the Demonstration Project Participant.

Cal. Code Regs. Tit. 22, § 126055

1. New section filed 1-31-2012; operative 1-31-2012. Exempt from the rulemaking requirements of the Administrative Procedure Act and submitted to OAL for printing only pursuant to Health and Safety Code section 130278 (Register 2012, No. 5).

Note: Authority cited: Sections 130277 and 130278, Health and Safety Code. Reference: Sections 130200, 130277 and 130279, Health and Safety Code.