CALIFORNIA

Confidentiality of Health Information

• The “Confidentiality of Medical Information Act” requires health care providers, employers, and insurers to obtain written authorization from patients prior to disclosure of identifiable information. The Act regulates both medical information and genetic information. It grants patients access to healthcare information and protects the confidentiality of the information. [Annotated California Civil Code Section 56.10, 56.104, 56.20]
• Patients whose medical information is disclosed in violation of the Act may recovery compensatory or punitive damages [Annotated California Civil Code Section 56.35]
• Medical information is defined as “any individually identifiable information, in electronic or physical form, in possession of or derived from a provider of health care, health care service plan, or contractor regarding a patient’s medical history, mental or physical condition, or treatment. ‘Individually identifiable’ means that the medical information includes or contains any element of personal identifying information sufficient to allow identification of the individual, such as the patient’s name, address, electronic mail address, telephone number, or social security number, or other information that, alone or in combination with other publicly available information, reveals the individual’s identity.” [Annotated California Civil Code, 56.05(f)].
• California enacted the “Human Experimentation: Experimental Subject’s Bill of Rights” [Annotated California Civil Code, 24172] requiring the informed consent of human participants in medical research.

Conditions Imposed on Genetic Testing/Use of Genetic information

Legal restrictions on the use of genetic information and clinical genetic testing by health care service plans. Penalties are imposed for unauthorized or negligent disclosures of results of clinical genetic tests. [Annotated California Civil Code, 56.17]

Permitted Releases of Health Information or Genetic Information for Research

The Confidentiality of Medical Information Act permits disclosures without patient authorization to public agencies, clinical investigators, including investigators conducting epidemiologic studies, health care research organizations, and accredited public or private nonprofit educational or health care institutions for bona fide research purposes. However, no information so disclosed may be redisclosed by the recipient in any way that would disclose the identity of any patient. [Annotated California Civil Code 56.10(c)(7)]

Medical information may not be sold, intentionally shared, or otherwise used for any purpose not necessary to provide health care services to the patient, unless authorized by the patient or specifically permitted by the CMIA. [Annotated California Civil Code 56.10(d)]

Definition of Genetic Test/Genetic Information

“Genetic characteristics” means any scientifically or medically identifiable gene or chromosome, or alteration thereof, that is known to be a cause of a disease or disorder, or that is determined to be associated with a statistically increased risk of development of a disease or disorder, and that is presently not associated with any symptoms of any disease or disorder.

“Test of a person’s genetic characteristics” means a laboratory test which is generally accepted in the scientific and medical communities for the determination of the presence or absence of genetic characteristics.

[Annotated California Civil Code, Section 10147 and Section 102331.1]

“Genetic characteristics” as used in this section means either of the following:

(1) Any scientifically or medically identifiable gene or chromosome, or combination or alteration thereof, that is known to be a cause of a disease or disorder in a person or his or her offspring, or that is determined to be associated with a statistically increased risk of development of a disease or disorder, and that is presently not associated with any symptoms of any disease or disorder. (2) Inherited characteristics that may derive from the individual or family member, that are known to be a cause of a disease or disorder in a person or his or her offspring, or that are determined to be associated with a statistically increased risk of development of a disease or disorder, and that are presently not associated with any symptoms of any disease or disorder.

[Annotated California Civil Code Section 56.17 uses the definition of “Genetic Characteristic” found in the Health and Safety Code Section 1374.7(d)]

State Law Covering Human Research Subjects

California has adopted the Protection of Human Subjects in Medical Experimentation Act. The Act requires informed consent to be obtained from participants in research; however, no independent scientific review is required.

“Experimental subject’s bill of rights,” means a list of the rights of a subject in a medical experiment, written in a language in which the subject is fluent. Except as otherwise provided in Section 24175, this list shall include, but not be limited to the subject’s right to: (a) be informed of the nature and purpose of the experiment. (b) Be given an explanation of the procedures to be followed in the medical experiment, and any drug or device to be utilized. (c) Be given a description of any attendant discomforts and risks reasonably to be expected from the experiment. (d) Be given an explanation of any benefits to the subject reasonably to be expected from the experiment, if applicable. (e) Be given a disclosure of any appropriate alternative procedures, drugs, or devices that might be advantageous to the subject, and their relative risks and benefits. (f) Be informed of the avenues of medical treatment, if any, available to the subject after the experiment if complications should arise. (g) Be given an opportunity to ask any questions concerning the experiment or the procedures involved. (h) Be instructed that consent to participate in the medical experiment may be withdrawn at any time and the subject may discontinue participation in the medical experiment without prejudice. (i) Be given a copy of the signed and dated written consent form as provided for by Section 24173 or 24178. (j) Be given the opportunity to decide to consent or not to consent to a medical experiment without the intervention of any element of force, fraud, deceit, duress, coercion, or undue influence on the subject’s decision.

24175. (a) Except as otherwise provided in this section, no person shall be subjected to any medical experiment unless the informed consent of such person is obtained.

24178. Except for this section and the requirements set forth in Sections 24172 and 24176, this chapter shall not apply to any person who is conducting a medical experiment as an investigator within an institution which holds an assurance with the Department of Health, Education and Welfare pursuant to Part 46 of Title 45 of the Code of Federal Regulations and who obtains informed consent in the method and manner required by such regulations.

[Annotated California Code, Section 24072]