NEW YORK

Confidentiality of Health Information

• HMOs must keep patient information confidential. [McKinney’s Consolidated Laws of New York Annotated 4410]
• Health care providers may disclose patient information to someone other than the subject of the information pursuant to a patient authorization or when otherwise authorized by law. [New York Public Health Law, Section 18(6)]

Conditions Imposed on Genetic Testing/Use of Genetic information

According to the New York law, genetic tests generally cannot be performed on a biological sample taken from an individual without the prior written informed consent of the individual. An informed consent must contain, among other things, the name of the person or categories of persons or organizations to whom the test results may be disclosed. Genetic testing may be performed on specimens from deceased persons if informed consent is provided by the next of kin. The statute defines “biological samples” as “any material part of the human body or of discharge therefrom known to contain DNA, including but not limited to tissue specimens, blood, or urine.”

[McKinney’s Consolidated Laws of New York Annotated, Section 79-l]

Authors’ note: Arkansas and Oklahoma utilize similar statutes that permit the use of excess surgical and diagnostic tissue (and blood) for genetic research or other research studies as long as patient privacy is assured.

Insurers must obtain informed consent prior to performing genetic testing. [McKinney’s Consolidated Laws of New York Annotated, Section 2612].

Permitted Releases of Health Information or Genetic Information for Research

• New York law allows access to information “to qualified researchers.” [McKinney’s Consolidated Laws of New York Annotated, Public Health, Title II, Section 18).
• Disclosure is permitted for medical research purposes, with the approval of an institutional review board and the written informed consent of the subject, samples may be kept for longer than sixty days and utilized for scientific research. [McKinney’s Consolidated Laws of New York Annotated Section 79-l. Confidentiality of records of genetic tests]

Definition of Genetic Test/Genetic Information

“Genetic test” shall mean any laboratory test of human DNA, chromosomes, genes, or gene products to diagnose the presence of a genetic variation linked to a predisposition to a genetic disease or disability in the individual or the individual’s offspring; such term shall also include DNA profile analysis. “Genetic test” shall not be deemed to include any test of blood or other medically prescribed test in routine use that has been or may be hereafter found to be associated with a genetic variation, unless conducted purposely to identify such genetic variation.

[McKinney’s Consolidated Laws of New York Annotated, Section 79-l].

State Law Covering Human Research Subjects

New York state public health statutes include an explicit requirement to obtain informed consent and to review research for studies not otherwise covered by the federal regulations. New York’s law on human subject protection exempts from the definition of human research “biological studies exclusively utilizing tissue or fluids after their removal or withdrawal from a human subject in the course of standard medical practice, or for epidemiological investigations.” By carving out tissue taken exclusively for research purposes, or excess surgical or diagnostic tissue, New York permits the use of tissue samples in research, without the attendant requirements for specific informed consent and review of the research. [McKinney’s Public Health Law 2440]

The New York state human subject legislation addresses tissue research, stating that some tissue research is not considered to be human subject research. [McKinney’s Public Health Law 2441]

“Human research” means any medical experiments, research, or scientific or psychological investigation, which utilizes human subjects and which involves physical or psychological intervention by the researcher upon the body of the subject and which is not required for the purposes of obtaining information for the diagnosis, prevention, or treatment of disease or the assessment of medical condition for the direct benefit of the subject. Human research shall not, however, be construed to mean the conduct of biological studies exclusively utilizing tissue or fluids after their removal or withdrawal from a human subject in the course of standard medical practice, or to include epidemiological investigations. “Fluid” means a normal body excretion or any fluid formed by normal or pathological body processes obtained during diagnostic or therapeutic procedures conducted for the benefit of the human subject. “Tissue” means part or all of any organ of a human subject removed during a diagnostic or therapeutic procedure conducted for the benefit of the human subject. [McKinney’s Public Health Law 2440]