MARYLAND

Confidentiality of Health Information

• Patient medical records must be kept confidential. Information may be disclosed only with patient consent. [Annotated Code of Maryland 4-302]
• HMOs must establish a medical records system that assures maximum confidentiality. [Annotated Code of Maryland Code 19-710(n)]

Conditions Imposed on Genetic Testing/Use of Genetic information

• Maryland law restricts the use and disclosure of genetic information by insurers, nonprofit health service plans, and HMOs. An authorization must be obtained for each disclosure and must meet certain statutory requirements. [Annotated Code of Maryland, Section 27-909]
• Discrimination by employers or insurers on the basis of genetic testing is prohibited. [Annotated Code of Maryland, Article 49B and 27-909]

Permitted Releases of Health Information or Genetic Information for Research

• Insurers are permitted to disclose health information for research purposes “to a researcher, on request, for medical and health care research in accordance with a protocol approved by an institutional review board.” [Annotated Code of Maryland 14-138]
• Health care providers are permitted to disclose information without the authorization of the person in interest in numerous situations, including to persons needing the information for educational or research purposes, subject to the applicable requirements of an institutional review board if the person given access to the medical record signs an acknowledgment of the duty under this Act not to redisclose any patient identifying information [Annotated Code of Maryland 4-305].

Definition of Genetic Test/Genetic Information

“Gene product” means the biochemical material, either RNA or protein, made by a gene.

“Genetic information” means information: 1. about chromosomes, genes, gene products, or inherited characteristics that may derive from an individual or a family member; 2. obtained for diagnostic and therapeutic purposes; and 3. obtained at a time when the individual to whom the information relates is asymptomatic for the disease. (ii) “Genetic information” does not include: 1. routine physical measurements; 2. chemical, blood, and urine analyses that are widely accepted and in use in clinical practice; 3. tests for use of drugs; or 4. tests for the presence of the human immunodeficiency virus.

“Genetic services” means health services that are provided to obtain, assess, and interpret genetic information for diagnostic and therapeutic purposes and for genetic education and counseling.

“Genetic test” means a laboratory test of human chromosomes, genes, or gene products that is used to identify the presence or absence of inherited or congenital alterations in genetic material that are associated with disease or illness.

[Annotated Code of Maryland, Section 27-909]

State Law Covering Human Research Subjects

A person may not conduct research using a human subject unless the person conducts the research in accordance with the federal regulations on the protection of human subjects.

[Annotated Code of Maryland, Human Subject Research, Section 13-2002]

Authors’ note: Maryland and Virginia extend the provisions of the Common Rule requiring informed consent from subjects (or waiver), and independent ethical review (by an IRB or other qualified entity), to all human subjects research, regardless of whether the funding source is federal or private. In addition, the Maryland law provides for public access to the minutes of IRB meetings, with confidential information redacted if necessary.