Md. Code Regs. 10.12.05.02

Current through Register Vol. 51, No. 21, October 18, 2024

Section 10.12.05.02 - Requirements for the Department of Health and Mental Hygiene

The Department shall:

A. Provide a standardized written summary in layperson's language that:

(1) Contains the information on breast implantation generally contained in the package inserts for breast implants, and

(2) Discloses side effects, warnings, and cautions for a breast implantation operation;

B. Update as necessary the standardized written summary;

C. Provide a statement indicating acknowledgment of receipt of the standardized written summary to be signed by the patient;

D. Provide a waiver form describing the conditions under which the usual time requirements of the summary distribution may be waived; and

E. Distribute copies of the standardized written summary, the acknowledgment of receipt statement, and the 5-day waiver form to all hospitals, clinics, other facilities, and physicians' offices where breast implantation is performed.

Md. Code Regs. 10.12.05.02