TITLE 25.HEALTH SERVICES

Part 7. TEXAS MEDICAL DISCLOSURE PANEL

Chapter 601. INFORMED CONSENT

25 TAC §601.2

The Texas Medical Disclosure Panel (panel) adopts an amendment to §601.2, concerning informed consent of the treatments and procedures requiring disclosure by a physician or health care provider to a patient or person authorized to consent for the patient without changes to the proposed text as published in the December 19, 2003, issue of the Texas Register (28 TexReg 11232), and therefore the section will not be republished. The section covers procedures requiring full disclosure - list A.

The Texas Civil Practice and Remedies Code, §74.102, requires the panel to determine which risks and hazards related to medical care and surgical procedures must be disclosed by health care providers or physicians to their patients or persons authorized to consent for their patients and to establish the general form and substance of such disclosure.

The amendment is adopted based upon the panel's review of House Bill (HB) 15, 78th Legislature, 2003, concerning the regulation of abortion, specifically, informed consent and the particular medical risks associated with the particular abortion procedure to be employed. The amendment to §601.2 includes the addition of clarifying and new language to the subsection concerning female genital system treatments and procedures. Risks are identified for dilation and curettage of uterus (diagnostic/therapeutic); surgical abortion/dilation and curettage/dilation and evacuation; and medical abortion/non-surgical procedures.

The following comments were received concerning the proposed section. Following each comment is the department's response and any resulting change(s).

Comment: Concerning §601.2(g)(13), several commenters requested that two additional items, breast cancer and pre-term birth, be listed as medical risks of surgical abortion. The commenters recommended that the additional items should be listed as new subparagraphs in §601.2(g)(13)(G) and (H).

Response: The panel disagrees that conclusive evidence exists to link surgical abortion to breast cancer and pre-term birth. No change was made as a result of this comment.

Comment: Concerning §601.2(g)(13), one commenter requested that adverse psychological consequences, damage, and injury be listed as a medical risk of surgical abortion. The commenter recommended that the additional item should be listed as a new subparagraph in §601.2(g)(13)(I).

Response: The panel disagrees that conclusive evidence exists to link surgical abortion to adverse psychological consequences, damage, and injury. No change was made as a result of this comment.

The commenters were Grace House Pregnancy Assistance Center, The Justice Foundation, Living the Redeemed Life Ministries, Inc., Reduce Preterm Risk Coalition, Pregnancy Care Center, and individuals. Commenters were neither for nor against the rules in their entirety, however, they expressed concerns and suggested changes as discussed in the summary of comments.

The amendment is adopted under the Texas Civil Practice and Remedies Code, §74.102, which provides the Texas Medical Disclosure Panel with the authority to prepare lists of medical treatments and surgical procedures that do and do not require disclosure by physicians and health care providers of the possible risks and hazards and to prepare the form(s) for the treatments and procedures which do require disclosure.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on February 27, 2004.

TRD-200401610

Melba W.G. Swafford, M.D.

Chairperson

Texas Medical Disclosure Panel

Effective date: March 18, 2004

Proposal publication date: December 19, 2003

For further information, please call: (512) 458-7236