Bill Text: NY S00168 | 2017-2018 | General Assembly | Introduced
Bill Title: Establishes requirements for informed consent to the provision of medical procedures by the patient or his or her legally authorized representative.
Spectrum: Partisan Bill (Democrat 1-0)
Status: (Introduced - Dead) 2018-01-03 - REFERRED TO HEALTH [S00168 Detail]
Download: New_York-2017-S00168-Introduced.html
STATE OF NEW YORK ________________________________________________________________________ 168 2017-2018 Regular Sessions IN SENATE (Prefiled) January 4, 2017 ___________ Introduced by Sen. RIVERA -- read twice and ordered printed, and when printed to be committed to the Committee on Health AN ACT to amend the public health law, in relation to the provision of informed consent, by patients or their representatives, to medical and surgical procedures; and to repeal certain provisions of such law relating thereto The People of the State of New York, represented in Senate and Assem- bly, do enact as follows: 1 Section 1. The public health law is amended by adding a new article 17 2 to read as follows: 3 ARTICLE 17 4 INFORMED CONSENT 5 Section 1700. Definitions. 6 1701. Notice of right to informed consent. 7 1702. Duty to obtain informed consent. 8 1703. Procedures and surgery requiring informed consent. 9 1704. Surgery; informed consent not required. 10 1705. Capacity to provide informed consent. 11 1706. Scope of informed consent. 12 1707. Patient involvement in their care. 13 § 1700. Definitions. As used in this article: 14 1. "Emergency" means a circumstance in which a patient's condition is 15 such that a failure to provide hospitalization, medical treatment and/or 16 surgery to a patient would result in undue suffering, death or substan- 17 tial impairment of physical or mental function. 18 2. "Informed consent" means the legally effective knowing consent of a 19 patient or his or her legally authorized representative, so situated as 20 to be able to exercise free power of choice without undue inducement or 21 any element of force, fraud, deceit, duress or other form of constraint EXPLANATION--Matter in italics (underscored) is new; matter in brackets [] is old law to be omitted. LBD02113-01-7S. 168 2 1 or coercion. With regard to consent to a medical procedure or surgery, 2 the elements of information necessary for consent include: 3 (a) a fair and understandable explanation to the patient or his or her 4 legally authorized representative of the procedures to be followed and 5 their purposes, including identification of any procedures which are 6 experimental; 7 (b) a description of any attendant pain, discomfort and material risks 8 possible and those that are reasonably expected; 9 (c) a description of any benefits reasonably to be expected; 10 (d) a disclosure of any appropriate alternative procedures that may be 11 advantageous to the patient; 12 (e) a disclosure of the risks, benefits, pain and discomfort of 13 election to refuse any procedure; 14 (f) an offer to answer any inquiries by the patient or his or her 15 legally authorized representative concerning any and all information 16 provided pursuant to this subdivision; 17 (g) a comprehensive inquiry by the health care provider to ensure that 18 the patient or his or her legally authorized representative has suffi- 19 cient understanding of the information provided pursuant to this subdi- 20 vision so as to understand the medical procedures and/or surgery that 21 the patient will undergo; and 22 (h) an instruction that the patient or his or her legally authorized 23 representative is free to withdraw his or her consent and discontinue a 24 medical procedure or surgery at any time. 25 3. "Invasive procedure" means a medical procedure involving a skin 26 incision or puncture, or insertion of an instrument or foreign material 27 into the body. 28 4. "Material risk" means a risk that a health care provider knows 29 would be regarded as significant by a reasonable person in the patient's 30 position when deciding to accept or refuse the recommended medical 31 procedure or surgery. 32 5. "Surgery" means a medical procedure performed to structurally alter 33 the human body by the incision or destruction of human tissue; or for 34 diagnostic or therapeutic treatment of conditions or disease processes 35 by any instruments causing localized alteration or transposition of live 36 human tissue. 37 6. "Unexpected complication" means an emergency in which care is imme- 38 diately necessary and presents an imminently life threatening risk to 39 the patient or to prevent a substantial impairment of physical or mental 40 function, which care exceeds that which was agreed to in an informed 41 consent. 42 § 1701. Notice of right to informed consent. Every health care provid- 43 er and health care facility which performs medical procedures or 44 surgery, shall, at the site on which such procedures or surgery is 45 performed, conspicuously post the following notice: 46 "Every patient has the right to be informed of any surgical or medical 47 procedure to be performed upon them, and shall have the right to consent 48 to or refuse such procedure. To assure informed decision making and 49 consent, patients or their legally authorized representatives must have 50 information on the patient's medical status, diagnosis and prognosis. 51 Informed consent is required to be documented prior to proceeding with 52 any medical or surgical procedure." 53 § 1702. Duty to obtain informed consent. It shall be the duty of the 54 health care provider who orders or performs any medical procedure or 55 surgery to obtain, in writing, the informed consent of the patient or 56 his or her legally authorized representative. The obtaining of suchS. 168 3 1 consent shall include the provision and discussion of all information 2 necessary for such consent, and the documentation in the patient's 3 medical record that all requirements for informed consent have been 4 complied with. No medical procedure or surgery shall be performed with- 5 out informed consent, and the health care provider who ordered such 6 procedure or surgery shall be solely responsible for ensuring informed 7 consent is obtained. 8 § 1703. Procedures and surgery requiring informed consent. The follow- 9 ing medical procedures shall require the obtaining of informed consent 10 prior to the performance thereof: 11 1. all surgery, except simple laceration repairs and dermatological 12 procedures performed on an outpatient basis; 13 2. experimental procedures or treatments; 14 3. administration of blood or blood products; 15 4. electroconvulsive therapy; 16 5. administration of neuroleptic medication for treatment of a mental 17 illness or a developmental disability; 18 6. any medical treatment necessary to preserve the life or health of a 19 person committed to a facility pursuant to the mental hygiene law; 20 7. radiation therapy; 21 8. invasive medical imaging; 22 9. procedures involving moderate to deep sedation where there is a 23 risk of the loss of protective reflexes; 24 10. invasive procedures; 25 11. circumcision; and 26 12. sterilization. 27 § 1704. Surgery; informed consent not required. 1. In the event that 28 an emergency makes it impossible or impractical to obtain informed 29 consent without jeopardizing the life or health of a patient, medical 30 treatment may be provided to preserve the life or health of such patient 31 without informed consent. In each such instance, the health care provid- 32 er providing such treatment shall document, in the patient's medical 33 record, the facts which establish that such situation was an emergency. 34 Such treatment may continue until the patient or his or her legally 35 authorized representative is able to provide informed consent. The 36 provisions of this subdivision shall not apply to any patient who has 37 previously made known in a document filed with his or her health care 38 provider that he or she does not wish to receive such emergency treat- 39 ment under the circumstances which exist. 40 2. In the event a medical complication arises in the course of a 41 medical procedure or surgery, a health care provider may provide such 42 treatment as is necessary to preserve the patient's life without 43 informed consent. 44 3. The provisions of this article shall not apply to any medical 45 procedure or surgery ordered by a court of competent jurisdiction. A 46 copy of such court order shall be included in the patient's medical 47 record. 48 § 1705. Capacity to provide informed consent. Absent a court finding 49 or legal documentation providing to the contrary, every person who is 50 eighteen years of age or older shall be deemed to be competent to 51 provide informed consent. Absent the designation of a legally authorized 52 representative, only such person may grant informed consent. Except as 53 otherwise provided in statutory or case law, unemancipated persons under 54 the age of eighteen years shall not be authorized to grant informed 55 consent, and such consent may only be provided by the minor's parent or 56 legal guardian.S. 168 4 1 § 1706. Scope of informed consent. 1. The following shall be addressed 2 prior to the provision of informed consent to a medical procedure or 3 surgery: 4 (a) a description of the proposed medical procedure or surgery, 5 including any anesthesia proposed to be administered; 6 (b) the indications for the proposed medical procedure or surgery; 7 (c) material risks and benefits to the patient from the proposed 8 procedure or surgery; 9 (d) treatment alternatives, and the risks and benefits thereof; 10 (e) consequences for declining the proposed or alternative treatments; 11 (f) designate the health care providers who will be engaged in the 12 provision of the medical procedure or surgery to the patient, and the 13 qualifications of such health care providers; and 14 (g) an ample opportunity for the patient or his or her legally author- 15 ized representative to ask questions and have such questions clearly and 16 fully answered relating to the proposed treatment of the patient. 17 2. Each informed consent shall be confined to those medical procedures 18 and surgeries that were discussed by the health care provider and the 19 patient or his or her legally authorized representative. Every informed 20 consent shall state the subjects discussed and the procedures and 21 surgeries that were agreed to. An informed consent may be rescinded at 22 any time prior to the performance of the medical procedure or surgery. 23 3. Every executed informed consent shall be included in the medical 24 record of the patient to whom it relates and shall include: 25 (a) the name of the facility at which the medical procedure or surgery 26 is to be performed; 27 (b) the designation of the medical procedure or surgery to be 28 performed and for which consent is given; 29 (c) the names of the health care providers performing the medical 30 procedure or surgery; 31 (d) a statement that the provisions of subdivision one of this section 32 have been complied with; 33 (e) the signature of the patient or his or her legally authorized 34 representative; 35 (f) the date and time the consent was executed; 36 (g) the name of the health care provider who discussed treatment with 37 the patient or his or her legally authorized representative; 38 (h) the signature of a person who witnessed the execution of such 39 consent, and the date and time thereof; 40 (i) the name of the patient; and 41 (j) statements of whether medical students will be viewing the proce- 42 dure or surgery, whether such procedure or surgery will be recorded, and 43 as to the removal, testing and disposition of tissue. 44 § 1707. Patient involvement in their care. Every patient and their 45 legally authorized representative shall have the right to be informed of 46 and involved in the decision making process relating to such patient's 47 medical care. To the extent practicable, all information provided pursu- 48 ant to this section shall be provided in clear and easily understandable 49 terms. Where medically significant alternatives for care and treatment 50 exist, the patient shall be so informed. 51 § 2. Subdivision 4 of section 2404 of the public health law is 52 REPEALED. 53 § 3. Subdivision 3 of section 2404-a of the public health law is 54 REPEALED. 55 § 4. Section 2442 of the public health law is REPEALED. 56 § 5. Section 2499 of the public health law is REPEALED.S. 168 5 1 § 6. Subdivision 4 of section 2783 of the public health law is 2 REPEALED. 3 § 7. Section 2805-d of the public health law is REPEALED. 4 § 8. This act shall take effect on the first of January next succeed- 5 ing the date on which it shall have become a law; provided, however, 6 that effective immediately, the addition, amendment and/or repeal of any 7 rule or regulation necessary for the implementation of this act on its 8 effective date are authorized and directed to be made and completed on 9 or before such effective date.
