S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   1029
 
                        2019-2020 Regular Sessions
 
                             I N  S E N A T E
 
                             January 10, 2019
                                ___________
 
 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:
 
   Section 1. The public health law is amended by adding a new article 17
 to read as follows:
                                ARTICLE 17
                             INFORMED CONSENT
 SECTION 1700. DEFINITIONS.
         1701. NOTICE OF RIGHT TO INFORMED CONSENT.
         1702. DUTY TO OBTAIN INFORMED CONSENT.
         1703. PROCEDURES AND SURGERY REQUIRING INFORMED CONSENT.
         1704. SURGERY; INFORMED CONSENT NOT REQUIRED.
         1705. CAPACITY TO PROVIDE INFORMED CONSENT.
         1706. SCOPE OF INFORMED CONSENT.
         1707. PATIENT INVOLVEMENT IN THEIR CARE.
   § 1700. DEFINITIONS. AS USED IN THIS ARTICLE:
   1.  "EMERGENCY" MEANS A CIRCUMSTANCE IN WHICH A PATIENT'S CONDITION IS
 SUCH THAT A FAILURE TO PROVIDE HOSPITALIZATION, MEDICAL TREATMENT AND/OR
 SURGERY TO A PATIENT WOULD RESULT IN UNDUE SUFFERING, DEATH OR  SUBSTAN-
 TIAL IMPAIRMENT OF PHYSICAL OR MENTAL FUNCTION.
   2. "INFORMED CONSENT" MEANS THE LEGALLY EFFECTIVE KNOWING CONSENT OF A
 PATIENT  OR HIS OR HER LEGALLY AUTHORIZED REPRESENTATIVE, SO SITUATED AS
 TO BE ABLE TO EXERCISE FREE POWER OF CHOICE WITHOUT UNDUE INDUCEMENT  OR
 ANY  ELEMENT OF FORCE, FRAUD, DECEIT, DURESS OR OTHER FORM OF CONSTRAINT
 OR COERCION. WITH REGARD TO CONSENT TO A MEDICAL PROCEDURE  OR  SURGERY,
 THE ELEMENTS OF INFORMATION NECESSARY FOR CONSENT INCLUDE:

  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
              

                                                            LBD06444-02-9

 S. 1029                             2
 
   (A) A FAIR AND UNDERSTANDABLE EXPLANATION TO THE PATIENT OR HIS OR HER
 LEGALLY  AUTHORIZED  REPRESENTATIVE OF THE PROCEDURES TO BE FOLLOWED AND
 THEIR PURPOSES, INCLUDING IDENTIFICATION OF  ANY  PROCEDURES  WHICH  ARE
 EXPERIMENTAL;
   (B) A DESCRIPTION OF ANY ATTENDANT PAIN, DISCOMFORT AND MATERIAL RISKS
 POSSIBLE AND THOSE THAT ARE REASONABLY EXPECTED;
   (C) A DESCRIPTION OF ANY BENEFITS REASONABLY TO BE EXPECTED;
   (D) A DISCLOSURE OF ANY APPROPRIATE ALTERNATIVE PROCEDURES THAT MAY BE
 ADVANTAGEOUS TO THE PATIENT;
   (E)  A  DISCLOSURE  OF  THE  RISKS,  BENEFITS,  PAIN AND DISCOMFORT OF
 ELECTION TO REFUSE ANY PROCEDURE;
   (F) AN OFFER TO ANSWER ANY INQUIRIES BY THE  PATIENT  OR  HIS  OR  HER
 LEGALLY  AUTHORIZED  REPRESENTATIVE  CONCERNING  ANY AND ALL INFORMATION
 PROVIDED PURSUANT TO THIS SUBDIVISION;
   (G) A COMPREHENSIVE INQUIRY BY THE HEALTH CARE PROVIDER TO ENSURE THAT
 THE PATIENT OR HIS OR HER LEGALLY AUTHORIZED REPRESENTATIVE  HAS  SUFFI-
 CIENT  UNDERSTANDING OF THE INFORMATION PROVIDED PURSUANT TO THIS SUBDI-
 VISION SO AS TO UNDERSTAND THE MEDICAL PROCEDURES  AND/OR  SURGERY  THAT
 THE PATIENT WILL UNDERGO; AND
   (H)  AN  INSTRUCTION THAT THE PATIENT OR HIS OR HER LEGALLY AUTHORIZED
 REPRESENTATIVE IS FREE TO WITHDRAW HIS OR HER CONSENT AND DISCONTINUE  A
 MEDICAL PROCEDURE OR SURGERY AT ANY TIME.
   3.  "INVASIVE  PROCEDURE"  MEANS  A MEDICAL PROCEDURE INVOLVING A SKIN
 INCISION OR PUNCTURE, OR INSERTION OF AN INSTRUMENT OR FOREIGN  MATERIAL
 INTO THE BODY.
   4.  "MATERIAL  RISK"  MEANS  A  RISK THAT A HEALTH CARE PROVIDER KNOWS
 WOULD BE REGARDED AS SIGNIFICANT BY A REASONABLE PERSON IN THE PATIENT'S
 POSITION WHEN DECIDING TO  ACCEPT  OR  REFUSE  THE  RECOMMENDED  MEDICAL
 PROCEDURE OR SURGERY.
   5. "SURGERY" MEANS A MEDICAL PROCEDURE PERFORMED TO STRUCTURALLY ALTER
 THE  HUMAN  BODY  BY THE INCISION OR DESTRUCTION OF HUMAN TISSUE; OR FOR
 DIAGNOSTIC OR THERAPEUTIC TREATMENT OF CONDITIONS OR  DISEASE  PROCESSES
 BY ANY INSTRUMENTS CAUSING LOCALIZED ALTERATION OR TRANSPOSITION OF LIVE
 HUMAN TISSUE.
   6. "UNEXPECTED COMPLICATION" MEANS AN EMERGENCY IN WHICH CARE IS IMME-
 DIATELY  NECESSARY  AND  PRESENTS AN IMMINENTLY LIFE THREATENING RISK TO
 THE PATIENT OR TO PREVENT A SUBSTANTIAL IMPAIRMENT OF PHYSICAL OR MENTAL
 FUNCTION, WHICH CARE EXCEEDS THAT WHICH WAS AGREED  TO  IN  AN  INFORMED
 CONSENT.
   § 1701. NOTICE OF RIGHT TO INFORMED CONSENT. EVERY HEALTH CARE PROVID-
 ER  AND  HEALTH  CARE  FACILITY  WHICH  PERFORMS  MEDICAL  PROCEDURES OR
 SURGERY, SHALL, AT THE SITE ON  WHICH  SUCH  PROCEDURES  OR  SURGERY  IS
 PERFORMED, CONSPICUOUSLY POST THE FOLLOWING NOTICE:
   "EVERY PATIENT HAS THE RIGHT TO BE INFORMED OF ANY SURGICAL OR MEDICAL
 PROCEDURE TO BE PERFORMED UPON THEM, AND SHALL HAVE THE RIGHT TO CONSENT
 TO  OR  REFUSE  SUCH  PROCEDURE.  TO ASSURE INFORMED DECISION MAKING AND
 CONSENT, PATIENTS OR THEIR LEGALLY AUTHORIZED REPRESENTATIVES MUST  HAVE
 INFORMATION  ON  THE  PATIENT'S MEDICAL STATUS, DIAGNOSIS AND PROGNOSIS.
 INFORMED CONSENT IS REQUIRED TO BE DOCUMENTED PRIOR TO  PROCEEDING  WITH
 ANY MEDICAL OR SURGICAL PROCEDURE."
   §  1702.  DUTY TO OBTAIN INFORMED CONSENT. IT SHALL BE THE DUTY OF THE
 HEALTH CARE PROVIDER WHO ORDERS OR PERFORMS  ANY  MEDICAL  PROCEDURE  OR
 SURGERY  TO  OBTAIN,  IN WRITING, THE INFORMED CONSENT OF THE PATIENT OR
 HIS OR HER LEGALLY AUTHORIZED  REPRESENTATIVE.  THE  OBTAINING  OF  SUCH
 CONSENT  SHALL  INCLUDE  THE PROVISION AND DISCUSSION OF ALL INFORMATION
 NECESSARY FOR SUCH CONSENT,  AND  THE  DOCUMENTATION  IN  THE  PATIENT'S

 S. 1029                             3
 
 MEDICAL  RECORD  THAT  ALL  REQUIREMENTS  FOR INFORMED CONSENT HAVE BEEN
 COMPLIED WITH. NO MEDICAL PROCEDURE OR SURGERY SHALL BE PERFORMED  WITH-
 OUT  INFORMED  CONSENT,  AND  THE  HEALTH CARE PROVIDER WHO ORDERED SUCH
 PROCEDURE  OR  SURGERY SHALL BE SOLELY RESPONSIBLE FOR ENSURING INFORMED
 CONSENT IS OBTAINED.
   § 1703. PROCEDURES AND SURGERY REQUIRING INFORMED CONSENT. THE FOLLOW-
 ING MEDICAL PROCEDURES SHALL REQUIRE THE OBTAINING OF  INFORMED  CONSENT
 PRIOR TO THE PERFORMANCE THEREOF:
   1.  ALL  SURGERY,  EXCEPT SIMPLE LACERATION REPAIRS AND DERMATOLOGICAL
 PROCEDURES PERFORMED ON AN OUTPATIENT BASIS;
   2. EXPERIMENTAL PROCEDURES OR TREATMENTS;
   3. ADMINISTRATION OF BLOOD OR BLOOD PRODUCTS;
   4. ELECTROCONVULSIVE THERAPY;
   5. ADMINISTRATION OF NEUROLEPTIC MEDICATION FOR TREATMENT OF A  MENTAL
 ILLNESS OR A DEVELOPMENTAL DISABILITY;
   6. ANY MEDICAL TREATMENT NECESSARY TO PRESERVE THE LIFE OR HEALTH OF A
 PERSON COMMITTED TO A FACILITY PURSUANT TO THE MENTAL HYGIENE LAW;
   7. RADIATION THERAPY;
   8. INVASIVE MEDICAL IMAGING;
   9.  PROCEDURES  INVOLVING  MODERATE  TO DEEP SEDATION WHERE THERE IS A
 RISK OF THE LOSS OF PROTECTIVE REFLEXES;
   10. INVASIVE PROCEDURES;
   11. CIRCUMCISION; AND
   12. STERILIZATION.
   § 1704. SURGERY; INFORMED CONSENT NOT REQUIRED. 1. IN THE  EVENT  THAT
 AN  EMERGENCY  MAKES  IT  IMPOSSIBLE  OR  IMPRACTICAL TO OBTAIN INFORMED
 CONSENT WITHOUT JEOPARDIZING THE LIFE OR HEALTH OF  A  PATIENT,  MEDICAL
 TREATMENT MAY BE PROVIDED TO PRESERVE THE LIFE OR HEALTH OF SUCH PATIENT
 WITHOUT INFORMED CONSENT. IN EACH SUCH INSTANCE, THE HEALTH CARE PROVID-
 ER  PROVIDING  SUCH  TREATMENT  SHALL DOCUMENT, IN THE PATIENT'S MEDICAL
 RECORD, THE FACTS WHICH ESTABLISH THAT SUCH SITUATION WAS AN  EMERGENCY.
 SUCH  TREATMENT  MAY  CONTINUE  UNTIL  THE PATIENT OR HIS OR HER LEGALLY
 AUTHORIZED REPRESENTATIVE IS  ABLE  TO  PROVIDE  INFORMED  CONSENT.  THE
 PROVISIONS  OF  THIS  SUBDIVISION SHALL NOT APPLY TO ANY PATIENT WHO HAS
 PREVIOUSLY MADE KNOWN IN A DOCUMENT FILED WITH HIS OR  HER  HEALTH  CARE
 PROVIDER  THAT  HE OR SHE DOES NOT WISH TO RECEIVE SUCH EMERGENCY TREAT-
 MENT UNDER THE CIRCUMSTANCES WHICH EXIST.
   2. IN THE EVENT A MEDICAL COMPLICATION  ARISES  IN  THE  COURSE  OF  A
 MEDICAL  PROCEDURE  OR  SURGERY, A HEALTH CARE PROVIDER MAY PROVIDE SUCH
 TREATMENT AS  IS  NECESSARY  TO  PRESERVE  THE  PATIENT'S  LIFE  WITHOUT
 INFORMED CONSENT.
   3.  THE  PROVISIONS  OF  THIS  ARTICLE  SHALL NOT APPLY TO ANY MEDICAL
 PROCEDURE OR SURGERY ORDERED BY A COURT  OF  COMPETENT  JURISDICTION.  A
 COPY  OF  SUCH  COURT  ORDER  SHALL BE INCLUDED IN THE PATIENT'S MEDICAL
 RECORD.
   § 1705. CAPACITY TO PROVIDE INFORMED CONSENT. ABSENT A  COURT  FINDING
 OR  LEGAL  DOCUMENTATION  PROVIDING TO THE CONTRARY, EVERY PERSON WHO IS
 EIGHTEEN YEARS OF AGE OR OLDER  SHALL  BE  DEEMED  TO  BE  COMPETENT  TO
 PROVIDE INFORMED CONSENT. ABSENT THE DESIGNATION OF A LEGALLY AUTHORIZED
 REPRESENTATIVE,  ONLY  SUCH PERSON MAY GRANT INFORMED CONSENT. EXCEPT AS
 OTHERWISE PROVIDED IN STATUTORY OR CASE LAW, UNEMANCIPATED PERSONS UNDER
 THE AGE OF EIGHTEEN YEARS SHALL NOT  BE  AUTHORIZED  TO  GRANT  INFORMED
 CONSENT,  AND SUCH CONSENT MAY ONLY BE PROVIDED BY THE MINOR'S PARENT OR
 LEGAL GUARDIAN.

 S. 1029                             4
 
   § 1706. SCOPE OF INFORMED CONSENT. 1. THE FOLLOWING SHALL BE ADDRESSED
 PRIOR TO THE PROVISION OF INFORMED CONSENT TO  A  MEDICAL  PROCEDURE  OR
 SURGERY:
   (A)  A  DESCRIPTION  OF  THE  PROPOSED  MEDICAL  PROCEDURE OR SURGERY,
 INCLUDING ANY ANESTHESIA PROPOSED TO BE ADMINISTERED;
   (B) THE INDICATIONS FOR THE PROPOSED MEDICAL PROCEDURE OR SURGERY;
   (C) MATERIAL RISKS AND BENEFITS  TO  THE  PATIENT  FROM  THE  PROPOSED
 PROCEDURE OR SURGERY;
   (D) TREATMENT ALTERNATIVES, AND THE RISKS AND BENEFITS THEREOF;
   (E) CONSEQUENCES FOR DECLINING THE PROPOSED OR ALTERNATIVE TREATMENTS;
   (F)  DESIGNATE  THE  HEALTH  CARE PROVIDERS WHO WILL BE ENGAGED IN THE
 PROVISION OF THE MEDICAL PROCEDURE OR SURGERY TO THE  PATIENT,  AND  THE
 QUALIFICATIONS OF SUCH HEALTH CARE PROVIDERS; AND
   (G) AN AMPLE OPPORTUNITY FOR THE PATIENT OR HIS OR HER LEGALLY AUTHOR-
 IZED REPRESENTATIVE TO ASK QUESTIONS AND HAVE SUCH QUESTIONS CLEARLY AND
 FULLY ANSWERED RELATING TO THE PROPOSED TREATMENT OF THE PATIENT.
   2. EACH INFORMED CONSENT SHALL BE CONFINED TO THOSE MEDICAL PROCEDURES
 AND  SURGERIES  THAT  WERE DISCUSSED BY THE HEALTH CARE PROVIDER AND THE
 PATIENT OR HIS OR HER LEGALLY AUTHORIZED REPRESENTATIVE. EVERY  INFORMED
 CONSENT  SHALL  STATE  THE  SUBJECTS  DISCUSSED  AND  THE PROCEDURES AND
 SURGERIES THAT WERE AGREED TO. AN INFORMED CONSENT MAY BE  RESCINDED  AT
 ANY TIME PRIOR TO THE PERFORMANCE OF THE MEDICAL PROCEDURE OR SURGERY.
   3.  EVERY  EXECUTED  INFORMED CONSENT SHALL BE INCLUDED IN THE MEDICAL
 RECORD OF THE PATIENT TO WHOM IT RELATES AND SHALL INCLUDE:
   (A) THE NAME OF THE FACILITY AT WHICH THE MEDICAL PROCEDURE OR SURGERY
 IS TO BE PERFORMED;
   (B) THE  DESIGNATION  OF  THE  MEDICAL  PROCEDURE  OR  SURGERY  TO  BE
 PERFORMED AND FOR WHICH CONSENT IS GIVEN;
   (C)  THE  NAMES  OF  THE  HEALTH CARE PROVIDERS PERFORMING THE MEDICAL
 PROCEDURE OR SURGERY;
   (D) A STATEMENT THAT THE PROVISIONS OF SUBDIVISION ONE OF THIS SECTION
 HAVE BEEN COMPLIED WITH;
   (E) THE SIGNATURE OF THE PATIENT OR  HIS  OR  HER  LEGALLY  AUTHORIZED
 REPRESENTATIVE;
   (F) THE DATE AND TIME THE CONSENT WAS EXECUTED;
   (G)  THE NAME OF THE HEALTH CARE PROVIDER WHO DISCUSSED TREATMENT WITH
 THE PATIENT OR HIS OR HER LEGALLY AUTHORIZED REPRESENTATIVE;
   (H) THE SIGNATURE OF A PERSON WHO  WITNESSED  THE  EXECUTION  OF  SUCH
 CONSENT, AND THE DATE AND TIME THEREOF;
   (I) THE NAME OF THE PATIENT; AND
   (J)  STATEMENTS OF WHETHER MEDICAL STUDENTS WILL BE VIEWING THE PROCE-
 DURE OR SURGERY, WHETHER SUCH PROCEDURE OR SURGERY WILL BE RECORDED, AND
 AS TO THE REMOVAL, TESTING AND DISPOSITION OF TISSUE.
   § 1707. PATIENT INVOLVEMENT IN THEIR CARE.  EVERY  PATIENT  AND  THEIR
 LEGALLY AUTHORIZED REPRESENTATIVE SHALL HAVE THE RIGHT TO BE INFORMED OF
 AND  INVOLVED  IN THE DECISION MAKING PROCESS RELATING TO SUCH PATIENT'S
 MEDICAL CARE. TO THE EXTENT PRACTICABLE, ALL INFORMATION PROVIDED PURSU-
 ANT TO THIS SECTION SHALL BE PROVIDED IN CLEAR AND EASILY UNDERSTANDABLE
 TERMS. WHERE MEDICALLY SIGNIFICANT ALTERNATIVES FOR CARE  AND  TREATMENT
 EXIST, THE PATIENT SHALL BE SO INFORMED.
   §  2.  Subdivision  4  of  section  2404  of  the public health law is
 REPEALED.
   § 3. Subdivision 4 of section 2404-a  of  the  public  health  law  is
 REPEALED.
   § 4. Section 2442 of the public health law is REPEALED.
   § 5. Section 2499 of the public health law is REPEALED.

 S. 1029                             5
 
   §  6.  Subdivision  4  of  section  2783  of  the public health law is
 REPEALED.
   § 7. Section 2805-d of the public health law is REPEALED.
   §  8. Subdivision 2 of section 2444 of the public health law, as added
 by chapter 450 of the laws of 1975, is amended to read as follows:
   2. The human research review committee in each institution  or  agency
 shall  require  that  institution or agency to promulgate a statement of
 principle and policy in regard  to  the  rights  and  welfare  of  human
 subjects  in  the  conduct  of human research, and the committee and the
 commissioner shall approve that statement prior to  its  taking  effect.
 The  committee  shall  review  each  proposed  human research project to
 determine (1) its necessity; (2) that the  rights  and  welfare  of  the
 human  subjects involved are adequately protected, (3) that the risks to
 the human subjects are outweighed by the potential benefits to  them  or
 by  the importance of the knowledge to be gained; (4) that the voluntary
 informed consent is to be obtained by  methods  that  are  adequate  and
 appropriate, and (5) that the persons proposed to conduct the particular
 medical  research are appropriately competent and qualified. The commit-
 tee shall periodically examine each existing human research project with
 regard to the proper application of the approved principles and policies
 which the institution or agency has  promulgated.  The  committee  shall
 report  any violation to the commissioner. [In addition to the voluntary
 informed consent of the proposed human subject as  required  by  section
 twenty-four  hundred  forty-two of this chapter, the] THE consent of the
 committee and the commissioner shall be required with  relation  to  the
 conduct of human research involving minors, incompetent persons, mental-
 ly disabled persons and prisoners.
   §  9. This act shall take effect on the first of January next succeed-
 ing the date on which it shall have become  a  law;  provided,  however,
 that effective immediately, the addition, amendment and/or repeal of any
 rule  or  regulation necessary for the implementation of this act on its
 effective date are authorized and directed to be made and  completed  on
 or before such effective date.