S T A T E   O F   N E W   Y O R K
       ________________________________________________________________________
                                         1424
                              2015-2016 Regular Sessions
                                   I N  S E N A T E
                                   January 12, 2015
                                      ___________
       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    S 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
   22  OR COERCION. WITH REGARD TO CONSENT TO A MEDICAL PROCEDURE  OR  SURGERY,
   23  THE ELEMENTS OF INFORMATION NECESSARY FOR CONSENT INCLUDE:
        EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                             [ ] is old law to be omitted.
                                                                  LBD05851-01-5
       S. 1424                             2
    1    (A) A FAIR AND UNDERSTANDABLE EXPLANATION TO THE PATIENT OR HIS OR HER
    2  LEGALLY  AUTHORIZED  REPRESENTATIVE OF THE PROCEDURES TO BE FOLLOWED AND
    3  THEIR PURPOSES, INCLUDING IDENTIFICATION OF  ANY  PROCEDURES  WHICH  ARE
    4  EXPERIMENTAL;
    5    (B) A DESCRIPTION OF ANY ATTENDANT PAIN, DISCOMFORT AND MATERIAL RISKS
    6  POSSIBLE AND THOSE THAT ARE REASONABLY EXPECTED;
    7    (C) A DESCRIPTION OF ANY BENEFITS REASONABLY TO BE EXPECTED;
    8    (D) A DISCLOSURE OF ANY APPROPRIATE ALTERNATIVE PROCEDURES THAT MAY BE
    9  ADVANTAGEOUS TO THE PATIENT;
   10    (E)  A  DISCLOSURE  OF  THE  RISKS,  BENEFITS,  PAIN AND DISCOMFORT OF
   11  ELECTION TO REFUSE ANY PROCEDURE;
   12    (F) AN OFFER TO ANSWER ANY INQUIRIES BY THE  PATIENT  OR  HIS  OR  HER
   13  LEGALLY  AUTHORIZED  REPRESENTATIVE  CONCERNING  ANY AND ALL INFORMATION
   14  PROVIDED PURSUANT TO THIS SUBDIVISION;
   15    (G) A COMPREHENSIVE INQUIRY BY THE HEALTH CARE PROVIDER TO ENSURE THAT
   16  THE PATIENT OR HIS OR HER LEGALLY AUTHORIZED REPRESENTATIVE  HAS  SUFFI-
   17  CIENT  UNDERSTANDING OF THE INFORMATION PROVIDED PURSUANT TO THIS SUBDI-
   18  VISION SO AS TO UNDERSTAND THE MEDICAL PROCEDURES  AND/OR  SURGERY  THAT
   19  THE PATIENT WILL UNDERGO; AND
   20    (H)  AN  INSTRUCTION THAT THE PATIENT OR HIS OR HER LEGALLY AUTHORIZED
   21  REPRESENTATIVE IS FREE TO WITHDRAW HIS OR HER CONSENT AND DISCONTINUE  A
   22  MEDICAL PROCEDURE OR SURGERY AT ANY TIME.
   23    3.  "INVASIVE  PROCEDURE"  MEANS  A MEDICAL PROCEDURE INVOLVING A SKIN
   24  INCISION OR PUNCTURE, OR INSERTION OF AN INSTRUMENT OR FOREIGN  MATERIAL
   25  INTO THE BODY.
   26    4.  "MATERIAL  RISK"  MEANS  A  RISK THAT A HEALTH CARE PROVIDER KNOWS
   27  WOULD BE REGARDED AS SIGNIFICANT BY A REASONABLE PERSON IN THE PATIENT'S
   28  POSITION WHEN DECIDING TO  ACCEPT  OR  REFUSE  THE  RECOMMENDED  MEDICAL
   29  PROCEDURE OR SURGERY.
   30    5. "SURGERY" MEANS A MEDICAL PROCEDURE PERFORMED TO STRUCTURALLY ALTER
   31  THE  HUMAN  BODY  BY THE INCISION OR DESTRUCTION OF HUMAN TISSUE; OR FOR
   32  DIAGNOSTIC OR THERAPEUTIC TREATMENT OF CONDITIONS OR  DISEASE  PROCESSES
   33  BY ANY INSTRUMENTS CAUSING LOCALIZED ALTERATION OR TRANSPOSITION OF LIVE
   34  HUMAN TISSUE.
   35    6. "UNEXPECTED COMPLICATION" MEANS AN EMERGENCY IN WHICH CARE IS IMME-
   36  DIATELY  NECESSARY  AND  PRESENTS AN IMMINENTLY LIFE THREATENING RISK TO
   37  THE PATIENT OR TO PREVENT A SUBSTANTIAL IMPAIRMENT OF PHYSICAL OR MENTAL
   38  FUNCTION, WHICH CARE EXCEEDS THAT WHICH WAS AGREED  TO  IN  AN  INFORMED
   39  CONSENT.
   40    S 1701. NOTICE OF RIGHT TO INFORMED CONSENT. EVERY HEALTH CARE PROVID-
   41  ER  AND  HEALTH  CARE  FACILITY  WHICH  PERFORMS  MEDICAL  PROCEDURES OR
   42  SURGERY, SHALL, AT THE SITE ON  WHICH  SUCH  PROCEDURES  OR  SURGERY  IS
   43  PERFORMED, CONSPICUOUSLY POST THE FOLLOWING NOTICE:
   44    "EVERY PATIENT HAS THE RIGHT TO BE INFORMED OF ANY SURGICAL OR MEDICAL
   45  PROCEDURE TO BE PERFORMED UPON THEM, AND SHALL HAVE THE RIGHT TO CONSENT
   46  TO  OR  REFUSE  SUCH  PROCEDURE.  TO ASSURE INFORMED DECISION MAKING AND
   47  CONSENT, PATIENTS OR THEIR LEGALLY AUTHORIZED REPRESENTATIVES MUST  HAVE
   48  INFORMATION  ON  THE  PATIENT'S MEDICAL STATUS, DIAGNOSIS AND PROGNOSIS.
   49  INFORMED CONSENT IS REQUIRED TO BE DOCUMENTED PRIOR TO  PROCEEDING  WITH
   50  ANY MEDICAL OR SURGICAL PROCEDURE."
   51    S  1702.  DUTY TO OBTAIN INFORMED CONSENT. IT SHALL BE THE DUTY OF THE
   52  HEALTH CARE PROVIDER WHO ORDERS OR PERFORMS  ANY  MEDICAL  PROCEDURE  OR
   53  SURGERY  TO  OBTAIN,  IN WRITING, THE INFORMED CONSENT OF THE PATIENT OR
   54  HIS OR HER LEGALLY AUTHORIZED  REPRESENTATIVE.  THE  OBTAINING  OF  SUCH
   55  CONSENT  SHALL  INCLUDE  THE PROVISION AND DISCUSSION OF ALL INFORMATION
   56  NECESSARY FOR SUCH CONSENT,  AND  THE  DOCUMENTATION  IN  THE  PATIENT'S
       S. 1424                             3
    1  MEDICAL  RECORD  THAT  ALL  REQUIREMENTS  FOR INFORMED CONSENT HAVE BEEN
    2  COMPLIED WITH. NO MEDICAL PROCEDURE OR SURGERY SHALL BE PERFORMED  WITH-
    3  OUT  INFORMED  CONSENT,  AND  THE  HEALTH CARE PROVIDER WHO ORDERED SUCH
    4  PROCEDURE  OR  SURGERY SHALL BE SOLELY RESPONSIBLE FOR ENSURING INFORMED
    5  CONSENT IS OBTAINED.
    6    S 1703. PROCEDURES AND SURGERY REQUIRING INFORMED CONSENT. THE FOLLOW-
    7  ING MEDICAL PROCEDURES SHALL REQUIRE THE OBTAINING OF  INFORMED  CONSENT
    8  PRIOR TO THE PERFORMANCE THEREOF:
    9    1.  ALL  SURGERY,  EXCEPT SIMPLE LACERATION REPAIRS AND DERMATOLOGICAL
   10  PROCEDURES PERFORMED ON AN OUTPATIENT BASIS;
   11    2. EXPERIMENTAL PROCEDURES OR TREATMENTS;
   12    3. ABORTIONS;
   13    4. ADMINISTRATION OF BLOOD OR BLOOD PRODUCTS;
   14    5. ELECTROCONVULSIVE THERAPY;
   15    6. ADMINISTRATION OF NEUROLEPTIC MEDICATION FOR TREATMENT OF A  MENTAL
   16  ILLNESS OR A DEVELOPMENTAL DISABILITY;
   17    7. ANY MEDICAL TREATMENT NECESSARY TO PRESERVE THE LIFE OR HEALTH OF A
   18  PERSON COMMITTED TO A FACILITY PURSUANT TO THE MENTAL HYGIENE LAW;
   19    8. RADIATION THERAPY;
   20    9. INVASIVE MEDICAL IMAGING;
   21    10.  PROCEDURES  INVOLVING  MODERATE TO DEEP SEDATION WHERE THERE IS A
   22  RISK OF THE LOSS OF PROTECTIVE REFLEXES;
   23    11. INVASIVE PROCEDURES;
   24    12. CIRCUMCISION; AND
   25    13. STERILIZATION.
   26    S 1704. SURGERY; INFORMED CONSENT NOT REQUIRED. 1. IN THE  EVENT  THAT
   27  AN  EMERGENCY  MAKES  IT  IMPOSSIBLE  OR  IMPRACTICAL TO OBTAIN INFORMED
   28  CONSENT WITHOUT JEOPARDIZING THE LIFE OR HEALTH OF  A  PATIENT,  MEDICAL
   29  TREATMENT MAY BE PROVIDED TO PRESERVE THE LIFE OR HEALTH OF SUCH PATIENT
   30  WITHOUT INFORMED CONSENT. IN EACH SUCH INSTANCE, THE HEALTH CARE PROVID-
   31  ER  PROVIDING  SUCH  TREATMENT  SHALL DOCUMENT, IN THE PATIENT'S MEDICAL
   32  RECORD, THE FACTS WHICH ESTABLISH THAT SUCH SITUATION WAS AN  EMERGENCY.
   33  SUCH  TREATMENT  MAY  CONTINUE  UNTIL  THE PATIENT OR HIS OR HER LEGALLY
   34  AUTHORIZED REPRESENTATIVE IS  ABLE  TO  PROVIDE  INFORMED  CONSENT.  THE
   35  PROVISIONS  OF  THIS  SUBDIVISION SHALL NOT APPLY TO ANY PATIENT WHO HAS
   36  PREVIOUSLY MADE KNOWN IN A DOCUMENT FILED WITH HIS OR  HER  HEALTH  CARE
   37  PROVIDER  THAT  HE OR SHE DOES NOT WISH TO RECEIVE SUCH EMERGENCY TREAT-
   38  MENT UNDER THE CIRCUMSTANCES WHICH EXIST.
   39    2. IN THE EVENT A MEDICAL COMPLICATION  ARISES  IN  THE  COURSE  OF  A
   40  MEDICAL  PROCEDURE  OR  SURGERY, A HEALTH CARE PROVIDER MAY PROVIDE SUCH
   41  TREATMENT AS  IS  NECESSARY  TO  PRESERVE  THE  PATIENT'S  LIFE  WITHOUT
   42  INFORMED CONSENT.
   43    3.  THE  PROVISIONS  OF  THIS  ARTICLE  SHALL NOT APPLY TO ANY MEDICAL
   44  PROCEDURE OR SURGERY ORDERED BY A COURT  OF  COMPETENT  JURISDICTION.  A
   45  COPY  OF  SUCH  COURT  ORDER  SHALL BE INCLUDED IN THE PATIENT'S MEDICAL
   46  RECORD.
   47    S 1705. CAPACITY TO PROVIDE INFORMED CONSENT. ABSENT A  COURT  FINDING
   48  OR  LEGAL  DOCUMENTATION  PROVIDING TO THE CONTRARY, EVERY PERSON WHO IS
   49  EIGHTEEN YEARS OF AGE OR OLDER  SHALL  BE  DEEMED  TO  BE  COMPETENT  TO
   50  PROVIDE INFORMED CONSENT. ABSENT THE DESIGNATION OF A LEGALLY AUTHORIZED
   51  REPRESENTATIVE,  ONLY  SUCH PERSON MAY GRANT INFORMED CONSENT. EXCEPT AS
   52  OTHERWISE PROVIDED IN STATUTORY OR CASE LAW, UNEMANCIPATED PERSONS UNDER
   53  THE AGE OF EIGHTEEN YEARS SHALL NOT  BE  AUTHORIZED  TO  GRANT  INFORMED
   54  CONSENT,  AND SUCH CONSENT MAY ONLY BE PROVIDED BY THE MINOR'S PARENT OR
   55  LEGAL GUARDIAN.
       S. 1424                             4
    1    S 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    S 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    S  2.  Subdivision  4  of  section  2404  of  the public health law is
   52  REPEALED.
   53    S 3. Subdivision 3 of section 2404-a  of  the  public  health  law  is
   54  REPEALED.
   55    S 4. Section 2442 of the public health law is REPEALED.
   56    S 5. Section 2499 of the public health law is REPEALED.
       S. 1424                             5
    1    S  6.  Subdivision  4  of  section  2783  of  the public health law is
    2  REPEALED.
    3    S 7. Section 2805-d of the public health law is REPEALED.
    4    S  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.