NY State Senate Bill 2013-S7550

Senate Bill S7550

2013-2014 Legislative Session

Establishes requirements for the informed consent to the provision of medical procedures; repealer

download bill text pdf

Archive: Last Bill Status - In Senate Committee Health Committee

Introduced
- In Committee Assembly
- In Committee Senate
- On Floor Calendar Assembly
- On Floor Calendar Senate
- Passed Assembly
- Passed Senate
Delivered to Governor
Signed By Governor

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	Assembly Actions - Lowercase Senate Actions - UPPERCASE
May 15, 2014	referred to health

2013-S7550 (ACTIVE) - Details

Current Committee:: Senate Health
Law Section:: Public Health Law
Laws Affected:: Add Art 17 §§1700 - 1707, rpld §2404 sub 4, §2404-a sub 3, §§2442, 2499 & 2805-d, §2783 sub 4, Pub Health L
Versions Introduced in Other Legislative Sessions:: 2015-2016: S1424
2017-2018: S168
2019-2020: S1029
2021-2022: S1172

2013-S7550 (ACTIVE) - Summary

Establishes requirements for the informed consent to the provision of medical procedures by the patient or his or her legally authorized representative.

2013-S7550 (ACTIVE) - Sponsor Memo

                                BILL NUMBER:S7550

TITLE OF BILL:  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

PURPOSE:  Establishes requirements for the informed consent to the
provision of medical procedures; repealer.

SUMMARY OF PROVISIONS:  The public health law is amended by adding a
new article 17: Informed Consent

Section 1700: Definitions

Section 1701: Notice of right to informed consent

Section 1702: Duty to obtain informed consent

Section 1703: Procedures and surgery requiring informed consent

Section 1704: Surgery; informed consent not required

Section 1705: Capacity to provide informed consent

Section 1706: Scope of informed consent

Section 1707: Patient involvement in their care

JUSTIFICATION:  Health care is extraordinarily complex. It is also an
industry where the difference in knowledge and understanding between
the health provider and patient is usually vast. It is therefore
critical that health care providers impart adequate information in a
manner that a patient can understand so that he or she can effectively
exercise the right to make informed decisions about the plan of care,
medical or surgical interventions, care after discharge, etc. In other
words, easy-to-understand health forms and accompanying information
are crucial. A simplified process of informing patients and receiving
consent does not prohibit a more in-depth conversation for patients
that desire more detailed information-but it is basic, necessary, and
should be required by all health providers. This bill seeks to do that
by laying out a comprehensive policy for informed consent.

LEGISLATIVE HISTORY: New bill

FISCAL IMPLICATIONS: To be determined

EFFECTIVE DATE:  This act shall take effect on the first of January
next succeeding 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.

2013-S7550 (ACTIVE) - Bill Text download pdf

                            
                    S T A T E   O F   N E W   Y O R K
________________________________________________________________________

                                  7550

                            I N  S E N A T E

                              May 15, 2014
                               ___________

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.
  S 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:
  (A) A FAIR AND UNDERSTANDABLE EXPLANATION TO THE PATIENT OR HIS OR HER
LEGALLY  AUTHORIZED  REPRESENTATIVE OF THE PROCEDURES TO BE FOLLOWED AND

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.
                                                           LBD14927-01-4

S. 7550                             2

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.
  S 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."
  S  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
MEDICAL  RECORD  THAT  ALL  REQUIREMENTS  FOR INFORMED CONSENT HAVE BEEN
COMPLIED WITH. NO MEDICAL PROCEDURE OR SURGERY SHALL BE PERFORMED  WITH-

S. 7550                             3

OUT  INFORMED  CONSENT,  AND  THE  HEALTH CARE PROVIDER WHO ORDERED SUCH
PROCEDURE OR SURGERY SHALL BE SOLELY RESPONSIBLE FOR  ENSURING  INFORMED
CONSENT IS OBTAINED.
  S 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. ABORTIONS;
  4. ADMINISTRATION OF BLOOD OR BLOOD PRODUCTS;
  5. ELECTROCONVULSIVE THERAPY;
  6.  ADMINISTRATION OF NEUROLEPTIC MEDICATION FOR TREATMENT OF A MENTAL
ILLNESS OR A DEVELOPMENTAL DISABILITY;
  7. ANY MEDICAL TREATMENT NECESSARY TO PRESERVE THE LIFE OR HEALTH OF A
PERSON COMMITTED TO A FACILITY PURSUANT TO THE MENTAL HYGIENE LAW;
  8. RADIATION THERAPY;
  9. INVASIVE MEDICAL IMAGING;
  10. PROCEDURES INVOLVING MODERATE TO DEEP SEDATION WHERE  THERE  IS  A
RISK OF THE LOSS OF PROTECTIVE REFLEXES;
  11. INVASIVE PROCEDURES;
  12. CIRCUMCISION; AND
  13. STERILIZATION.
  S  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.
  S  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 1706. SCOPE OF INFORMED CONSENT. 1. THE FOLLOWING SHALL BE ADDRESSED
PRIOR  TO  THE  PROVISION  OF INFORMED CONSENT TO A MEDICAL PROCEDURE OR
SURGERY:

S. 7550                             4

  (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.
  S  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.
  S 2. Subdivision 4 of  section  2404  of  the  public  health  law  is
REPEALED.
  S  3.  Subdivision  3  of  section  2404-a of the public health law is
REPEALED.
  S 4. Section 2442 of the public health law is REPEALED.
  S 5. Section 2499 of the public health law is REPEALED.
  S 6. Subdivision 4 of  section  2783  of  the  public  health  law  is
REPEALED.
  S 7. Section 2805-d of the public health law is REPEALED.

S. 7550                             5

  S  8. 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.

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