NY State Senate Bill 2015-S1424A

Senate Bill S1424A

2015-2016 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
Jan 06, 2016	referred to health
Mar 05, 2015	print number 1424a
Mar 05, 2015	amend and recommit to health
Jan 12, 2015	referred to health

Bill Amendments

Original

A (Active)

2015-S1424 - Details

See Assembly Version of this Bill:: A7346
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:: 2013-2014: S7550
2017-2018: S168, A5888
2019-2020: S1029, A2410
2021-2022: S1172, A4954

2015-S1424 - Summary

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

2015-S1424 - Sponsor Memo

                                BILL NUMBER:S1424

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.

2015-S1424 - Bill Text download pdf

                            
                    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:

  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:

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.
                                                           LBD05851-01-5

S. 1424                             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.
  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

S. 1424                             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.
  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. 1424                             4

  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:
  (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. 1424                             5

  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  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.

2015-S1424A (ACTIVE) - Details

See Assembly Version of this Bill:: A7346
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:: 2013-2014: S7550
2017-2018: S168, A5888
2019-2020: S1029, A2410
2021-2022: S1172, A4954

2015-S1424A (ACTIVE) - Summary

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

2015-S1424A (ACTIVE) - Sponsor Memo

                                BILL NUMBER:S1424A

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.

2015-S1424A (ACTIVE) - Bill Text download pdf

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

                                 1424--A

                       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  --  committee
  discharged, bill amended, ordered reprinted as amended and recommitted
  to said committee

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

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.
                                                           LBD05851-02-5

S. 1424--A                          2

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
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

S. 1424--A                          3

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-
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. 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.
  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. 1424--A                          4

  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:
  (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. 1424--A                          5

  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  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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