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S01633 Summary:

BILL NOS01633A
 
SAME ASNo Same As
 
SPONSORFERNANDEZ
 
COSPNSRCLEARE, COMRIE, FAHY, GOUNARDES, HARCKHAM, HOYLMAN-SIGAL, JACKSON, KRUEGER, LIU, SALAZAR
 
MLTSPNSR
 
Add §§25 & 26, Pub Health L
 
Provides additional protections for sensitive health information; requires all health information networks, electronic health record systems, and health care providers to provide patients with a right to restrict the disclosures of such patient's health information; defines terms; provides for exceptions; clarifies that such provisions shall not create, establish or authorize a new private cause of an action by an aggrieved person against a health information networks, electronic health records systems, and health care providers.
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S01633 Text:



 
                STATE OF NEW YORK
        ________________________________________________________________________
 
                                         1633--A
 
                               2025-2026 Regular Sessions
 
                    IN SENATE
 
                                    January 13, 2025
                                       ___________
 
        Introduced  by  Sens. FERNANDEZ, CLEARE, COMRIE, FAHY, GOUNARDES, HARCK-
          HAM, JACKSON, KRUEGER, LIU, SALAZAR -- read twice and ordered printed,
          and when printed to be committed to the Committee on Health --  recom-
          mitted  to  the  Committee on Health in accordance with Senate Rule 6,
          sec. 8 -- committee discharged, bill  amended,  ordered  reprinted  as
          amended and recommitted to said committee
 
        AN  ACT  to  amend the public health law, in relation to providing addi-
          tional protections for sensitive health information and requiring  all
          health  information  networks,  electronic health records systems, and
          health care providers to provide patients with a right to restrict the
          disclosures of such patient's health information
 
          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 two new sections
     2  25 and 26 to read as follows:
     3    §  25.  Privacy  of  information  disclosed through health information
     4  networks. 1. Definitions. For purposes of this section:
     5    (a) "Business associate" shall have the same meaning as set  forth  in
     6  45 CFR 160.103.
     7    (b)  "Codified  sensitive information" means patient information that,
     8  by associated standard codes commonly used in the  exchange  of  patient
     9  information including, but not limited to ICD-10 or SNOMED, can be iden-
    10  tified  as sensitive information in accordance with subdivision three of
    11  this section.
    12    (c) "Disclosure" means the release, transfer, provision of access  to,
    13  or divulging in any manner of information outside the entity that deliv-
    14  ered  the  health  care  and the patient who received the care, and such
    15  term shall not include any of the exceptions set forth in the definition
    16  of "disclosure to any other person"  as  defined  in  paragraph  (e)  of
    17  subdivision one of section eighteen of this chapter.
 
         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD04417-03-6

        S. 1633--A                          2
 
     1    (d)  "Electronic  health records system" means any entity operating in
     2  the state of New York that electronically stores  or  maintains  patient
     3  information,  electronic health records, personal health records, health
     4  care claims, or payment and other administrative data  on  behalf  of  a
     5  health  care provider, health care service plan, pharmaceutical company,
     6  contractor, or employer.
     7    (e) "Health care provider" shall have the same meaning as set forth in
     8  paragraph (b) of subdivision one of section eighteen of this  title  and
     9  for  purposes  of this section shall refer to health care providers that
    10  are located in the state of  New  York  and  use  a  health  information
    11  network  to  receive,  hold  or  exchange  patient  information on their
    12  behalf.
    13    (f) "Health information network" shall mean any  entity,  including  a
    14  health  information technology developer of certified health information
    15  technology, that receives, holds or  exchanges  patient  information  in
    16  electronic  form  on  behalf  of  a  health care provider and makes such
    17  information available to two or more individuals or  entities  that  are
    18  unaffiliated  with  the  health care provider for purposes of treatment,
    19  payment, or health care operations, as those  terms  are  defined  under
    20  HIPAA,  or  a  qualified health information network as established under
    21  TEFCA, which exchanges patient information on behalf of  a  health  care
    22  provider  located  in  the state of New York. An entity may qualify as a
    23  "health  information  network"  irrespective  of  whether  such   entity
    24  receives  funding  from  the  department.  The  term "health information
    25  network" shall not include:
    26    (i) a health care provider;
    27    (ii) an entity that makes patient information available solely:
    28    (1) from one health care provider to a single health care provider  as
    29  part of a referral, prescription, or consultation;
    30    (2) as necessary for the payment of a health care claim;
    31    (3) among affiliates of a single health care provider;
    32    (4)  to  individuals  and  entities under contract with the entity who
    33  meet the definition of a "business associate" under HIPAA and who  proc-
    34  ess  patient  information only as directed by a health care provider and
    35  do not disclose patient information; or
    36    (5) as necessary to operate clinical data  registries,  provide  organ
    37  donation  coordination  services  and  other  similar services as deemed
    38  appropriate by the department in regulation;
    39    (iii) a health insurer or  a  health  maintenance  organization,  when
    40  acting  as a health insurer, to the extent it exchanges patient informa-
    41  tion via HIPAA standard transactions; and
    42    (iv) an entity that makes patient information available solely to  and
    43  between  health information networks and has no ability to access, modi-
    44  fy, or further disclose patient information, including, but not  limited
    45  to, the recognized coordinating entity under TEFCA.
    46    (g)  "HIPAA" means the Health Insurance Portability and Accountability
    47  Act of 1996 and its implementing regulations at  45  C.F.R.  Parts  160,
    48  162, and 164.
    49    (h)  "Non-codified  sensitive  information"  means patient information
    50  that contains or reveals sensitive information, but that is not  associ-
    51  ated  with  standardized  codes and shall include, but is not limited to
    52  notes, visit summaries, laboratory results and images.
    53    (i) "Patient information" shall have the same meaning as set forth  in
    54  paragraph (e) of subdivision one of section eighteen of this chapter.
    55    (j)  "Qualified  person"  shall  have the same meaning as set forth in
    56  paragraph (g) of subdivision one of section eighteen of this title.

        S. 1633--A                          3
 
     1    (k) "Sensitive information" means patient information that contains or
     2  reveals reproductive health services as  defined  in  paragraph  (a)  of
     3  subdivision one of section sixty-five hundred thirty-one-b of the educa-
     4  tion  law, gender-affirming care as defined in paragraph (c) of subdivi-
     5  sion  one  of  section  sixty-five hundred thirty-one-b of the education
     6  law, care protected under 42 CFR part 2, diagnosis and treatment  for  a
     7  sexually  transmitted  infection or HIV, mental health services, alcohol
     8  or substance use treatment, and any other health  care  services  deter-
     9  mined  by  the  commissioner  through  regulations, in consultation with
    10  health care providers, patient advocates,  health  information  networks
    11  and other relevant stakeholders.
    12    (l)  "TEFCA" means the Trusted Exchange Framework and Common Agreement
    13  authorized by the 21st Century Cures Act.
    14    2.  Patient  right  to  restrict  disclosures  by  health  information
    15  networks. Within one hundred eighty days from the effective date of this
    16  section,  the department shall establish rules and regulations requiring
    17  any health information network to:
    18    (a) provide qualified persons with the means  of  requesting,  without
    19  undue  effort,  restrictions  on disclosures of patient information from
    20  all health information networks;
    21    (b) subject to any regulatory exceptions established  by  the  depart-
    22  ment,  abide  by the terms of a qualified person's requested restriction
    23  made under paragraph (a) of this subdivision; and
    24    (c) subject to any regulatory exceptions established  by  the  depart-
    25  ment,  provide  or  cause  to  be  provided  to  qualified persons, upon
    26  request, a report or notifications detailing disclosures of the applica-
    27  ble patient's patient information by or through all  health  information
    28  networks.
    29    3. Additional protections for codified sensitive information by health
    30  information networks. (a) Within one hundred eighty days from the effec-
    31  tive  date  of  this  section,  the department shall establish rules and
    32  regulations, consistent with state  and  federal  law  and  regulations,
    33  including  but not limited to article thirty-three of the mental hygiene
    34  law and section twenty-seven hundred eighty-two of this chapter, requir-
    35  ing any health information network to:
    36    (i) develop the capacity to limit the disclosure of codified sensitive
    37  information while allowing for  the  disclosure  of  a  patient's  other
    38  health information;
    39    (ii) when directed by a qualified person, limit user access privileges
    40  to  codified  sensitive information to only those HIPAA covered entities
    41  whom the qualified person has  specifically  authorized  to  access  the
    42  codified sensitive information;
    43    (iii)  provide the ability to automatically disable access to codified
    44  sensitive information by an individual or  entity  located  outside  the
    45  state of New York as directed by a qualified person; and
    46    (iv)  unless  otherwise  ordered by a court of competent jurisdiction,
    47  notify the qualified person and the provider  who  rendered  the  health
    48  care  documented  in  the codified sensitive information at least thirty
    49  days prior to complying with a civil, criminal, or  regulatory  inquiry,
    50  investigation, subpoena, or summons for codified sensitive information.
    51    (b) Such rules and regulations shall also:
    52    (i)  establish  a list of procedure codes, diagnosis codes, medication
    53  codes, and other appropriate codes that  constitute  codified  sensitive
    54  information;
    55    (ii)  set  forth exceptions to the requirement to block the disclosure
    56  of codified sensitive information as required by paragraph (a)  of  this

        S. 1633--A                          4
 
     1  subdivision, including for disclosures to individuals and entities under
     2  contract  with a health information network who meet the definition of a
     3  "business associate" under HIPAA and who do not re-disclose such patient
     4  information; and
     5    (iii)  establish  guidelines  for the authorization necessary to limit
     6  disclosure of codified sensitive information pursuant  to  subparagraphs
     7  (ii) and (iii) of paragraph (a) of this subdivision.
     8    4.  Additional  protections  for  sensitive  information by electronic
     9  health records systems. (a) Within one hundred eighty days of the effec-
    10  tive date of this section, the  department  shall  establish  rules  and
    11  regulations,  consistent  with  state  and  federal law and regulations,
    12  including but not limited to article thirty-three of the mental  hygiene
    13  law and section twenty-seven hundred eighty-two of this chapter, requir-
    14  ing any electronic health records system to:
    15    (i)  develop  the capacity to provide qualified persons with the means
    16  of requesting, without undue  effort,  restrictions  on  disclosures  of
    17  patient information;
    18    (ii)  develop  the capacity to limit the disclosure of codified sensi-
    19  tive information while allowing for the disclosure of a patient's  other
    20  health information;
    21    (iii)  when  directed  by a qualified person, limit user access privi-
    22  leges to codified sensitive information  to  only  those  HIPAA  covered
    23  entities whom the qualified person has specifically authorized to access
    24  the sensitive information;
    25    (iv)  provide  the ability to automatically disable access to codified
    26  sensitive information by an individual or  entity  located  outside  the
    27  state of New York as directed by a qualified person; and
    28    (v)  unless  otherwise  ordered  by a court of competent jurisdiction,
    29  notify the qualified person and the provider  who  rendered  the  health
    30  care  documented  in  the codified sensitive information at least thirty
    31  days prior to complying with a civil, criminal, or  regulatory  inquiry,
    32  investigation, subpoena, or summons for codified sensitive information.
    33    (b) Within one year of the effective date of this section, the depart-
    34  ment  shall  establish  rules and regulations, consistent with state and
    35  federal law and regulations, including but not limited to article  thir-
    36  ty-three  of  the  mental  hygiene  law and section twenty-seven hundred
    37  eighty-two of this chapter,  requiring  any  electronic  health  records
    38  system to:
    39    (i)  develop  the  capacity  to  limit  the disclosure of non-codified
    40  sensitive information while allowing for the disclosure of  a  patient's
    41  other health information;
    42    (ii) when directed by a qualified person, limit user access privileges
    43  to  non-codified sensitive information to only those HIPAA covered enti-
    44  ties whom the qualified person has specifically authorized to access the
    45  non-codified sensitive information;
    46    (iii) provide the ability to automatically disable access to non-codi-
    47  fied sensitive information by an individual or  entity  located  outside
    48  the state of New York as directed by a qualified person; and
    49    (iv)  unless  otherwise  ordered by a court of competent jurisdiction,
    50  notify the qualified person and the provider  who  rendered  the  health
    51  care documented in the non-codified sensitive information at least thir-
    52  ty  days  prior  to  complying  with  a  civil,  criminal, or regulatory
    53  inquiry, investigation, subpoena, or summons for non-codified  sensitive
    54  information.
    55    (c)  The  rules  and regulations required by paragraphs (a) and (b) of
    56  this subdivision shall also:

        S. 1633--A                          5

     1    (i) set forth exceptions to the requirement to block the disclosure of
     2  codified and non-codified sensitive information  as  required  by  para-
     3  graphs  (a)  and  (b)  of this subdivision, including for disclosures to
     4  individuals and  entities  under  contract  with  a  health  information
     5  network  who  meet  the definition of a "business associate" under HIPAA
     6  and who do not re-disclose such patient information; and
     7    (ii) establish guidelines for the  authorization  necessary  to  limit
     8  disclosure  of  codified and non-codified sensitive information pursuant
     9  to subparagraphs (iii) and (iv) of paragraph (a) and subparagraphs  (ii)
    10  and (iii) of paragraph (b) of this section.
    11    5.  Authorization.  Notwithstanding section eighteen of this title and
    12  subdivision twenty-three of section sixty-five  hundred  thirty  of  the
    13  education  law,  a health information network that abides by a qualified
    14  person's request to limit disclosure of sensitive information shall  not
    15  be  otherwise  required  to  obtain  authorization for the disclosure of
    16  patient information, unless authorization is required in accordance with
    17  subdivisions three or four of this section,  article  twenty-seven-F  of
    18  this  chapter, the provisions of section seventeen of this title related
    19  to prohibiting the release to an infant patient's parent or guardian  of
    20  information related to the treatment of such infant patient for venereal
    21  disease  or  the  performance  of an abortion operation upon such infant
    22  patient, section 33.13 of the mental hygiene law, section seventy-nine-l
    23  of the civil rights law, section  three  hundred  ninety-four-e  of  the
    24  general  business  law, 42 CFR part 2, HIPAA, or other relevant federal,
    25  state, or local laws.
    26    § 26. Privacy of patient information held by  health  care  providers.
    27  1. Definitions. For purposes of this section:
    28    (a)  "Disclosure" means the release, transfer, provision of access to,
    29  or divulging in any manner of information outside the entity that deliv-
    30  ered the health care and the patient who received  the  care,  and  such
    31  term shall not include any of the exceptions set forth in the definition
    32  of  "disclosure  to  any  other  person"  as defined in paragraph (e) of
    33  subdivision one of section eighteen of this chapter.
    34    (b) "Health care provider" shall have the same meaning as set forth in
    35  paragraph (b) of subdivision one of section eighteen of this chapter.
    36    (c) "HIPAA" shall have the same meaning as set forth in paragraph  (g)
    37  of subdivision one of section twenty-five of this title.
    38    (d)  "Patient information" shall have the same meaning as set forth in
    39  paragraph (e) of subdivision one of section eighteen of this title.
    40    (e) "Qualified person" shall have the same meaning  as  set  forth  in
    41  paragraph (g) of subdivision one of section eighteen of this title.
    42    (f)  "Sensitive  information" shall have the same meaning as set forth
    43  in paragraph (k) of subdivision  one  of  section  twenty-five  of  this
    44  title.
    45    2.  Patient  right  to  restrict disclosures by health care providers.
    46  (a) Within one hundred eighty days  from  the  effective  date  of  this
    47  subdivision,  the  department shall establish rules and regulations that
    48  require health care providers to take reasonable steps to:
    49    (i)  provide  qualified  persons  with   the   means   of   requesting
    50  restrictions  on  disclosures of patient information consistent with the
    51  obligations imposed by section twenty-five of this title;
    52    (ii) notify qualified persons of their right to restrict  the  disclo-
    53  sure  of  patient information consistent with the capabilities developed
    54  by the electronic health records system  utilized  by  the  health  care
    55  provider;

        S. 1633--A                          6
 
     1    (iii)  subject to any regulatory exceptions established by the depart-
     2  ment, abide by the terms of a qualified person's requested  restriction;
     3  and
     4    (iv)  unless  otherwise  ordered by a court of competent jurisdiction,
     5  notify the qualified person at least thirty days prior to complying with
     6  a civil, criminal, or regulatory inquiry,  investigation,  subpoena,  or
     7  summons for sensitive information.
     8    (b)  Nothing  in  paragraph  (a)  of  this subdivision shall create an
     9  affirmative obligation on a health care provider to review  non-codified
    10  data  created  prior  to the effective date of any rules and regulations
    11  promulgated pursuant to this section.
    12    (c) The department's rules and regulations shall set forth  exceptions
    13  to a qualified person's right to restrict disclosures and shall include,
    14  at a minimum, exceptions for:
    15    (i)  disclosures  to public health authorities located in the state of
    16  New York in accordance with New York law;
    17    (ii) disclosures necessary to facilitate  payment  of  a  health  care
    18  claim;
    19    (iii) disclosures necessary to ensure that a provider is in compliance
    20  with  applicable  quality of care, licensure or accreditation standards;
    21  and
    22    (iv) disclosures strictly necessary to fill a prescription or  provide
    23  a service.
    24    (d)  The  department  shall establish phase-in periods for health care
    25  providers to implement the requirements of this subdivision, taking into
    26  account the technical feasibility  of  implementing  restrictions  among
    27  various  sectors,  including  (i)  small health care providers; and (ii)
    28  health care providers in sectors that do not typically utilize certified
    29  health information technology, as well as the  time  it  takes  for  the
    30  health information systems or electronic health record systems to devel-
    31  op and implement the capacity to segment health records.
    32    (e)  The  department  shall provide guidance to health care providers,
    33  including model notices health care providers may use to  notify  quali-
    34  fied persons to permit them to exercise their rights under this subdivi-
    35  sion.    Such  guidance shall recommend more prominent notices and means
    36  for a qualified person to exercise their rights in health care  settings
    37  where sensitive information is frequently generated as part of patients'
    38  health care records.
    39    3.  Authorization  for  a health care provider's disclosure of patient
    40  information. Notwithstanding section eighteen of this title and subdivi-
    41  sion twenty-three of section sixty-five hundred thirty of the  education
    42  law, if a health care provider has provided actual notice to a qualified
    43  person  of such person's right to restrict disclosures of patient infor-
    44  mation in accordance with the requirements of subdivision  two  of  this
    45  section  and  abides by a qualified person's request to restrict disclo-
    46  sures, no authorization shall be required for such health care  provider
    47  to  disclose  a patient's other patient information unless authorization
    48  is required by this section or section twenty-five of this title,  arti-
    49  cle  twenty-seven-F of this chapter, the provisions of section seventeen
    50  of this title relating to prohibiting the release to an infant patient's
    51  parent or guardian of information  related  to  the  treatment  of  such
    52  infant  patient  for  venereal disease or the performance of an abortion
    53  operation upon such infant patient, section 33.13 of the mental  hygiene
    54  law,  section  seventy-nine-l  of  the  civil  rights law, section three
    55  hundred ninety-four-e of the general business law, 42 CFR part 2, HIPAA,
    56  or other relevant federal, state, or local laws.

        S. 1633--A                          7
 
     1    4. Authorization for a health  care  provider's  request  for  patient
     2  information. Notwithstanding section eighteen of this title and subdivi-
     3  sion  twenty-three of section sixty-five hundred thirty of the education
     4  law, if a health care  provider  provides  actual  notice  to  qualified
     5  persons  that  it  makes  routine  requests for patient information from
     6  other individuals or entities, no authorization  shall  be  required  to
     7  make  a request for patient information unless authorization is required
     8  by  this  section  or  section  twenty-five  of  this   title,   article
     9  twenty-seven-F  of  this chapter, the provisions of section seventeen of
    10  this title relating to prohibiting the release to  an  infant  patient's
    11  parent  or  guardian  of  information  related  to the treatment of such
    12  infant patient for venereal disease or the performance  of  an  abortion
    13  operation  upon such infant patient, section 33.13 of the mental hygiene
    14  law, section seventy-nine-l of  the  civil  rights  law,  section  three
    15  hundred ninety-four-e of the general business law, 42 CFR part 2, HIPAA,
    16  or other relevant federal, state, or local laws.
    17    5.  Disclosure  of  de-identified patient information. Nothing in this
    18  section shall prohibit a health care provider's disclosure of de-identi-
    19  fied patient information  for  the  purposes  of  quality  assurance  or
    20  improvement  activities,  clinical  trials  or research. For purposes of
    21  this section, "de-identified" means that the information cannot identify
    22  or be made to identify or be associated with  a  particular  individual,
    23  directly  or indirectly and is subject to technical safeguards and poli-
    24  cies and  procedures  that  prevent  re-identification,  whether  inten-
    25  tionally or unintentionally, of any individual.
    26    §  2.  Nothing  set  forth in this act shall be construed as creating,
    27  establishing, or authorizing  a  new  private  cause  of  action  by  an
    28  aggrieved person against a health information network, electronic health
    29  records  system, or health care provider who has violated, or is alleged
    30  to have violated, any provision of this act.
    31    § 3. Severability. If any provision of this act, or any application of
    32  any provision of this act, is held to be invalid, or ruled to violate or
    33  be inconsistent with any applicable  federal  law  or  regulation,  that
    34  shall not affect the validity or effectiveness of any other provision of
    35  this  act,  or of any other application of any provision of this act. It
    36  is hereby declared to be the intent of the  legislature  that  this  act
    37  would  have  been  enacted  even if such invalid provisions had not been
    38  included herein.
    39    § 4. This act shall take effect immediately.
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