2023 New York Laws › PBH - Public Health › Article 28 - Hospitals › 2816-A - Cardiac Services Information.

§  2816-a.  Cardiac  services  information.  1.  Definitions.  For the
purposes of this section, the following terms shall have  the  following
meanings:
(a)   "Cardiac  services  information"  shall  mean  the  demographic,
clinical, procedural and outcome information  collected  from  hospitals
and  maintained  by  the  department  regarding  patients  who have been
diagnosed or treated for cardiac disease or conditions.
(b) "Cardiac data  set"  shall  mean  a  subset  of  cardiac  services
information consisting of data elements relevant to a research project.
2.  Notwithstanding articles six and six-A of the public officers law,
the commissioner may collect and maintain cardiac  services  information
and  prepare  and release cardiac data sets for use in research projects
as set forth in this subdivision. Any cardiac data  set  released  shall
contain  the  minimum  amount of personally identifiable and demographic
information which the commissioner determines is  necessary  to  conduct
the  research  project provided, however, that no cardiac data set shall
be released that contains patient names,  social  security  numbers,  or
other data elements that directly identify any patient.
3.  The  commissioner  may  release  cardiac  data  sets  for research
projects based on the following factors:
(a) the research project's potential  contribution  to  improving  the
quality  of  care and outcomes experienced by patients receiving cardiac
services, the appropriateness of cardiac  services,  access  to  cardiac
services, and/or the cost effectiveness of cardiac services;
(b)  the  technical  feasibility  of  preparing  the  cardiac data set
requested;
(c) the scientific merit of the research project;
(d) the experience and qualifications of the researchers;
(e) the research project's feasibility;
(f)  the  applicant's  capacity   and   agreement   to   protect   the
confidentiality of the data;
(g)  the  research  project's  compliance  with  applicable  state and
federal laws, policies and regulations governing the protection of human
subjects; and
(h) such other criteria as the commissioner develops  in  consultation
with experts in cardiac services.
4.  Any  researcher authorized by the commissioner to access a cardiac
data set shall:
(a) maintain the security and confidentiality of the information;
(b) not disclose the cardiac data set, or any portion thereof,  unless
specifically permitted to do so by the commissioner;
(c)  restrict  the  use  of  the data to the specific research project
approved by the commissioner;
(d) destroy, and document the destruction of, the data within  a  time
period specified by the commissioner; and
(e)  execute  and  comply  with a cardiac services data use agreement,
which includes but is not limited to provisions restricting the use  and
disclosure of the data.
5.  The  commissioner  shall  charge  a  fee for each cardiac data set
released. Such fee shall be payable to  the  department,  prior  to  the
release of any cardiac data set, for deposit into the general fund.
6.  The  commissioner  may  promulgate  and  enforce  such  rules  and
regulations as he or she deems necessary to effectuate the  purposes  of
this section.