2014 New York Laws
PBH - Public Health
Article 28 - (2800 - 2826) 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.