N.Y. Public Health Law § 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.