N.Y. Comp. Codes R. & Regs. tit. 10 § 400.18

Current through Register Vol. 46, No. 45, November 2, 2024

Section 400.18 - Statewide Planning and Research Cooperative System (SPARCS)

(a) Definitions.

For the purposes of this section, these terms shall have the following meanings:

(1)Health care facilities shall mean facilities licensed under article 28 of the Public Health Law.

(2)Identifying data elements shall mean those SPARCS data elements that, if disclosed without any restrictions on use or re-disclosure would constitute an unwarranted invasion of personal privacy. A list of identifying data elements shall be specified by the commissioner and will be made available publicly.

(3)Inpatient hospitalization data shall mean SPARCS data submitted by hospitals for patients receiving inpatient services at a general hospital that is licensed under article 28 of the Public Health Law and that provides inpatient medical services.

(4)Outpatient data shall mean emergency department data, ambulatory surgery data, and outpatient services data.

(i)Emergency department data shall mean SPARCS data submitted by a facility licensed to provide emergency department services under article 28 of the Public Health Law.

(ii)Ambulatory surgery data shall mean SPARCS data submitted by a facility licensed to provide ambulatory surgery services under article 28 of the Public Health Law.

(iii)Outpatient services data shall mean all data submitted by licensed article 28 facilities excluding inpatient hospitalization data, emergency department data, and ambulatory surgery data.

(5)SPARCS Administrator shall mean a person in the SPARCS program designated by the commissioner to act as administrator for all SPARCS activities.

(6)SPARCS data shall mean the data collected by the commissioner under section 2816 of the Public Health Law and this section, including inpatient hospitalization data and outpatient data.

(7)SPARCS program shall mean the program in the New York State Department of Health (NYSDOH) that collects and maintains SPARCS data and discloses SPARCS data.

(b) Reporting SPARCS data.

(1) Health care facilities shall report data as follows:

(i) Health care facilities shall submit, or cause to have submitted, SPARCS data in an electronic, computer-readable format through a secure electronic network designated by the department according to specifications provided by the commissioner.

(ii) All SPARCS data must be supported by documentation in the patient's medical and billing records.

(iii) Health care facilities must submit on a monthly basis to the SPARCS program, or cause to have submitted on a monthly basis to the SPARCS program, data for all inpatient discharges and outpatient visits. Health care facilities must submit, or cause to have submitted, at least 95 percent of data for all inpatient discharges and outpatient visits within 60 days from the end of the month of a patient's discharge or visit. Health care facilities must submit, or cause to have submitted, 100 percent of data for all inpatient discharges and outpatient visits within 180 days from the end of the month of a patient's discharge or visit.

(iv) The SPARCS program may conduct an audit evaluating the quality of submitted SPARCS data and issue an audit report to a health care facility listing any inadequacies or inconsistencies in the data. Any health care facility so audited must submit corrected data to the SPARCS program within 90 days of the receipt of the audit report.

(2) Content of the SPARCS data.

(i) Health care facilities shall submit, or cause to have submitted, uniform bill data elements as required by the commissioner. The data elements required by the commissioner shall be based on those approved by the National Uniform Billing Committee (NUBC) or required under national electronic data interchange (EDI) standards for health care transactions and shall be published on the NYSDOH website to the extent allowed by copyright law.

(ii) Health care facilities shall submit, or cause to have submitted, additional data elements as required by the commissioner. Such additional data elements shall be from medical records or demographic information maintained by the health care facilities.

(iii) The list of specific SPARCS data elements and their definitions shall be maintained by the commissioner, will be made available publicly, and may be modified by the commissioner.

(c)Maintenance of SPARCS data.

The commissioner shall be responsible for protecting the privacy and security of the health care information reported to the SPARCS program.

(d)Requests for SPARCS data.

(1) SPARCS data may be used for medical or scientific research or statistical or epidemiological purposes approved by the commissioner.

(2) The commissioner may determine that additional purposes are proper uses of SPARCS data.

(3) In determining the purpose of a request for SPARCS data, the SPARCS program shall not be limited to information contained in the data request form and may request supplemental information from the applicant.

(4) The commissioner shall charge a reasonable fee to all persons and organizations receiving SPARCS data based upon costs incurred and recurring for data processing, platform/data center and software. The commissioner may discount the base fee or waive the fee upon request to the SPARCS program. The fee may be waived in the following circumstances:

(i) Use by a health care facility of the data it submitted to the SPARCS program.

(ii) Use by a health care facility that is licensed under article 28 of the Public Health Law for the purpose of rate determinations or rate appeals and for health care-related research.

(iii) Use by a Federal, New York State, county or local government agency for health care-related purposes.

(5) The SPARCS program shall follow applicable Federal and State laws when determining whether SPARCS data contain identifying data elements may be shared and whether a disclosure of SPARCS data constitutes an unwarranted invasion of personal privacy.

(6) All entities seeking SPARCS data must submit a request to the SPARCS program using standard data request forms specified by the SPARCS program. Data users shall take all necessary precautions to prevent unwarranted invasions of personal privacy resulting from any data analysis or release. Data users may not release any information that could be used, alone or in combination with other reasonably available information, to identify an individual who is a subject of the information. Data users bear full responsibility for breaches or unauthorized disclosures of personal information resulting from use of SPARCS data. Applications for SPARCS data must provide an explicit plan for preventing breaches or unauthorized disclosures of personal information of any individual who is a subject of the information.

(7) Each data request form must include an executed data use agreement in a form prescribed by the SPARCS program. Data use agreements are required of: a representative of the requesting organization; a representative of each other organization associated with the project; and all individuals who will have access to any data including identifying data elements.

(8) The SPARCS program shall publish and make publicly available the name of the project director, the organization, and the title of approved projects.

(9) The SPARCS administrator shall review and make recommendations on requests for SPARCS data containing identifying data elements to a data release committee established by the commissioner. The data release committee shall have at least three members, including at least one member not otherwise affiliated with NYSDOH. The members of the data release committee shall be posted on the NYSDOH website. Requests will be granted only upon formal, written approval for access by a majority of the members of the data release committee. The commissioner has the final authority over the approval, or disapproval, of all requests. Requests for identifying data elements shall be approved only if:

(i) the purpose of the request is consistent with the purposes for which SPARCS data may be used;

(ii) the applicant is qualified to undertake the project; and

(iii) the applicant requires such identifying data elements for the intended project and is able to ensure that patient privacy will be protected.

(10) The SPARCS administrator may recommend approval of a request in which future SPARCS data is to be supplied on a periodic basis under the following conditions:

(i) SPARCS data may be requested for a predetermined time not to exceed three years beyond the current year provided that the organization and uses of the data remain as indicated in the data request form submitted to the SPARCS program.

(ii) During the period of retention of SPARCS data, no additional individuals may access SPARCS data without an executed data use agreement on file with the SPARCS program.

(11) The commissioner may rescind for cause, at any time, approval of a data request.

(e)Penalties.

(1) Any person or entity that violates the provisions of this section or any data use agreement may be liable pursuant to the provisions of the Public Health Law, including, but not limited to, sections 12 and 12-d of the Public Health Law.

(2) Any person or entity that violates the provisions of this section or any data use agreement may be denied access to SPARCS data.

N.Y. Comp. Codes R. & Regs. Tit. 10 § 400.18

Amended, New York State Register September 3, 2014/Volume XXXVI, Issue 35, eff.9/3/2014

Amended New York State Register January 30, 2019/Volume XLI, Issue 05, eff. 1/30/2019

Amended New York State Register November 13, 2019/Volume XLI, Issue 46, eff. 11/13/2019