Identifying Data Overview and Instructions

Overview
Application Process
Detailed Instructions for Form DOH-4385
Download Identifying Data Overview and Instructions (MS Word - 75 KB, 10 pages)
Download Identifying Data Request Form (DOH-4385) (MS Word - 176 KB, 17 pages)


Overview

The New York State Health regulations, NYCRR Title 10 §400.18, define how requests for deniable (identifying) Statewide Planning and Research Cooperative System (SPARCS) and Patient Review Instrument (PRI) data will be released. Deniable data are those specific data elements that, by itself or in combination, might identify an individual. A seventeen member Data Protection Review Board (DPRB) reviews all requests for deniable data. This public review body is broadly representative of the community, industry and government and is appointed by the Commissioner of Health. As per regulation, (NYCRR Title 10 §400.18) the SPARCS Unit of the Department of Health processes and reviews each data access application and then, prior to each DPRB meeting, submits a written recommendation to the Board for its consideration.

The DPRB and the New York State Department of Health recognize the need for data to be accessible so that there is a more effective, efficient, and responsive health care system. The identifying data access application process balances the need to know with the need to protect the confidentiality of patient records.

The Board's approval of a deniable data request is for a specific timeframe not to exceed three years. All approved data requests must be sent to the Commissioner of Health for ratification. The Commissioner may ratify or reverse the decision of the Board. The Board has the ability to overturn the Commissioner's decision by a two-thirds vote. This system of checks and balances, applied to all identifying data requests, guards the rights of individuals while providing access to needed health care information.

The Identifying Data Access Application supplies the Board with the information necessary to determine whether: the purpose of the request is consistent with the uses of the data as defined by regulation, the applicant is qualified to undertake the study, the proposed study/research is technically feasible, the applicant needs all the data requested and is able to ensure that patient privacy is protected.

Application Process

  1. Visit our Output Data Dictionaries and our DPRB Meeting Schedule for additional information.
  2. Complete SPARCS/PRI Identifying Data Request Form (DOH-4385), answering all questions. Please follow the detailed instructions below. All seventeen (17) pages of the application MUST be submitted. Even if a page is not applicable to your request, you MUST still complete it and indicate "N/A" - not applicable.
  3. Send 20 copies prior to application deadline for desired DPRB meeting:
    Executive Secretary
    Data Protection Review Board
    New York State Department of Health
    800 North Pearl Street, Room 231
    Albany, New York 12204
    Phone: (518) 473-8144
    sparcs.submissions@health.ny.gov
  4. Representatives for each application must be available to answer questions from the DPRB prior to and during the review session.
  5. A final approval letter will be forwarded to the applicant once the DPRB approved application is ratified by the Commissioner of Health. This letter will give instructions on how to initiate the release of approved data.

Detailed Instructions for Form DOH-4385 (For each line item)

  1. ORGANIZATION AND INDIVIDUAL REQUESTING USE OF DATA
    1. Project Director and Title: Provide the name and title of the individual who is primarily responsible for conducting the study/project.
    2. Organizational Affiliation: List the organization with which the project director is associated when conducting the project/study. This may be a hospital, college/university, association, contractor/vendor, etc. Health Department applicants must also fill out Appendix A.
    3. Contact Person: List the individual who is responsible for application questions. This may or may not be the project director.
    4. Street Address or P.O. Box: List the address of the individual who will receive all correspondence regarding this application.
    5. City/State/Zip Code: List the address of the individual who is to receive all correspondence regarding this application.
    6. Telephone of Contact Person: List the telephone number of the contact person.
    7. E-mail of Contact Person: List the e-mail of the contact person.
  2. NATURE OF REQUEST
    1. Title of Study/Project: List the title of the study/project.
    2. Name and Affiliation of Project Participants: List all the organizations, individuals, and contractors who are not directly employed or considered staff of the Project Director, and who will be involved with this study/project.
    3. Sources of funding: Specify all sources of funding/sponsors for this study/project. Please include all sponsors who will be providing financial participation in the study/project.
    4. Type of request: Check the appropriate boxes designating the specific type of request that is being made. These categories and their descriptions are taken from the regulations (NYCRR Title 10 §400.18) governing the uses for which data may be released. The check-off criteria descriptions below is taken from NYCRR Title 10 §400.18:
      "...the purposes for which data from SPARCS, the PRI, ESD or ASDAP may be used to include the following:
      (a) Financial Studies-investigation of alternate means of paying for hospital, ambulatory surgery, emergency department services, and/or residential health care facilities care to bring about a more cost-effective system of hospital, ambulatory surgery, emergency department services, and/or residential health care facility financing;
      (b) Rate Setting-modeling of rate policies and calculating of reimbursement rates for hospitals, ambulatory surgery, emergency departments, and/or residential health care facilities;
      (c) Surveillance-surveillance of hospitals, ambulatory surgery, emergency departments, and/or residential health care facilities including investigation of fraud and abuse, medical audit, utilization review, and outbreak detection;
      (d) Health Planning and Resource Allocation Studies-the rational allocation of limited resources to health care, provision of adequate health care and article 28 approval processes;
      (e) Epidemiological Studies-epidemiology identification of exceptional morbidity or mortality patterns for more in-depth study. Studies of prevalence and incidence of diseases can be indicated by these data;
      (f) Research Studies-investigation into a number of health care research studies, including utilization, variations of length of stay, disease dynamics and health economics, for patient use patterns;
      (g) Utilization Review of Resources-identification of emergency service patterns of utilization to assist in resource or intervention planning;
      (h) Quality of Care Assessment-review of hospital, ambulatory surgery, emergency department, and/or residential health care facility to assess quality of care; or
      (i) Other-please list other potential possibilities for research and study."
    5. Protection of Human Subjects: Research applicants must fill out this section indicating whether or not Institutional Review Board (IRB) review has been sought for this study/project. For this application, the research definition is taken from the National Association for Healthcare Quality (NAHQ), which states: "research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge" of health care services. A research study tests a general hypothesis and may lead to the publication of the results. Non-research studies would involve Department of Health functions such as surveillance, registry and intervention activities. Research for the means of promoting, marketing, selling, commercial or competitive purposes, or for distributing the data as a product or service is not permitted. Furthermore, research identifying individuals (including but not limited to patients, physicians, and other health care providers) would violate the use of this data and the HIPAA Privacy Rule.

      The IRB may waive the need for such an approval and this should be indicated. If IRB approval is pending this should also be noted. It is important to note that although there may not be direct patient contact some types of data reviews involving confidential patient data do require IRB review.
    6. Data Requested: The DPRB takes special precautions in releasing these deniable (identfifying) data elements. The Board will consider the merits of the proposed study/research and the need for these particular data elements in the study. This will be weighed against the need for patient confidentiality. This section identifies the types of data requested:
      1. Type and Time Period of Requested Data: Select the specific data files and list the years needed: (a) Patient Review Instrument (PRI) is the data submitted on PRI forms by residential health care facilities pursuant to NYCRR Title 10 §86-2.30 (b) SPARCS Inpatient Data File contains all inpatient discharges for Article 28 facilities as per NYCRR Title 10 §400.18 (c) SPARCS Outpatient Data Files contain ambulatory data and emergency department data. The SPARCS Outpatient file has three versions. One version consists of both ambulatory surgery and emergency department services discharges. Another version contains only ambulatory surgery discharges. A third version contains only emergency department services discharges.
        1. SPARCS Ambulatory Surgery Data is defined in NYCRR Title 10 §755.1. It is a surgical procedure performed in an operating room on an anesthetized patient with a stay less than 24 hours. Procedures which can be performed safely in a private physician's office or outpatient treatment room are not collected by SPARCS.
        2. Emergency Department Services are defined as those services having a revenue code of 045X.
      2. HIV/AIDS Records: Denote the specific need for patient identifiers associated with HIV/AIDS records on the SPARCS datasets. Health Department policy stipulates that patient identifiers be filtered for those records that contain HIV/AIDS diagnosis.
      3. Abortion Records: Denote the need for physician identifiers associated with abortion records on the SPARCS datasets. Current Health Department policy dictates that physician license numbers are deniable when an abortion diagnosis or procedure code is present.
    7. Data Selection/Extraction Criteria: Select how the data files are to be extracted. If you select "none", the data file would contain all facilities statewide. The selection of specific facilities would result in a data file that contained only the facilities requested. If a facility specific study is being done, a notification letter to each targeted facility with a copy to DPRB Executive Secretary is required. Selection may also be based on specific patient populations, diagnoses or by other data elements or a combination of data elements. The DPRB will be reviewing the data applications to see if the release of SPARCS or PRI data should be limited due to the purpose of the proposed study/research.
  3. SUMMARY OF STUDY PROPOSAL AND PROJECT ACTIVITIES

    This study proposal section should be able to stand alone without any appendices. You may submit additional documentation, however items a through e must be answered succinctly in the body of this application.
    1. Primary Purpose: The specific health or medical conditions to be examined listed here will determine the only purpose for which the SPARCS data may be used. The approved data release can only be used for the primary purpose stated in this section.
    2. Objective(s): Include a description of the main issues to be addressed and the analysis to be conducted: hypothesis to be tested, publications, treatment practices, etc.
    3. Benefit(s): Describe the merit(s) of this study/research. The benefit of the project or research will be weighed against patient confidentiality issues.
    4. Contractor(s): Identify and include a description of their involvement in the study/research. Please note whether their involvement would be at the raw or aggregate data level.
    5. Linkage: Linkage of SPARCS or PRI data with other data sources must be identified.
      1. Describe what data elements in SPARCS or PRI will be used to link with the other data source(s) and identify what data elements in the other data source that will link with the SPARCS or PRI data.
      2. Describe what SPARCS or PRI data is linked with another data source and the data elements the linked data file contains. The data received from the Department of Health may not be linked with any data that contains identifying data/patient information for which the applicant is not approved.
      3. Approvals must be secured from the owners of the data sources to be linked.
  4. QUALIFICATIONS OF THE APPLICANT TO UNDERTAKE THE STUDY
    1. In evaluating the need for the release of deniable data, the Board assesses the organization's mission, goals and past research or studies and how it relates to the study/project.
    2. The DPRB must determine the ability of the applicant to carry out the proposed study/project. Describe the qualifications and credentials of the project director.
    3. Describe the qualifications and credentials of those individuals listed on this application as having access to identifying SPARCS/PRI data.
  5. PAST REQUESTS

    Indicate whether the project director or organization has previously requested SPARCS or PRI identifying information. Provide the Identifying Data Request Number(s) and the approximate date(s) for previously approved applications.
  6. IDENTIFYING DATA ELEMENTS REQUESTED

    There are two sections for Identifying Data Elements: a. SPARCS Identifying Data Elements, and b. PRI Identifying Data Elements. Please use the appropriate section. Please check off the appropriate box for each deniable (identifying) data element requested. Provide a justification for each specific data element requested as it relates to your study/research in the space provided. There must be a specific need for each identifying data element. If the data element requested is not adequately justified then that data element will be denied. The implementation dates for each data element are listed under Collection Start Date.
    a. SPARCS Identifying Data Elements Collection Start Date
    Inpatient Outpatient
    Accident Related Date 1994 2003
    Admission Date/Start of Care 1982 1995
    Date Alternate Care Required 1982-1999
    Discharge Date (Ambulatory Surgery Service Date) 1982 1983
    Medical Record Number 1982 1983
    Mother's Medical Record Number for Newborn Child 1990
    Non-Acute Care from Date 1999
    Non-Acute Care through Date 1999
    Patient Birth Date 1982 1983
    Patient Control Number 1982 1983
    Patient Residence Address - Address Line 1 1982 1997
    Patient Residence Address - Address Line 2 1994 2003
    Patient Zip Code Extension 1994 1994
    Policy Number 1992
    PreHospital Care Report Number 1994-1997
    Principal Procedure Date 1983 2003
    Statement Covers Period - from Date 1982
    Statement Covers Period - thru Date 1982
    Unique Personal Identifier 1995 1997
    Other Procedure Date 1-4 1982
    Other Procedure Date 5 1992
    Other Procedure Date 6-14 1994
    Identifying Data Elements
    Requiring Additional Consideration
    Collection Start Date
    Inpatient Outpatient
    Physician ID/State License Numbers w/Abortion Records 2000 1999
    HIV/Aids Deniable Data Element 1999 1999

    Note: The SPARCS data elements definition along with its codes, values and edit applications can be found in the Inpatient Output Data Dictionary and Outpatient Output Data Dictionary.

    b. PRI Identifying Data Elements Collection Start Date
    Admission Date 1986
    Medical Record Number 1986
    Medicaid Number of Patient 1986
    Medicare Number of Patient 1986
    Operating Certificate Number 1986
    Patient Birth Date 1986
    Patient Name 1987
    Patient Room Number 1986
    Patient Unit Number 1986
    Social Security Number 1986
  7. CONFIDENTIALITY OF DATA
    1. Narratives: Describe how the confidentiality of the requested data will be maintained. If SPARCS or PRI data are to be linked with other data sources, describe the confidentiality measures that will be in place for this linked data file. In order to ensure that patient privacy is protected, please provide an explanation of how and where identifying data will be stored, how access to that data will be regulated and how and when you plan to dispose of the data after the study/project is completed.
      1. Processing and Storage of Data:
      (a) Indicate whether the identifying data will be stored at the project director's employment location.
      (b) Indicate whether another organization, vendor, contractor or other identity will store, manipulate or process this identifying data.
    2. Affidavits: Every individual that has any access to the identifying data as approved for release by the Data Protection Review Board must be listed in the affidavit section of the application. Each individual must have a signed affidavit on file with the Bureau of Biometrics and Health Statistics or data will not be released. Each affidavit is signed and notarized, and reiterates the confidential nature of the data release, restrictions and responsibilities regarding the use of such data. In addition, the approved data release can only be used for the primary purpose as stated in the "Summary of Study Proposal and Project Activities", question 3a. The "Confidentiality of Data" (Question 7) section of the application and the affidavit state that only those individuals that are listed in the data application and have a signed affidavit may have any access to this data, and that this data can only be used for the specific purpose contained in the application.
    3. Release of Data: Please explain how any aggregate data derived from the approved application will be used. List any potential uses such as presentations, publications, release to clients, consultants, contractors, etc.
      1. List the specific release of information.
      2. Describe what will be released and in what format. If any examples of previous releases are available, please attach it to the application.
  8. DPRB REQUIREMENTS: ONLY USE FOR THE PURPOSE OF THIS STUDY
    1. Data Retention: Indicate whether there are any problems with destroying or returning the deniable (identifying) data and any data sources containing identifying data to the Bureau of Biometrics and Health Statistics. If there is an expectation that the retention of the requested identifying data will be beyond two years, a request for this extension must be requested and granted in writing from the Bureau of Biometrics and Health Statistics before the expiration of the two-year timeframe. Please provide an explanation of why this extension of data retention is expected.
    2. Required Signatures: This section requires the signature of the project director and the organization representative.
      1. Project Director:
      The signature of the project director is to attest to the understanding that Health Department's staff can request the project director to submit quarterly statements describing how the deniable data elements are being used and all releases of these data elements including aggregate data releases. The statement requested is to include the identification of who received the information, data elements released and purpose of the release. By signing below the project director attests that this data will be used for the sole purpose of the research study/project identified in the data application and that the identifying data will not be shared with any person or entity not covered by this application.
      2. Organization:
      The signature of the project director is to attest to the understanding The signature of the organization representative (the individual that is responsible for the work of the project director) is required. This organization representative attests to the fact that confidential data is being requested for certain usage by the project director and that there are special confidentiality requirements regarding the use, maintenance, storage, and destruction of this data.

Organizational Affidavit (DOH-4385, pages 13-14)

Please complete the affidavit with the appropriate signatures and notarization. If this affidavit is not applicable to your request, you MUST still complete the form by indicating "N/A" - not applicable.

Individual Affidavit (DOH-4385, pages 15-16)

Please complete the affidavit with the appropriate signatures and notarization. If this affidavit is not applicable to your request, you MUST still complete the form by indicating "N/A" - not applicable.

NYS DOH Application (DOH-4385, page 17)

Please complete the affidavit with the appropriate signatures and notarization. If this affidavit is not applicable to your request, you MUST still complete the form by indicating "N/A" - not applicable.