Section He-C 1504.04 - Release of Limited Use Facility Discharge Data Sets Except as otherwise provided by law, limited use facility discharge data sets shall be released to principal investigators for the purposes of research under the following conditions.
(a) The principal investigator shall submit a written application on a form provided by the department containing: (1) The principal investigator's: a. Name, address, and phone number;b. Organizational affiliation;c. Professional qualification; andd. Name and phone number of principal investigator's contact person, if any;(2) The names and qualifications of additional research staff, if any, who will have access to the data;(3) A research protocol containing: a. A summary of background, purposes, and origin of the research;b. A statement of the health-related problem or issue to be addressed by the research;c. The research design and methodology, including either the topics of exploratory research or the specific research hypotheses to be tested;d. The procedures that will be followed to maintain the confidentiality of any data or copies of records provided to the principal investigator; ande. The intended research completion date; and(4) Information about the data set being requested, including: a. The time period of the data requested;b. The minimum needed data elements required;c. A justification for the need for any data elements that are potentially indirect patient identifiers and specification of how the data should be recoded by the department to make the data element less of a potentially indirect patient identifier;d. The selection criteria for the minimum needed data records required; ande. Any special format or layout of data requested by the principal investigator.(b) The principal investigator shall submit a signed data use agreement that specifies that the principal investigator shall: (1) Use the data for only the purpose specified in the application;(2) Establish appropriate safeguards to protect the confidentiality of the data and prevent unauthorized use of the data;(3) Not use or further disclose or sell the data set or statistical tabulations derived from the data set to any person or organization other than as described in the application and as permitted by the data use agreement without the written consent of the department;(4) Not use or further disclose the information as otherwise required by law;(5) Not seek to ascertain or disclose the identity of patients, employer groups or purchaser groups revealed in the limited use data set;(6) Not seek to ascertain or disclose any of the information removed from the data or encrypted as specified in He-C 1502.01(u) above that specifies the exclusions from the limited use data set;(7) Not publish or make public the content of cells that contain counts of patients in statistical tables in which the cell size is more than 0 and less than 5;(8) Not publish or make public any information that could be used to ascertain the identity of providers of abortion services;(9) Report to the department, within 5 days, any unauthorized use or disclosure of the information, of which the principal investigator becomes aware, that is contrary to the agreement;(10) Provide the department with a preview copy of a proposed release at least 15 days prior to any publication or release of any reports or publications containing information derived from the data set for review and verification that the conditions of the agreement have been met;(11) Not release any document determined to breach the conditions of the agreement;(12) Acknowledge the department as the source of the data in any and all public reports, publications, or presentations generated by the principal investigator from these data;(13) Specify that the analyses, conclusions, and recommendations drawn from such data are solely those of the principal investigator and are not necessarily those of any agency of the State of New Hampshire;(14) Retain the data only for the period of time necessary to fulfill the requirements of the data request;(15) Return the data within 30 days of the scheduled completion date of the project, or destroy the data, so certifying by submitting a written notice to the department, or reapply for approval within 60 days of scheduled completion if the principal investigator determines the end date of the project needs to be extended; and(16) Acknowledge that failure to adhere to the data use agreement shall be cause for immediate recall of the data, revocation of permission to use the data, and application of any applicable criminal liability under New Hampshire state law.(c) Applications for the release of limited use data sets shall be approved when the department determines that: (1) The application submitted is complete pursuant to (a) above and the principal investigator has signed the data use agreement as specified in (b) above;(2) Procedures to ensure the confidentiality of any patient and any confidential data are documented;(3) The qualifications of the investigator and research staff are documented by: a. Training and previous research, including prior publications; andb. An affiliation with a university, private research organization, medical center, state agency, or other institution that will provide sufficient research resources; and(4) No other state or federal law, or federal regulation, prohibits release of the requested information.(d) The department shall provide notification of denial or approval within 30 days of receipt of the application.(e) Notification of denial shall include a written statement identifying of the specific criteria that are the basis for denial of the application.(f) Studies taking longer than 2 years shall require annual application after the first 2-year period.(g) The principal investigator shall comply with the conditions in the data use agreement in (b) above.(h) In the event the department determines that any report or publication referenced in (b) above might lead to direct or indirect identification of patients, employers, or other group purchasers, the department shall provide a written statement to the researcher stating specifically the problematic sections in the publication. The requesting party shall modify the report or publication prior to its release by fully addressing the problematic sections. No cause other than direct or indirect identification of patients, employers or other group purchasers shall be given to prevent publication of information derived from the data.(i) When multiple reports of a similar nature will be created from the data, upon request the department shall waive the requirement that any subsequent reports or publications be provided to the department prior to release by the requesting party.(j) Any draft reports or publications supplied to the department shall be treated as confidential and shall not be released by the department.(k) Information regarding release of limited use data sets and records of the review of publications shall be made available upon request.N.H. Admin. Code § He-C 1504.04
Amended by Volume XXXVII Number 15, Filed April 13, 2017, Proposed by #12139, Effective 3/22/2017, Expires 9/18/2017.