Section He-W 950.05 - Release of Limited Use Data Sets(a) In accordance with 45 CFR 164.514(e) (3) (i) , limited use data sets shall only be released for purposes of research.(b) Any researcher requesting access to limited use data sets shall submit a completed "Application for Access to New Hampshire Limited Use Commercial Health Claims Research Data Set" form (October 2014), and shall execute a contract which describes the permitted uses of data.(c) Except as otherwise provided by law, the department shall release the requested limited data sets when: (1) The application is complete pursuant to (b) above;(2) The applicant demonstrates the following:a. How inventory of data files will be maintained and updated;b. That physical access to the data files will be restricted to only research staff;c. That safeguards are in place for research staff, having access to the data files, including but not limited to confidentiality agreements and training on stewardship responsibilities;d. Procedures for tracking active employment and project participation status of research staff throughout the life the project(s);e. The technical and physical safeguards which will be performed to maintain security of the data files, including but not limited to site and office access controls, secured file cabinets and locked offices;f. The technical safeguards performed to protect data stored on local workstations and onsite and external servers;g. The method of encryption used as the data sets are moved between computers; and h. The technical safeguards performed to prevent the creation of additional copies of the data;(3) The qualifications of the investigator and research staff demonstrate their ability to undertake the study or accomplish the intended study as documented by: a. Training and previous research, including prior publications in the proposed or related area; andb. An affiliation with a university, private research organization, medical center, state agency, or other institution that will provide sufficient research resources;(4) The applicant has demonstrated that the data sets are required in order to undertake the study or accomplish the intended use; (5) The applicant has never been found to have violated the terms of a prior data use agreement; (6) The claims data release advisory committee has been given 45 days after receipt of the application to comment on the merits of the application to the department in accordance with He-W 950.06(d) below; and(7) No other state or federal law, or federal regulation prohibits release of the requested information.(d) If the department declines to release the limited use data sets, within 60 days of receipt of the application, the department shall provide a written statement identifying the specific criteria that are the basis for denial of the application.(e) Studies taking longer than 2 years shall require annual renewal of the request.(f) Except as provided in (i) below, the researcher shall provide the department with a copy of any proposed release at least 15 days prior to publication or release of any report or publication that contains information derived from the data set so that the department has the opportunity to review the release and verify that the agreed upon conditions have been applied. (g) If the department determines, based on the review required in (f) above, that a report or publication contains information that 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. (h) When the department issues a statement in accordance with (g) above, the researcher shall modify the report or publication prior to its release by fully addressing the problematic sections.(i) When the department determines that multiple reports will be of a similar nature, the department shall waive the requirement that any subsequent reports or publications be provided to the department prior to release by the researcher.(j) Any draft reports or publications supplied to the department shall be treated as confidential and shall not be released by the department.(k) The department shall:(1) Maintain records of applications for, and releases of, limited use data sets and make them available for public inspection;(2) Maintain a system for tracking the dates by which data sets shall be returned or destroyed; and(3) Maintain records of the review of publications, if applicable.N.H. Admin. Code § He-W 950.05
Amended byVolume XXXIV Number 46, Filed November 13, 2014, Proposed by #10703, Effective 10/23/2014, Expires10/23/2024.