Current through Register No. 40, October 3, 2024
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; and
d. 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; and
e. 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; and
e. 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; and
b. 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.