(d) Health information and
individually identifiable health information that is made available to the
NHBCP concerning an individual, and any other information maintained by the
NHBCP, which, because of a personal identifier, can be readily associated with
an individual, shall only be released:
(1) To
the individual upon receipt of:
a. A written
request which shall be signed by the individual;
b. A certified copy of the birth certificate
of the individual; and
c. A copy of
the individual's identification, such as a driver's license;
(2) If the individual is a minor,
to a parent of the individual upon receipt of:
a. A written request, which shall be signed
by the parent;
b. A certified copy
of the birth certificate of the individual; and
c. A copy of the parent's identification,
such as a driver's license by the parent;
(3) If the individual has a court-appointed
guardian or if the individual is deceased, to the court-appointed guardian or
to the executor or administrator of the individual's estate upon receipt of:
a. A written request, which shall be signed
by the court-appointed guardian, executor, or administrator of the
estate;
b. A certified copy of the
order or decree which appoints the guardian, executor, or administrator;
and
c. A copy of identification,
such as a driver's license, of the guardian, executor, or
administrator;
(4) To an
attorney or other person designated by the individual upon receipt of a written
medical release request which shall be signed by the individual;
(5) Pursuant to
RSA
141-J:7, relative to a legal proceeding upon
receipt of a written authorization from the person about whom the information
relates; and
(6) To persons
conducting health related research upon receipt and approval of a written
request to the department pursuant to
He-P
3012.08, which shall be signed by the requestor and
include:
a. The following information about
the principal investigator:
1. Name, address,
and phone number;
2. Organizational
affiliation;
3. Professional
qualification; and
4. Name and
phone number of principal investigator's contact person, if any;
b. The following information about
the data or record copies being requested:
1.
Type of event or record copies;
2.
Time period of the data or record copies;
3. Specific data items required, if
applicable;
4. Medium in which the
data or record copies are to be supplied; and
5. Any special format or layout of data
required by the principal investigator;
c. A research protocol containing the
following:
1. A summary of the background and
origin of the research;
2. A
statement of the health-related problem or issue to be addressed by the
research;
3. The primary research
hypothesis to be tested;
4. The
research design, which shall include:
(i) Case
definition;
(ii) Method of case
selection; and
(iii) Method of data
analysis;
5. The
research methodology, including:
(i) The way
in which the requested data will be used; and
(ii) The procedures for follow-back to any
persons or facilities named in records, if applicable;
6. Procedures to obtain informed consent from
the research participants, if applicable;
7. The procedures that will be followed to
maintain the confidentiality and security of any data or copies of records
provided to the requester; and
8.
The intended completion date;
d. A written statement signed by the
principal investigator agreeing to the following:
1. "I am the person in charge of the
health-related research project, as described in the written request. I am the
custodian of the data responsible for the observance of all conditions of use
and for establishment and maintenance of security arrangements to prevent
unauthorized use of the data and copies of records obtained";
2. "I acknowledge that the department is the
source of the data in any and all public reports, publications, or
presentations generated by me or the written research request from this
data";
3. "I acknowledge and
specify that the analyses, conclusions, and recommendations drawn from the data
are solely my own or those developed as part of the health related research and
are not necessarily those of the department";
4. "I agree that any copies of data or
records provided during the health related research shall not be used for any
purpose other than that described in the written request";
5. "I shall not disclose the identity of
individuals revealed in the data or record copies to any persons except as is
necessary to perform the research described in the written request";
6. "I agree to have a procedure in place to
require research staff to agree not to disclose the identity of individuals
revealed in the data or record copies to any persons except as is necessary to
perform the research described in the written request";
7. "I agree that the data record shall not be
further released to any other person or organization without the written
consent of and under the terms specified by the commissioner or his designee";
and
8. "I agree that no form of
information derived from the data or record copies that identifies any
individuals shall be made public.";
e. A written statement signed by the
principal investigator stating: "I agree to indemnify the department accepting
all responsibility on behalf of the research project if I or a member of the
research staff cause an unauthorized disclosure of individually identifiable
health information"; and
f.
Documentation of Institutional Review Board (IRB) approval for the study by an
IRB formed in accordance with the requirements of the U.S. Department of Health
and Human Services Code of Federal Regulations for Protection of Human
Subjects, 45 CFR 46.
