N.H. Admin. Code § He-P 3012.07

Current through Register No. 45, November 7, 2024

Section He-P 3012.07 - Program Ability to Share Data

(a) Health information, including individually identifiable health information available to the NHBCP under He-P 3012.03, shall be used to determine the prevalence and trends of birth conditions, to develop and assess prevention strategies, and to promote scientific collaboration through analyses, investigations, and epidemiological studies on the public health impact and possible causes of birth conditions.

(b) Pursuant to RSA 141-J:3, I, the NHBCP shall not provide individually identifiable health information relating to New Hampshire residents to any similar program operated by any other state or the federal government.

(c) The NHBCP shall maintain the confidentiality of all individually identifiable health information collected, except as allowed pursuant to RSA 141-J:4 and RSA 141-J:7 and in accordance with (d) below.

(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.

(e) Persons who fraudulently request data shall be subject to the penalty for unsworn falsifications in accordance with RSA 641:3.

N.H. Admin. Code § He-P 3012.07

#9404, eff 3-5-09, EXPIRED: 3-5-17

Amended by Volume XXXVII Number 32, Filed August 10, 2017, Proposed by #12333, Effective 7/22/2017, Expires 1/18/2018.

Amended by Volume XXXVIII Number 06, Filed February 8, 2018, Proposed by #12448, Effective 1/9/2018, Expires 1/9/2028.