Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 253 - MAINE CHRONIC DISEASE SURVEILLANCE DATA QUALITY AND FOLLOW-UP STUDY RULES › Section 144-253-7 - CONDUCT OF INVESTIGATIONS AND CONFIDENTIALITY

Current through 2024-29, July 17, 2024
A.
				Responsibilities of investigators
1
				Department investigators and investigation staff/employees will sign a
				confidentiality agreement regarding study conduct and assurances of
				confidentiality when working with confidential data elements.
2 Appointed investigation personnel, those
				who are deemed necessary to the function of the study, who are not, however,
				Department employees, will need the approval of the oversight advisory body and
				their conduct shall be governed by these same Department rules and regulations
				and who will be required to abide by the same confidentiality assurances and
				restrictions as Department employees.
3 The Department investigator and
				investigation staff are to follow professional standards when using identifying
				information and conduct themselves in a manner to assure
				confidentiality.
4 Measures for
				assuring confidentiality and the integrity of the Maine chronic disease
				surveillance program databases as well as restricting access to case specific
				data by employees of the Department and others include:
(a) establishing a series of passwords and
				internal security codes for access to the Maine chronic disease surveillance
				databases;
(b) storing all
				completed hardcopy of confidential case-specific information in locked file
				cabinet, secure room, safe or similar container; or a locking valise when
				performing field investigations;
(c) disposing of all chronic disease program
				preliminary data listings, test retrievals and other sensitive information in a
				confidential manner, e.g., shredding of documents with identifying
				information;
(d) the use of system
				IDs and other intermediate codes to prevent case-specific
				identification.
5 Prior
				to requesting access to medical records Department investigators shall inform
				the hospital administrator, director of the Medical Record Department and
				President of the Medical Staff of the intentions of the investigator with a
				brief description of the purpose of the investigation/verification. If a
				full-scale follow-up epidemiologic study is involved, a copy of the study
				protocol with methodology shall be included. If the investigation/verification
				is of a general protocol nature as described in Section 8(A), a copy of the
				general study protocol with methodology and advisory body approval shall be
				provided to the aforementioned members of the hospitals participating in this
				project.
6 Discussion, transfer,
				and/or review of identifying information will be restricted to Department and
				advisory body approved and appointed investigation members, involved health
				practitioners and hospital personnel who have custody of such data.
7 Those persons participating in the
				investigation will not disclose medical information about an identified patient
				to any other person except a health care practitioner responsible for treating
				the patient and other responsible hospital personnel.
8 Department investigators and investigation
				staff shall not release, furnish, disclose, publish or otherwise disseminate
				any identifying information to any person except those specified above and
				those who have agreed in writing to comply with the confidentiality agreement
				after advisory body approval.
9
				Investigators gaining access to medical information about an identified patient
				shall use that information to the minimum extent necessary to accomplish the
				purposes of the investigation.
10 The
				investigators and investigation staff shall make only such additional copies of
				the data as are required in the conduct of the research and, after the term of
				the research concludes, shall retain only one copy of the data for a period of
				time specified in the study protocol.
11 Additionally, unless specifically
				addressed in the study protocol or explicitly directed to do so by the advisory
				body, the investigators and investigation staff shall not use the data provided
				to take legal, administrative or other actions against individuals, nor shall
				the requesting party make contact with or assist others in making contact with
				any patients who may be indirectly identified in the data provided.