Release of Patient Identifiable Medical Records For Research Purposes
Policy Number RES 100.02 (Approved 12/99) Policy
It is the policy of Allina Health System (“Allina”) to consistently and fully
comply with state and federal law pertaining to the release of medical records
for research purposes. Specifically, and in no way limiting the foregoing, it
is Allina’s policy to comply with the provisions of Minnesota Statute Sections
144.291 to 144.298.
Goal
The goal of this policy is to ensure that Allina conducts the internal use and
external release of medical records for research purposes in accordance with
all applicable laws.
Definitions · External release of medical records: The release of medical records to individuals
or entities outside of Allina for research purposes. This includes, but is not
limited to, the release of medical records to: (a) medical staff members who
are not employed or under contract with Allina, (b) study coordinators who request
patient records to facilitate their work for such medical staff members, and
(c) physicians under contract with Medica to provide health care services to
Medica members.
· Internal access to medical records: Allina employee and/or medical director
access to medical records to facilitate research conducted by such individuals
when the scope of such research is consistent with and reasonably related to
the individual’s duties as an Allina employee or his/her role as a medical director.
Overview
Prior to allowing an external release of medical records for research purposes,
Allina shall obtain written consent for such release from the affected patient
or his/her authorized representative. Such consent shall apply to the patient’s
entire medical record held by Allina, and not simply to the portion of the record
documenting a particular hospital admission. Additionally, before allowing an
external release of medical records, Allina shall confirm with the researcher
that the disclosure of records in patient identifiable form is necessary to
conduct the research, that the researcher will safeguard the records to protect
them from unauthorized disclosure, and that the researcher will not release
the records to anyone else without patient consent.
Patient consent is not required for internal access to medical records for research
purposes. Additionally, patient consent is not required for the release of medical
records generated prior to January 1, 1997, as long as (1) the patient has not
objected to the release of his/her records for research purposes, and (2) Allina
confirms with the researcher that the disclosure of such records in patient
identifiable form is necessary to conduct the research, that the researcher
will safeguard the records to protect them from unauthorized disclosure, and
that the researcher will not release the records to anyone else without patient
consent.
Whenever Allina allows an external release of medical records for research purposes
(whether with or without consent, as set forth in applicable law), Allina shall
document such release in the patient’s medical record. In the event a patient
requests information about the release of his/her records, Allina shall inform
the patient of how he/she can contact the external researcher to whom the record
was released and the date the record was released.
Specific procedures consistent with this overview will be developed, and such
procedures will be implemented at the business unit level.
Accountabilities
Individuals at each Allina business unit that houses medical records will be
responsible for compliance with applicable law and this policy when considering
release of such records for research purposes. Procedures consistent with this
policy shall identify such individuals more specifically. In the event there
is a dispute with regard to the release of medical records for research purposes,
the accountable individual at the business unit involved shall contact Allina
Research Administration for assistance. In the event the dispute can not be
resolved through Research Administration, Research Administration will then
forward the issue to the Research Compliance Oversight Committee for resolution.
Allina Research Administration
Mailing Address:
Mail Route 10105
PO Box 43
Minneapolis, MN 55440-0043
Phone: 612-262-4922
Fax: 612-262-4953
Office Location:
Allina Commons at Midtown Exchange
Mail Route 10105
2925 Chicago Avenue
Minneapolis, MN 55407-1321
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