Guidance Pertaining to Minnesota Statute Sections §144.291 to 144.298
Release of Medical Records for Research Purposes
As a general rule, a provider may not release a patient’s health record without
consent of the patient or the patient’s legally authorized representative, unless
the release is specifically authorized by law.
Prior to January 1, 1997, the law allowed the release of medical records for
research purposes without specific patient consent, as long as the patient had
not objected to the release of his records for research purposes and the provider
releasing the records determined that:
The disclosure of the records did not violate any limitations under which
the record was collected;
The disclosure in patient identifiable form was necessary in order to conduct
the research;
The researcher safeguarded the records, to protect them from unauthorized
disclosure (including a procedure for removal or destruction of patient identifiable
information); and
The researcher did not release the records in identifiable form to anyone
else without patient consent.
Effective January 1, 1997, the law was changed to allow the release of medical
records to external researchers only with written consent.
The consent applies to the patient’s entire medical record, rather than to
just the portion of the record generated during any particular admission. The
consent does not expire, but may be revoked or limited in writing at any time.
Consent may be established if a consent form is mailed to the patient at least
twice, the correspondence indicates that the patient’s medical records may be
released for research if the patient does not object, and at least 60 days have
elapsed since the second notice was sent.
The law still states that a provider may release records for research purposes
only after determining that:
· The disclosure of the records does not violate any limitations under which
the record was collected;
· The disclosure in patient identifiable form is necessary in order to conduct
the research;
· The researcher safeguards the records, to protect them from unauthorized disclosure
(including a procedure for removal or destruction of patient identifiable information); and
· The researcher does not release the records in identifiable form to anyone
else without patient consent.
Providers that release records for research purposes must, at the request
of the patient, tell the patient how he may contact an external researcher to
whom the record was released and the date the record was released.
The law requires consent for the release of records to external
researchers.
As a general rule, Allina employees and medical directors serving Allina will
not be considered to be external researchers as long at the research they are
conducting is consistent with and reasonably related to their duties to Allina.
Patient consent will not be required in these instances.
Private physicians who are on the medical staff at a facility, but who are
not employed by or under contract with Allina, are considered to be external
to Allina, and patient consent is required in order to release records
to such physicians. Study coordinators working for such physicians are also
considered to be external to Allina in these circumstances, even if the study
coordinators are employed by or under contract with Allina. This is the case
because the coordinators are attempting to access records to serve the purposes
of the medical staff member, who is external.
Physicians who are under contract with Medica to provide services to Medica
members are considered to be external to Allina, and patient consent
is required in order to release records to such physicians.
The necessary consent may be established if a consent form is mailed to the
patient at least twice, the correspondence indicates that the patient’s medical
records may be released for research if the patient does not object, and at
least 60 days have elapsed since the second notice was sent.
A provider that releases a medical record in violation of this statute is liable
to the patient for compensatory damages, and such a release may be grounds for
disciplinary action against a provider by the appropriate licensing board.
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