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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.

Minnesota Statute Sections §144.291 to 144.298



 

 

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:
The Commons at Midtown Exchange
Mail Route 10105
2925 Chicago Avenue
Minneapolis, MN 55407-1321