Research Community Resources
Hennepin Healthcare and the Hennepin Healthcare Research Institute are committed to improving patient care and the health of our community through research and education. In the spirit of transparency, below you will find documents relating to past findings by the FDA and the steps we have taken to improve.
Resources and Reports
The following documents are in PDF format.
Hennepin Healthcare Statement
Hennepin Healthcare statement on notification of compliance - Oct 19, 2021
PREHOSPITAL
FDA Notification of Compliance, Prehospital - Oct. 6, 2021
FDA Warning letter and Hennepin Healthcare response letter, Prehospital - May/June 2021
FDA 483 Observation and Hennepin Healthcare response letter, Prehospital - April 26, 2019
HOSPITAL
FDA Notification of Compliance, Hospital - Oct. 6, 2021
FDA Warning Letter and Hennepin Healthcare response letter, Hospital - May/June, 2021
FDA 483 Observation and Hennepin Healthcare response letter, Hospital - April 23, 2019
IRB
FDA 483 Observation and Hennepin Healthcare response letter, IRB - August 23, 2018
The following documents are in PDF format.
- January 24, 2019 Statement from Hennepin Healthcare
- January 24, 2019 Summary of the group review of body camera footage of incidents cited in the OPCR draft report
- January 23, 2019 Assessment of Hennepin Healthcare’s Response to Prehospital Sedation Concerns
- November 15, 2018 Review of EMS clinical protocols and practice
- November 12, 2018 Review of the IRB process and waiver of consent
Reaccreditation awarded to Hennepin Healthcare for research program involving human participants.
