The Impact of the 21st Century Cures Act & Electronic Medical Records Access on Clinical Research

 

As a result of the 21st Century Cures Act, Penn Medicine is required to allow patients increased access to their electronic medical record. With the Cures Act, by default, research-related information* that is placed in the participant’s EMR will now be available within 10 days via MyPennMedicine (MPM), Penn Medicine’s patient portal. This goes into effect on April 2, 2021.

 

Research-related information refers to research data or information that may be contained in research notes, clinical progress notes, physician orders, test results, etc.

 

The law allows for suppressing research-related information within the medical record. The law also allows for delayed release of research-related information within the medical record.

 

Please review the IRB Guidance on the impact of 21st Century Cures Act on research protocols and consent forms here to determine whether you may need to submit an amendment to the IRB.

 

Due to these requirements, changes were made to the Informed Consent Form templates. 

• If you have questions about the Cures Act and how to suppress or delay results in the EMR, you should reach out to the Office of Clinical Research at psom-ocr@pobox.upenn.edu.
  
  
• If you have questions about IRB consent form template language or whether to submit an amendment, please contact the IRB PO Box: PROVOST-IRB@pobox.upenn.edu. New templates are available on the IRB Forms & Templates webpage.