Release of Research Information to the Electronic Medical Record
HIPAA provides patients with access to their medical records and more control over how their PHI is used and disclosed. Therefore, participants must be informed when research related information will be released to their medical records. Likewise, the 21st Century Cures Act established increased patient access to their electronic medical records as of April 2, 2021.
Release of Study Related Information into the Electronic Medical Record (EMR)
The biomedical informed consent form template includes required template language to inform subjects about the potential for research information to appear in their electronic medical record maintained by Penn Medicine.
21st Century Cures Act and EMR Access
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.
Research Related Information
Research-related information refers to research data or information that may be contained in research notes, clinical progress notes, physician orders, test results, etc.
When is EMR language required?
This language is required for research being conducted within Penn Medicine when research information and results may be placed into the electronic medical record, or the study is otherwise built in the EMR. Studies must be built into the EMR/ PennChart if the study will be utilizing PennChart EMR ordering, billing, or recruitment capabilities.
Suppressing or Delaying Release of Information in the EMR
The Cures Act 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. However, there are limits. Please review the IRB Guidance below on the impact of 21st Century Cures Act on research protocols. If you have more general questions about the Cures Act, please review OCR’s FAQ and contact OCR Operations with further questions.
Certificates of Confidentiality (COC) and the EMR
If you have obtained a COC from the NIH and need more information about entering information protected by a COC in a subject’s medical record, please review the guidance of COCs.
Frequently Asked Questions about the EMR and Release of Study Related Information
If you have additional questions that are not answered below, please contact the Office of Clinical Research.
What do you mean when you say Electronic Medical Record?
The electronic medical record (“EMR”) refers to all potential sources of electronic information in which an individual’s record of care may be captured. This includes but is not limited to EPIC, Medview, eWebHealth, Sunrise, Cerner, GECentricity and other diagnostic testing systems.
My study does not use Penn Medicine or UPHS clinical services. Why do I have to include this language in my consent form?
Even if your study uses an external service (e.g., a commercial lab) there is a potential that results from these tests may feed back into the EMR for an individual. This could occur because of links established for billing purposes or may occur simply because an individual scans the record and inputs it into the system. Since there can be no guarantee that research results will not be included in a subject’s EMR, this language is required to inform subjects of this potential.
Can certain research-related information remain outside of the EMR?
Although there are mechanisms in place to restrict the information that may be included in the EMR, these mechanisms cannot be guaranteed as research-related information can be placed in the EMR by a simple action such as a fax between investigators for consultation on a test result. For this reason, subjects must be informed of the potential that research-related information may be included in the EMR. Furthermore, once placed in the record, clinicians may subsequently incorporate that information into future clinical decision making.
What if a subject asks not to have research-related information included in their EMR?
The study team should inform the subject that unfortunately, this cannot be guaranteed and agreeing to participate in this study means that the subject is willing to participate knowing that this may occur.