Office of Clinical Research

It is a law passed by Congress that went through its final review and regulatory rule making recently. Implementation of the key features of the Act are taking place. As a result of the 21st Century Cures Act and the new ruling from the Health and Human Services department of the Federal Government, Penn Medicine is required to allow patients increased access to their electronic medical record. The purpose of this Act is to promote the patient’s right to electronically access their information, expand the electronic exchange of health information, standardize & expand the content of the health information dataset, reduce barriers for electronic health information exchange, and prevent health information exchange blocking.

 See direct link to the FDA’s website on the 21^st Century Cures Act: CLICK HERE 

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Studies have found that patients are more engaged, more likely to adhere to care team instructions, and are better able to engage family members in their care when they can understand they ‘why ‘behind various treatments, tests, etc. Even more importantly, patients have a right, under HIPAA to their own protected health information. This act does not necessarily add to what a patient can see coming from the electronic records and systems, it just makes it easier and, more direct, and in some cases, faster.

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Almost everything that is in the electronic medical record (EMR) PennChart such as clinic notes, test results, and medications will be shared with the subject via the patient portal, MyPennMedicine (MPM). Much of this information is already shared with patients but this is new in terms of speed of sharing and a greater scope of information shared.

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You may already know that MyPennMedicine (MPM) is Penn Medicine’s patient portal. Patients currently schedule appointments, communicate with their care team, receive certain test results, and can choose to participate in research via MPM.

With the Cures Act, information from the patient’s chart/ EMR will be more transparently available to the patient. Clinical care and research visit information will be available in MPM for the patient to view immediately as they are made available in the EMR.

This will impact the way some research information is currently communicated to Penn Medicine patients that participate in research studies.

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You should release results and notes to subjects per protocol and consent form in accordance with your clinical trial agreement (CTA). To release results that were previously suppressed you may use the following tip sheet- Suppressing PennChart Research Results from Being Released via MyPennMedicine

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The goal of this Act is increased transparency and Penn Medicine is required by law to send/ communicate research documentation and Results through MPM as soon as they are available in the EMR. The bar for not sharing information is high such as, risk of immediate physical harm to self (like Huntington’s diagnosis that has evidence of high suicidality) or immediate harm to care team. A reason must be provided within PennChart if research teams choose to not send results to patients’ MPM portal at the time of placing the order.

Possibility of mental harm, and risk of proxy viewing for pediatric population does not meet the threshold of suppression, under the Act.

The law does allow for delayed release (see table below) for research and certain exceptions where results can be suppressed from communication.

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*NOTE: If the research team (coordinator, nurse or provider) choose to not send the results to the patients MPM portal at the time of placing the order, or through the Provider’s InBasket at the time of results review; justification must be documented, such as patient consent or specified exempt such as blinding. 

**NOTE: Must be detailed in the Informed Consent Form

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For many clinical research studies, study documentation (progress note, research note) has occurred within PennChart, as well as various other sources. Many teams utilize notes in PennChart to document information about the subject in the trial including, but not limited to adverse event tables and assessments, smartphrases, study medication orders, etc.

Notes about research subjects recorded in progress notes will be shared with research subjects. If a protocol dictates that notes should not be shared with a research subject then the research note type may be used. The research note type by default will not be released to subjects- unless the research team chooses to release it. The consent form must specify in detail what information will be delayed, or not shared, with subjects and why. This may be common for blinded studies or where it would not be clinically appropriate to share the information. Research results will be shared with research subjects after 10 days, via the subject portal MyPennMedicine. However, when the protocol or contract with the sponsor dictates results should not be shared with a subject, results can be suppressed on an individual patient basis. This is the same as the current process used for blinded research studies. For more information refer to the following tip sheet- Blinded Studies in MyPennMedicine. Results may not be shared because they are blinded, there is no clinical relevance or documentation, the sponsor dictates this, etc.

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The informed consent process is a great vehicle for explaining to subjects the study protocol procedures as well as expectations for the subject. Template language has been added to the biomedical IRB informed consent to explain the impact of the Cures Act and what it means for subject participants. This is the place where research teams can describe what will be shared with subject during the course of the trial and what will not be. This section has heightened importance now to ensure subjects understand what information may be delayed and can consent to why it is being suppressed. This section should also specify the timeframe with which research information will be withheld i.e. till end of intervention, end of follow up period, end of study or, potentially never released.

Do I need to reconsent my subjects?

No, you do not need to reconsent your subjects as the current consent form should already cover what will and will not be shared with the research subjects. If upon review of your consent, you determine it does not explain well enough if there will be delays in sharing, then you should modify your consent and reconsent subjects.

New language appears in the biomedical research IRB consent template and that should be used moving forward but does not, in itself, elicit reconsent.

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If you are using an external lab in your study (e.g. Quest, LabCorp, etc.) we encourage you to discuss with your sponsor, or if you are the sponsor investigator with the vendor themselves, if they are releasing results directly to patients in compliance with the CuresAct. If, for your particular study, lab results are coming back to PennChart, then they will be subject to our release restrictions. If they have been marked as research they will follow the ten day release for research results unless manually suppressed by the research team.

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As stated above with labs, if the vendor is collecting health related data they may be subject to release under the Cures Act. Discuss with the sponsor and/ or vendor what will be released and what may delayed and discuss with the subject during the consent process.

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Paper records are not subject to this particular law since it is in regards to EMRs and electronic information. However, in the spirit of transparency, should a subject request a copy of their research record it should be provided to them, even if it means they may need to be withdrawn from the study. Additionally, teams should review with subjects what will and will not be shared with them and information that is specified per protocol to be shared ; as would be the standard consent process.

Medical Records Release Website at Penn Medicine: https://www.pennmedicine.org/for-patients-and-visitors/patient-information/wellness-and-patient-support/medical-records

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Research information is shared via CareEverywhere. This includes research notes and results. These can be suppressed, when appropriate per protocol and consent. Patients are able to opt out of Care Everywhere or Health Information Exchange (HIE) by contacting their front desk staff or privacy office here: INSERT LINK.

Please note that Care Everywhere rules are organization specific. For example, if a patient may choose to opt out of Care Everywhere at Penn Medicine but may not choose to opt out at Thomas Jefferson University Hospitals. 

Notice of Privacy Options: https://www.pennmedicine.org/for-patients-and-visitors/patient-information/hipaa-and-privacy/hipaa-notice-of-privacy-practices

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Telephone encounters will display in MyPennMedicine, so they will be shared in MPM.  Telemedicine encounters and notes from those encounters are shared. 

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Radiology results/ reads are also subject to immediate release starting on 5/16/2022. If you need do suppress them from going to a patient you can use the MPM results release suppression tip sheet. If there needs to be a delay for research specific reasons please discuss with OCR/ PennChart research team. There is a Cures Act grouper that can be used to suppress results for up to 10 days.

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