Waiver of HIPAA Authorization: Meeting IRB Requirements

Posted by Ann Bittinger on 18/04/2017

IRB - ClinithinkProtecting the patients who participate in clinical trials is a legal requirement and a top priority for owners of e-health databases. Health systems, academic medical centers and other healthcare providers are looking for ways to make compliance with HIPAA and the Common Rule easier, while at the same time harnessing the e-health information in their databases to identify potential clinical trial participants.

As primary protectors of patient safety and privacy, IRBs play a key role in being able to meet these two objectives but getting a waiver of Authorization of the Rule’s informed consent requirements means proving that there is a low level of risk that patients’ privacy would be breached. However, most owners of e-health databases don’t have the in-house technical tools to quickly and easily scan patient information. More often than not, they require the implementation of a third party solution. This is typically considered another layer of complexity to leveraging health data, particularly with the advent of accessing and using unstructured clinical narrative. However, it really isn’t that complex. Think of it as just having a computer automate the pre-screening of patient records instead of having humans manually review. In addition, for many years now, sites have been using structured or discreet data sets to search for patients meeting clinical trial criteria, this information includes Protected Health Information (PHI).

CLiX ENRICH is a software application that allows organizations to search and interrogate their e-health databases to identify eligible clinical trial participants in a manner that is within the legal framework of both the HIPAA Privacy Rule and the Common Rule; and gives IRB members the confidence that PHI is safeguarded and simplifies the approval process of waivers.

Privacy as a priority

Simply put, CLiX ENRICH is installed in the organizations own environment and stays there. Unlike other third-party solutions, absolutely no e-health data is shared with the owners of CLiX ENRICH or any third party whatsoever.

Think of a health system’s e-health database as a library and its employees in charge of data management as its librarian. CLiX ENRICH empowers the librarian to identify potential participants without checking data out of the library and without inviting anyone into the library. The organization keeps its data in its library and most importantly, identifiable private patient information never leaves the site.

This in itself negates the risk associated with hiring an outside party or outsourcing the analysis of health information stored in the site’s databases or medical records. But before the clinical use of Natural Language Processing (NLP) technology to review health data, accessing data by a third party was unavoidable because health systems alone lacked the ability to identify potential subjects from the library’s private patient information.

Empowering stakeholders safely

Any time an outsider is given access to a patient’s records there is risk of inappropriate disclosure. In these situations IRBs were reluctant to grant waivers of the informed consent requirement to allow the researcher to review health information without patient consent.

Because CLiX ENRICH alleviates the need for an outsider and no identifiable private information is provided to Clinithink, patient privacy and accountability for that privacy is much more seamless and smart to an IRB processing a request for a waiver.

CLiX ENRICH is a self-use, HIPAA compliant tool that automates the cumbersome, time consuming task of searching databases and medical records for potential patients to recruit into clinical trials. Stakeholders of CLiX ENRICH, such as PI’s, research coordinators and others; use it as a workflow tool that automates the pre-screening process to generate a list of qualified potential participants against trial-specific inclusion and exclusion criteria – no other processes are changed.

Compliance before approval

In generating the pre-screened list of patients, stakeholders tell CLiX ENRICH what to find; for example, ‘women age 45 and older who have co-morbidities involving hypertension and diabetes’.

CLiX ENRICH takes those criteria- or queries- and searches the e-health information in the library that meet the parameters and produces a list of possible study participants that can be de-identified or used as is.

Once the list of eligible patients is produced, users with an authorized username are able to access the list to begin contacting the patients to request study participation. Healthcare providers are able to use the tool to dramatically accelerate pre-screening and enrollment. Because Clinithink understands and respects the requirements of HIPAA, the Common Rule and the role of the IRB in the process of identifying patients for clinical trials, it provides the following language to include in IRB meeting minutes to document waiver approval:

“…finding no or minimal risk of exposure of patient’s health information because the information never leaves the [principal investigator’s entity] and because no individual from outside the [principal investigator’s entity] workforce ever has access to PHI and because the scope of the waiver is only as to the preparatory - to - research/subject identification process. Once identified, the patients’ consent will be obtained before they are enrolled in the study, as normal.”

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