Research and PHI – Oh, the many issues…

In the course of a clinical research project or trial, researchers must gather patient data and records and prepare them for adjudication and analysis. In keeping with the spirit of HIPAA and PHI regulations, the organization conducting this research or trial likely wishes to control access from both within and outside of its firewall to ensure that any potential for breach of this personal information is strictly curtailed. 

The hard fact of the matter is that often times, this data is in the form of unstructured data in documents. It could be prior patient history or perhaps information was collected in a way that it ended up in a document or needed to be exported from a healthcare information system into a document before sharing with researchers. Typical workflows required for handling all of these documents might involve gathering the data or records for required patients, sorting to ensure all essential records are included, labeling records as appropriate, highlighting important fields, etc. Scanning of these documents may take place before or after any of these steps.

Also typically, the records being reviewed are of widely varying legibility, frequently range from 10-500 pages in length and may include both machine and hand-print. Unfortunately, the documents are usually manually redacted to remove any PHI that needs to be removed under the guidelines of HHS. Care must be taken to not only accurately locate any sensitive information, but also to successfully mask those fields or annotations without obliterating adjacent data that may prove useful to researchers.

What if there was an automated solution to identify and redact all PHI as defined by HHS guidelines in the records associated with your current research project? What if it could actually route and identify documents based on criteria that you identify? Would this make things easier for sharing with outside researchers? Would this allow you to place more focus on the research itself instead of the logistics of getting documents ready for researchers to review? It does exist, actually, and is helping many organizations today already. Learn more today by talking with one of our clinical data redaction specialists.

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About the Author: Ellen Bzomowski

With 20 years of experience in data capture and voice recognition, Ellen’s experience has focused on achieving higher efficiency and automation in getting data where it will be most useful to an organization. At Extract Systems, she continues to focus on the same ideas and works to get the word out about how Extract Systems’ advanced data capture and redaction solutions make more data valuable and accessible, while securing anything that is private. She holds an MBA from Northeastern University and lives and works in Boston.