Question

how to address the following challenges feasible, and realistic.

2. Controlling access to PHI in clinical area, specifically for research study recruitment

Challenge: An increase in the number of clinical research studies and the use of undergraduate students as research assistants for subject recruitment was perceived as risk for a medium-sized academic hospital. Student were enrolled at the affiliated University but still required a credentialing process to be able to be in the clinical area of the hospital and access clinical systems. The Hospital wants to meet IRB, HIPAA research regulations, and follow the minimum necessary principle.

Answer 1

Solution

The above mentioned challenge becomes evident in case of subject recruitment in clinical study. As we know that as per the HIPPA privacy policy, all the health care settings and the associated professionals must have knowledge to keep the trial related data safe although during the subject enrolment as many undergraduate students are engaged in the process there might have some risk associated with the data generated during the course of enrolment of the subject in the study. Herewith to minimize the risk, academic hospital must be regularly checking the implementation of the HIPPA privacy policy in the hospital. Further regular meeting with the IRB to evaluate whether the correct enrolment are taking place in the trial study or not. Moreover there are two specific ways by which a person can control the access of the health documents

1. Restricting a document to prevent healthcare providers and nominated representatives viewing certain information.

2. Removing any confidential document so that only the person and their representative can have access to the documents from My Health Record. However in case of emergency situation only healthcare providers have the right to access the private data.

Hence to maintain the personal health information (PHI) in a safe and confidential way medium academic hospital must be operated with the close association with HIPPA guidelines and the recommendation of the IRB committee related to clinical trial study.