Influence of Technology on Confidentiality

“HIPPA and Patient Rights” Program Transcript

NARRATOR: In this video, Dr. Karen Woodin discusses the Health Insurance Portability and Accountability Act, or HIPAA, which is the legislation which was enacted in 1996 to protect the health information and privacy of patients and research volunteers. Dr. Woodin also explains the impact HIPAA has on the conduct of clinical trials, particularly how informed consent is affected.

KAREN WOODIN: HIPAA is the Health Information Privacy Act. It was enacted some years ago now by the federal government in order to ensure continuity of insurance when someone changes from job to job and insurance company to insurance company and to protect people's health information and privacy. It does impact clinical trials. Of course, it impacts all of us now because you know every time you go into a doctor's office, if you haven't already signed one, you get a HIPAA release that says they can use your information for these purposes and not for others.

When it comes to clinical trials, obviously we are using people's protected information--names, addresses, medical conditions, all kinds of identifiers, even vehicle numbers. If you have an implanted pacemaker, the number of your pacemaker--all those kinds of things. The thing is that subjects in trials need to know that their information is not completely confidential. And you need to spell out what access other people have to their information.

Now we did this anyway. But you have to be even more careful about it now with HIPAA. So in your consent form it will tell the subject who else might see their information. And sometimes the consent form will cover the HIPAA information. Sometimes it's two different documents that have to be signed.

One thing to think about is there is a difference--and this difference is important with HIPAA--between use and disclosure of protected health information. Use of the information is usually within the organization. So if you're in a study center or a clinic, and somebody's a study coordinator, and somebody's a nurse, and somebody's a doctor, they use that same information. They all have access to it. It's not a problem.

Disclosure of the information comes in when a study monitor comes in and looks at that patient's chart for the study. And that's an outside person. So that's a disclosure that needs to be covered under HIPAA. And that's why most consents will say that people from the sponsor or the FDA or any other organization that's listed might have access to your health information.

Get information from this cite:

· U.S. Department of Education. (n.d.). Family Educational Rights and Privacy Act (FERPA). Retrieved from http://www2.ed.gov/policy/gen/guid/fpco/ferpa/index.html

· U.S. Department of Health & Human Services. (n. d.). Understanding health information privacy.Retrieved from http://www.hhs.gov/ocr/privacy/hipaa/understanding/index.html