The reality and unfortunate idealism is that there is no perfect systematic and legal loopholes reformation in the patient’s health information privacy globally. Health information privacy is a very important aspect of an individual’s security. Thus, an individual’s privacy and security must be assured in clinical studies because subject’s participatory role in a clinical research is an altruism gift to humanity in pursuit of better research and development in scientific/medical innovations.

For instance, the US health department intended to achieve health privacy and security by introducing the health insurance portability and accountability act (HIPAA). Hence, whether the 1996 HIPAA regulation affects the recruitment of potential human subjects is of less concern, but rather, it is a reasonable armamentarium factor that should be needed to protect the privacy, rights and anonymity of the primary sources (human subjects) in any scientific research (Dombey, Markel, & Derenzo, 2012). Nonetheless, the HIPAA regulations may seem to have added tougher layers of human subjects’ recruitment scrutiny. Perhaps, it may have added layers of comfort with greater confidence on subjects’ participatory intent in clinical studies, by ensuring their privacy protection in any medical research (Myers, Frieden, Bherwani, & Henning, 2008). Therefore, the effectiveness of the HIPAA enforcement could be the determining factor to the success rate of recruiting potential subjects.

With the idea of de-identification and appropriately worded informed consent, the HIPAA privacy rule may act as an additional layer of inducement that may encourage potential subjects to provide biological material and genetic information (NIH, 2004). Perhaps, it is important noting, the HIPAA privacy rule is just one factor among many that affects subjects’ participatory decision. In addition, when sick patients or subjects enroll in a research study for an alternative treatment option, there may not be many choices available, but optimistic recommendations are embraced. On the other hand, healthy individuals, usually in a phase 1 clinical studies, debate on participatory decision for their rights to samples collected during the clinical trial, is of great concern (Hakimian, & Korn, 2004).

The controversial qualms surrounding Henrietta (HeLa) and John Moore cell lines which were obtained without appropriate informed consent, are good examples of privacy infringement. In both cases, profit that were generated from these cell lines were not shared with the individuals or their families (Devine, 2010). Clearly, the Herientta (HeLa) and John Moore’s cell line collection incident may have been an intentionally-orchestrated theft under the pretense of practicing protected medical practice. By so doing, the professional code of medical conduct is violated without proper informed consent and researchers’ intent disclosures including vested financial interests.

It is an overstatement to assume that the HIPAA regulation is the ultimate conviction in protecting patient health information or genetic information. HIPAA is a guide and deterrent tool intended to ward off the intrusion of unauthorized personal medical information (Erlen, 2006). Ultimately, it is the act of humans that break the rule of law and regulation intended to secure patient health information and privacy. For instance, the United States’ fourth amendment affirmed “The right of the people to be secured in their persons, houses, papers, and effects against unreasonable searches and seizures, shall not be violated.” (Do, 2004, para. 31). Thus, the HIPAA regulation was intended to strengthen the US fourth amendment provision, but unfortunately, there are several loopholes such as allowing government and secondary users’ to access personal health information (PHI) without even requiring patient’s informed consent (Do, 2004). In addition, the original HIPAA privacy rule drafted was re-drafted by the Health and Human Services (HHS) in an attempt to reduce the cost associated with the privacy rule, which was estimated at $25 billion (Do, 2004). Consequently, the HHS amendment of the privacy rule reduced the standards of the privacy protection in marketing, limited data set, informed consent, disclosure and enrollment data sharing with plan sponsors or organizational healthcare providers. In addition, the government can at-will use the Patriot Act to override the HIPAA privacy rule (Do, 2004).

There is almost general consensus among the public about the importance of maintaining personal privacy and limiting government intrusion to personal information, a right that was legally betrothed to everyone in the USA via the fourth amendment provision. In 1993, a survey showed that 80% of Americans believed that they lost control of their protected health information (Do, 2004). Furthermore, other surveys indicated that 88% of Americans are concerned about insurers and employers gaining access to their medical records without consent (Do, 2004). The Equifax sponsored survey also indicated that 85% of Americans are concerned and believed that protecting the confidentiality of medical record is very important (Do, 2004). These concerns gathered through the ethical health privacy issue may not go away if the loopholes are not corrected and if human subjects or patients do not have the right to place a disclosure restriction on their medical records and requirement of informed consent for PHI access.

References

Do, G. (2004).  Electronic record, patient confidentiality and the impact of HIPAA.  Retrieved from http://www.psqh.com/octdec04/dudley.html.

Dombey, S., Markel, D., & Derenzo, E. (2012).  Privacy and confidentiality. [Waldenu DVD]. Retrieved from https://class.waldenu.edu/webapps/portal/frameset.jsp?tab tab_group _id=_2_1 &url=%2Fwebapps%2Fblackboard%2Fexecute%2Flauncher%3Ftype%3DC ourse%26id%3D_552454_1%26url%3D.

Erlen, J. (2005). HIPAA—Implications for research. Orthopaedic Nursing, 24(2), 139–142. Retrieved from http://ezp.waldenulibrary.org/login?url=http://search.ebs cohost.com /login.aspx?direct=true&db=rzh&AN=2005076789&site=ehost-live&scope=site.

Hakimian, R., & Korn, D. (2004). Ownership and use of tissue specimens for research. JAMA, 292, 2500–2505. Retrieved from http://jama.ama-assn.org.ezp.waldenulibrary.org/cg i/reprint/292/20/2500?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=Ownership+and+use+of+tissue+specimens+for+research&searchid=1&FIRSTINDEX=0&res.

Myers, J., Frieden, T., Bherwani, K., & Henning, K. (2008). Ethics in public health research: Privacy and public health at risk: Public health confidentiality in the digital age. American Journal of Public Health, 98, 793–801. Retrieved from http://ezp .waldenulibrary.org/login?url= http:/search.ebscohost.com/login.aspx?direct =true&db=ehh&AN=32130147&site=ehost-live&scope=site.

National Institute of Health (NIH). (2004). Clinical research and the HIPAA privacy rule. NIH Publication Number 04-5495. Retrieved from http://privacyruleandresearch.nih.gov clinres earch.asp.