While banning trans fat has been at the forefront of my weekly topics, this week we will be taking a slight detour as we discuss an important aspect of modern healthcare: access to data, privacy protection, and electronic health records (EHRs). The key points from the readings this week focus on electronic health records, privacy protection, direct-to-consumer (DTC) genetic testing, and at what level these policies regarding health information are regulated. The healthcare documentation laws expanding to electronic medical records (EMRs) and the vulnerability of patient confidentiality and protection is a delicate balance. These transitions have caused a significant concern for health care consumers to keep their health records protected and private.
Established in 1996 and then reformed a few years later, The Health Insurance Portability and Accountability Act (HIPPA) or “The Privacy Rule” is a set of federal rules that govern how health information is utilized and disclosed (Pritts, 2008; U.S. Department of Health and Human Services, 2014). Pritts (2008) echoes the importance of maintaining patients’ basic right of privacy as a necessary component to human well-being. Privacy and protection of records also advocates for personal autonomy, individuality, and self-respect (Pritts, 2008).
DTC genetic testing has come under much scrutiny as it is growing more popular in the United States (US). Due to growing consumer interest, greater awareness of the Human Genome Project, and the American consumers’ desire to access self-governed healthcare, many companies began offering genetic testing directly to the public. One issue with this type of advanced technology availability is that the majority of these DTC genetic tests do not have any pre-market review requirements nor do they need approval from the Food and Drug Administration (Hogarth, Javitt, & Melzer, 2008). Although several of the large professional organizations such as the American Medical Association (AMA) support genetic testing performed without a licensed health care professional (Caulfield & McGuire, 2012), perhaps this is an area that advanced practice nurses need to step in and advocate on behalf of the patient and demand expert consultation in order to disseminate the results. Comprehensive genetic testing should include consultation with a healthcare professional and an evaluation including the implications of the results. Are advanced practice nurses better equipped to fill this professional role? With the questionable validity of these companies, lack reputability of the DTC tests, and absence of medical counseling it is easy to see how consumers could easily be misled into making inappropriate health care decisions. It seems that the only way to get consistent regulation throughout the US is by way of federal regulation, but currently DTC genetic testing is dealt with on a state to state basis.
Some may argue that disallowing the consumer access to data, EHRs or DTC genetic testing we would be infringing upon an individual’s right to information or technology. Information is not necessarily a bad thing, but the sensitive nature of healthcare information needs to be dealt with in a way that consumers understand the information that they are receiving. If information lacks understanding, it cannot be thought of as knowledge!
References
Caulfield, T., & McGuire, A. L. (2012). Direct-to-consumer genetic testing: Perceptions, problems, and policy responses. Annual Review of Medicine, 63, 23-33.
Hogarth, S., Javitt, G., & Melzer, D. (2008). The current landscape for direct-to-consumer genetic testing: legal, ethical, and policy issues. Annu. Rev. Genomics Hum. Genet., 9, 161-182.
Pritts, J.L. (2008). The importance of value of protecting the privacy of health information: The roles of the HIPPA privacy rule and the common rule in health research. Retrieved fromhttp://www.iom.edu/~/media/Files/Activity%20Files/Research/HIPAAandResearch/PrittsPrivacyFinalDraftweb.ashx
U.S. Department of Health and Human Services. (2014). Indian health service: Health insurance portability and accountability act (HIPPA). Retrieved from http://www.ihs.gov/hipaa/
Preventive Care for Heart Health in the United States 
Thank you for your informative post. Health care can utilize knowledge bases from other fields in order to enhance health policy making and ultimately health care delivery. As strong influencers of the future of our health care, we, as DNP leaders, must take a stand to improve upon the conditions that affect our health as a nation. As health care leaders, we need to develop a health promotional campaign that sweeps across the legislative bills. In order to continually enhance the value of our work, we must be active participants on committees and councils making these health care decisions, gaining insight into ways we can improve the health and quality of life of others, and ascertain optimal health care delivery. In this way, we can truly transform care delivery at the bedside and revolutionize our health care system by advocating for the adoption of quality improvement strategies through innovative processes. We need to revert to health living and the promotion thereof. As it applies to the obesity epidemic and unhealthy lifestyles, in particular, the unintended consequences of doing nothing will result in a worsening of conditions. As DNP leaders, we must work stealthily to restore health and healing of all people. There is a pressing need for a health revolution to sweep through this nation. This requires us to be advocates and educators as it affects all levels of health policy.
LikeLike
Thank you for your discussion of direct-to-consumer genetic testing. While I think a large proportion of our population understand that this exists it hasn’t yet made its way into mainstream medicine- but you can see that this may not be far of. As you alluded to in your post, the topic of DTC genetic testing brings up numerous privacy and safety concerns for the public. The clinical utility of many genetic tests has not been proven. No large longitudinal studies have been published that show behavior or lifestyle modification based on genetic testing results (Anderson, 2009). Where are these results stored after testing is complete? Who can access these results? How will insurance companies become involved? Anderson (2009) writes that although personalized medicine is the trend in American healthcare, DTC genetic testing could undermine the patient’s trust in their provider and the system as a whole. It appears that providers are not prepared to interpret and utilize the results of DTC testing at this time. We should approach with caution when evaluating the safety and privacy concerns involved with ‘commercial’ genetic testing!
Anderson, E. (2009). Direct-to-consumer personal genome services: Need for more oversight. AMA Journal of Ethics, 11, 701-708.
LikeLike
You have provided some good information related to direct to consumer testing. This is a topic that creates all sorts of concerns related to privacy. While privacy and data security really can’t relate to trans fat ban, what about health issues associated with trans fats? Are there any potential privacy concerns with DTC testing and those health issues?
LikeLike
DTC companies are not subject to the same privacy regulations under HIPPA. This can lead to unscrupulous companies selling personal genetic information for profit. If these companies are sold or go bankrupt there could be a breach in privacy, especially since there are varying levels of security depending on the company. this can lead to many people genetic profile not being secure. And with a majority of people believing that genetic information is highly personal a private, this is a important privacy issue.
Caulfield, T., & McGuire, A. L. (2012). Direct-to-consumer genetic testing: Perceptions, problems, and policy responses. Annual Review of Medicine, 63, 23-33.
LikeLike