What obligations do DNA testing services have in notifying people or not about genetic disorders?

What obligations do DNA testing services have in notifying people or not about genetic disorders?

A recent development in technology has greatly improved the accuracy of genetic testing and analysis and significantly decreased its cost, leading to a dramatic increase in the quantity of genetic information generated, analyzed, shared, and stored by different individuals and bodies. Given the diversity of stakeholders and their interests, together with the huge variety of ways genetic data are held, it has been not easy to develop broadly applicable legal principles for genetic privacy.Genetic information comprises the information that concerns the genotype of an individual (Lynch, Jennifer, and Saira). It is typically generated through the processing of saliva by 23andMe.This paper discusses the current area of genetic privacy to identify the roles that the law does or should play, focusing on federal statutes and regulations. Such statues and regulations include the Health Insurance Portability and Accountability Act as well as Health Information Nondiscrimination Act. After taking into account the numerous contexts in which issues of genetic privacy arise, the paper notes that few if any applicable legal laws or enactments offer adequate protection or meaningful control to individuals over disclosures that impact them. The paper describes the reasons why there is a need to change attention from trying to control access to genetic information to considering the more challenging question of how these data can be employed and under what conditions, explicitly addressing trade-offs between individual and social goods in various applications.

Genetic testing is the current paradigm for the diagnosis and treatment of numerous illnesses.

Genetic data can be employed in developing the cures for cancer, tooth decay, among other illnesses. Therefore, there is a need to protect the privacy of genetic data. As such, some laws hinder how the data can be employed, but none really protects privacy. This seems to be impossible as each individual has his or her genetic information.

Some of the federal laws that address genetic information include the  Genetic Information Nondiscrimination Act of 2008. The law prevents group health and Medicare supplemental plans from employing genetic data to discriminate against everyone in matters of insurance (National Human Genome Research Institute). There are some of the significant issues that remain unaddressed with regard to genetic information privacy. When it comes to accessing and recording genetic data, there are some of the issues raised. One of the severe problems in regard to obtaining and recording genetic data is the consent for disclosure. Consent is always though as individual consent, which makes sense when the health information is primarily about that person. Typically, genetic information is usually different, and analysis of an individual is considered informative when it comes to the offspring and parents..

Some of the risks and considerations of privacy in genetic testing include the following: One may identify things about oneself or about the family members that are likely to cause anxiety and or shocking. As a result, it becomes hard to control or change the situation. More so, it possible to discover that the relatives who were previously unknown to you. In addition, one may find that the relative that one thought was related; they do not have biological ties. In such cases, if the data is breached, it is likely that the data could be used against someone’s interest.

Some people become worried that they would know new things concerning their DNA, and that is likely to be astonishing. For example, they worry about the risks of learning to acquire some illnesses and not understand how to move forward with the information. Professional scientists believe that the data is likely to inaccurate and therefore is likely to cause individuals to make questionable health decisions. Besides,  another kind of risk and consideration is privacy. Personal genetic information is supposed to be very private, and therefore, disposing away to an own genome kit insinuates sharing someone’s DNA with the testing companies.

The stakeholders such as the 23andMe, Ancestry, and Veritas Genetics are supposed to have the responsibility of protecting someone’s DNA as their business future is likely to be determined on how one maintains the trust of consumers. Nonetheless, genetic privacy has shortcomings that still today do not have easy answers. More so, regulators have not yet been convinced that they are doing right by consumers. For example, research done by a Fast Company shows that 23andMe has, in the past, been investigated by the Federal Trade Commission over their policies for handling personal info and genetic data and how they share that info with third parties.

Some of the most significant privacy risks for consumers sharing their DNA with testing companies include the following: Hacking is one of the most significant privacy risks for consumers sharing their DNA with testing companies (Lynch, Jennifer, and Saira). A hack in the space of genetic testing can be an issue of concern. Therefore, the responsible companies are supposed to give protection of data of their consumers the highest priority. They should focus on building strong data security and make ongoing investments to strengthen their security measures continuously. Another challenge associated with the privacy of genetic testing is that laws covering genetic privacy are not broad enough. It is argued that the current legislation covering genetic privacy is considered too narrow, and it fails in focusing on banning employers or insurance companies from having access to the data. Therefore, the lack of strict legislation may eventually haunt customers. Another risk linked with data privacy is that the law enforcement knowing that these organizations have people’s DNA, they may ask for it if they want it. It is evidenced that the law enforcement and courts are requesting DNAs of some individuals. For instance, there is a case whereby the DNA of a suspect was acquired by employing the DNA of their relatives. Therefore, this indicates that when an individual offers genetic information to a DNA testing company, one is also providing information concerning those related to an individual. For example, distant cousins. When some of the relatives send their DNA, they are also giving genetic information about their relatives.

Another risk associated with DNA privacy is the situation of the Company, or the privacy statement is likely to change.  Some of the unintended consequences are likely to pose a risk as privacy is concerned. For instance, firms change by being bought or being sold. Companies can also go out of business. Therefore, in such a scenario, the data is at risk. Typically, these companies do not have limits on what they can do, and thus they just state it in their privacy policies, which they are likely to change at any time they want.

On the other hand, DNA testing services may help in avoiding, preventing, and treating inherited disorders when they disclose the information to the consumers. One of the benefits linked with disclosing the information is that a negative test usually leads in an individual from a family in which affected relatives are known to have illness-associated mutation shows a low risk of the illness (Ready, Kaylene, et al.).This is likely to lower the level of anxiety, and for some diseases, it is expected to decrease the frequency of periodic monitoring for early signs of the illness. An example of such a condition is breast cancer. A negative test depending on the disease also enables an individual to buy life insurance at the standard rate. A positive test result assists a person in preparing for the illness. Parents who learn from carrier screening tend to fall at the risk of having an affected child hence taking steps to avoid the conception or birth of an affected child. Individuals at the risk of disease later in life are likely to take steps to prevent transferring the disease-causing allele on to their future generations. Besides, they can also plan for the condition. Another advantage of disclosing genetic information is discovering that one is a carrier or has inherited a susceptibility to illness assist the person to inform relatives that they are likely to be at risk.

However, some of the problems facing genetic testing in the United States are that sometimes genetic tests are introduced before they have been demonstrated to be safe, effective, and useful. Additionally, it is not certain that every laboratory performing genetic tests for clinical purposes meets high standards. Moreover, in most cases, the informational materials provided by academic and commercial genetic testing laboratories do not offer sufficient information to fill in the gaps in providers’ and patient’s understanding of genetic tests.

Some of the stakeholders that should be involved in genetic testing include the following: Professional societies that cover pathologists, doctors, genetic counselors, and geneticists. Other stakeholders that should be involved include the biotechnology industry, customers, insurers, government as well as other interested parties. The concerned stakeholders should ensure that new genetic tests have been introduced into clinical use, and it is based on evidence of their analytical and clinical validity and utilization of those tested. Genetic testing laboratories should collaborate with customers, health-care providers, and professional societies to determine the main set of genes that consumers are likely to agree to cover. Then the laboratories require clear guidance from insurers in regard to the evidence they need to institute coverage.

Additionally, the stakeholders should ensure that all the levels of the genetic testing process in clinical laboratories meet quality standards. Besides, the health providers who provide and order genetic tests have the required competence in genetics and genetic testing. There will aid in protecting the welfare of their patients. Additionally, stakeholders should push for the continuation and expansion of the availability of tests for rare genetic illness. Policies that determine the genetic tests that require stringent scrutiny should be implemented. Strict scrutiny should be applied in cases whereby the trial is likely to cause a prediction of the future inherited illness in healthy people. The overall responsibility of stakeholders involved in genetic testing should be ensuring that the patients receive appropriate genetic testing, and eventually, creative and effective solutions should be evident. The government and the genetic testing companies should ensure that the genetic laboratories are improved to provide sufficient genetic testing. Additionally, the government should respect the privacy of the genetic testing companies and prevent interfering with the DNA results of suspects. Geneticists, pathologists, and doctors should conduct professionally correct and accurate genetic tests to the clients (Institute of Medicine (US) Committee on Assessing Genetic Risks). The other stakeholder involved is the insurers. Insurers should not interfere with the privacies of genetic testing companies. This usually happens when they want to know the genetic compositions of their clients, which is unethical and unacceptable. Patients also should play their role by ensuring that the genetic testing companies protect their data. The government needs to implement the need to enforce policies that will provide the effective and safe use of genetic tests. Laboratories that perform genetic tests requires special quality assurance procedures.

Some of the policies that should be implemented in the genetic testing are that the Genetic testing should be expected to have suppliers and manufacturers of genetic tests should meet efficacy and product information. The genetic protocols are supposed to be reviewed by research ethics committees. Another policy that should be implemented is the improvement of laboratory quality. In this case, every laboratory conducting genetic tests will be expected to comply with the unique requirements. These requirements are supposed to be followed by both private and public genetic testing institutions.Another policy that should be implemented is that genetic testing should be made mandatory. This policy would ensure that the transmission of genetic illnesses is stopped. This will eventually eliminate harm, which is likely to be caused by the transmission of diseases. Therefore, some of the principles of genetic testing are supposed to be applied to enable the patients to make personal decisions without disturbance. Some of the laws that should be followed include privacy, confidentiality, equity, autonomy, among others. Autonomy is one of the principles associated with genetic testing. This principle implies that an individual is supposed to have sufficient information to be able to decide on whether to under genetic testing process (Lynch, Jennifer, and Saira). In genetic testing, the patient is supposed to be informed about the risks, advantages as well as alternatives to the procedure being done. Some of the information people undertaking this process need to know is the extent of severity of the procedure, treatability of the disorders being tested, among others (Institute of Medicine (US) Committee on Assessing Genetic Risks).

Therefore, the patient should be able to make a decision on whether to undertake the procedure or not. Additionally, the procedure should be voluntary, and the patient should not be coerced. Besides, the principle of confidentiality should be addressed. The policy is aimed at encouraging the free flow of information between the client and the geneticist so that the patient’s illness may be adequately treated. Genetic information shows the potential disease or other risks to the patient. It also offers potential threats to the next generation of the patient. However, in this case, the geneticists may be willing to protect third parties from harm by breaching confidentiality and disclosing risks to relatives. The breaching of the secrecy is expected to assist the relatives in avoiding damage.

In conclusion, It is evident that stakeholders’ support participation in genetic testing may contribute to improved genetic testing results, access, and privacy. The current policies do not assure that enough data on the predictability of genetic tests will be collected before they enter clinical practice. Additionally, they do not ensure that the genetic testing laboratories will provide analyses of high quality. Besides, those policies do not guarantee that the results will be significant to those who are tested. Some of the serious problems facing data privacy are the confidentiality of the test results, the specimens, discrimination in regard to the test results, psychological issues, among others. If the challenges are entirely addressed, it will be an advantage to the public. Some of the policies that should be implemented should address the discrimination of genetic testing in the employment sectors and the insurance providers. Laws should also be passed to minimize the danger of genetic discrimination. These laws should be passed in both the federal and state level. Some government agencies, some departments cause some of the problems associated with genetic testing. Thus, there is an urgent need for new legislation.

Works Cited

Institute of Medicine (US) Committee on Assessing Genetic Risks. “Social, Legal, and Ethical Implications of Genetic Testing.” Assessing Genetic Risks: Implications for Health and Social Policy., U.S. National Library of Medicine, 1 Jan. 1994, www.ncbi.nlm.nih.gov/books/NBK236044/.

Lynch, Jennifer, and SairaHussain. “Genetic Information Privacy.” Electronic Frontier Foundation, www.eff.org/issues/genetic-information-privacy.

National Human Genome Research Institute. “Promoting Safe and Effective Genetic Testing in the United States – Chapter 1.” Genome.gov, www.genome.gov/10002405/genetic-testing-reportchapter-1.

Ready, Kaylene, et al. “Strategies for Improving Access to Hereditary Cancer Testing: Recommendations from Stakeholders.” Nature News, Nature Publishing Group, 28 Jan. 2019, www.nature.com/articles/s41436-018-0430-9.