The United States Genetic Information Non-discrimination Act also known as GINA, on May 21 in the year 2008, was signed into law by President George W. Bush. It has been seen throughout, over a period of 13 years, that a collective effort that includes lawmakers, patients, and science advocacy groups, such as ASHG, was undertaken to establish these crucial protections against genetic discrimination.
The aforesaid line of thought refers to the inception of the Genetic Information Non-Discrimination Act, which can be traced back to its initial introduction in Congress in the year 1995, which highlights the early stages of the Human Genome Project specifically.
The torch-bearers of the GINA were bestowed with the power of having a forward-looking perspective that simply anticipated a future where genome sequencing would become standard practice not only in the capacity of research laboratories but also in clinical settings.
Diving deeper into the aforesaid concept, it was witnessed at the time when the said legislation became law, the efforts taken by Dr Francis Collins, who was then serving as the director of the National Human Genome Research Institute, also known as the NHGRI.
Not only did he commend its significance for the fields of science and medicine, but he also expressed the same confidently, which is the following line of thought:
“This is a significant gift to all Americans. It will ensure that Americans can confidently reap the benefits of the medical discoveries stemming from the Human Genome Project, an endeavour in which they had invested significantly. It will also guarantee that individuals can undergo genetic testing without the apprehension of potential discrimination in the realms of employment or health insurance.”
In other words, the Genetic Information Non-discrimination Act is a federal law in the United States that has been solely curated to safeguard individuals from genetic discrimination in both the workplace and within the domain of health insurance.
Not only the aforesaid, but the fact that it serves to preserve the privacy of genetic information for individuals and their families serves to be a key highlight. What marks it crucially different is the essence that in the face of evolving developments in the fields of science, technology, and data management, the Act not only assumes a critical role by setting a fundamental standard of protection that applies to all the citizens of the United States but also ensure that they are safeguarded against discriminatory practices.
1. Discrimination Under the Ambit of Genetic Testing
To highlight the idea that revolves around discrimination that occurs at various stages, which stands inclusive of the collection, utilization, and retention of human genomic information deemed to be highly essential. Unfortunately, emphasizing the idea that discrimination can manifest even before the processes of regulating the information above commence is a point of concern.
Relating to distributive justice are concerns that can emerge when it comes to determining and pinpointing what individuals or groups have access to the advantages of genetic testing as well as those who do not.
Along the same lines of thought, elaborating on the idea of distributive justice seems to be of great importance. The term refers to the equitable distribution of benefits or resources among individuals or groups within a community/population.
Complementing the same set of ideas lies the fact that if any kind of obligations, burdens or disadvantages are playing in the field, then distributive justice necessitates the essence that they must be distributed proportionally among the groups above.
Running on the same lines of thought lies the essence of the issues about distributive injustice. The aforesaid often arises in underserved populations, particularly among racial minorities who have vehemently scarce and restricted access to genetic testing.
The absence of the above-mentioned access or lack of information about genetic testing can not only foster distrust within the community towards the medical institutions that are bestowing upon these services but also obstruct the utilization of genetic medical technologies that could enhance the well-being of these communities, as an addition to diminishing health disparities in all capacities.
Take, as an illustration, the fact that genetic testing has the potential to predict various hereditary conditions, and it enables individuals to make informed preparations.
Elaborating on the same, the said mistrust can result in an underrepresentation of racial minorities in clinical genetic research, which can lead to a bias in genomic databases as well as AI algorithms in favour of individuals of European descent.
On the same lines, the research based on such limited data fails to bring about meaningful insights that could seriously benefit diverse crowds.
2. Protections Given by The Genetic Information Non-Discrimination Act
As it has been made clear as to what the GINA is about, to dive into the protections offered by the Act, it deems it essential to mention as it bestows upon safeguards that have been established in both the workplace as well as health insurance realms.
The aforesaid legislation not only ensures that any individual can access their genetic information but also makes significant choices regarding their lifestyle and medical decisions, which is devoid of the fear of genetic information-related discrimination at their job or within their health insurance coverage.
On the same lines of thought, which highlights the practical sense of it, the Act forbids employers from using genetic health information as a basis for job-related determinations, which includes decisions pertaining to hiring as well as termination.
Not only the aforesaid, but it imposes restrictions on health insurers, which prevents them from using an individual’s genetic information to influence arenas involving eligibility, costs, coverage, or benefits that are associated with a health insurance policy.
The Genetic Information Non-discrimination Act not only defines genetic information as details regarding an individual’s genetic tests and family history but also encompasses both the individual’s own genetic data as well as that of their family members.
Limitations for Protections Offered Under the Act –
1. With Regard To Insurance Coverage:
The safeguards granted by the Act primarily concentrate and revolve around the domain of health insurance. Thus, it holds no power to have the Genetic Information Non-Discrimination Act extended, in terms of its protections, to any other form of insurance that includes life insurance, disability insurance, or long-term care insurance.
2. With Regard To Small Business Exemption:
An exemption within the Act focuses on the applicability to small businesses that have fewer than 15 employees. In other words, this refers to the idea that some employers of smaller businesses are not bound by the said legislation’s regulations that circle the aspect of genetic information.
3. With Regard to Government and Military Insurance:
The provisions under the said legislation do not cover individuals who obtain their insurance either via the federal government or the military, as these entities have separate regulations and policies in place for smoother functioning.
3. Genetics Research and The Genetic Information Non-Discrimination Act
The grants bestowed upon by the Act onto the general public not only protect their privacy and guard them against the misuse of genetic information obtained through research but also reassure the research participants that they can volunteer for studies without harming their jobs or health insurance.
On the same lines of thought, both the NHGRI and the Office of Human Research Protections, commonly called the OHRP, offer resources for researchers in addition to the Institutional Review Boards about the law as well as the information that is curated to be conveyed to the research participants.
4. The Dimensions of Genetic Privacy
In order to understand genetic privacy, it is essential to consider the complex concept of privacy as a whole. Considered as a state of limited access to an individual or information about an individual is the idea of privacy.
Diving further into the aforementioned, the right to privacy refers to the ethical and legal principles that recognize the importance of limited access to an individual or information with regard to the said individual.
In addition to this, proposing four categories of privacy is what Anita Allen considers to be applicable to terms such as ‘the ambiguous concept’ of genetic privacy.
Elaborating categorically on the said concept, it has been said that when privacy is used to label issues that arise in contemporary bioethics and public policy, it generally refers to one of four categories of concern, which are as follows:
(1) informational privacy concerns circling the essence of access to personal information in a nutshell
(2) physical privacy concerns about access to persons and personal spaces
(3) decisional privacy concerns revolving around government, in addition to other third-party interference with personal choices
(4) proprietary privacy concerns with regard to the appropriation as well as ownership of interests prevailing in the human personality
An important dimension of genetic privacy is informational privacy, which makes it essential to emphasize it. From the huge dataset that serves to be every human’s genome to family pedigrees complemented with the genetic test results, the fact that genetics has been closely associated with information is important.
Not only the aforementioned, but the fact that genomics, as well as any related analytical approaches that stand inclusive of proteomics, metabolomics, transcriptomics, and epigenomics, greatly increases the amount of potential gene-associated information about individuals serves to be of utmost essentiality.
Lying on the same lines of thought, genetic information has often been considered a sensitive piece of information only because of the fact that it has implications for the current and future health of individuals as well as their family members.
Not only that, but the said information can also impact them socially and economically with regard to having consequences circling the said idea.
Confidentiality, Security, and Anonymity –
Standing strong within the realm of privacy and genetic privacy are confidentiality, security, and anonymity.
Stepping into the idea of confidentiality, it simply describes a situation where information is disclosed within a trusting relationship, such as a bond between the doctor and patient on the express or implied agreement that it will not be divulged to a third party without the permission of the source of the information.
On the same lines of thought, the idea of confidentiality, which has applied to the nondisclosure of genetic information, is a foundational principle in the ethical codes of many health professions. Not only this, but it also serves as a key element in a wide range of laws.
The very fact that the duty to protect confidentiality is not absolute is a point of contention, however. In certain circumstances that have been recognized by law or ethical codes, other interests may be paramount, such as the safety and health of any other third party.
The next aspect in question is the essence of security, which, in the informational sense, speaks of an increasingly important idea prevailing in the digital age. From referring to a condition where individuals or entities with appropriate authority are bestowed with access to certain information to prohibiting authorization to those without such power or authority, the concept of security is as straightforward as it can get.
Running on a similar plane is the idea revolving around the concept that security can be protected by various means, which includes training employees, adopting administrative procedures for handling sensitive information, and implementing technical access controls, such as keeping track of passwords and encryption.
As a last branch of the idea, the fact of anonymity makes up the entire essence of privacy. It is a form of privacy protection where the identity of the source of certain health information is either not obtained or is removed by researchers or other custodians of the information.
Reading further, the concepts of anonymization, de-identification, and similar measures are not just frequently applied to genetic information in an effort to protect individual privacy while retaining the scientific value of the information, but they also raise two concerns with regard to genetic information.
The first concept revolves around the aspect of technical methods that are not completely effective in preventing the re-identification of genetic information. On the other hand, to understand that there is a plausible argument that considers an individual’s interest in autonomy that can afford them the opportunity to learn about and control the use of even their anonymized health information or biospecimens lies on the second point.
Diving deeper into the said idea is the fact that no matter how people choose to define the term ‘privacy’, there is a widespread sentiment among legal, as well as ethics scholars that state the fact revolving around the existing privacy laws, do not provide as much privacy as many people expect or erroneously believe they have.
On the same lines of thought, the United States federal privacy regulations that date back to the early 1970s not only strike a balance that grants people some control over their data through the essence of informed consent rights but also allows at least some unconsented collection as well as use of people’s data which stands inclusive of their genetic information for various purposes that lawmakers consider socially beneficial.
Not only the aforementioned but the fact that the “individual control” the said laws provide stands as incomplete.
Reeling back to the past, speaking in the timeframe of the 1970s, Congress had commissioned a Privacy Protection Study Commission, also known as the PPSC, which was solely curated to recommend appropriate privacy protections for many types of data.
Complementing the same set of idealogy, the Privacy Protection Study Commission’s 1977 report not only acknowledged that unconsented uses of people’s data, under certain circumstances, can be ethically justified but also put forth a cautionary tale that revolved around the idea that if data cannot be ‘totally protected’ against unconsented access by others, then citizens might face privacy risks as well as be able to access their data themselves in order to assess and manage those risks.
It can be hence stated that, acting in accordance with many privacy laws, both in the USA and elsewhere, has the power to offer individual access rights as a core part of their scheme of privacy protections.
Talking in a practical sense, however, healthcare institutions do not always provide patients with access to their medical records in a timely manner, which often results in patients facing tremendous difficulties in amending errors in their records.
5. The Concept of Genetic Information in Healthcare
Speaking of genetic information, it is an ideology that is linked to personal identifiers, which are generated as well as utilized in various contexts, whether health-related or not. From clinical genetics and direct-to-consumer, also known as DTC testing, to forensics, these are the contexts that fall under the ambit of the aforementioned.
Along the same lines of thought, the concept of genetic information plays a very crucial role in multiple medical specialities that stand inclusive of clinical genetics, oncology, obstetrics, neurology, paediatrics, and behavioural health. The fact that clinicians handle increasing amounts of genetic data, the risk of privacy, confidentiality, and security breaches, serves as an essential aspect in this arena.
Not only the aforesaid, but certain potential scenarios that circle around breaches, which stand inclusive of unauthorized access by healthcare providers, disclosure of more information than necessary for a legitimate healthcare purpose, and the use of genetic information for unrelated purposes, is an important element in the aforesaid field. Complementing the same, each of these situations that have clinical settings not only raises significant legal but also takes into account the ethical concerns.
5.1. Disclosure of Health Information
Running on similar planes of thought, the utilization as well as disclosure of health information, which stands inclusive of genetic data, especially in a healthcare setting, gives rise to various issues.
From identifying the need for consent or authorization and the lawful extent of information disclosure to determining which members of the treatment or research team should have access to specific information, these aforesaid questions are to be answered when dealing with the aforesaid line of thought.
Diving deeper into the said idea, it can be said that while individuals often worry about discrimination when their health information is disclosed outside the healthcare ambit, it is within these settings that their primary concerns revolve around safeguarding privacy, autonomy, as well as dignity.
What serves as a highlight under the said essence of thought is the fact that despite these concerns potentially appearing abstract or indirect, many individuals consider them highly essential for functioning.
It is such apprehensions that have a significant impact on a patient’s behaviour as well as health outcomes, where the patients sometimes restrict the disclosure of sensitive information to healthcare providers in order to simply safeguard their privacy in a nutshell.
5.2. The Other Uses and Disclosures of Genetic Information
Comprehending the concept of genetic information further, in order to optimize the healthcare advantages which are generally derived from individuals’ genetic data, that is obtained through research initiatives like All of Us, direct-to-consumer also known as the DTC genetic tests, as well as other channels, it is essential for this information to be submitted and incorporated into the individual’s health record securely.
On the same lines of thought, once integrated into an electronic health record, also known as EHR, it becomes susceptible to a range of non-consensual disclosures permitted by the Health Insurance Portability and Accountability Act Privacy Rule, in addition to the various other disclosures which have been mandated by entities possessing legal as well as/or economic influence over the individual.
The aforesaid entities are bestowed with the power to enforce the individual to execute a Health Insurance Portability and Accountability Act-compliant authorization.
Not only the aforementioned, but with the recent estimates, it is suggested that in the United States of America, there are a minimum of 25 million compelled disclosures of health information annually for diverse purposes that stand inclusive of employment and life insurance applications.
Complementing the same lies the fact that many of these authorizations lack limitations in scope or even fail to prohibit the redisclosure of the information to other authorities.
Speaking of the Genetic Information Non-discrimination Act, it is safe to say that it is a federal law brought into existence, the sole aim of which is to provide protection to individuals against genetic discrimination that prevails not just in the workplace but also within the domain of health insurance.
From understanding the safeguards bestowed upon under GINA and the limitations falling under the same ambit to comprehending the scope of genetic research as well as the concept of genetic privacy and genetic information in the healthcare region in the United States, for the benefit of the citizens, this legislation, that refers to the Genetic Information Non-Discrimination Act, has been enacted.