Many people in this country are apprehensive about taking part in genetic research or submitting to genetic testing due to fears that they will be discriminated against because of possible genetics findings. These concerns can deter people from agreeing to take part in research needed to develop new genetic tests, intervention and cures for genetic conditions. Anxiety about the potential for discrimination can also prevent people from undergoing genetic clinical tests. In order to these fears, the Genetic Information Nondiscrimination Act of 2008 was passed. This Act banned any type of discrimination by insurance providers and employers based on genetics information or family medical history. There are also other legal safeguards that protect people from genetic discrimination in the workplace, by health insurance providers and others.
The Genetic Information Nondiscrimination Act of 2008 (GINA), Employment and Health Insurance
Protection from genetic discrimination in the workplace and by insurance companies is provided by GINA. Under GINA employers cannot utilize genetic information for the purposes of hiring, firing, promoting, job assignment or any other employment decisions. Additionally, GINA ensures that individuals cannot be required to submit to genetics testing by employers or other employment related entities including labor unions and staffing agencies. Furthermore, these entities are prohibited from even requesting this information even if it is not required.
GINA prevents employers from using genetic information in employment decisions such as hiring, firing, promotions, pay, and job assignments. Furthermore, GINA prohibits employers or other covered entities (employment agencies, labor organizations, joint labor-management training programs, and apprenticeship programs) from requiring or requesting genetic information and/or genetic tests as a condition of employment. The regulations governing implementation of GINA in employment took effect on January 10, 2011 and are implemented by the Equal Employment Opportunity Commission (EEOC).
The HIPAA Omnibus Final Rule and Genetics Information
The Omnibus Final Rule for HIPAA/HITECH adopted GINA for inclusion to protect against genetic discrimination based on requirements to disclose the finding of genetic testing or research data. Now a fundamental piece of the HIPAA Privacy Rule, it is not permissible to solicit or use genetics information for health insurance underwriting or hiring decisions.
The Omnibus Final Rule includes several important alterations and clarifications that are important for healthcare providers and business associates to be aware of and to fully understand. Without such comprehension the risk of breaches increases substantially. The Omnibus Rule modified the Privacy Rule to clarify that the definition of protected health information under the provisions of HIPAA incorporates all genetics information and information on family medical history. Included in the Privacy Rule, under the Omnibus Rule is the restriction that genetic information cannot be utilized or disclosed for purposes related to issuing health insurance, deciding on premiums or canceling health insurance. The only exception to this rule is for long-term care insurers who can use genetics information for policy institution. However, HHS stated that they reserve the right to restrict or alter long term care companies use of genetics information based on further investigation. It should be noted that a health plan is allowed to use genetic information in order to determine the “medical appropriateness” of a treatment when the individual is using benefits to obtain.
Important Cautions
The adoption of GINA and clarification and modification of the HIPAA rules and regulations are increasingly important as the use of genetics testing grows at an increasingly fast rate. There are several areas that policy makers and health care providers must be fully aware of and vigilant about as further developments occur in the areas of genetics research and technology.
• Without adequate protection put in place before new testing procedures for different diseases are approved, companies may take advantage of the ability to use genetics information not technically included under HIPAA at the time. In the interim between new technological developments, the discovery of new ways to use genetic information to save companies money and updating HIPAA policy and procedures to cover these changes, many people may be harmed through unauthorized but legally permissible genetics related ePHI disclosures.
• While the door has been left open for the use of genetics information in specific areas such as gaging the risk of developing different diseases for use as a criteria to determine the appropriateness of using certain treatment methods based on inferred health impact, extreme care must be taken to ensure information is used in the best interests of the patient.
• It is important to recognize that genetics testing doesn’t just affect the individual but can affect any family members who share their genetic code. This is a crucial point to comprehend in order to discern the potential impact of disclosing information about an individual. Genetics information links individuals to a number of biologically linked relatives and in many cases, family members may be affected by a disclosure made of which they are not aware. This means the cause or even sometimes the presence of genetics related discrimination may go undetected by relatives when genetics information related to a family member was used inappropriately.
• Additionally, it is not unusual for one family member to decide to be tested for a genetic link to a disease while others decide to forego testing. In cases when genetics information about one family member is inappropriately disclosed, other family members may be informed as well. This not only could compromises their right to receive care and coverage without bias, but may also negate their right to determine whether or not they want information about their genetic risk profile. While some may argue that everyone should know this information in order to prevent irreparable medical consequences, whether to undergo genetics testing is a decision every individual has the right to decide for themselves and their dependents.
HIPAA regulations related to the disclosure of genetics information recognize that any disclosure of genetics information is like Pandora’s Box. An individual’s genetic makeup does not change, so once disclosed the information is permanently in the public it could affect the individual’s ability to get affordable healthcare, along with their family members including future generations, indefinitely. Given the constant innovations of the internet and the speed with which information now travels, the implications of future developments cannot be predicted. Therefore getting out ahead of such developments by maintaining constant awareness of advances in the field of health care technology is crucial in order to prevent undue harm from new genetics innovations.