What Lawyers Need to Know  

about the Final GINA Regulations 
E. Jason Tremblay 
A R NS T EI N   &  L E H R  LLP  
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ejtremblay@arnstein.com 

As previously reported, the Genetic Information and Nondiscrimination Act (“GINA”) was
passed into law by President Bush in 2008 and became effective on November 21, 2009. On
November 9, 2010, the U.S. Equal Employment Opportunity Commission (“EEOC”) published
its final regulations that interpret and implement Title II of GINA. The final GINA regulations
take effect on January 10, 2011. This article summarizes GINA and some of its significant
regulations, as well as provides constructive guidance to employers in order to help them
comply with GINA.

Brief Summary of GINA

GINA is designed to prevent the misuse of certain genetic information for employment
purposes. Specifically, GINA prohibits employers from making employment decisions on the
basis of genetic information and family medical history. It further restricts employers from
acquiring genetic information and family medical history about applicants, employees, and
former employees, and requires that genetic information be maintained as a confidential
medical record. The Act applies to private employers who have 15 or more employees.

Under GINA, “genetic information” includes, among other things, information about an
individual’s genetic test and information about the manifestation of a disease or disorder in
an individual or an individual’s family members (e.g., family medical history). Examples of a
“genetic test” include breast cancer exams, colon cancer exams or other screening tests for
diseases such as cystic fibrosis. A genetic test, however, does not include tests such as
cholesterol tests, liver function tests or tests for the presence of alcohol or illegal drugs. The
final GINA regulations also do not necessarily limit the definition of family medical history to
only hereditary diseases such as Parkinson’s or Huntington’s Disease. Therefore, as you can
imagine, even friendly inquiries by coworkers into the heath of an employee or their relative
have the potential to violate GINA.

Inadvertent Acquisition of Genetic Information

The GINA regulations appear to address an employer’s inadvertent acquisition of genetic

information and specifically state that GINA’s prohibition on acquiring genetic information
does not apply to the “inadvertent” acquisition of such information or to an employer’s

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request for a family member’s medical history in a lawful FMLA certification request. This
should provide employers with some comfort that requesting medical information pursuant
to the FMLA, Americans with Disabilities Act (“ADA”) and other federal, state or local laws will
generally not result in a GINA violation, even if the request discloses genetic information.
However, in order to qualify for this “safe harbor,” employers should notify employees of
GINA’s limitations in requesting genetic information. An employer can satisfy this notice
requirement by inserting the following language in any written request for medical
information:

The Genetic Information Nondiscrimination Act of 2008 (GINA) prohibits

employers and other entities covered by GINA Title II from requesting or
requiring genetic information of an individual or family member of the
individual, except as specifically allowed by this law. To comply with this law,
we are asking that you not provide any genetic information when responding
to this request for medical information. “Genetic Information” as defined by
GINA includes an individual’s family medical history, the results of an
individual’s or family member’s genetic tests, the fact that an individual or an
individual’s family member sought or received genetic services, and genetic
information of a fetus carried by an individual or an individual’s family member
or an embryo lawfully held by an individual or family member receiving
assistive reproductive services.

Even without the above Notice, the receipt by an employer of genetic information may still be
considered inadvertent if the employer’s request was not “likely to result in a covered entity
obtaining genetic information.” For example, an employer’s receipt of genetic information
will be inadvertent if the employer receives unsolicited genetic information about the health
of an employee or an employee’s family member. As well, a third party’s overly broad
response to a narrowly tailored request for medical information may be considered
inadvertent.

Care must certainly be taken when inquiring into the medical condition of an employee or an
employee’s family member. For example, the exception applies when the employer (through
an employee) asks initial health questions (e.g., “How are you?” or “Did they catch the cancer
early?” or “How’s your daughter feeling today?”). However, this exception does not apply
when those questions are followed up by probing questions about, for example, whether
other family members have the condition or whether the employee has been tested for the
condition, because the employer should know that such follow-up questions are likely to lead
to the acquisition of genetic information.

Confidentiality Provisions of GINA

Similar to the ADA, GINA requires employers to maintain records containing genetic
information in separate medical files and to treat them as confidential medical records. In this
regard, GINA regulations provide that genetic information placed in an employee’s personnel

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file prior to November 21, 2009, does not need to be removed from the file, but that any
subsequent genetic information collected must be maintained in separate medical files,
much like workers’ compensation and other employee medical files are segregated from an
employee’s personnel file.

Permissible Disclosure of Genetic Information

Generally, the disclosure of genetic information and family medical history is prohibited
under GINA. However, the Act and its regulations lay out a number of exceptions to this
general rule. For example, GINA permits an employer to disclose the genetic information to
the employee or family member to whom the information relates upon written request.
Employers may also disclose protected genetic information if compelled by court order.
Another exception allows an employer to disclose genetic information consistent with the
requirements of the FMLA or similar state or local leave laws. This exception would apply in
the circumstance where an FMLA leave request needs to be circulated to others within the
company in order to process and handle the FMLA leave paperwork.

Health Wellness Programs

Many companies have implemented health wellness and other programs in order to keep
their employees healthy and reduce health insurance premiums. In this regard, GINA
specifically allows employers to obtain genetic information in connection with employer-
provided wellness programs, as long as they are voluntary and any individually identifiable
genetic information that discloses the identity of the employee is accessible only to the
employee and the health care provider involved in the program. Additionally, employers may
provide financial incentives for employees to participate in a wellness program (e.g., fill out a
health risk assessment) as long as the employer specifically identifies which questions request
protected genetic information and make clear to the employee that they are not required to
respond to those questions in order to receive the financial incentive.

Practical Advice for Employers

As this article details, GINA may prove to be one of the most significant laws facing in
employers in the years to come. It is different from virtually all of the existing employment
laws, such as Title VII, because it protects employees and applicants who, in many cases, have
no readily identifiable sign of a protected characteristic, such as race, age and gender.
Similarly, unlike under the ADA where covered employees must be qualified and have a
manifested disability, GINA is much broader in that it protects employees and applicants who
have manifested and/or unmanifested conditions that may never rise to the level of a
protected disability. Therefore, if not done so already, employers should take several
immediate steps in order to prepare for the implementation of the new GINA regulations as
follows:

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 1) Educate human resources personnel, managers, supervisors and recruiters
about GINA and its prohibitions.
2) Train supervisors and managers about what they can and cannot say when
genetic information and/or family medical history is inadvertently disclosed.
3) Amend EEO and non-discrimination policies to include prohibitions against
discrimination based on genetic information and family medical history.
4) Maintain all future records containing genetic information and family medical
history - such as FMLA certification forms seeking leave for the serious illness of
a family member - in separate, confidential medical files.
5) Discontinue any request to provide family medical history or other genetic
information in connection with an employee’s request for a reasonable
accommodation under the ADA, for FMLA leave for an employee’s own serious
health condition, pursuant to a company leave policies, or for any other
employment-related applications.
6) Add the “safe harbor” warning to all requests for medical information such as
on FMLA medical certifications or other requests for medical information forms.
7) Implement policies and/or procedures to prevent the disclosure of genetic
information in response to a document request or subpoena to avoid the
production of genetic information without a court order.
8) If the employer maintains a wellness program, ensure that each participating
employee knowingly and voluntarily authorizes their participation in the
wellness program through the use of a written authorization forms/releases.
9) Post the GINA poster in the premises where other federally and state-
mandated posters are maintained.

For further information on GINA or its regulations, please contact E. Jason Tremblay or your
employment and labor law attorney at Arnstein & Lehr LLP.

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