Privacy and Protection

Is genetic testing voluntary?

Genetic testing is performed for several purposes, such as diagnosis of diseases, risk determination for future pregnancies, research and individual identification. Genetic testing is voluntary, except for newborn screening, which is mandatory in most states.

What is informed consent?

Before any test, it is important to understand the following:

  • Testing is your choice
  • The risks, limitations and benefits of testing or not getting tested
  • There are alternatives to genetic testing
  • The details of the testing process (for example, what type of sample is required, accuracy of test, how long it takes to get test results, etc.)
  • That health care providers should ensure that results will be kept private and confidential
  • The potential consequences related to these test results including:

Impact on health

  • Possible emotional and psychological reactions
  • Availability and access to treatment/prevention options
  • Information about other family members may be provided
  • How are my rights protected as private information?

Results can only be released to individuals for whom the recipient has given consent.

Genetic information is protected by the Health Information Portability and Accountability Act privacy rule, which created national standards to protect an individual’s medical records and other health information. All information regarding your genetic tests are protected from being shared with people other than your medical doctor. Privacy for medical and genetic information is your right, and all the information can only be shared with your permission.

Test results can NOT be provided to outside parties, such as employers, insurers, or government agencies WITHOUT WRITTEN CONSENT.

Does my health provider have the right to disclose my genetic test information?

Health providers may not inform other family members of genetic test results without permission from the person tested.

If the health professional believes that someone may be at risk, the patient will be encouraged to disclose results to other family members.

Laws regarding Duty to Inform third parties vary by state.

Protecting Your Privacy

These laws protect persons from stigmatization, discrimination, and breaches of privacy.

The Health Insurance Portability and Accountability Act (HIPAA) of 1996 states that genetic information is “protected health information’’. Genetic information is any written or recorded individually identifiable health information resulting from genetic testing or medical evaluation. Protected Health Information is any information about a patient, including that which will identify the patient (such as name, address, birthday, and social security number), that relates to a patient’s past, present and future physical or mental health or condition, related to healthcare services or payment for these services. You often get a HIPAA privacy notice when you have a medical visit.

The Genetic Information Non-discrimination Act (GINA) was passed into law in May 2008. Its intent is to prohibit discrimination by employers and insurance companies. It changes some key definitions used by HIPAA relating to genetic information, genetic testing, and genetic services. GINA prohibits group health plans and health insurance issuers. That is, insurance companies or health maintenance organizations (HMOs) from using genetic information to adjust premium or contribution amounts for the group covered under the plan. Plans and issuers in the group market are still allowed to increase the premium rates for an employer based on the manifestation of a disease or disorder of an individual enrolled in the plan. They are prohibited from using the manifested disease or disorder of one individual as genetic information about other group members to further increase premiums.

For individual plans, health insurance issuers are prohibited from using genetic information to determine individual eligibility or premium rates, although they are allowed (to the extent consistent with other provisions of law) to use information about a manifestation of a disease or disorder to determine eligibility or premium rates for an individual who is covered or would be covered by a policy. Individual health insurance issuers are also prohibited from using genetic information in imposing a pre-existing condition exclusion. A manifestation of a disease or disorder in an individual can be the basis for exclusion from a health plan. In the Medicare Supplement market, GINA prohibits issuers from denying or conditioning the issuance or effectiveness of a policy (including the imposition of any exclusion of benefits based on a pre-existing condition) or discriminating in the pricing of the policy based on an individual’s genetic condition. When permitted under section 1882 of the Social Security Act, the issuer can impose such limitations based on a manifested disease of an individual who is covered or would be covered under the policy.

GINA also prohibits group health plans and health insurance issuers from requesting or requiring an individual or family member of an individual to undergo a genetic test. Plans and issuers are not precluded from obtaining and using the results of a genetic test to make a determination regarding payment. They may only use the minimum amount of information necessary.

Should I use direct-to-consumer tests?

Many companies market genetic tests to consumers without a doctor’s involvement. People should be very cautious when they get tested in this way. Understanding genetic test results may be complicated.

If you are considering testing from a company like this, consult your health care professional. A genetic counselor may help you make an informed decision and also help you interpret the results.

Make sure that any company you choose to provide genetic tests is certified to do these tests.


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