The Human Genome and Patient Privacy: A Proposal to Expand Protections for Patients and Family Members

As medical and biological technology has progressed in recent years, concerns have been raised about the privacy implications of genetic records that can identify individuals and predict future conditions to which they are predisposed. According to the Electronic Privacy Information Center, genetic material has special privacy concerns for three reasons: the ease with which it can be collected; its ability to reveal information about not just the subject, but also their family members; and the fact that it can point towards future medical conditions (2009, Overview).

As of last year, legislation prohibits employers and health insurers from discriminating against individuals based on their genetic records, but offers little regulation of who can require genetic testing and what they can do with the records afterwards (EPIC, 2009). Further problems are created by the fact that private corporations and universities have patented approximately 20 percent of the human genome (ACLU, 2009), forcing medical professionals and individuals to use those companies’ services with no control over what will be done with the results of their tests.

Important steps have been taken in the past two years to address the growing concerns over privacy and genetic information. However, more needs to be done in order to protect the rights of patients and their family members. In the following pages, I will assess what is and is not protected under existing laws, and call upon Congress to take further action to ensure that individuals are shielded from unwanted knowledge, abuse, and exploitation caused by release of their genetic information.

Background Information

Three principles (“spheres”) of privacy law affect genetic information: Control of Personal Information, Personal Autonomy, and Control of Property. Each of the three encompasses different aspects of genetic information, and current legal protections vary from sphere to sphere.

Control of Personal Information

Existing laws cover the release of health information, which includes genetic information. The Genetic Information Nondiscrimination Act (GINA) of 2008 (Pub. L. No. 110-223) adds genetic information to the definition of “health information” under the Health Insurance Portability and Accountability Act (HIPAA) regulations, severely restricting its release without a patient’s express consent (CRS, 2008; NIH, 2009). GINA also prohibits insurance companies and employers from requiring genetic testing of clients and employees except in a limited number of circumstances, and prohibits insurance and employment discrimination based on genetic information (CRS, 2008). At this time, it appears that the protections implemented in 2008 adequately address the threat of disclosure to third parties.

Personal Autonomy

The predictive and revealing nature of genetic information means that third parties are not the only ones affected by privacy considerations. Margaret Everett explains that “genetic privacy” also includes “[…]the right not to know one’s own genetic fate, as well as the right to use information in accordance with one’s own values.” (2003, 55). While it has not yet become an issue in the courts, the law does not address whether medical professionals should obtain informed consent before releasing genetic information to a patient. Additionally, since genetic information contains information about not only oneself but also one’s relatives, there exists an unresolved question of whose consent should be required for release of that information. Essentially, the law does not yet offer any guidance on personal autonomy in relation to genetic information.

Control of Property

Control of property is perhaps the most complex of the privacy concerns with genetic information, because existing case law contradicts itself. According to Everett (2003, 57), the courts disagree over whether DNA and genetic code should be the property of individuals who produce it or that of researchers who sequence it.

One California Supreme Court case often referenced by those researchers is Moore v. Regents of the University of California, in which Moore’s removed spleen was used for research without his knowledge; this research led to the discovery of a potentially lucrative cell sequence. The court ruled that Moore had failed to assert ownership rights of his discarded spleen, and therefore had no claim to profits made from its research. Some point to this case as precedent denying individual ownership rights to genetic information, while others argue that it simply denied Moore ownership of his spleen (Everett, 2003, 57).

Other cases appear to confer some property rights over genetic material. Michael Markett (1996) points to three cases: United States v. Arora, 860 F. Supp. 1091 (in which a scientist who maliciously destroyed a cell line being researched at the NIH was found liable under the tort of conversion); York v. Jones, 717 F. Supp. 421 (ruling that a pre-zygote was property that could be subjected to an enforceable contract); and Davis v. Davis, 842 S.W.2d 588 (affirming that although a pre-embryo was in an “interim category” between property and person, both of its creators had an equal quasi-ownership interest in what could be done with it).

Additionally, a case currently pending before the U.S. District Court for the Southern District of New York, Association for Molecular Pathology et al. v. United States Patent and Trademark Office et al. (hereafter, AMP v. USPTO), concerns the question of ownership and property rights with respect to patent and trademark law.