Genetic Privacy Page
About genetic privacy, World Privacy Forum publications on genetic privacy,
genetic privacy issues, and other resources
What is Genetic Privacy?
Genetic privacy relates to the complex set of issues surrounding how
DNA information about individuals is handled and used. Some genetic privacy
issues relate to the acquisition of DNA samples from individuals, other
genetic privacy issues relate more to what is done with the DNA information
One of the challenges with genetic privacy is that genes reveal information
about the person they are directly attached to, but they also reveal information
about the blood relatives of that person. This means that a person making
a decision about, for example, getting a commercial gene test. is actually
making decisions that can impact other blood relatives. How does privacy
work in this kind of situation? In the area of genetics and privacy, there
are more questions than answers.
The World Privacy Forum has focused on several aspects of genetic privacy,
including the use of genetic data in research, pharmacogenomics and personalized
medicine, direct-to-consumer marketing, and genetic data in electronic
health records and exchanges.
Key Issues in Genetic Privacy
Genetic privacy is an area rich with policy issues related to privacy
and human rights. A few of the key policy areas include, (among many others):
- Use of genetic material to discriminate against individuals
(for example, for employment and insurance);
- Storage issues related to genetic material after
sample collection (for example, how long are samples kept and
why, how securely are the samples kept, how are the samples
destroyed, and so on);
- Access and purpose specification issues who has
access to genetic material that has been collected,
and is that access in tandem with the original purpose for which the
DNA was collected? (For example, are newborn screening samples also
used for law enforcement purposes, etc.);
- Identifiability issues -- can "anonymous"
research be re-linked with a person? The answer is increasingly yes.
The World Privacy Forum believes that the capability of identifying
individuals from subsets of genetic information will expand greatly
in the future.
- Consent issues, especially related to the genetic
ripple effect, that is, the ability to tie other members of a family
to a single source of genetic material. While robust consent may have
been obtained for a single original use, if the DNA is used for secondary
purposes to identify or describe a relative that has not given consent,
challenging ethical questions arise. The issue of compelled or coerced
consent also raises numerous ethical and legal issues.
- Direct-to-Consumer marketing issues, the marketing
of genetic tests directly to consumers through the Internet and generally
outside the clinical setting has many difficulties attached to it. Much
of the material about direct to consumer tests focus on the quality
issues. But there are plenty of privacy risks. In particular, the privacy
risks for consumers come in through privacy policies that may allow
for further uses of the genetic materials, or the inappropriate marketing
uses of consumer genetic information, even marketing uses of consumer
requests for genetic tests.
World Privacy Forum Resources and Work
Following are links to information the World Privacy Forum has created
as part of its work in the area of genetic privacy.
PUBLIC COMMENTS: Comments of the World Privacy Forum on Proposed
GINA Regulation, Title II Proposed Implementation.
May 1, 2009
Read the public comments, Proposed rule to implement Title II of
the Genetic Information Nondiscrimination Act of 2008, March 2, 2009,
at 74 Fed. Reg. 9056-9071, (PDF, 10 pages). Read
the comments (PDF).
The World Privacy Forum filed comments on the proposed regulations on
the Genetic Information NonDiscrimination Act, or GINA. The comments request
that the Equal Opportunity Employment Commission close down several potential
loophole in consumer protection in the regulations. The Forum specifically
asked the EEOC to consider curtailing the amount of commercially available
information employers could access about employees, for example, through
marketing databases. WPF also requested that those covered under GINA
be required to maintain audit trails in certain circumstances, and urged
that wellness programs be structured in such a way as to prevent information
leakage through billing and other activities.
the comments | Related: WPF
Genetic Privacy Page
PUBLIC COMMENTS: Comments of the World Privacy Forum on GINA clarification
December 9, 2008
- Read the public comments, Comments of the World Privacy Forum
on Request for Information Regarding Secctions 101 - 104 of the Genetic
Information Nondiscrimination Act of 2008, (PDF, 11 pages) Read
the comments (PDF).
In response to a Request for Information (RFI) from U.S. federal
agencies regarding the recently passed GINA (Genetic Information Nondiscrimination
Act), the World Privacy Forum filed a detailed response with suggestions
on what aspects of GINA need clarification. The comments focus on
a number of privacy issues the RFI raised, including model privacy
notices and the issue of what the GINA statute calls "incidental
collection" of genetic information. Currently, GINA states that
some kinds of information are exempted from being considered as regulated
for medical underwriting purposes. For example, medical information
gleaned about patients for underwriting purposes from medical databases
is regulated. But medical information gleaned about patients for underwriting
purposes from, for example, marketing lists containing robust patient
information may be unregulated if the law is not clarified in the
regulatory process. The World Privacy Forum urged HHS and the Department
of Labor to substantially clarify what constitutes "incidental
collection," and urged the agencies to consider lists containing
identifiable patient information to be considered in the same category
as a "medical database."
TESTIMONY and PUBLIC COMMENTS: Comments of the World Privacy Forum
Regarding Privacy Aspects of Direct-To-Consumer Marketing of Genetic Tests
February 13, 2008
- Read the public comments, Comments of the World Privacy Forum
to the Secretary’s Advisory Committee on Genetics, Health, and
Society regarding the draft report, U.S. System of Oversight of Genetic
Testing: A Response to the Charge of the Secretary of HHS, (PDF,
11 pages) Read
the comments (PDF)
These comments include a discussion of the market that exists for
consumer health data and contains recommendations on how to begin
to approach the issue of direct to consumer tests. The comments are
from December 2007. In February 2008, the World Privacy Forum testified
to the Secretary's Advisory Committee on Genetics Health and Society
on the privacy issues connected to direct-to-consumer genetic tests.
PUBLIC COMMENTS: Comments of the World Privacy Forum on protecting
privacy in pharmacogenomics research
May 23, 2007
PUBLIC COMMENTS: Comments of the World Privacy Forum on genome-wide
July 18, 2006
- Read the comments, Comments of the World Privacy Forum on the
Draft Report on Policy Issues Associated with Undertaking a Large U.S.
Population Cohort Project on Genetics, Environment, and Disease. (PDF,
9 pages) Read
the comments (PDF) or Read
the comments on the Web
Large genetic cohort projects involve the creation of large databases
or biobanks of genes that can be used for hundreds, even thousands,
of detailed research studies. Genetic biobanks and projects of this
kind raise significant ethical, legal, social, and public policy questions,
including significant questions about privacy protections and rights.
The WPF recommended that either laws were passed to protect privacy
the Forum recommended a privacy officer be appointed to the project,
and that uses of the records by third parties be curtailed by the
use of certificates of confidentiality and through other means.
PUBLIC COMMENTS: Comments of the World Privacy Forum on privacy and
personalized health care
February 5, 2007
- Read the comments, Comments of the World Privacy Forum to the
U.S. Department of Health and Human Service on its Request For Information
regarding Improving Health and Accelerating Personalized Health
Care Through Health Information Technology and Genomic Information in
Population- and Community-Based Health Care Delivery Systems (PDF,
10 pages )
Read the comments (PDF)
The WPF expressed concern about approach to personalized medicine
that the U.S. Department of Health and Human Services articulated
in a notice. The WPF comments focus on proposed use of genomic information
without sufficient attention to privacy controls. The comments recommended
that HHS pay attention to medical identity theft, implement full Fair
Information Practices in its genetic programs, implement an ELSIE
committee for each project, hire a chief privacy officer, and publish
a Privacy Impact Assessment for all personalized medicine projects.
Other Genetic Privacy Resources (external links)
Many of organizations relating to genetic interests exist. The focus
here is on organizations that are doing work that touches on the privacy
aspects of genetic issues, particularly the consumer aspects.
- Secretary's Advisory
Committee on Genetics, Health and Society SACHGS
The SACGHS is the U.S. Government's official advisory body on human
genetics. The SACGHS reports to the U.S. Secretary of Health. SACGHS
has put forward a number of important documents and policy statements
regarding genetic policy and regulation. This board has tackled the
issue of genetic discrimination, direct-to-consumer marketing, and
oversight of genetic testing, among others.
- Human Genetics Commission
Human Genetics Commission is the UK Government's official advisory
body on human genetics. HGC has groups that focus on identity testing,
genetic discrimination, intellectual property and genetics, databases,
and genetic services.
Selected Articles and Research
Confidentiality, and Identifiability in Genomic Research, William
Lowrance PhD, (2006) (PDF)
The National Human Genome Research Institute's white paper on confidentiality
and the use of genetic data outlines the key issues relating to confidentiality,
identifiability, de-identifiability, and genomics. It is a good place
to start if new to the area of genetics and identifiability.
- A Critical Appraisal of the Scientific Basis of Commercial Genomic
Profiles Use to Assess Health Risks and Personalize Health Interventions,
American Society of Human Genetics, (2008) (PDF;
also available on the web)
- Electronic Privacy Information Center, Genetic
Privacy. The Electronic Information Privacy Center has a web
page on genetic privacy that contains an edited listing of genetic databases,
cases, and other information. This is a good page to look at for an
overview of the myriad privacy issues intersecting with genetics.