New Fuel for the Genomic Privacy Debate
The growth of prominent genomics research and direct-to-consumer (DTC) commercial services that combine genomic data with phenotypic data, environmental data and personal health surveys continues to spur debate over the appropriate privacy safeguards and expectations for individuals who participate in such research or enroll in such services. From large-scale genomic research projects such as the Coriell Personalized Medicine Collaborative (pdf) and the UK BioBank to popular DTC genomics services such as those offered by Navigenics, many influential players in the public genomics space continue to strongly emphasize their commitment to absolute data privacy. Prominent skeptics, including geneticist George Church and lawyer and ethicist Hank Greely, argue that any such privacy promise is impossible to keep because of the inherent nature of such genomic data, particularly when paired with phenotypic data or other potentially personally identifying information.
Two recent developments may add further fuel to this debate. First, California recently issued a report on the first five months of results from a new state law (effective January 1, 2009) requiring health care organizations in California to report breaches in the security of personally identifiable health information. In publishing the report the California Department of Public Health was surprised at the high volume of reports and confirmed 116 privacy breaches during the five-month period, most of which were inadvertent. Given the early results, the agency expects the number of reported breaches to increase dramatically as organizations become more familiar with their reporting obligations.
Strict Liability for Sperm?
The ABA Journal notes an interesting case from a federal district court Pennsylvania, Donovan v. Idant Laboratories (pdf). In 1995, Donna Donovan, the plaintiff, was artificially inseminated with sperm provided by Idant Laboratories, the defendant. Ms. Donovan signed a consent form in which Idant represented that “(1) semen stored at Idant is exceptionally safe; (2) Idant has a screening program that far exceeds mandated standards and (3) Idant’s donors go through a rigorous screening process to ensure that they have a good genetic background and history.”
Donovan gave birth to a daughter, Brittany, in January 1996 using sperm from Idant Donor G738. Brittany was diagnosed with developmental difficulties related to her status as a carrier of the Fragile X gene (FMR1). Testing revealed that Donor G378, not Donna Donovan, carried the Fragile X gene. Donna Donovan sued Idant under a multitude of theories,* both as Brittany’s guardian and on her own.
