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Maryland ’s new law provides a model for others

Large sets of health data can enable innovation and quality measurement but can also create technical challenges and privacy risks. When entities such as health plans and health care providers handle personal health information, they are often subject to data privacy regulation. But amid a flood of new forms of health data, some third parties have figured out ways to avoid some data privacy laws, developing what we call “shadow health records”—collections of health data outside the health system that provide detailed pictures of individual health—that allow both innovative research and commercial targeting despite data privacy rules. Now that space for regulatory arbitrage is changing. The long arms of Europe's new General Data Protection Regulation (GDPR) and California's new Consumer Privacy Act (CCPA) will reach shadow health records in many companies. In this article, we lay out the contours of the GDPR's and CCPA's impact on shadow health records and health data more broadly, highlight critical remaining uncertainty, and call for increased clarity from lawmakers and industry on the use of such data for research. (Less)

Sharing data, protecting privacy Although data-sharing is crucial for making the best use of genetic data in diagnosing disease, many individuals who might donate data are concerned about privacy. Jagadeesh et al. describe a solution that combines a protocol from modern cryptography with frequency-based clinical genetics used to diagnose causal disease mutations in patients with monogenic disorders. This framework correctly identified the causal gene in cases involving actual patients, while protecting more than 99% of individual participants' most private variants. Science , this issue p. 692

Bias and privacy concerns cloud police use of genetics

It9s becoming more and more difficult to safeguard the privacy of patients who participate in scientific studies. Many patient samples today are banked, sequenced, and shared with potentially thousands of researchers, and it9s widely accepted that if you can read someone9s DNA, you may be able to figure out who they are. That9s why researchers are seeking new ways of gaining patients9 trust and keeping them involved—for instance by giving them more control over how their samples are used or being more transparent about the studies that their data are used in. Some are looking at popular websites like Uber and Airbnb as they develop new ways of building trust between patients and researchers.

Genetic Privacy Recent advances in DNA technology and companies that provide array-based testing have led to services that collect, share, and analyze volunteered genomic information. Privacy concerns have been raised, especially in light of the use of these services by law enforcement to identify suspects in criminal cases. Testing models of relatedness, Erlich et al. show that many individuals of European ancestry in the United States—even those that have not undergone genetic testing—can be identified on the basis of available genetic information. These results indicate a need for procedures to help maintain genetic privacy for individuals. Science , this issue p. [690][1] [1]: /lookup/doi/10.1126/science.aau4832

This letter enumerates three major factors that make trawling DNA databases designed for genealogical research to identify individuals who may have left DNA traces at crime-scenes less invasive of legitimate privacy interests than one might assume.

In her News story “Trust me, I'm a medical researcher” (special section on The end of privacy, 30 January, p. [501][1]), J. Couzin-Frankel concludes that mutual trust is key for truthful collaboration between patients and medical researchers. The comparison to collaborations between service

Rapid advances in genetics research and the emerging applications to medical practice have heightened public awareness and public concerns about who will have access to this information and how it will be used. In addition to concerns about the privacy of genetic information maintained in medical records, however, is the concern about the privacy of genetics information maintained in experimental research records. This article presents the National Action Plan on Breast Cancer (NAPBC) recommendations to protect the privacy of experimental genetics research records.

The use of genetic information in the workplace poses societal risks that have an impact on employment possibilities, health insurance, and privacy. Individuals who might otherwise believe they can benefit from genetic testing may decline it because of their fear of employment discrimination and lack of privacy in the workplace. As a consequence, the future of research on the benefits and risks of predictive genetic testing may also be compromised. Thus, policy-makers need to evaluate legislative and regulatory strategies to address these concerns. This paper analyzes state and federal legislative approaches to genetic information in the workplace and concludes with a discussion of policy considerations and recommendation.

Many of the challenges in genomics derive from the informatics needed to store and analyze the raw sequencing data that is available from highly multiplexed sequencing technologies. Because single week-long sequencing runs today can produce as much data as did entire genome centers a few years ago, the need to process terabytes of information has become de rigueur for many labs engaged in genomic research. The availability of deep (and large) genomic data sets raises concerns over information access, data security, and subject/patient privacy that must be addressed for the field to continue its rapid advances.

Sequencing human DNA to discover genetic variation should be governed by existing regulations for human subjects.

Jocelyn Kaiser's article on the U.S. federal regulations known as the HIPAA Privacy Rules ([1][1]) describes these laws as overly complicated and obstructing life-saving research (“Privacy rule creates bottleneck for U.S. biomedical researchers,” News Focus, 9 July 2004, p. 168.). It ends with

In their Policy Forum "The complexities of genomic identifiability" (18 January, p. [275][1]), L. L. Rodriguez et al. correctly point out that in view of the intriguing recent demonstration of the identifiability of donors participating in genomic studies ("Identifying personal genomes by surname inference," M. Gymrek et al. , Reports, 18 January, p. [321][2]), the research community needs to optimize the balance between the need for data sharing and respect for the privacy of research participants. In our 2009 Science Policy Forum ([ 1 ][3]), we proposed specific measures to improve the current policies and provide greater protection for children. Children are among the most vulnerable populations whose DNA samples are being collected in large numbers for epidemiologic studies. Sadly, it seems that our suggestions have not led to distinct biobanking policies for children. We reiterate our 2009 call for the scientific research community to agree on extra safeguards, particularly restrictions on sharing the individual genome sequences of children, unless they are contacted again as adults and provide their own consent at that time. In the case of fatal pediatric disease research (when obtaining adult and consented donor samples is implausible), conditions for sharing the personal genome sequences of children could be eased. In spite of the current genetic nondiscrimination legislation widely enacted, our duty remains to ensure extra privacy protections for children, balanced with the need to continue research on pediatric diseases. 1. [↵][4] 1. D. Gurwitz, 2. I. Fortier, 3. J. E. Lunshof, 4. B. M. Knoppers , Science, 325, 818 (2009). [OpenUrl][5][Abstract/FREE Full Text][6] [1]: /lookup/doi/10.1126/science.1234593 [2]: /lookup/doi/10.1126/science.1229566 [3]: #ref-1 [4]: #xref-ref-1-1 "View reference 1 in text" [5]: {openurl}?query=rft.jtitle%253DScience%26rft.stitle%253DScience%26rft.issn%253D0036-8075%26rft.aulast%253DGurwitz%26rft.auinit1%253DD.%26rft.volume%253D325%26rft.issue%253D5942%26rft.spage%253D818%26rft.epage%253D819%26rft.atitle%253DChildren%2Band%2BPopulation%2BBiobanks%26rft_id%253Dinfo%253Adoi%252F10.1126%252Fscience.1173284%26rft_id%253Dinfo%253Apmid%252F19679798%26rft.genre%253Darticle%26rft_val_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Ajournal%26ctx_ver%253DZ39.88-2004%26url_ver%253DZ39.88-2004%26url_ctx_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Actx [6]: /lookup/ijlink/YTozOntzOjQ6InBhdGgiO3M6MTQ6Ii9sb29rdXAvaWpsaW5rIjtzOjU6InF1ZXJ5IjthOjQ6e3M6ODoibGlua1R5cGUiO3M6NDoiQUJTVCI7czoxMToiam91cm5hbENvZGUiO3M6Mzoic2NpIjtzOjU6InJlc2lkIjtzOjEyOiIzMjUvNTk0Mi84MTgiO3M6NDoiYXRvbSI7czoyNToiL3NjaS8zMzkvNjEyMy8xMDMzLjEuYXRvbSI7fXM6ODoiZnJhZ21lbnQiO3M6MDoiIjt9

By applying an algorithm to anonymized genomes from a research database and doing some online sleuthing with popular genealogy Web sites, researchers were able to guess the true identities of DNA donors. Privacy concerns have been raised about publicly accessible genome data before, and managers of a popular repository were aware of the risks posed, but few people had guessed how easy deanonymizing the data was. As genealogy databases and other resources improve, how can individuals be protected, and what are the implications?

PATIENT RECORDSA complicated new regulation is hindering a broad swath of science, from population-based and genetics studies to tissue repositories (see related Policy Forum on p. [183][1]). [1]: http://www.sciencemag.org/cgi/content/short/305/5681/183

A paper published recently in PLOS Genetics ([1][1]) describes a statistical method for resolving individual genotypes within a mix of DNA samples or data sets containing aggregate single-nucleotide polymorphism data. This scientific advance may have important implications for forensics and for

After 13 years of rejection, a bill to protect individuals from employment and insurance discrimination based on their DNA, the Genetic Information Nondiscrimination Act, is poised to become law. Science interviews its most stalwart backer, Representative Louise Slaughter (D-NY).

On 31 May 2007, James Watson was handed a miniature hard drive containing his personal genome sequence, which was subsequently uploaded onto publicly accessible databases. Craig Venter’s personal genome was published a few months later (1). These projects represent research milestones. They also present an opportunity to examine the ethical, social, and clinical implications of personal genomics.

The author endorses the early release into the public domain of all genomic sequence data produced by sequencing centers. Such informal prerelease of data before the finishing stage would have many advantages for both research and commercial exploitation. The data would be of sufficiently high quality to be useful in biological and genetic studies, and restrictions on their early release would impede scientific progress. Free release of raw genomic sequence would lead to unimpeded competition among academic and commercial interests to create new therapeutic agents.

A report completed last month recommends that a high-level policy board be created in the office of the Secretary of Health and Human Services to help develop policies on such sensitive issues as genetic privacy, anti-discrimination legislation, public education on genetic risks, and the regulation of genetic testing.