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Personal genetics, the European regulations maze and the way out

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dc.contributor.author Colaiacovo, M en
dc.contributor.author Grimaldi, KA en
dc.date.accessioned 2014-03-01T11:47:07Z
dc.date.available 2014-03-01T11:47:07Z
dc.date.issued 2012 en
dc.identifier.issn 17410541 en
dc.identifier.uri http://hdl.handle.net/123456789/38096
dc.subject direct-to-consumer en
dc.subject European law en
dc.subject health genetics en
dc.subject personal genetics en
dc.subject regulations en
dc.subject.other apolipoprotein E en
dc.subject.other Europe en
dc.subject.other genetic counseling en
dc.subject.other genetics en
dc.subject.other genotype en
dc.subject.other health care access en
dc.subject.other health care policy en
dc.subject.other health care system en
dc.subject.other law en
dc.subject.other practice guideline en
dc.subject.other priority journal en
dc.subject.other review en
dc.title Personal genetics, the European regulations maze and the way out en
heal.type other en
heal.identifier.primary 10.2217/pme.12.62 en
heal.identifier.secondary http://dx.doi.org/10.2217/pme.12.62 en
heal.publicationDate 2012 en
heal.abstract Personal genetics and regulations have been the subject of active debate for at least the last 10 years, since the first direct-to-consumer tests were sold in the UK by Sciona Inc. (CO, USA). Opinions range from prohibition to free-for-all and all the shades in between. However, there has been very little progress in formulating regulations and the situation in Europe is particularly confusing, making it difficult for the provider and the consumer alike. The regulations maze is likely to be one major reason why the growth and public uptake has been slow: it is hard for companies to know how to operate and equally hard for consumers to understand what tests are useful versus those of dubious quality. This article gives a brief overview of the current situation regarding what regulations exist and looks closely at the areas where more clarity is needed. These include, exactly what should be regulated? What is health-related data? Who can and who should be able to have access to personal genetics? We conclude with specific proposals for improving the protection for consumers and encouraging growth of useful services. © 2012 Future Medicine Ltd. en
heal.journalName Personalized Medicine en
dc.identifier.doi 10.2217/pme.12.62 en
dc.identifier.volume 9 en
dc.identifier.issue 5 en
dc.identifier.spage 515 en
dc.identifier.epage 522 en


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