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So Many Laws, So Little Coverage

Oct 29, 2009

Lawrence Moore and Emily Sherlock, from the Genomics Law Report, examine whether federal regulations, such as HIPPAA and GINA, affect direct-to-consumer genetic testing firms. First, they discuss whether DTC companies are covered by HIPAA, though, at first glance, it looks like these companies aren't involved in healthcare. But, as Moore and Sherlock point out, many have lately been partnering with healthcare providers and if companies provide "diagnostic or analytical information," they are covered by HIPAA.
They then determine that the Federal Trade Commission has a little jurisdiction, but only to the extent that the companies organize and share personal health records. Finally, they turn to GINA — while that act treats genetic information as health information, the proposed rules say that the act only extends to HIPAA-covered entities. Moore and Sherlock conclude:

The trend toward clinical activity on the part of many DTC genomics companies could ultimately bring them within the ambit of HIPAA and its Privacy Rule. However, at present it does not appear that there is any federal regulation — including HIPAA — that clearly restricts the transfer of customers' information as part of a sale of assets by a troubled DTC genomics company.

(HT: Genetic Future)

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