23andMe – ‘Cooing’ and ‘Wooing’


If you have considered obtaining your genetic information from 23andMe or elsewhere (and including it in your PHR), then you might want to inform yourself on the issues before proceeding.

If there’s a gene for hubris, the 23andMe crew has certainly got it. Last Friday the U.S. Food and Drug Administration (FDA) ordered the genetic-testing company immediately to stop selling its flagship product, its $99 “Personal Genome Service” kit. In response, the company cooed that its “relationship with the FDA is extremely important to us” and continued hawking its wares as if nothing had happened. Although the agency is right to sound a warning about 23andMe, it’s doing so for the wrong reasons. — Scientific American

While the FDA’s concerns–the safety and efficacy of ‘medical devices’–are important, broader privacy issues have subsequently been raised and discussed in the SA post, comments, and elsewhere.

23andMe Is Terrifying, but Not for the Reasons the FDA Thinks
[November 2013, Scientific American]

More on the 23andMe controversy and genetic privacy, here.

Now, 23andMe is trying to win back FDA favor and approval.

23andMe Tries to Woo the FDA
[July 2014, MIT Technology Review]

Might we expect some form of regulation of genetic testing products and services marketed directly to patients? Regulations such as those provided by the HIPAA Privacy Rule 1 for medical and health information in our medical records (EMR) and personal health records (PHR)?

1. The HIPAA Privacy Rule is part of the implementation of  HIPAA, the federal Health Insurance Portability and Accountability Act of 1996. The primary goal of the law is to make it easier for people to keep health insurance, protect the confidentiality and security of healthcare information, and help the healthcare industry control administrative costs. – Google     → More

About Tom

Retired Educator
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1 Response to 23andMe – ‘Cooing’ and ‘Wooing’

  1. Tom says:

    In the November 2014 JASON report, Data for Individual Health (pp. 76-80), there is an interesting discussion of the FDA/23andMe issues and controversy.

    “In a world of individual-centric health care delivery there is an intrinsic tension between the free flow of health and wellness-related information to the
    individual and the need for government to protect individuals from medical
    harm. On the one hand, enabled by the Internet, the individual is able to
    learn vastly more about health, diet, disease prevention, specific symptoms,
    diagnostic procedures, prognosis, alternative medicine, and so forth, than
    was ever before imaginable in history. Moreover, content providers on the
    web are often protected from censorship or regulation (at least in the US) by
    their First Amendment rights. The result is a web that is full of good information that can promote wellness, and also full of bad information that can
    lead an individual to make misguided, and sometimes dangerous, decisions
    about their own health.

    “The rocky relationship between the FDA and the company 23andMe
    perfectly illustrates the dilemma.” Read More

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