The U.S. Food and Drug Administration's decision to allow 23andMe to market a genetic test directly to consumers will help further innovation, but will also open the doors for the sale of personal patient information, according to Vivek Wadhwa, a fellow at Rock Center for Corporate Governance at Stanford University.
The move from the FDA came after much debate over 23andMe's tests. In 2013, the agency told the company to stop its health-related genetic tests because the results could mislead consumers without the right education on what the results mean. The FDA said the startup did not submit adequate data to support its claims and had continued to sell unapproved, unverified service for years, FierceHealthIT previously reported.
With the new FDA decision, there needs to be a greater urgency in making policies that will regulate what rights companies have when it comes to reselling information gleaned from DNA and patient medical records, Wadhwa writes at Venture Beat.
"Once this information is made public, its privacy is lost forever," he says. "Devising and implementing safeguards will require significant discussion and debate, so that needs to begin now."
In addition, while Wadhwa says he is excited to see what innovation will grow from the FDA's decision, we still don't know how to deal with personal data online.
To that end, recent cyberattacks already have consumers on edge over the safety of their medical information.
A recent, massive hack on health insurer Anthem's database that compromised information for 78.8 million consumers has been connected to the Chinese government.
To learn more:
- read the Venture Beat article