The sudden ubiquity of home DNA kits is giving rise to a lot of new clinical potential — and a lot of privacy concerns at the same time, Axios’ Kim Hart writes this morning.
The big picture: “I think there’s a future in which everyone is sequenced, prenatally or at birth, and their genomic data is part of their medical record and is continually analyzed and that information is integrated into your medical care,” NIH bioethicist Benjamin Berkman told Kim.
- "We're getting better and better at understanding how different variants impact human health," he said. "But we have a long way to go before personalized medicine becomes a reality — we're still learning how the genome works."
Drug companies clearly see that potential.
- Ancestry.com and 23andMe — which, combined, store the DNA data of 15 million users — both sell anonymized genetic data to pharmaceutical companies. 23andMe is also working on its own line of potential treatments.
- "It's not individual data that's interesting — it's the ability to look at large groups of people to see what's unique. It's the aggregate data, not individual data, that's meaningful," said Kathy Hibbs, 23andMe's chief legal and regulatory officer.
Yes, but: DNA-testing services aren't specifically covered by federal privacy rules, such as HIPAA. They are subject to the FTC’s privacy rules, and some FDA research standards.
- But protections can get murky when genomic data is used for human-subject medical research, says Pam Hepp, a healthcare attorney at Buchanan Ingersoll and Rooney specializing in data privacy.