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23andMe Saga Doesn’t Bode Well for EMR Genetics Integration

Posted on December 5, 2013 I Written By

As Social Marketing Director at Billian, Jennifer Dennard is responsible for the continuing development and implementation of the company's social media strategies for Billian's HealthDATA and Porter Research. She is a regular contributor to a number of healthcare blogs and currently manages social marketing channels for the Health IT Leadership Summit and Technology Association of Georgia’s Health Society. You can find her on Twitter @JennDennard.

I wrote about the direct-to-consumer genetic testing company 23andMe back in mid-October, posing the idea that genetic information provided by the patient could only serve to enrich EMR data. I noted, “Genetic testing seems to be about empowering patients to take more proactive roles in managing their health today in an effort to prevent what might happen to their health in the future. It would make sense to share these test results with providers who can aid in that journey.”

Two readers chimed in. One noted that, “No [current] EMR can run genetic risk models or use genetic clinical decision support, [and ] [n]one of these fit into Meaningful Use, so it will be years until the EMR have the capability needed to use genomics.”

Another pointed out that, “the price point on 23andMe was all I was waiting for, and I have my gene sequence already. Yes, there are some risks, but that argument falls into the same category as any technology or innovation – it can be used for good or bad. The value this information brings far exceeds the downsides, and is now an essential part of the data feed to my personal healthcare.”

That last comment is especially interesting in light of the well-publicized tiff going on between 23andMe and the FDA. I won’t waste your time attempting to summarize the string of events that have led 23andMe to stop marketing its products, as well as a class action lawsuit and an official petition to overrule the FDA’s decision. Instead, I’ve compiled a few articles that detail the saga as it has unfolded.

Why Genetic Testing Could Endanger Your Health / ChicagoTribune.com

The FDA Drops an Anvil on 23andMe – Now What? / Stanford.edu

Founder of 23andMe speaks on FDA concerns / USAToday.com

Can 23andMe Survive the FDA? / TheVerge.com

Class Action Lawsuit Filed Against 23andMe / Forbes.com

23andMe Shuts down health-related genetics testing to work with FDA / Gigaom.com (Updated 12/6)

As far as the connection between genetic information gathered via commercial means by patients being incorporated into EMRs, it doesn’t look like it will happen easily anytime soon. It seems there are bigger debates brewing over the scope of the FDA’s regulatory power over companies like 23andMe, what the definition of a medical device should be, and the value consumers find in these services. Do they really lead to unnecessary medical tests and procedures? Let me know your thoughts on the 23andMe saga in the comments below. You can also join me this Friday at 12 ET for the weekly #HITsm tweet chat. We’ll be touching on the impact 23andMe’s big genetics data could have on healthcare, provided they’re allowed to stay in business.

EMRs Get Personal with 23andMe

Posted on October 18, 2013 I Written By

As Social Marketing Director at Billian, Jennifer Dennard is responsible for the continuing development and implementation of the company's social media strategies for Billian's HealthDATA and Porter Research. She is a regular contributor to a number of healthcare blogs and currently manages social marketing channels for the Health IT Leadership Summit and Technology Association of Georgia’s Health Society. You can find her on Twitter @JennDennard.

I had the pleasure of visiting the dentist this week. My dental hygienist and I end up having pretty lengthy conversations as we catch up on the previous six months. It’s almost like therapy in that you get to lay down the whole time, talk a bit, listen a bit, talk some more. At any rate, we commiserated about our experiences with cancer; I with my near-brush with melanoma and she with melanoma and then some. Due to her history with several kinds of cancer, she is thinking about having her daughter take a look at genetic testing service 23andMe.

The company’s $99 spit kit can generate reports on 256 health conditions and traits including inherited traits, carrier status for those traits, genetic health risks, likely drug responses, and updates on your DNA as they become available. As a recent Fast Company article on the company and its founder Anne Wojcicki notes, 23andMe’s mission is to bring the “power of genetic testing to everyday consumers so they can better manage their own health care, and [to use] the aggregated data from those tests to help doctors, scientists, hospitals, and researchers discover new cures for diseases that emanate from troublesome genetic mutations.”

As I left my dentist’s office, which ironically had just switched from paper to digital, I thought about the likelihood of genetic data ever finding its way into a personal health record or EMR. The Fast Company piece mentioned one doctor who pretty much didn’t want to have anything to do with his patient’s genetic data, which I duly noted she presented to him on sheaves of paper. One is a mighty small sample, of course, and so I can’t help but wonder what other providers think the value of this kind of data has, and how likely they might be to try and incorporate it into a medical record. 23andMe’s terms of service do state that, “Genetic Information that you choose to share with your physician or other health care provider may become part of your medical record and through that route be accessible to other health care providers and/or insurance companies in the future.”

But how will it get there? Is there an interface in the works? A partnership between 23andMe and an up-and-coming PHR or EMR? The company entered into a Parkinson’s study last year with Cleveland Clinic, so it obviously has direct relationships with providers. A news release announcing the study noted that findings from the study would not be placed in Cleveland Clinic patients’ medical records. Why not?

Genetic testing seems to be about empowering patients to take more proactive roles in managing their health today in an effort to prevent what might happen to their health in the future. It would make sense to share these test results with providers who can aid in that journey. I’m hoping providers in the audience can tell me if it makes sense for them to join in their patient’s genetic journey, or if they’re more likely to opt out. Please share your comments below.