TESTING TRENDS

Genetics Update: 23andMe Seeks to Upend the Medical Industry via Genetic Testing Information Sharing

Can one company disrupt the entire lab industry? 23andMe seems determined to find out. The Mountain View, California-based personal genomics and biotechnology company, which first marketed its consumer services for tracing ancestry before moving into analysis of health traits, is now planning to take another conceptual leap. According to CNBC reports, 23andMe is looking at a pilot program that would incorporate customers’ lab results, prescription information and medical history with genetic test findings using third-party medical data sharing platform Human API.

Implications of Information Sharing

The implications are significant. The new information sharing program would put genetics data front and center, allowing it to become a primary tool for evaluating and treating patients. It would also further medical research.

Of course, 23andMe isn’t the only consumer company seeking to leverage medical information. Other notable examples include Apple which has developed the Health app enabling patients to aggregate their health records, including lab tests and prescription information, alongside data they generate on their own. Increasingly, Apple Health is used in conjunction with healthcare providers’ patient portals.

Diagnostic Challenges

The difference between 23andMe and Apple, CNBC points out, is genetics data. And no question, DNA provides the missing link, in more ways than one. This potentially makes it a much more attractive and far-reaching option.

But there are also big concerns. One of these is that providing genetic testing information directly to consumers without a medical professional’s intervention will lead to misinterpretation of test results and promote false reassurance or unwarranted panic. Of course, the same concern applies to information aggregated and shared via Apple’s Health app, but to a lesser extent.

While acknowledging the potential risks, proponents contend that knowledge is power and cite how patients have increasingly become more involved in their own healthcare decisions, which include researching treatment options and becoming their own patient advocates. This is a positive approach, one shared by many family caregivers.

Privacy Concerns

The other big concern is privacy. The customer data that 23andMe proposes to share is considered personal health information (PHI) under HIPAA and the companies would need consent to use it for the project. And that may prove to be a big stumbling block at least with some customers. After all, there’s a big difference between using PHI for tracing a customer’s ancestry and using it for providing healthcare services. In addition to these privacy issues, the proposed pilot raises concerns to the extent it redefines what constitutes a medical record.

Of course, providing consumers with health information is nothing new; the internet has been a source of information for decades. The difference is that personal data, including genetic testing and other lab results, has now become available to individuals who may or may not be qualified to interpret it.

Going Forward

For labs and other providers, this new genetic information sharing frontier will likely continue to raise questions, including legal ones. For example, if a patient has access to healthcare information such as lab test results via technology, is the healthcare service provider responsible for further outreach? And where does responsibility for interpretation of test results now begin and end?

The line between patient and provider continues to blur at the same time technology allows for new ways to share information and breakthroughs in medicine allow for new insight. It’s a prescription for disruption, to be sure, with missteps likely to forge the path forward.

Yet, make no mistake ;there will be a path forward. Although 23andMe has indicated that its pilot program is still in the planning stages and is subject to change, the company has more than 10 million customers. That’s a lot of data.

(Note: The number of individuals using Apple Health is not available. However, Apple has compiled a list of hospitals and clinics that share health records via the app. The list, updated on July 1 of this year and available at the company’s website, is extensive.)

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