The Federal Communications Commission’s (FCC) National Broadband Plan was released to Congress today. (Depending on your perspective, that’s either one day ahead or 30 days behind schedule.) What, you might ask, does a broadband report prepared by an agency better known for handing out fines in the aftermath of wardrobe malfunctions have to say that could possibly interest the Genomics Law Report?
For most of the broadband plan’s 376 pages (pdf) the answer is “nothing at all.” However, Chapter 10 focuses on Health Care (pdf), with several discussions of potential relevance to the future of genomics and personalized medicine, at least in the United States. The bulk of the chapter is devoted to issues of indisputable importance – e-care, health IT, mobile and rural healthcare delivery, for instance – that will be capably covered elsewhere. (mobihealthnews, for instance, is already providing coverage of aspects of the plan that will impact mobile health care: here and here.) However, Section 10.4 (“Unlocking the Value of Data”) offers up two important themes that are relevant to how at least one government agency views the future of genomics and personalized medicine.
The Value of Data. Section 10.4 begins with the declaration that “data are becoming the world’s most valuable commodity,” and carries on from there. The promise of data and health care is reflected, according to the plan, in the possibility of better treatment evaluations (i.e., comparative effectiveness research), personalized medicine, enhanced public health, empowered consumers and improved policy decisions. The timing of the plan’s release is propitious, particularly with respect to its discussion of the value of data to personalized medicine, as it coincides with today’s joint MedCo-Mayo Clinic study that supports genetic testing prior to prescribing the blood thinner warfarin (Coumadin) and last week’s decision by the FDA to update the label for the anti-clotting medication Plavix (clopidogrel) to reflect that patients with certain genetic variants may not effectively metabolize that drug.
In focusing on the value of data the FCC clearly indicates that it’s interested in liberating all types of healthcare data – patient and provider, administrative, research and clinical – from the “proprietary ‘siloed’ systems that do not communicate with one another and therefore cannot be easily exchanged, aggregated or analyzed.” Credit goes to the FCC for recognizing that this is not simply a matter of electronic medical record (EMR) adoption: interoperable data standards, as well as regulatory and policy changes that promote the free flow of data, are needed as well. Perhaps this will spur the NIH to speed up its review of its genomic-data sharing policies?
The FCC also explicitly recognizes the importance of aggregating data in the area of genomic research: “the analysis of combined genomic, clinical and real-time physiological data (often captured wirelessly) could help researchers better understand the interplay of genetics and the environment.” The need to construct rich datasets that combine genomic, environmental and trait data is one that we’ve written about at the GLR before, but it’s good to see the FCC on board as well. Maybe the FCC will send a representative to next month’s GET (Genomes, Environments, Traits) conference in Boston.
The Importance of Consumer Access. As for who should be receiving access to all of that health care data, the FCC has a single word answer: “consumers.” The problem today, as the FCC puts it bluntly, is that “there are too many barriers between consumers and their health data.” In fact, the FCC makes it quite clear that it is looking to individuals as consumers, not as patients, to take charge of their health care. According to the FCC:
…it is consumers’ data…Consumers armed with the right information could do a better job managing their own health, demanding higher quality services from their providers and payors and making more informed choices about care. With seamless access to their raw health data including lab data and prescriptions, consumers could plug the information into specialized applications of their choice and get personalized solutions for an untold number of conditions. (emphasis in original text)
This should make Thomas Goetz, and others who stress the importance of consumers taking control of their own health care, quite happy. While the brief section in the report focuses primarily on data access with respect to medical records, prescription data and lab results, the arguments could be easily extended to apply to personal genomic data as well.
With apologies to Camilla Long and others who would prefer that consumers be kept at an arms’ distance from their genomic and other health data, relying on physician gatekeepers when such data must be accessed, the FCC has taken an extremely consumer-empowering stance toward health data access.
The FCC also closes Section 10.4 by urging Congress to “examine and remove” the barriers that stand between consumers and their health data. The FCC is not Congress – or even the FDA – so it’s important to take these recommendations for what they are: recommendations to Congress. As we discussed in the context of the recent SACGHS gene patent recommendations, it’s a long road to travel from agency recommendation to positive Congressional action. Still, for those reading the regulatory tea leaves, it’s hard to view these recommendations in anything other than a positive light for personal genomics consumers, businesses and investors.