mHealth on the Horizon: Federal Agencies Paint Regulatory Landscape with Broad Brushstrokes
For years, and with increasing frequency, health care and information technology companies have touted the potential of mobile medical and health applications and technologies to improve the quality and delivery of health care through the use of technology. While the future of mobile health (frequently referred to as “mHealth”) is undoubtedly filled with promise, the legal and regulatory landscape in which mHealth technologies reside is only now beginning to take shape.
As mHealth developers, funders and even users consider investing in the field, or including in particular mHealth technologies, they should keep in mind the emergent and fluid nature of the mHealth regulatory landscape. Here, we outline the likely key players and discuss several recent and projected initiatives with respect to the oversight of mHealth technologies:
Supreme Court to Rule on Patentability of Human Genes
Robert Cook-Deegan contributed to this commentary. Dr. Cook-Deegan is a research professor in the Institute for Genome Sciences and Policy and the Sanford School of Public Policy at Duke University.
The Supreme Court today granted a writ of certiorari (meaning they agreed to hear the appeal) in Assoc. for Molecular Pathology v. Myriad Genetics, Inc., et al., the famous case centered on patents covering two human genes: BRCA1 and BRCA2.
Of note is that the Court limited its grant of the appeal to the first of the three questions posed by the petitioners/plaintiffs: “Are human genes patentable?”
DNA DTC: The Return of Direct to Consumer Whole Genome Sequencing
This morning, Gene By Gene, Ltd. – better known as the parent company of the popular genetic genealogy provider Family Tree DNA – formally announced a corporate reorganization that includes the debut of a new division, DNA DTC. (Apparently the news was also announced earlier this month at the Family Tree DNA Conference, although the company waited until today to launch press releases.)
The announcement from Gene By Gene is newsworthy for several reasons, including:
1. The Return of True DTC Whole Genome and Whole Exome Sequencing. According to DNA DTC, the company offers a range of products “utilizing next generation sequencing including the entire exome (at 80x coverage) and the whole genome.” The company’s website, while fairly spartan, appears to bear this out. Whole exomes ($695 at 80x coverage) and genomes ($5,495 at 30x coverage) are both listed as available products.
Now, Gene By Gene is not, as its Wikipedia page claims (as of this writing), “the first commercial company to offer whole genome sequencing tests.” Knome earned that honor more than four years ago, when it started selling whole genome sequences for $350,000; an astounding price, either low (given the cost of the first human genome was $3 billion) or high (given that, well, it was $350,000) depending on your perspective. Gene By Gene probably does represent, however, the only commercial company currently offering a whole genome sequence in a truly direct-to-consumer (DTC) manner.
Myriad Updates: Clinical Data as Trade Secrets and a Pending Certiorari Decision
Earlier this month, my colleagues John Conley, Robert Cook-Deegan, James Evans and I published a policy article in the European Journal of Human Genetics (EJHG) entitled “The next controversy in genetic testing: clinical data as trade secrets.”
The EJHG article is open access so you can read the entire article at the EJHG website, but here is the abstract:
ENCODE, CODIS, and the Urgent Need to Focus on what is Scientifically and Legally Relevant to the DNA Fingerprinting Debate
Sara Huston Katsanis, MS is an Associate in Research at the Institute for Genome Sciences & Policy at Duke University.
On September 5, 2012, a coordinated release of 30 articles in Nature, Cell, Science, Genome Research, Genome Biology and other journals published the long-awaited findings of The Encylopedia of DNA Elements (ENCODE) Consortium. The press coverage of ENCODE data is deafening at this point, and ENCODE’s relevance to GLR readers may not be immediately apparent.
Across the U.S., numerous groups are challenging the integration of CODIS profiles (sometimes called “DNA Fingerprints”) into the routine booking procedures upon arrest for certain crimes (depending on the state), placing genetic profiling among other standard procedures such as fingerprinting and mug shot photographs. The GLR has covered these legal challenges previously (including here, here, and here).
Read the rest of this entry »
Applying Mayo to Myriad: Latest Decision Brings No New News (Plus: Why the Final Myriad Decision Might Not Matter for Personalized Medicine)
The latest chapter in the Myriad gene patent litigation was written yesterday, with the Federal Circuit issuing its much anticipated opinion (pdf) after rehearing the case following the Supreme Court’s unanimous decision earlier this year in Prometheus v. Mayo.
Or perhaps we should say that the latest chapter was “rewritten” as, in a move that surprised approximately nobody, and as we predicted earlier this spring, the Federal Circuit reached precisely the same result in its opinion today as it did last July when it issued its first substantive ruling in the Myriad litigation. Below, we examine how the Federal Circuit applied Mayo to Myriad, what the next step in the Myriad litigation is likely to be (spoiler alert: it’s another appeal) and why we think the final opinion in this case, whenever it arrives and whatever it says, might not matter all that much.
Applying Mayo to Myriad. As mentioned, the only major change since the last time the Federal Circuit ruled in Myriad, and the reason for the re-hearing, was the Supreme Court’s decision earlier this spring in Mayo.
However, Mayo was about method patents and the boundary between a patent-eligible method and a law of nature. It was not about product patents or the product of nature doctrine. Since the Federal Circuit had already invalidated all but one of Myriad’s method patents even before the Supreme Court tightened the criteria for method patents in Mayo, it was hard to see much of substance changing the second time around.
Removing the Cables: New FCC Rule Paves Way for Utilization of Wireless Medical Technology
Amit Bhagwandass is a rising third-year student at University of North Carolina School of Law.
New rules adopted by the Federal Communications Commission (FCC) have an appreciable impact on the way that hospitals, nursing homes and other inpatient and outpatient health care providers will monitor their patients in the future. The new FCC rules enable the use of Medical Body Area Networks (MBANs). MBANs are low-power wideband networks consisting of multiple body-worn sensors that transmit various patient data to a control device that collects data from the sensors.
Wireless devices operating on the MBAN spectrum can be used to continuously monitor a patient’s health by measuring indicators such as blood glucose levels, blood pressure and electrocardiogram results. Additionally, wireless health devices can include mobile devices and associated applications of increasing relevance to consumer health and personalized medicine, such as mobile-device enabled sensors that monitor vital signs for any number of traits or conditions like blood pressure, glucose levels or even the early signs of an asthma attack.
23andMe Seeks FDA Clearance (Podcast)
Last week, personal genetics company 23andMe announced that it had formally delivered the first round of documentation to the U.S. Food and Drug Administration (FDA) in an attempt to receive 510(k) clearance for its consumer product.
23andMe declared itself “first in the [ direct-to-consumer (DTC) genetic testing] industry to announce it is working towards FDA clearance.” That first followed another first for the company earlier in the summer: 23andMe’s first patent, which covers a method of predicting susceptibility to Parkinson’s Disease.
I sat down last week with The Burrill Report to discuss 23andMe’s recent activities and their implications for the future of DTC genetic testing and personalized medicine. You can listen to the complete podcast here.
The Burden of Enforcing GINA: EEOC v. Nestle Illustrates One Challenge in Pursuing Genetic Discrimination Claims
The Genetic Information Nondiscrimination Act of 2008 (GINA) is a federal law making it illegal for insurers and employers to acquire and to use genetic information in certain contexts. Specifically, Title II of GINA prohibits employers with more than 15 employees, employment agencies, labor organizations, and joint labor-management training and apprenticeship program committees from using genetic information when making employment decisions (e.g. hiring, firing, promotions, placement, compensation, privileges, seniority, etc).
The employment discrimination provisions took effect on November 21, 2009, with an air of uncertainty, as the Final Rules implementing Title II of GINA were not issued by the Equal Employment Opportunity Commission (EEOC) until a year later (See 75 Fed Reg 68912-68939 [pdf], issued November 9, 2010) and did not take effect until January 10, 2011. (See previous GLR coverage of GINA Title II here and of GINA generally here).
Patenting and Personal Genomics: 23andMe Receives its First Patent, and Plenty of Questions
Earlier this week 23andMe, the Silicon Valley-based personal genomics company, was awarded its first patent: US Patent Number 8,187,811, entitled “Polymorphisms associated with Parkinson’s disease”.
23andMe co-founder Anne Wojcicki announced the issuance of the patent via a post on the company’s blog late Monday evening, attempting to strike a tenuous balance between her company’s oft-championed philosophical devotion to providing individuals with “unfettered access to their genomes” and its desire to commercialize the genomic information so many of those very same individuals have shared, free of charge, with 23andMe. With its new patent, 23andMe also injected itself into the middle of what Wojcicki herself described as the “hot debate” surrounding the patentability of “inventions related to genetics.” Wojcicki’s announcement appeared to catch more than a few of the company’s customers by surprise, sparking concern about the company’s intentions on 23andMe’s blog, Twitter and elsewhere, along with rapid and pointed commentaries from Stuart Hogarth and Madeleine Ball, among others.
Of the various questions asked of and about 23andMe and its new patent, these may be the three most common: Where did this patent come from, and why didn’t I hear about it before? What does 23andMe’s patent cover? How is 23andMe going to use its patent? Let’s take each question in turn.
