Prove It or Lose It: The FTC’s Standard for Scientific Support of Medical App Claims

Medical-Apps-in-HealthcareBy Julie Liu

Among the countless mobile applications that allow us to control much of our lives, the growing wave of medical apps allows us to manage and improve our health with the convenience of a phone or tablet. But, as illustrated by the Federal Trade Commission’s approval of its final order against the maker of the UltimEyes app, this possibility comes with important limitations. Continue reading

The 21st Century Cures Act Will Be Implemented Piecemeal

fdaBy Jason Liu

As technology and medicine advance, the need to streamline and regulate medicine will increase. One can visit a virtual doctor, connect medical devices to the internet, and access cutting-edge gene therapy precision medicine. However, government agencies work with laws that never considered these innovations. To update these laws, the House passed the 21st Century Cures Act in 2015. The Act currently sits in the Health, Education, Labor and Pensions Senate (HELP) committee. Congress may also break the bill into smaller pieces of legislation.

Lamar Alexander (R-Tenn.), the leader of the HELP committee, recently stated that the panel will divide the 21st Century Cures Act into smaller pieces of legislation. The Act has stalled in the Senate because Democrats and Republicans disagree on how to fund the bill. Beginning Feb. 9, the committee will vote on at least seven bipartisan bills ranging from expediting therapies for rare diseases to improving electronic health records. Continue reading

Banking on Your Child’s Future: Is There Sufficient Legal Recourse Against the Unregulated Private Cord Blood Bank Industry?

bankingBy Robin Hammond

Cord blood and tissue banking has significantly increased in the past few years, with 2.6% of parents using private banks and over a thousand transplants from public banks. Some benefits are concrete, and others speculative. The stem cells collected can be used to treat several diseases, including leukemia, lymphoma, anemia, and some immune system disorders. Currently, there are over 200 registered clinical trials currently underway around the world investigating the role that stem cells may play in the various systems of the human body, including Macular Degeneration and Cerebral Palsy.

The standards for public and private banks vary like night and day. As with many emergent technologies, the regulation of private banks has been slow. Currently, private banks only need to provide the FDA with their business name and address to be FDA registered. In contrast, public banks are licensed by the FDA and are responsible for adhering to strict quality standards including documentation on processing, storage and sterility, and site inspection. Additionally, public banks are coordinated by Be The Match®, which works with doctors and researchers to improve cord blood transplantation and education as mandated by the Stem Cell Therapeutic and Research Act of 2005 and Reauthorization Act of 2010. Continue reading

Securing Dr. Robot

unnamed By Brooks Lindsay

Medical device robots present a number of cybersecurity, privacy, and safety challenges that regulation and industry standards must address in order to safely and rapidly advance innovation in the field.

The University of Washington’s Computer Science Department recently highlighted the problem. Computer Science Researchers hacked a teleoperated surgical robot called the Raven II during a mock surgery. The hack involved moving pegs on a pegboard, launching a denial-of-service attack that stopped the robot, and making it impossible for a surgeon to remotely operate. The researchers maliciously controlled a wide range of the Raven II’s functions and overrode command inputs from the surgeon. The researchers designed the test to show how a malicious attack could easily hijack the operations of a medical device robot. The researchers concluded that established and readily available security mechanisms, like encryption and authentication, could have prevented some of these attacks.  Continue reading

Two Mums and a Dad: UK Approves Technique by Which a Child Has Three Genetic Parents

Screen Shot 2015-02-18 at 12.26.44 PMBy Sam Hampton

On February 3, 2015, the UK House of Commons voted to authorize a fertility technique known as mitochondrial donation. The babies that result from such a technique would have three genetic parents: one father and two mothers. The process shows promise in preventing the passing on of serious mitochondrial diseases from mother to infant. Perhaps belying the controversy surrounding a novel reproductive technology, the vote in the House of Commons was fairly one-sided; there were 382 members in approval and 128 against. Approval by the House of Lords is necessary, but if it is forthcoming, babies conceived by this process could be born in 2016.

The process involves the manipulation of embryos from two women. The nuclear DNA of a woman who will pass on a mitochondrial disease is transplanted into the de-nucleated embryo of a donor. The resulting embryo has sets of nuclear and mitochondrial DNA from two different women, and the process of in vitro fertilization is then used to carry out the pregnancy. The infant born of this process would have the genetic material of three people, but would also hopefully be free of the diseases resulting from the defective mitochondrial DNA. Mitochondrial diseases are untreatable, and those afflicted by them often do not live into adulthood. This new fertility process is the result of lengthy scientific research, and heralded as a medical breakthrough. Proponents of the process say that it provides women who would otherwise pass on these debilitating diseases with the opportunity to have healthy genetic offspring. Continue reading