The health care industry has seen a jump in the number of medical devices that use wireless technology.  With this rapid technologic development comes concern about the safety, security and privacy of patients.  There is specific concern in this regard with respect to the following commonly used devices: Implantable Medical Devices (IMDs), External Medical Devices, and Portable Devices.[i]

Last year a security researcher successfully demonstrated how an outside breach of a wireless insulin pump allows for the hacker to shut off or alter the settings of the device.  This poses a serious risk for those with portable and implantable medical devices that are controlled via wireless technology.  In addition to a breach of control of these devices, the risk of malware on such FDA-approved medical devices is also a concern.  In the event that an FDA-approved medical device is infected with … Read More »

For the first time in Olympic history, advanced imaging technology will be used to help detect athletes’ use of performance-enhancing drugs.  GE Healthcare Life Sciences’ biomolecular imager will lend a big hand in helping to test athletes for recombinant erythropoietin (EPO), a performance-enhancing drug used to boost the number of red blood cells, which enables improved oxygen flow and allows athletes to raise their workout intensity and endurance.  The GE provided equipment, the ImageQuant LAS4000, uses technology that offers extremely detailed information to accurately identify EPO doping.  We first saw the popularity of this drug grow among Tour de France cyclists.

Many other tests will be performed, in addition to the EPO test, in an attempt to create the most advanced drug testing laboratory in the history of the Olympics.  GlaxoSmithKline will be the official lab services provider for the 2012 Olympic … Read More »

The District of Columbia regulates many activities that go unregulated in other jurisdictions.  One example relevant to pharmaceutical companies is the requirement that in D.C., detailers must obtain a license before they may speak in person with a physician, nurse or other health professional.  Pharmaceutical detailers also must undergo 15 hours of continuing education every two years and must keep records of their interactions with licensed health professionals or their employees.

The District of Columbia requires that individuals obtain a license from the D.C. Board of Pharmacy in order to engage in the practice of “pharmaceutical detailing” in D.C.  See D.C. Code § 3-1207.41; 17 DCMR § 8300.1.  A person is engaged in pharmaceutical detailing if, acting as a representative of a pharmaceutical manufacturer or labeler, he or she communicates in-person with a licensed health professional or a representative of a … Read More »

A July 11, 2012 article by Gina Kolata in the New York Times describes a recent discovery of a rare gene mutation that protects people from Alzheimer’s disease by slowing the production of beta amyloid.  Excessive amounts of beta amyloid in the brain are believed to cause Alzheimer’s.  The discovery bolsters hope that drugs, currently in development, that reduce levels of brain amyloid will prove effective in slowing the progression of Alzheimer’s.

The lack of clear guidelines for enrolling in clinical research decisionally-impaired subjects, or those who may become impaired over the course of a study  may hinder efforts to conduct trials of Alzheimer’s drugs.  In 2010, an Institute of Medicine summary  of a workshop on the state of clinical trials in the United States noted that 27% of investigators in the U.S. failed to enroll any subjects in trials in … Read More »

On July 8, Governor Deval Patrick signed a bill amending the Massachusetts law regulating marketing activities by pharmaceutical and device manufacturers, one of the strictest state laws in the country.

The law previously barred pharmaceutical and device manufacturers from providing meals to health care practitioners outside the practitioner’s office or hospital setting.  See 111N  Mass. Gen. Laws § 2.  The amendment will now permit pharmaceutical and device manufacturers to provide modest meals and refreshments outside of the practitioner’s office or hospital setting, if the meal or refreshment is furnished with a non-CME educational presentation for the purpose of providing bona fide medical information, and the meal is furnished in a venue and manner conducive to communicating information.  The amendment directs the Massachusetts Department of Public Health to promulgate regulations to define “modest meals and refreshments.”  Pharmaceutical and device companies, however, will … Read More »

Jesse Witten was recently interviewed by Law360 Life Sciences:

Read More

Robyn Shapiro was recently interviewed by Law360 Life Sciences:

Read More