On October 28, 2015, the U.S. Copyright Office of the Library of Congress (the “Office”) issued a Final Rule containing several exemptions to the Digital Millennium Copyright Act that expanded access to medical device computer programs and the patient data they generate.  The Digital Millennium Copyright Act allows intellectual property holders to install “technological protection measures” (TPMs) in their software which blocks unauthorized inspection of data to protect copyright.  Under the Act, the Library of Congress grants exemptions to TPMs every three years.

In the Final Rule, the Office included an exemption for researchers investigating computer programs on devices and machines for good faith security research. The Office found that legitimate security research has been hindered by TPMs that limit access.  Covered devices include medical devices used for patient implantation or corresponding personal monitoring systems, as long as they are not used by patients or for patient care.  The research exemption begins 12 months after the regulation’s effective date, meaning it starts on October 28, 2016.  Additionally, the Office created an exemption for patients who seek to passively access information that is already being generated by their own medical devices or personal monitoring systems.  Unlike the research exemption, the patient monitoring exemption takes effect immediately, and it is limited to patients themselves, as opposed to researchers or other parties.Continue Reading U.S. Copyright Office Authorizes New Access to Medical Device Programs and Data under Digital Millennium Copyright Act

The Food and Drug Administration’s (FDA) March 2015 approval of Zarxio, the first biosimilar product licensed under the Biologics Price Competition and Innovation Act of 2009 (BPIA) is expected to usher in a new wave of faster approvals, greater choice, and lower costs for the biologics market. Along with these exciting opportunities, however, come a

In late 2014, Congress passed the Sunscreen Innovation Act (SIA) to speed the approval of innovative new sunscreen ingredients and formulations, many of which have long been available in Europe, Asia, and Latin America. While the SIA requires FDA to take concrete steps to more quickly review submissions regarding OTC sunscreen ingredients, the SIA does

On December 23, 2014, FDA Commissioner Margaret A. Hamburg announced that the agency favors supplanting the outright ban on blood donations from men who have sex with men (MSM) with a new policy that would prohibit donations from men who have engaged in homosexual activity in the previous 12 months. This shift for MSM would

On October 2, 2014, the FDA released a set of comprehensive guidelines governing the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. The guidelines are intended to provide direction for manufacturers of medical devices on how to appropriately safeguard devices from a potential security breach; particularly in light of the sensitive

The Food and Drug Administration (“FDA”) is considering whether to revise a controversial policy prohibiting blood donations from men who have sex with other men. Dating to 1983, the FDA policy, commonly referred to as the “MSM Deferral Policy,” which prohibits men who have had sex with other men (referred to in medical literature as “MSMs”), at any time since 1977 (ostensibly the dawn of the AIDS epidemic in the United States), from donating blood. While FDA regulations require blood banks to screen potential blood and plasma donors for risk factors related to HIV and other infectious diseases (See 21 C.F.R. § 640.3(b)(6) (2013)), the FDA also has advised blood banks that some potential donors—such as MSMs—are inherently high-risk, and consequently must never be allowed to donate blood. The FDA has explained that this policy is necessary “because MSM[s] are, as a group, at increased risk for HIV, hepatitis B and certain other infections that can be transmitted by transfusion.”

The controversial policy has come under fire from AABB, which argues that it is both medical and scientifically unwarranted and discriminatory. AABB, along with the American Red Cross and America’s Blood Centers, have urged the FDA to abandon the indefinite deferral in favor of a 12-month deferral. Similarly, in 2013, a bipartisan Congressional group challenged the ban by stating that the policy “turn[s] away healthy, willing donors, even when we face serious blood shortages. Further, the existing lifetime ban continues to perpetuate inaccurate stereotypes against gay and bisexual men, and fosters an atmosphere that promotes discrimination and discourages individuals from seeking HIV testing and treatment services.”Continue Reading FDA May Consider Lifting Controversial Ban on Blood Donations from Men Who Have Sex with Men