On 9 July 2018, the Economic Affairs Committee of the European Parliament (the “EP”) published a study identifying potential competition law concerns in the financial technology (“FinTech”) sector (the “Study”).… Continue Reading
On October 22, Rep. Marsha Blackburn (R-TN) introduced a bill serving to “provide for regulating medical software, and for other purposes” in the House of Representatives. The bill, entitled the Sensible Oversight for Technology which Advances Regulatory Efficiency (“SOFTWARE”) Act (“the bill”), was co-sponsored by a bi-partisan group of lawmakers. The bill creates a regulatory … Continue Reading
On Monday, FDA released a final version of its guidance document, Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff. The guidance describes FDA’s approach for regulating certain mobile applications (apps) as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA). Although the final guidance retains the basic framework of … Continue Reading
FDA’s regulation of Health IT under its medical device authorities can be seen as proceeding on two separate tracks during the last year. Track one is FDA’s ongoing policymaking. In 2011, FDA issued a draft guidance document on mobile medical applications and a final rule on medical device data systems, setting forth an approach for … Continue Reading
The issue of cybersecurity has been on FDA’s radar in the last year, due in part to a Government Accountability Office report issued last August that urged FDA to consider the risk of intentional threats to device information security. Although the GAO report noted that FDA was not aware of any actual incident of device … Continue Reading
As our colleagues discussed in a previous post on InsideMedicalDevices, FDA took its first publicly announced enforcement action against a mobile app developer on May 22, issuing an “It Has Come to Our Attention Letter” to India-based app developer, Biosense Technologies. The letter received extensive media coverage, and the mHealth sector was immediately abuzz with interest (and concern) … Continue Reading
Earlier this week, Xiang Li pleaded guilty in Delaware federal court to one count of conspiracy to commit criminal copyright infringement and one count of conspiracy to commit wire fraud. Li, a Chinese national, was charged with selling “cracked” software (i.e., software for which access controls had been circumvented) to customers around the world through … Continue Reading
