Robin Blaney has broad experience in the life sciences sector including involvement in corporate, commercial, litigation, data privacy, and regulatory matters. He has gained particular experience in licensing, collaborative, and commercial transactions for life sciences clients. His regulatory practice includes pharmaceutical, medical device, food, and consumer product regulation.
The French Health Minister recently unveiled its 2020 eHealth National Strategy, with the intent to boost innovations through the use of big data in health. The initiative is prompted by the advances in the ability to collect massive amounts of health data through connected devices such as phones, watches and apps, which present the opportunity … Continue Reading
Over the past few years, several scandals (e.g., Poly Implant Prothèse (“PIP”) breast implants, Mediator weight-loss drug, etc.) have tarnished the public perception of France’s healthcare sector and raised serious questions about the independence of medical decision-making by practitioners. As it sets a new course, France is now at the European forefront of increasing the … Continue Reading
The European Commission has proposed a revision to the regulatory framework for in vitro diagnostic medical devices (IVDs) that could have a significant impact on the operations of commercial laboratories in the EU or those offering testing services to customers in the EU. Laboratory-Developed Tests Under current EU rules, laboratory-developed tests (colloquially known as “home … Continue Reading
On September 26, 2012 the European Commission adopted its long awaited proposals for the revision of the EU regulatory framework for medical devices. Three Directives, i.e., Directive 90/385/EEC on active implantable medical devices, Directive 93/42/EEC on medical devices and Directive 98/79/EC on in vitro diagnostic medical devices (IVDs), will be replaced by two Regulations: one … Continue Reading