Inside EU Life Sciences

Contact:Email

The European Food Safety Authority (EFSA) is launching an ambitious project of public access to data that it collects and holds through the launch of a scientific “data warehouse.” EFSA announced this initiative on March 2, 2015, with the aim to create an “open science organisation” and increase public access to data that it holds. The ultimate goal is to enhance scientific progress by allowing the use of data by third parties for other purposes.
Continue Reading EFSA Grants Public Access to Data through Scientific “Data Warehouse”

Article originally posted on our sister blog InsidePrivacy

The Article 29 Data Protection Working Party (Working Party), an independent EU advisory body on data protection and privacy, responded to a request from the European Commission made in the framework of the Commission’s  mHealth initiative to clarify the definition of data concerning health in relation to lifestyle and wellbeing apps.  (See more here, and here for our blog post on the European Commission’s Summary Report of the mHealth consultation.)

In its latest paper on health data in apps and devices, the Working Party supports a broad definition of health data, distinguishing the following three categories of health data:

  1. The data are inherently/clearly medical data, especially those generated in a professional, medical context.
  2. The data are raw sensor data that can be used in itself or in combination with other data to draw a conclusion about the actual health status or health risk of a person.
  3. Conclusions are drawn about a person’s health status or health risk (irrespective of whether these conclusions are accurate, legitimate or otherwise adequate or not).
    Continue Reading Article 29 Working Party Clarifies Scope of Health Data in Apps and Devices

On 21 January 2015, the European Medicines Agency (“EMA”) launched a public consultation on how the transparency rules of Regulation EU No 536/2014 (the “Clinical Trials Regulation”) should apply to the new clinical trials database.  The consultation document of the EMA discusses the practical application of the new transparency rules, sets different options on the application of the exceptions to the disclosure of information, and invites stakeholders to comment.
Continue Reading EMA Transparency Policy – EMA Launches Public Consultation On The Publication Of Information Under The New EU Clinical Trials Regulation

 This post originally appeared on our sister blog, Covington eHealth.

The European Commission has finally published its summary of 211 responses to its mobile health (“mHealth”) consultation. The summary and original responses to the consultation have been made available on the Commission’s website at https://ec.europa.eu/digital-agenda/en/news/summary-report-public-consultation-green-paper-mobile-health
Continue Reading Summary Report of European Commission’s mHealth Consultation Published

France has enacted new rules on the off-label use of medicines.  A new Decree amending the rules on Temporary Recommendations for Use (“RTU”) established pursuant to Article L5121-12-1 of the French Public Health Code (“PHC”) was published on 31 December 2014 (the “Decree”).  This Decree follows the adoption of the amended social security budget bill in August last year, which introduced revisions to the preexisting Article L5121-12-1 PHC.  According to the legislative history of the law, this change may have been intended to allow off-label prescription of Roche’s cancer drug Avastin® after reformulation to treat the eye condition age-related macular degeneration, instead of the Novartis product Lucentis®, which is specifically developed and approved for that indication.
Continue Reading New French Rules On Off-Label Use

A new food labeling regulation, which revamps the entire EU regulatory framework on food information, including labeling, starts to apply from this Saturday, 13 December 2014. Regulation 1169/2011 on the provision of food information to consumers (FIC Regulation) consolidates a number of EU food laws and establishes some new principles to provide better consumer protection in relation to food information whilst ensuring smooth functioning of the EU market.

The FIC Regulation governs all food information provided to the consumer through any commercial communication, including in particular labeling and websites. The Regulation affects all food business operators along the whole supply chain as it changes the existing provisions and introduces new ones:
Continue Reading Comprehensive New EU Food Labeling Regulation Goes Into Effect December 13

The European Commission published its Fifth Monitoring Report of Patent Settlements today. Patent settlements enable patent-related disputes to be resolved without having to litigate issues such as patent validity or patent infringement.  The Commission takes the view that patent settlements can infringe competition law when they prompt generic suppliers to delay entry in return for…

 This post originally appeared on our sister blog, InsideMedicalDevices.

The UK Information Commissioner’s Office (ICO) has launched an informal survey of current practices relating to the use of data-enabled medical devices and apps.

The short and anonymous survey explores whether organisations have put in place specific policies and procedures, asset registers, IT security requirements for medical device procurement policies, information governance and incident response processes, and an “end of life” policy for defunct/decommissioned devices.
Continue Reading UK Data Protection Regulator Surveys Use Of Smart Medical Devices

On 20 November 2014 the German Supreme Administrative Court (Bundesverwaltungsgericht, “BVerwG”) confirmed that nicotine-containing liquids that are vaporised and inhaled via e-cigarettes are not medicines and therefore e-cigarettes are not medical devices.
Continue Reading The German Supreme Administrative Court Confirms That E-Cigarettes Are Not Medicines Or Medical Devices

The health sector handles substantial quantities of personal information, including information that is deemed to be “sensitive” under European data protection regimes.  For that reason, health care providers sometimes question their ability to take advantage of increasingly popular e-health cloud services.  While EU lawmakers are contemplating a “European Privacy Seal” – which could, if done properly, be useful for would-be cloud customers to assess the robustness of a cloud provider’s data protection measures – a leaked EU Council document revealed that discussions over the scheme are floundering.  We therefore learnt with interest from our colleagues at the InsidePrivacy blog that the International Standards Organization (ISO) and the International Electrotechnical Commission (IEC) jointly adopted a new standard this summer governing the processing of personal data in the cloud — ISO/IEC 27018 (“ISO 27018”).
Continue Reading E-Health Take Note: Standards Published For Personal Data In The Cloud