Réglementaire - Sciences de la Vie

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• Genomics: Transforming the life experience of humanity

  Article

  Envoyé: 17 October 2018

  We recently held a Simmons & Simmons Healthcare Hub dinner discussing the ground-breaking genomics work that is currently taking place in the UK and the potential for the mapping of genomes to transform our everyday healthcare.

• UK Government publishes draft Code of Conduct for data-driven healthcare technology

  Article

  Envoyé: 18 September 2018

  Issues to consider in a new Code of Conduct for data-driven healthcare technology providers issued by the Department of Health and Social Care.

• GDPR and Blockchain

  Article

  Envoyé: 13 September 2018

  Are Blockchain and GDPR compatible? Some issues to consider.

• New Mdeon Code - What are the main changes?

  Article

  Envoyé: 03 September 2018

  The ethical health platform Mdeon published a new code of ethics on 31 August 2018 (the Code). As compared to the previous code of ethics (last reviewed by Mdeon on 01 January 2017), the new Code provides for several new provisions that are likely to impact on pharmaceutical and medical devices’ compliance policies.

• Variations to IP licences - who is holding the pen?

  Article

  Envoyé: 09 August 2018

  This article discusses the IP licensing implications of the recent decision in Rock Advertising on no oral modification clauses and the potential for informal variation arrangements.

• Increased focus of tax authorities on transfer pricing valuation

  Article

  Envoyé: 08 August 2018

  ​Clive Jie-A-Joen, Liu Lu and Fan Bai examine recent TP developments that are relevant for the arm's-length pricing of transactions of intangibles and other items of value between group entities resulting from business restructuring. Each of these developments is specific and can be useful considering the specific facts and circumstances of the case at hand.

• Fabricants de dispositifs médicaux – les difficultés posées par la mise en conformité au Règlement (UE) 2017/745

  Article

  Envoyé: 02 August 2018

  Cet article présente les difficultés posées par la mise en conformité au Règlement (UE) 2017/745 adopté le 5 avril 2017 pour les fabricants de dispositifs médicaux.

• Selon le Conseil d’Etat, la procédure de certification des logiciels d’aide à la prescription viole la directive sur les dispositifs médicaux

  Article

  Envoyé: 18 July 2018

  Analyse de l’arrêt rendu par le Conseil d’Etat annulant la procédure de certification HAS imposé aux logiciels d’aide à la prescription.

• Digital health in Belgium: Recent legislative evolutions, promising perspectives

  Article

  Envoyé: 20 June 2018

  ​With the 2013-2018 Belgian E-Health Programme due to expire at the end of this year, the time has come to consider the most recent steps that have been taken in the area of digital health and set out in broad terms the challenges that remain for digital health in Belgium.

• Towards a legislative framework for Patient Support Programmes (PSP’s) in Belgium

  Article

  Envoyé: 29 May 2018

  In the past years, the Federal Agency for Medicines and Health Products (FAMHP) recorded an increase in the use of Patient Support Programmes (PSP’s) in Belgium.

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