HIPAA document with magnifying glass

OCR Releases Long-awaited “Guidance on HIPAA & Cloud Computing”

Last week, the HHS Office of Civil Rights (OCR) released its long-awaited “Guidance on HIPAA & Cloud Computing” (Guidance). Using 11 questions and comprehensive responses, the Guidance details OCR’s position on the obligations of covered entities and business associates who use cloud services providers (CSPs) to manage their electronic protected health information (ePHI). There are […]

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France – Changes in Approval Requirements for NIS

Guest Contributor – Mark Heinemann, Principal Regulatory Specialist, Late Stage, InVentiv Health Clinical   The French Ministry of Research and Higher Education (MESR) informs in a recent update of its website (https://appliweb.dgri.education.fr/appli_web/codecoh/IdentCodec.jsp) of the modification of the declaration and authorization procedures for the preparation and / or storage of human biological samples for research purposes. […]

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Off-label Use: A Comparator in Health Technology Assessments

It is becoming more difficult to demonstrate that new treatments are cost efficient and should be included in the reimbursement scheme. A pharmaceutical company’s application to the Dental and Pharmaceutical Benefits Agency (TLV) for a pricing and reimbursement decision regarding a medicinal product with orphan drug status has been rejected. The decision to deny reimbursement […]

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The RWE Equation: Finding the Right Late-Stage Study Design

White Paper – The Real-World Evidence Equation: Finding the Right Late-Stage Study Design Florian Eichmann, PhD, Principal, Scientific Affairs & Real World Evidence, Late Stage, inVentiv Health Clinical Stuart McCully, PhD, Vice President, Regulatory Consulting, Late Stage, inVentiv Health Clinical Although real-world evidence (RWE) has become increasingly popular for its insight into the use and […]

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Is your App a medical device? It’s healthy to know: MHRA issues updated guidance

Updated guidance issued to help identify the health apps which are medical devices and make sure they comply with regulations and are acceptably safe. From counting steps to helping healthcare professionals prescribe treatment for burns injuries, healthcare apps and stand-alone software are a part of everyday life. You might not realise depending on an unregulated […]

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EU Commission releases draft Privacy Code of Conduct for mHealth apps

The European Commission has drafted a code of conduct on privacy for mobile health (mHealth) apps (the “Code”). The Code has been submitted to the Article 29 Data Protection Working Group for approval. The Code aims to provide a user friendly guide to compliance with European data protection legislation for mHealth app developers. Once the […]

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Antibody on a white background. Vector diagram of the basic unit of immunoglobulin.

New GVP Module – Biological Medicinal Products

Guideline on Good Pharmacovigilance Practices (GVP). Product- or Population-Specific Considerations II: Biological Medicinal Products The European Medicines Agency (EMA) has adopted a new chapter to its guidelines on good pharmacovigilance practices (EU-GVP), entitled “Product- or population-specific considerations II: Biological medicinal products“.  The new chapter provides guidance on how to better monitor and manage the safety […]

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EU Collaboration Strengthens Safety Monitoring of Medicines

European Commission publishes three-year report on implementation of pharmacovigilance legislation Closer collaboration between the European Medicines Agency (EMA), the European Commission and the EU Member States, enabled by the new European pharmacovigilance legislation, has enhanced the monitoring of the safety of human medicines throughout their life cycle, for the benefit of patients. This is highlighted […]

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GVP Module IX – Consultation Open

Draft guideline on good pharmacovigilance practices (GVP) – Module IX – Signal management (Rev. 1) Regulation (EC) No 726/2004, Directive 2001/83/EC and Commission Implementing Regulation (EU) No 520/2012 (hereinafter referred to as REG, DIR and IR, respectively) include provisions for signal management in the European Union (EU) [DIR Art 107h, REG Art 28a, IR Chapter […]

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