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France’s New Requirements for Clinical Research – Refreshing Clarity or Regulatory Nightmare?

Note – Amended text in RED Décret n° 2016-1537 du 16 novembre 2016:  publication in the French Official Journal of a decree concerning research involving the human person Decree No. 2016-1537 of 16 November 2016, published in the Official Gazette of 17 November 2016, is now in force. It specifies the modalities for research involving […]

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E-Health

EU Commission Proposes mHealth App Assessment Guidelines

‘In 2016 users will trust health apps more than their doctors’. So predicted Forbes Magazine in 2015 in reference to Mobile Health (“mHealth”) apps, which are becoming increasingly popular to monitor health and well-being. However, the rapid proliferation of these apps with no clear evidence on their quality and reliability has raised concerns about the […]

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What’s the deal with Watson?

Last month, three life sciences giants announced new or deepening partnerships with IBM, to capitalise on IBM’s supercomputer, ‘Watson’, an artificially intelligent computer system. There has been a lot of buzz recently about how big data can be meaningfully applied in the healthcare setting to assist with product development and disease treatment. The European Medicines […]

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Navigating ClinRegs has never been easier

The National Institute of Allergy and Infectious Diseases (NIAID) announced that the ClinRegs website, which provides clinical regulations for countries around the world, has undergone several functionality upgrades to make the site easier to use. The updated site includes: A new interactive map on the homepage to provide a clearer picture of the countries included […]

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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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