Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE-MD (Coordinating Research and Evidence for Medical Devices)

: In the European Union (EU) the delivery of health services is a national responsibility but there are concerted actions between member states to protect public health. Approval of pharmaceutical products is the responsibility of the European Medicines Agency, whereas authorizing the placing on the market of medical devices is decentralized to independent 'conformity assessment' organizations called notified bodies. The first legal basis for an EU system of evaluating medical devices and approving their market access was the medical device directives, from the 1990s. Uncertainties about clinical evidence requirements, among other reasons, led to the EU Medical Device Regulation (2017/745) that has applied since May 2021. It provides general principles for clinical investigations but few methodological details-which challenges responsible authorities to set appropriate balances between regulation and innovation, pre- and post-market studies, and clinical trials and real-world evidence. Scientific experts should advise on methods and standards for assessing and approving new high-risk devices, and safety, efficacy, and transparency of evidence should be paramount. The European Commission recently awarded a Horizon 2020 grant to a consortium led by the European Society of Cardiology and the European Federation of National Associations of Orthopaedics and Traumatology, that will review methodologies of clinical investigations, advise on study designs, and develop recommendations for aggregating clinical data from registries and other real-world sources. The CORE-MD project (Coordinating Research and Evidence for Medical Devices) will run until March 2024; here we describe how it may contribute to the development of regulatory science in Europe

Some notes on the values of safety and security

The presentation can be accessed through: https://www.law.kuleuven.be/citip/en/30-years-icri-cir-citip/anton-vedder-some-notes-on-the-values-of-security.pdfstatus: Published onlin

Machine Learning In A Big Data Context: Why Regulatory Approaches Merely In Terms Of Transparency And Data Protection Are Not Enough

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WHAT PEOPLE THINK ABOUT THE RELIABILITY OF MEDICAL INFORMATION ON THE INTERNET

Is the quality of medical information on the Internet a matter of concern to people? How do they assess the reliability of medical information on the Internet? In this paper, I present the first results of an enquiry (through semi-structured in-depth interviews held in the spring and early summer of 2002) among a group of patients/consumers and physicians in the Netherlands in order to answer these questions. The paper describes the respondents ’ views on the reliability of information on the Internet when compared to other media, on the factors that cause the (un-) reliability, on markers of reliability of information, experiences of possibly negative consequences of unreliable information on the Internet, possible remedies, and the possible conflicts between these solutions and commonly accepted principles of freedom of speech, privacy, tolerance, and the informational freedoms. 1

Technologische vernieuwing en vernieuwing van ethiek en recht

Technology is developing at an enormous speed. How should law and ethics respond to technological innovations? In this inaugural lecture, I do not deliver conclusive substantial answers to various ethical and legal questions arising in the wake of the many technological innovations that we have witnessed over the last decades. Instead, I concentrate on three general dimensions of ethi-cal and legal responses to technological innovations that tend to impede an open and future-oriented attitude towards technology: a tendency to focus on the technology rather than on the practices and routines changed by technology, a tendency for professional conservatism of people engaged in law and ethics, and a negativist approach of technology inherent to Europe-an culture. I explain and illustrate these tendencies and show the often unin-tended impacts they may have for the actual substantial legal and ethical responses to technological innovations.nrpages: 32status: publishe