836 research outputs found
Kosciusko [music] /
No full textFor voice and piano.; Cover title.; "Introduced & sung by Miss Nella Webb."; Cover carries portraits of Nella Webb (by Rudolph Buchner), Charles Vaude and Moritz Lutzen.; Words printed as text on p. [4].; "During Moritz Lutzen's visit to Australia he offered a prize for the best lyric, by an Australian author to be set to music by himself. The prize was awarded to Charles Vaude, for his lyric 'Kosciusko,' and Miss Nella Webb produced this song with instantaneous success."--P. [4].; Also available online http://nla.gov.au/nla.mus-an8393500; 1913, by Victor J. Draper, Sydney.; NLA's NL copy from the collection of Keith Watson. ANL
Letter containing inquiry regarding the ethnic identity of the descendents of Georg Moritz Oppenheim.
No full textLetter from Wilhelm Gehlig to Rabbi Dr. Freudenthal in Nuremberg with a genealogical question regarding Georg Moritz Oppenheim. Of particular interest to the author is to determine whether Oppenheim's descendents are "rein jüdischen Blutes (=of pure Jewish blood)."Robert Singermandigitize
Conventional and circular economy compliant modification strategies for recycled polypropylene
No full textAuthor Moritz MagerMasterarbeit Universität Linz 2021Arbeit gesperr
Conventional and circular economy compliant modification strategies for recycled polypropylene
No full textAuthor Moritz MagerMasterarbeit Universität Linz 2021Arbeit gesperr
The regulation of medical devices in developing EU frameworks
No full textBackground
The regulation of medical devices plays an important role in ensuring patient safety and promoting innovation in healthcare. Medical devices include a variety of technologies, applications, and products, ranging from simple everyday items like bandages and thermometers to sophisticated systems such as pacemakers and computed tomography scanners. Digital medical products, including software, artificial intelligence (AI), and mobile health applications, which have increasingly entered the market in recent years, are also often considered medical devices, depending on the intended purpose defined by the manufacturer. If a product is designed for medical purposes, such as diagnosing, treating, or monitoring diseases, it is considered a medical device under many regulatory frameworks worldwide.
In the European Union (EU), medical devices are regulated under Regulation (EU) 2017/745 on medical devices, commonly referred to as the Medical Device Regulation (MDR). The MDR was adopted in 2017 and entered into force in the early 2020s. It was introduced as a response to prior safety scandals involving defective medical devices to enhance patient safety, improve market surveillance, and increase transparency. Unlike pharmaceuticals, which require centralized approval in the EU, medical devices undergo a decentralized conformity assessment process that relies on independent Notified Bodies to certify compliance. The MDR categorizes medical devices into four risk classes, with regulatory requirements increasing according to the level of risk.
Despite the intended improvements, the MDR has introduced new challenges, particularly in the context of innovative technologies. While providing a structured regulatory pathway for traditional hardware-based devices, its suitability for innovative and often digital technologies such as medical extended reality (MXR), gamification in health applications, cybersecurity, and generative AI remains uncertain. These technologies introduce new risks and complexities that were not fully anticipated when the MDR was drafted. Gaps in the current regulatory framework have raised concerns about barriers to innovation, increased costs for manufacturers, and potential delays in market access for new medical devices. Addressing these regulatory challenges is essential to ensure that the European medical device ecosystem remains competitive while maintaining high standards of safety and efficacy.
Research Question/Hypothesis
Technological progress in the healthcare sector and the risks associated with the specific characteristics of these technologies have highlighted the challenges associated with the regulation of these products. This thesis aims to examine these challenges by analyzing how innovative technologies, such as cybersecurity and generative AI, interact with the existing regulatory framework in the EU. This thesis has two main objectives: (1) to identify gaps in the EU regulatory framework that hinder the adoption of innovative medical devices, and (2) to develop recommendations for an improved EU regulatory framework that promotes medical device innovation while ensuring patient safety. By addressing these objectives, this work aims to contribute to the development of a resilient and innovative medical device ecosystem in Europe.
Materials and Methods
To achieve the research objectives of this thesis, innovative technologies that challenge the current EU regulatory framework were identified. The selected technologies, MXR, gamification, cybersecurity, and generative AI, were analyzed using various methodologies to ensure a diverse and comprehensive perspective.
MXR was examined as an example of hardware innovation in medical devices. The analysis focused on how immersive technologies balance technological potential and practical implementation in healthcare. Current guidance documents were examined to assess the regulatory framework and existing solution strategies.
Gamification has been identified as a growing trend in healthcare, particularly in digital health applications. This study examined its regulatory implications by identifying gamified health apps available in app stores and evaluating their compliance with the EU regulatory framework through an expert panel assessment.
Cybersecurity was examined as a significant challenge for medical software and healthcare infrastructure. The research systematically assessed how cybersecurity risks are integrated into the regulatory benefit-risk evaluation of medical devices, highlighting gaps in existing frameworks and the implications for medical device certification.
Generative AI, with a focus on Large Language Models (LLMs), was investigated in two publications. In the first publication, existing LLM-based health applications have been identified, and a subset has been tested and assessed for their compliance with regulatory requirements. The second publication built upon these findings by examining the risks associated with unregulated LLM-based health applications and suggesting recommendations for a future regulatory framework.
Results and Conclusions
The analysis of four innovative medical device technologies showed substantial regulatory gaps and challenges in the current EU framework. However, the implications of these gaps and challenges differ depending on the technology due to their varying regulatory statuses and the necessary adjustments to regulatory systems.
The main challenge for MXR is that there are no clear regulatory guidelines for usability, validation methods, and performance evaluation. Gamification in digital health applications has introduced unique mechanisms for patient engagement that could influence patient behaviour and which are not sufficiently addressed in the current risk management frameworks. Additionally, the regulatory compliance of these applications remains problematic, as many gamified health apps are not adequately certified as medical devices. Cybersecurity was identified as a critical area where regulatory gaps present substantial risks to patient safety. The regulatory framework lacks clear methodologies for incorporating cybersecurity risk into benefit-risk assessments. The publications on generative AI, particularly LLMs, have revealed the most substantial regulatory challenges. These models exhibit unpredictable behaviour, have limited explainability, and introduce new risks that are not compatible with traditional safety assessment methods. Despite their growing importance in healthcare, there is currently no structured approval process for generative AI-based medical applications, which results in unregulated and potentially unsafe products entering the market.
Adapting the existing regulatory framework to address these gaps and challenges involves, among other things, developing specific guidelines for MXR and gamification, defining benefit-risk methodologies for cybersecurity, and establishing a structured regulatory pathway for generative AI. By updating regulations to keep pace with technological advances, the EU can promote a more flexible, efficient, and innovation-friendly regulatory environment that ensures both the safety and accessibility of new medical devices.:Table of Contents – I
List of Tables – III
List of Figures – IV
List of Abbreviations – V
Zusammenfassung – 1
Summary – 5
Introduction – 8
Medical Devices – 8
The Regulation of Medical Devices – 11
The Current Regulatory Framework in the EU – 13
Steps of the Regulatory Process for Medical Devices in the EU – 14
Additional Applicable Regulations for Medical Devices in the EU – 17
Limitations and Challenges of the Current Regulatory Framework in the EU – 21
Regulatory Science – 23
Rational and Research Objectives – 24
Methodology – 25
Publications – 27
Author contributions – 27
Publication 1 - Bridging between hype and implementation in medical extended reality – 29
Publication 2 - The regulatory status of health apps that employ gamification – 33
Publication 3 - Consideration of Cybersecurity in the Benefit-Risk Analysis of Medical Devices: A Scoping Review – 52
Publication 4 - A future role for health applications of large language models depends on regulators enforcing safety standards – 77
Publication 5 - Policing the Boundary Between Responsible and Irresponsible Placing on the Market of LLM Health Applications – 89
Discussion – 101
Primary Results – 101
Gaps and Challenges of the Regulatory Framework – 102
Gaps and Challenges Related to MXR and Gamification – 103
Gaps and Challenges Related to Cybersecurity – 103
Gaps and Challenges Related to AI – 104
Gaps and Challenges Related to Software – 105
Technology-Independent Gaps and Challenges – 105
Consequences for the European Market – 107
Recommendations for an Improved Regulatory Framework – 108
Recommendations Related to MXR and Gamification – 108
Recommendations Related to Cybersecurity – 108
Recommendations Related to AI – 108
Recommendations Related to Software – 109
Recommendations Related to Non-Technical Aspects – 110
Conclusion – 111
References – 113
Acknowledgements – 128
Anlage 1 – 129
Anlage 2 – 13
Hayo Haya Maaseh [= Once upon a time]
No full textAnthology of East European Jewish folklore, with introduction and sources. The anthology includes: songs, tales, traditions, customs, jokes, proverbs, riddles. Authored by Chaim Ben Zion Elon-Baranik (born 1901). Published immediately after the Second World War. Illustrations by Moritz Oppenheimer, L. Pilichowski, Yosef Budko, E.M. Lilien (his signature in print). Most of the illustrations are printed on separated chrome paper, on one side of the page. Folklore publishing, Tel Aviv. HaIvri press, Jerusalem. 22 em. [1],303, [3] pages. Excellent condition. Chipped top of spine. . '... Olb price140-160This is a hardbound book (hard cover)Language note: HebrewChaim Ben Zion Elon-Barani
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