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The EU passes the AI Act and its implications for digital medicine are unclear
On 13 March 2024, the much-anticipated AI Act was passed by the EU parliament and will soon be adopted as EU law. It will apply new requirements for developers and deployers of AI-enabled digital health tools (DHTs), including for a defined class of high-risk AI systems and for general-purpose AI. Although the text of the law is available, complete in all but the final checks of legal wording much is still not known about how the AI Act will affect the digital health landscape in the EU and beyond. The wording of many aspects of the Act is ambiguous, and often high-level objectives are stated, with the detail to come later in associated guidance, standards, and member state law and policy. It is also uncertain how the Act will intersect with pre-existing sector-specific legislation for medical AI. There are future steps in the legislative process that can clarify ambiguity, including standards, guidelines, and implementing laws, and the author remains optimistic the EU will get the implementation right.
Journal Article
The Bayeux tapestry and its contexts : a reassessment
\"Aspects of the Bayeux Tapestry (in fact an embroidered hanging) have always remained mysterious, despite much scholarly investigation, not least its design and patron. Here, in the first full-length interdisciplinary approach to the subject, the authors (an art historian and a historian) consider these and other issues. Rejecting the prevalent view that it was commissioned by Odo, the bishop of Bayeux and half-brother of William the Conqueror, or by some other comparable patron, they bring new evidence to bear on the question of its relationship to the abbey of St Augustine's, Canterbury. From the study of art-historical, archeological, literary, historical and documentary materials, they conclude that the monks of St Augustine's designed the hanging for display in their abbey church to tell their own story of how England was invaded and conquered in 1066.\" -- Publisher's description.
Book
Supplier Encroachment Under Asymmetric Information
Prior literature has shown that, for a symmetric information setting, supplier encroachment into a reseller's market can mitigate double marginalization and benefit both the supplier and the reseller. This paper extends the investigation of supplier encroachment to the environment where the reseller might be better informed than the supplier. We find that the launch of the supplier's direct channel can result in costly signaling behavior on the part of the reseller, in which he reduces his order quantity when the market size is small. Such a downward order distortion can amplify double marginalization. As a result, in addition to the \"win-win\" and \"win-lose\" outcomes for the supplier and the reseller, supplier encroachment can also lead to \"lose-lose\" and \"lose-win\" outcomes, particularly when the reseller has a significant efficiency advantage in the selling process and the prior probability of a large market is low. We further explore the implications of those findings for information management in supply chains. Complementing the conventional understanding, we show that with the ability to encroach, the supplier may prefer to sell to either a better informed or an uninformed reseller in different scenarios. On the other hand, as a result of a supplier developing encroachment capability, a reseller either may choose not to develop an advanced informational capability or may become more willing to find a means of credibly sharing his information.
This paper was accepted by Yossi Aviv, operations management.
Journal Article
Digital medicine’s international race for regulatory sandboxes and voluntary alternative pathways picks up tempo
The last months of 2025 have brought major new policy initiatives and pilots for digital medicine and AI regulatory sandboxes from the EU, UK, and US regulators. The EU has seen a regulatory simplification package with the promotion of sandboxes for innovative technologies. The UK sees the start of an important second phase of the world-leading ‘AI Airlock’ regulatory sandbox program. TEMPO, a major voluntary alternative pathway regulatory innovation pilot for digital health in chronic disease has been announced by the US FDA. These frameworks bring flexible approaches to explore digital health technology innovation together with regulatory innovation. They will all substantially advance digital medicine, with the US TEMPO project being the most innovative, bringing sandboxing principles to the on-market phase.
Journal Article
The Implications of Visibility on the Use of Strategic Inventory in a Supply Chain
It is now widely accepted that a retailer’s use of strategic inventory can mitigate double marginalization and improve the coordination of a supply chain, potentially benefiting both the downstream retailer and an upstream manufacturer. However, this conclusion has typically been based on the assumption that the manufacturer can observe the retailer’s level of inventory before making wholesale pricing decisions. In reality, there are many situations in which neither the retailer’s sales nor inventory are observable to the manufacturer, effectively concealing the action taken by the retailer. We investigate the implications of such a lack of observability on the use of strategic inventory in a supply chain consisting of a single retailer and a single manufacturer. We find that the manufacturer’s inability to observe inventory has significant implications for the amount of inventory and the range of holding cost for which it is held in equilibrium. In addition, we find that, in the absence of any form of uncertainty, which the manufacturer could benefit from responding to, he may prefer
not
to observe the retailer’s inventory. On the other hand, the retailer’s willingness to make her inventory visible depends on the holding cost.
The electronic companion is available at
https://doi.org/10.1287/mnsc.2018.3033
.
This paper was accepted by Gad Allon, operations management.
Journal Article
Effects of short-term, medium-term and long-term resistance exercise training on cardiometabolic health outcomes in adults: systematic review with meta-analysis
ObjectiveTo examine the effects of short-term, medium-term and long-term resistance exercise training (RET) on measures of cardiometabolic health in adults.DesignIntervention systematic review.Data sourcesMEDLINE and Cochrane Library databases were searched from inception to February 2018. The search strategy included the following keywords: resistance exercise, strength training and randomised controlled trial.Eligibility criteria for selecting studiesRandomised controlled trials published in English comparing RET≥2 weeks in duration with a non-exercising control or usual care group. Participants were non-athletic and aged ≥18 years.ResultsA total of 173 trials were included. Medium-term and long-term RET reduced systolic blood pressure (−4.02 (95% CI −5.92 to −2.11) mm Hg, p<0.0001 and −5.08 (−10.04 to –0.13) mm Hg, p=0.04, respectively) and diastolic blood pressure (−1.73 (−2.88 to –0.57) mm Hg, p=0.003 and −4.93 (−8.58 to –1.28) mm Hg, p=0.008, respectively) versus control. Medium-term RET elicited reductions in fasted insulin and insulin resistance (−0.59 (−0.97 to –0.21) µU/mL, p=0.002 and −1.22 (−2.29 to –0.15) µU/mL, p=0.02, respectively). The effects were greater in those with elevated cardiometabolic risk or disease compared with younger healthy adults. The quality of evidence was low or very low for all outcomes. There was limited evidence of adverse events.ConclusionsRET may be effective for inducing improvements in cardio metabolic health outcomes in healthy adults and those with an adverse cardio metabolic risk profile.PROSPERO registration number CRD42016037946.
Journal Article
Artificial Intelligence awarded two Nobel Prizes for innovations that will shape the future of medicine
John J. Hopfield and Geoffrey E. Hinton were awarded the 2024 Nobel Prize in Physics for developing machine learning technology using artificial neural networks. In Chemistry it was awarded to Demis Hassabis and John M. Jumper for developing an AI algorithm that solved the 50-year protein structure prediction challenge. This highlights AI’s impact on science, medicine and society; however, the winners acknowledge ethical aspects of AI that must be considered.
Journal Article
Augmented non-hallucinating large language models as medical information curators
Reliably processing and interlinking medical information has been recognized as a critical foundation to the digital transformation of medical workflows, and despite the development of medical ontologies, the optimization of these has been a major bottleneck to digital medicine. The advent of large language models has brought great excitement, and maybe a solution to the medicines’ ‘communication problem’ is in sight, but how can the known weaknesses of these models, such as hallucination and non-determinism, be tempered? Retrieval Augmented Generation, particularly through knowledge graphs, is an automated approach that can deliver structured reasoning and a model of truth alongside LLMs, relevant to information structuring and therefore also to decision support.
Journal Article
Learning From Experience and Finding the Right Balance in the Governance of Artificial Intelligence and Digital Health Technologies
Artificial intelligence (AI) and machine learning medical tools have the potential to be transformative in care delivery; however, this change will only be realized if accompanied by effective governance that ensures patient safety and public trust. Recent digital health initiatives have called for tighter governance of digital health. A correct balance must be found between ensuring product safety and performance while also enabling the innovation needed to deliver better approaches for patients and affordable efficient health care for society. This requires innovative, fit-for-purpose approaches to regulation. Digital health technologies, particularly AI-based tools, pose specific challenges to the development and implementation of functional regulation. The approaches of regulatory science and “better regulation” have a critical role in developing and evaluating solutions to these problems and ensuring effective implementation. We describe the divergent approaches of the European Union and the United States in the implementation of new regulatory approaches in digital health, and we consider the United Kingdom as a third example, which is in a unique position of developing a new post-Brexit regulatory framework.
Journal Article