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Recent achievements in respect of Artificial Intelligence (AI) open up opportunities for new tools to assist medical diagnosis and care delivery. However, the typical process for the development of AI is through repeated cycles of learning and implementation, something that poses challenges to our existing system of regulating medical devices. Product developers face tensions between the benefits of continuous improvement/deployment of algorithms and keeping products unchanged. The latter more easily facilitates collecting evidence for safety assurance processes but sacrifices optimisation of performance and adaptation to user needs gained through learning-implementation cycles. The challenge is how to balance potential benefits with the need to assure their safety. Governance and assurance processes are needed that can accommodate real-time or near-real-time machine learning. Such an approach is of great importance in healthcare and other fields of application. AI has stimulated an intense process of learning as this new technology embeds in application contexts. The process is not only about the application of AI in the real world but also about the institutional arrangements for its safe and dependable deployment, including regulatory experimentation involving new market pathways, monitoring and surveillance, and sandbox schemes. We review the key themes, challenges and potential solutions raised at two stakeholder workshops and highlight recent attempts to adapt the laws for AI-enabled medical devices (AIeMD) with a special focus on the regulatory proposals in the UK and internationally. The UK regulatory trajectory shows signs of alignment with the US thinking, and yet the European Union model is still the most closely aligned framework.

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.

Integrating health and social care delivery with the help of digital technologies is a grand challenge. We argue that previous attempts have largely failed to achieve their objectives because implementers and decision makers disregard the complex socio-organizational dimensions of change associated with initiatives. These include structural and organizational complexity inhibiting the development of shared care pathways; professional jurisdictions, interests, and expertise; and existing data and governance structures. We provide an overview of those dimensions that can inform strategic decisions going forward, thereby contributing to the chances of success of shared care initiatives.

Abstract We modeled 3D structures of all SARS‐CoV‐2 proteins, generating 2,060 models that span 69% of the viral proteome and provide details not available elsewhere. We found that ˜6% of the proteome mimicked human proteins, while ˜7% was implicated in hijacking mechanisms that reverse post‐translational modifications, block host translation, and disable host defenses; a further ˜29% self‐assembled into heteromeric states that provided insight into how the viral replication and translation complex forms. To make these 3D models more accessible, we devised a structural coverage map, a novel visualization method to show what is—and is not—known about the 3D structure of the viral proteome. We integrated the coverage map into an accompanying online resource ( https://aquaria.ws/covid ) that can be used to find and explore models corresponding to the 79 structural states identified in this work. The resulting Aquaria‐COVID resource helps scientists use emerging structural data to understand the mechanisms underlying coronavirus infection and draws attention to the 31% of the viral proteome that remains structurally unknown or dark.

After exploratory research in the 1950s, HF skywave ‘over-the-horizon’ radars (OTHR) were developed as operating systems in the 1960s for defence missions, notably the long-range detection of ballistic missiles, aircraft, and ships. The potential for a variety of non-defence applications soon became apparent, but the size, cost, siting requirements, and tasking priority hindered the implementation of these societal roles. A sister technology—HF surface wave radar (HFSWR)—evolved during the same period but, in this more compact form, the non-defence applications dominated, with hundreds of such radars presently deployed around the world, used primarily for ocean current mapping and wave measurements. In this paper, we examine the ocean monitoring capabilities of the latest generation of HF skywave radars, some shared with HFSWR, some unique to the skywave modality, and explore some new possibilities, along with selected technical details for their implementation. We apply state-of-the-art modelling and experimental data to illustrate the kinds of information that can be generated and exploited for civil, commercial, and scientific purposes. The examples treated confirm the relevance and value of this information to such diverse activities as shipping, fishing, offshore resource extraction, agriculture, communications, weather forecasting, and climate change studies.

Radars operating in the HF band are widely used for over-the-horizon remote sensing of ocean surface conditions, ionospheric studies and the monitoring of ship and aircraft traffic. Several hundreds of such radars are in operation, yet only a handful of experiments have been conducted to assess the prospect of utilizing this technology for the remote sensing of sea ice. Even then, the measurements carried out have addressed only the most basic questions: is there ice present, and can we measure its drift? Recently the theory that describes HF scattering from the dynamic sea surface was extended to handle situations where an ice cover is present. With this new tool, it becomes feasible to interpret the corresponding radar echoes in terms of the structural, mechanical, and electrical properties of the ice field. In this paper we look briefly at ice sensing from space-borne sensors before showing how the persistent and synoptic wide area surveillance capabilities of HF radar offer an alternative. The dispersion relations of different forms of sea ice are examined and used in a modified implementation of the electromagnetic scattering theory employed in HF radar oceanography to compute the corresponding radar signatures. Previous and present-day HF radar deployments at high latitudes are reviewed, noting the physical and technical challenges that confront the implementation of an operational HF radar in its ice monitoring capability.

Radars operating in the high-frequency (HF) band can exploit propagation modes other than line-of-sight and are hence widely employed to provide over-the-horizon surveillance and remote sensing. Most HF radars operating today rely on surface wave propagation; while opportunities for enhancing their performance by adding cognitive features exist, these have not been widely seized. In contrast, designers of HF skywave radars, which exploit ionospheric reflection to achieve ranges in excess of 4000 km, have long sought to counter the enormous challenges of the geophysical environment by implementing schemes to raise radar intelligence quotient (IQ) and autonomy. Measures that have been explored relate to resource allocation, operating procedures, signal processing, target classification and remote sensing. The perception–action cycle constitutes the structural element of these developments, accessing prior knowledge and input from auxiliary sensors, exactly as proposed by those who later coined the term cognitive radar. Here, the roles of cognition in HF skywave radars are reviewed, illustrating the needs and benefits with examples including detection in sea clutter, ionospheric channel compensation and multiple-input and multiple-output HF radar.

Background: Knowledge transfer has been well recognised as an effective enabler to access existing evidence and learning on integrated care. It requires dedicated support to ensure that the flow of appropriate information and knowledge between adopting and transferring entities is tailored appropriately to the context and maturity of the adopting system. SCIROCCO is an online participatory tool that helps stakeholders to understand: 1) The context requirements of a particular good practice that is considered for adoption; 2) The level of maturity required for a health and social care system to adopt and scale up integrated care; 3) The actions that more progressive regions have taken to be successful and enable information sharing, twinning and coaching to overcome barriers and accelerate results in integrated care. The functionality of the tool for twinning and coaching was designed following the initial testing of the knowledge transfer activities in three regions. The design followed an iterative process involving the active participation of the SCIROCCO partners. Aims and Objectives: The objective of this workshop is to present the SCIROCCO tool and lessons learned from its application as a tool to facilitate the knowledge transfer in integrated care. We aim to present the functionalities of the tool in the context of twinning and coaching; the transferability of a good practice and/or improvement of particular dimension of integrated care. It will be an opportunity to learn about the experience of SCIROCCO regions in using SCIROCCO tool to facilitate the twinning and coaching activities. This experience was captured using focus group. We also aim to gather feedback from the workshop participants on the SCIROCCO tool and its potential impact and added value in their own regions in terms of knowledge transfer. Format: To meet these objectives, a workshop will be organised as follows: Introduction (10 min): presentation of the objectives and content by Diane Whitehouse (EHTEL). SCIROCCO tool (15 min): presentation on the tool and its development process, with a focus on the twinning and coaching activities, by Cristina Alexandru (University of Edinburgh). Analysis of users’ experiences from focus groups (15 min): presentation on the users’ experiences with the twinning and coaching process and perspectives on the use of the SCIROCCO tool for knowledge transfer collected though focus group, by Tamara Alhambra-Borrás (University of Valencia). Discussion and dialogue (15 min): opportunity to ask questions and discuss emerging issues with the presenters and stakeholders in the room, moderated by Diane Whitehouse. Wrap up (5 min): The main outcomes and next steps will be summarised by Diane Whitehouse. Target audience: People interested in scaling-up integrated care, self-assessment of integrated care, new tools and knowledge transfer. Learnings: Workshop participants will learn about: Development of the twinning and coaching functionality. The experience of using the SCIROCCO tool to facilitate knowledge transfer. How twinning, coaching, and the use of the tool can help with the scaling-up of Integrated Care. Ways in which the tool has been used and can be used in the future.

Most HF radars operate in a monostatic or quasi-monostatic configuration. The collocation of transmit and receive facilities simplifies testing and maintenance, reduces demands on communications networks, and enables the use of established and relatively straightforward signal processing and data interpretation techniques. Radars of this type are well-suited to missions such as current mapping, waveheight measurement, and the detection of ships and aircraft. The high scientific, defense, and economic value of the radar products is evident from the fact that hundreds of HF radars are presently in operation, the great majority of them relying on the surface wave mode of propagation, though some systems employ line-of-sight or skywave modalities. Yet, notwithstanding the versatility and proven capabilities of monostatic HF radars, there are some types of observations for which the monostatic geometry renders them less effective. In these cases, one must turn to more general radar configurations, including those that employ a multiplicity of propagation modalities to achieve the desired illumination, scattering selectivity, and echo reception. In this paper, we survey some of the considerations that arise with bistatic HF radar configurations, explore some of the missions for which they are optimal, and describe some practical techniques that can guide their design and deployment.

As the HIV population ages, the prevalence of cognitive impairment (CI) is increasing, yet few services exist for the assessment and management of these individuals. Here we provide an initial description of a memory assessment service for people living with HIV and present data from a service evaluation undertaken in the clinic. We conducted an evaluation of the first 52 patients seen by the clinic. We present patient demographic data, assessment outcomes, diagnoses given and interventions delivered to those seen in the clinic. 41 patients (79%) of those seen in the clinic had objective CI: 16 (31%) met criteria for HIV-associated Neurocognitive Disorder (HAND), 2 (4%) were diagnosed with dementia, 14 (27%) showed CI associated with mental illness and/or drugs/alcohol, 7 (13%) had CI which was attributed to factors other than HIV and in 2 (4%) patients the cause remains unclear. 32 (62%) patients showed some abnormality on Magnetic Resonance Imaging (MRI) brain scans. Patients attending the clinic performed significantly worse than normative scores on all tests of global cognition and executive function. Interventions offered to patients included combination antiretroviral therapy modification, signposting to other services, case management, further health investigations and in-clinic advice. Our experience suggests that the need exists for specialist HIV memory services and that such a model of working can be successfully implemented into HIV patient care. Further work is needed on referral criteria and pathways. Diagnostic processes and treatment offered needs to consider and address the multifactorial aetiology of CI in HIV and this is essential for effective assessment and management.

Following the thalidomide disaster1961 many accounts of pre-thalidomide drug safety history appeared. Some identified events which represented missed opportunities or ignored warning signs. This paper reviews three assertions made in these accounts; that an opportunity to introduce a spontaneous reporting system for suspected adverse drug reactions in 1893 was missed; that concerns about dangers of drugs in pregnancy identified in 1904 were ignored; and that a proposal to establish a drug regulatory body made in 1914 was abandoned. The paper concludes that even if all had been acted upon it is unlikely that the thalidomide disaster could have been entirely avoided. http://dx.doi.org/10.14195/1647-6336_14_3