A Framework for eHealth Interoperability Management

Reliable and secure access to and sharing of medical data can help patients practice self-care, promote patient engagement and improve their communication with healthcare professionals. This requires overcoming several interoperability, usability, ethics, security, and regulatory issues. The existence of a common interoperability framework can accelerate digital transformation in support of disease specific solutions. This paper presents a useful and relevant interoperability management framework with the potential to improve the quality of life and better control costs for the development and provision of electronic health services to individuals, within a coordinated care environment, under a local, regional, national, or cross-border setting

Improving Risk Regulation

Confronted with the challenge of improving regulatory performance, many governments in the world are looking for ways to better manage risks, in particular those risks that develop in complex systems, with stakeholders from various sectors, and that are marked by uncertainty. This report includes five authored pieces about: The contribution of transnational private regulation to revisiting risk regulation (Scott), Emerging strategies to manage system-level risks: an examination of private sector, government and non-governmental organization initiative (Yosie), Potential scope and challenges of behaviourally informed regulation (Renn and Florin), and Managing uncertainty in drug development and use, by enhancing adaptability and flexibility in pharmaceuticals regulation (Oye et al.)

Regulatory justifications: regulating European medicines to maximise market potential

The justification for regulating is generally considered to rely on benefitting interested groups. Whereas the traditional view is that regulators act as impartial arbiters balancing competing public and private interests, modern accounts consider regulation to be dominated by single interests, such as those of industry. This article challenges these theories by arguing that regulators are substantively (not just procedurally) motivated to justify their actions according to the goals set for them by the bodies that empower them. In consequence, regulators understand their goals as market-based objectives, prompting them to focus on maximising market potential. This is demonstrated in the context of regulating medicines in Europe, through the European Patent Organisation, the CJEU, and the European Medicines Agency. The analysis identifies that regulating to achieve market benefits is a better predictor of regulatory behaviour, but this behaviour frustrates goal-achievement (relating to effective and affordable medicines) and only incidentally enables benefits to accrue to specific groups

The case for open science: rare diseases.

The premise of Open Science is that research and medical management will progress faster if data and knowledge are openly shared. The value of Open Science is nowhere more important and appreciated than in the rare disease (RD) community. Research into RDs has been limited by insufficient patient data and resources, a paucity of trained disease experts, and lack of therapeutics, leading to long delays in diagnosis and treatment. These issues can be ameliorated by following the principles and practices of sharing that are intrinsic to Open Science. Here, we describe how the RD community has adopted the core pillars of Open Science, adding new initiatives to promote care and research for RD patients and, ultimately, for all of medicine. We also present recommendations that can advance Open Science more globally

Usability analysis of contending electronic health record systems

In this paper, we report measured usability of two leading EHR systems during procurement. A total of 18 users participated in paired-usability testing of three scenarios: ordering and managing medications by an outpatient physician, medicine administration by an inpatient nurse and scheduling of appointments by nursing staff. Data for audio, screen capture, satisfaction rating, task success and errors made was collected during testing. We found a clear difference between the systems for percentage of successfully completed tasks, two different satisfaction measures and perceived learnability when looking at the results over all scenarios. We conclude that usability should be evaluated during procurement and the difference in usability between systems could be revealed even with fewer measures than were used in our study. © 2019 American Psychological Association Inc. All rights reserved.Peer reviewe

The collection, linking and use of data in biomedical research and health care: ethical issues

This report takes as its starting point the massive accumulation of data in biomedical research and health care, and the increasing power of data science to extract value by linking and re-using that data, for example in further health or population research. It examines the scientific, policy and economic drivers to exploit these opportunities, and the concerns and potential risks associated with doing so. The faltering ability of conventional information governance measures to keep pace with these developments is identified as a significant problem. The report therefore poses and addresses the following question: "how can we define a set of morally reasonable expectations about the use of data in any given data initiative and what conditions are required to give sufficient confidence that those expectations will be satisfied?" The report sets out a number of general recommendations, including four guiding principles for ethical design and governance of data initiatives. These help to identify specific examples of existing good practice and to make recommendations for improved practice in the use of data in the fields of health care (re-use of NHS records, clinical research, etc.) and population research (biobanks, epidemiological studies, etc.)

A Zebra\u27s Trust: How Rare Disease Communities\u27 Participation in Data Trusts\u27 Governance Builds Trust and Drives Research

Data sharing plays an increasingly prominent role in society, but it remains a necessary component of rare disease research. Because rare diseases are--as the name indicates-- rare, researchers have only a small number of patients from whom to collect data, and the expense of cross-border data sharing to increase research data is significant. Nevertheless, the rise of artificial intelligence and precision medicine increases the need for usable rare disease data. Current legislation and regulations aimed at addressing rare diseases fall short in addressing these data sharing needs for rare disease research. While the European Union (EU) has invested in rare disease data sharing more than most of the world, its programs are fragmented and limited to the rare disease community. Simultaneously, data is becoming increasingly viewed as a necessary component of a competitive economy, driving interest in data sharing platforms and initiatives, including the EU\u27s new Trusted Secure Data Sharing Space (TRUSTS) initiative. Perhaps the most promising instrument for data sharing is the data trust, but it suffers from an undefined and uncertain legal structure. This Note suggests that the rare disease community should embrace these broader data sharing initiatives in order to ensure the representation of rare disease data in these data sets and to harness the power of large-scale data sharing. Simultaneously, data trusts should look to rare disease communities for representation in their governance structures in order to establish the patient-centricity and public trust necessary for data trusts to thrive in an uncertain legal environment

Strategic Intelligence Monitor on Personal Health Systems (SIMPHS): Market Structure and Innovation Dynamics

Personal Health Systems (PHS) and Remote Patient Monitoring and Treatment (RMT) have the potential to alter the way healthcare is provided by increasing the quantity and quality of care. This report explores the current status of PHS and, more specifically of the RMT market in Europe. It addresses the question of how these technologies can contribute facing some of the challenges standing in front of the European healthcare delivery systems causes by higher demand pressures through chronic diseases and demographic change combined with diminishing resources for health care. An uptake and diffusion of these services would potentially lead to benefits through a reduction in death rates, and avoid recurring hospitalisation in a cost-effective manner. Yet the report identifies different categories of barriers hampering a full deployment of RMT in Europe. In the concluding part the reports provides a number of tentative policy options specifically aimed at fostering EU-wide deployment of RMT/PHS.JRC.DDG.J.4-Information Societ