Which computable biomedical knowledge objects will be regulated? Results of a UK workshop discussing the regulation of knowledge libraries and software as a medical device.

Introduction: To understand when knowledge objects in a computable biomedical knowledge library are likely to be subject to regulation as a medical device in the United Kingdom. Methods: A briefing paper was circulated to a multi-disciplinary group of 25 including regulators, lawyers and others with insights into device regulation. A 1-day workshop was convened to discuss questions relating to our aim. A discussion paper was drafted by lead authors and circulated to other authors for their comments and contributions. Results: This article reports on those deliberations and describes how UK device regulators are likely to treat the different kinds of knowledge objects that may be stored in computable biomedical knowledge libraries. While our focus is the likely approach of UK regulators, our analogies and analysis will also be relevant to the approaches taken by regulators elsewhere. We include a table examining the implications for each of the four knowledge levels described by Boxwala in 2011 and propose an additional level. Conclusions: If a knowledge object is described as directly executable for a medical purpose to provide decision support, it will generally be in scope of UK regulation as "software as a medical device." However, if the knowledge object consists of an algorithm, a ruleset, pseudocode or some other representation that is not directly executable and whose developers make no claim that it can be used for a medical purpose, it is not likely to be subject to regulation. We expect similar reasoning to be applied by regulators in other countries.

NHS knowledge and library services in England in the digital age.

National Health Service (NHS) knowledge and library services in England are integrating digital advances into their systems and services. Health Education England (HEE) leads on the development of NHS library services. A key workstream focuses on (1) improving the infrastructure to enable discovery and management of digital knowledge resources; (2) collaborating with local teams to establish regional library management systems that are integrated with the new national discovery service for healthcare staff and learners. This article explores initiatives on resource discovery as well as the need for system-wide partnership working to ensure that biomedical knowledge in computable form is findable, accessible, interoperable and reusable. Low levels of health and digital literacy pose a significant barrier to using health information and accessing health services. A range of interventions are aimed at enhancing citizens' digital and health literacy skills. The education and life-long learning needs of the knowledge and library services workforce are considered. Working with CILIP and higher education institutions, HEE delivers a range of educational offers through its Learning Academy. As Artificial Intelligence and automation are implemented in health systems, knowledge and library staff form a crucial bridge between technology and those who use it.

Forward view: advancing health library and knowledge services in England.

This article is the fourth in a series on New Directions. The National Health Service is under pressure, challenged to meet the needs of an ageing population, whilst striving to improve standards and ensure decision making is underpinned by evidence. Health Education England is steering a new course for NHS library and knowledge services in England to ensure access to knowledge and evidence for all decision makers. Knowledge for Healthcare calls for service transformation, role redesign, greater coordination and collaboration. To meet user expectations, health libraries must achieve sustainable, affordable access to digital content. Traditional tasks will progressively become mechanised. Alongside supporting learners, NHS librarians and knowledge specialists will take a greater role as knowledge brokers, delivering business critical services. They will support the NHS workforce to signpost patients and the public to high-quality information. There is a need for greater efficiency and effectiveness through greater co-operation and service mergers. Evaluation of service quality will focus more on outcomes, less on counting. These changes require an agile workforce, fit for the future. There is a bright future in which librarians' expertise is used to mobilise evidence, manage and share knowledge, support patients, carers and families, optimise technology and social media and provide a keystone for improved patient care and safety.

Becoming business critical: Knowledge for Healthcare.

Significant progress has been made in implementing Knowledge for Healthcare. This editorial reports the central contribution of effective partnerships and the involvement of librarians and knowledge specialists in this work. There are compelling business priorities. Key elements of work-streams on demonstrating impact, workforce development and streamlining are indicated, along with areas of growing importance - knowledge management, embedded roles and health information for the public and patients. Knowledge, and the skills to help people to use it, are business critical.