Insights From a Clinically Orientated Workshop on Health Care Cybersecurity and Medical Technology: Observational Study and Thematic Analysis.

BACKGROUND: Health care professionals receive little training on the digital technologies that their patients rely on. Consequently, practitioners may face significant barriers when providing care to patients experiencing digitally mediated harms (eg, medical device failures and cybersecurity exploits). Here, we explore the impact of technological failures in clinical terms. OBJECTIVE: Our study explored the key challenges faced by frontline health care workers during digital events, identified gaps in clinical training and guidance, and proposes a set of recommendations for improving digital clinical practice. METHODS: A qualitative study involving a 1-day workshop of 52 participants, internationally attended, with multistakeholder participation. Participants engaged in table-top exercises and group discussions focused on medical scenarios complicated by technology (eg, malfunctioning ventilators and malicious hacks on health care apps). Extensive notes from 5 scribes were retrospectively analyzed and a thematic analysis was performed to extract and synthesize data. RESULTS: Clinicians reported novel forms of harm related to technology (eg, geofencing in domestic violence and errors related to interconnected fetal monitoring systems) and barriers impeding adverse event reporting (eg, time constraints and postmortem device disposal). Challenges to providing effective patient care included a lack of clinical suspicion of device failures, unfamiliarity with equipment, and an absence of digitally tailored clinical protocols. Participants agreed that cyberattacks should be classified as major incidents, with the repurposing of existing crisis resources. Treatment of patients was determined by the role technology played in clinical management, such that those reliant on potentially compromised laboratory or radiological facilities were prioritized. CONCLUSIONS: Here, we have framed digital events through a clinical lens, described in terms of their end-point impact on the patient. In doing so, we have developed a series of recommendations for ensuring responses to digital events are tailored to clinical needs and center patient care.

Institutional and infrastructure challenges for hospitals producing advanced therapies in the UK: the concept of 'point-of-care manufacturing readiness'.

Aim: To propose the concept of point-of-care manufacturing readiness for analyzing the capacity that a country, a health system or an institution has developed to manufacture therapies in clinical settings (point-of-care manufacture). The focus is on advanced therapies (cell, gene and tissue engineering therapies) in the UK. Materials & methods: Literature review, analysis of quantitative data, and qualitative interviews with professionals and practitioners developing and administering advanced therapies. Results: Three components of point-of-care manufacturing readiness are analyzed staff and institutional procedures, infrastructure, and relations between hospitals and service providers. Conclusion: The technical and regulatory experience that has been gained through manufacturing advanced therapies at small scale in hospitals qualifies the UK for more complex and larger-scale production of therapies in the future.

Point-of-care manufacture is the production of therapies in hospitals, carried out when there is no time for storing the medicine, which is delivered to the patient with no delays. Such procedures can be useful for advanced therapies derived from techniques such as gene editing, cell manipulation and tissue engineering. Over the last decades, UK hospitals have produced advanced therapies in small quantities. In the future, this production will likely be more thoroughly integrated into clinical routines. In this way, the technical and regulatory experience that hospitals have accumulated so far underpins the more frequent and larger-scale work expected for the future. This accumulation of expertise, infrastructure and institutional contacts provides the foundation for what we call 'point-of-care manufacturing readiness'.