McInerney, C.D. orcid.org/0000-0001-7620-7110, Scott, B.C. and Johnson, O.A. (2021) Are regulations safe? reflections from developing a digital cancer decision-support tool. JCO Clinical Cancer Informatics, 5. pp. 353-363. ISSN 2473-4276
Abstract
PURPOSE
Informatics solutions to early diagnosis of cancer in primary care are increasingly prevalent, but it is not clear whether existing and planned standards and regulations sufficiently address patients' safety nor whether these standards are fit for purpose. We use a patient safety perspective to reflect on the development of a computerized cancer risk assessment tool embedded within a UK primary care electronic health record system.
METHODS
We developed a computerized version of the CAncer Prevention in ExetER studies risk assessment tool, in compliance with the European Union's Medical Device Regulations. The process of building this tool afforded an opportunity to reflect on clinical concerns and whether current regulations for medical devices are fit for purpose. We identified concerns for patient safety and developed nine practical recommendations to mitigate these concerns.
RESULTS
We noted that medical device regulations (1) were initially created for hardware devices rather than software, (2) offer one-shot approval rather than supporting iterative innovation and learning, (3) are biased toward loss-transfer approaches that attempt to manage the fallout of harm instead of mitigating hazards becoming harmful, and (4) are biased toward known hazards, despite unknown hazards being an expected consequence of health care as a complex adaptive system. Our nine recommendations focus on embedding less-reductionist and stronger system perspectives into regulations and standards.
CONCLUSION
Our intention is to share our experience to support research-led collaborative development of health informatics solutions in cancer. We argue that regulations in the European Union do not sufficiently address the complexity of healthcare information systems with consequences for patient safety. Future standards and regulations should continue to follow a system-based approach to risk, safety, and accident avoidance.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2021 by American Society of Clinical Oncology. Article available under a Creative Commons Attribution Non-Commercial No Derivatives 4.0 License (https://creativecommons.org/licenses/by-nc-nd/4.0/) |
Dates: |
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Institution: | The University of Sheffield |
Academic Units: | The University of Sheffield > Faculty of Medicine, Dentistry and Health (Sheffield) > The Medical School (Sheffield) > Academic Unit of Medical Education (Sheffield) |
Depositing User: | Symplectic Sheffield |
Date Deposited: | 28 Sep 2022 11:55 |
Last Modified: | 28 Sep 2022 12:05 |
Status: | Published |
Publisher: | American Society of Clinical Oncology |
Refereed: | Yes |
Identification Number: | 10.1200/cci.20.00148 |
Related URLs: | |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:190911 |
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