Existing provision of regulations for medical devices may be insufficient for the digital age. In our recent paper, we argue that the complexity of healthcare information systems is not being acknowledged and incorporated in the design of many regulations and standards.
National Institute for Care Excellence (NICE) guidance from 2015 promoted the use of QRISK2. This computerised tool calculated someone’s risk of having a heart attack or stroke in the next 10 years. It was designed, developed and approved in accordance with the safety guidelines at the time. But by 2016, the regulatory agency in the UK raised an alert about the use of the computerised tool in some practices [https://www.digitalhealth.net/2016/06/qrisk2-in-tpp-fixed-but-up-to-270000-patients-affected/].
Thankfully, the errors in the risk calculated by QRISK2 were minimal. The UK’s commitment to electronic health systems were leveraged to track down the source of the problem and follow up with patients. Although the connectivity of the UK’s increasingly-digitised healthcare system helped to remedy some safety concerns, its connectedness can also be a cause for concern.
What’s the problem?
Perhaps the biggest problem faced by regulators of medical devices is that there isn’t just a single problem to solve. Healthcare is an ever-changing and complex system, where not only the parts need to be considered, but their interactions, too. With so many dynamic interacting parts, it can be practically impossible and hubristic to think we can observe and control everything.
Many standards are available but are not compulsory. For example, decisions made by the European Union in the 1980s separated law and technical standards, which makes it difficult to enforce standards (1). Even if standards were enforceable, they often don’t acknowledge the contemporary systemic and connected ecology of medical devices in the age of digital health and Healthcare 4.0 (2).
Are regulations safe for patients?
It has become increasingly apparent that existing regulation of medical devices is insufficient for the digital age, despite progress in the European Union’s Medical Device Regulation (3). In our paper [https://ascopubs.org/doi/full/10.1200/CCI.20.00148], we argue that the complexity of healthcare information systems is not being acknowledged and incorporated in the design of many regulations and standards (4).
Medical device regulations were initially created for hardware devices rather than software and offer one-shot approvals rather than supporting iterative innovation and learning. Such iterative development has been the keystone to agile methods in product and service innovation that enable timely responsiveness to emerging contexts. A further issue with many medical device regulations is the bias toward loss-transfer approaches that attempt to manage the fallout of harm instead of mitigating hazards becoming harmful. This often manifests as bias toward known hazards, despite unknown hazards being an expected consequence of health care as a complex adaptive system.
What’s being done about it?
Despite the aforementioned concerns, many theoretical and practical strategies have been proposed to improve the provision of effective medical devices in a safe and timely manner. In our paper[https://ascopubs.org/doi/full/10.1200/CCI.20.00148], we summarise nine recommendations that focus on embedding less-reductionist and stronger systemic perspectives into regulations and standards (4). These recommendations include a Safety II perspective of risk (5), systemic models of accident and safety (6–8), realignment of standards and regulations, and gradual approval of devices. Frameworks like Idea-Development-Exploration-Assessment-Long-term-study (IDEAL)[https://pubmed.ncbi.nlm.nih.gov/29697448/] are examples of gradual approval processes that have shown some effectiveness (9).
Advocates for digital health care about its speed, coverage, and capacity but perhaps without considering its own suite of challenges (10) and safety concerns, e.g. underuse, misuse or abuse due to lack of training and improper integration. Future development of regulations should make it easier for clinical and academic institutions like the NIHR PSTRCs to produce healthcare information technology in a way that contributes state-of-the-art patient care and safety science insight.
How can I get involved?
What other recommendations would you like to see? What other ways are there to foster the production of healthcare products that are simultaneously effective and safe? Let us know your thoughts by commenting below or joining in on the conversation on Twitter [https://twitter.com/ASCO_pubs/status/1381306063996268548]
- Altenstetter C. EU and member state medical devices regulation. Int J Technol Assess Health Care. 2003;1(2003):228–48.
- Aceto G, Persico V, Pescapé A. Industry 4.0 and Health: Internet of Things, Big Data, and Cloud Computing. J Ind Inf Integr [Internet]. 2020;18(February 2019):100129. Available from: https://doi.org/10.1016/j.jii.2020.100129
- Medicines and Healthcare products Regulatory Agency. An introductory guide to the medical device regulation (MDR) and the in vitro diagnostic medical device regulation (IVDR) [Internet]. 2020. Available from: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/640404/MDR_IVDR_guidance_Print_13.pdf
- McInerney CD, Scott B, Johnson OA. Are regulations safe? Reflections from developing a digital cancer decision support tool. JCO Clin Cancer Informatics. 2021;353–63.
- Hollnagel E. Safety-I and safety-II: the past and future of safety management. Ashgate; 2018.
- Ravitz AD, Sapirstein A, Pham JC, Doyle PA. Systems approach and systems engineering applied to health care: Improving patient safety and health care delivery. Johns Hopkins APL Tech Dig (Applied Phys Lab. 2013;31(4):354–65.
- Underwood P, Waterson P. Systemic accident analysis: Examining the gap between research and practice. Accid Anal Prev [Internet]. 2013;55:154–64. Available from: http://dx.doi.org/10.1016/j.aap.2013.02.041
- Leveson NG. A new accident model for engineering safer systems. Saf Sci. 2004;42(4):237–70.
- Hirst A, Philippou Y, Blazeby J, Campbell B, Campbell M, Feinberg J, et al. No Surgical Innovation Without Evaluation: Evolution and Further Development of the IDEAL Framework and Recommendations. Ann Surg. 2019;269(2):211–20.
- Sittig DF, Wright A, Coiera E, Magrabi F, Ratwani R, Bates DW, et al. Current challenges in health information technology–related patient safety. Health Informatics J. 2020;26(1):181–9.