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Navigating Patient Safety: The Crucial Role of Compliance in Robotic Process Automation Technology

In the ever-evolving landscape of healthcare, the adoption of technology is transforming the way patient care is delivered. As organisations embrace innovations like Robotic Process Automation (RPA) to streamline operations, the spotlight on patient safety has never been brighter. This blog touches merely on the surface of the intricacies between technology procurement, compliance with safety standards, and the implications for patient well-being.

The Significance of Compliance in Healthcare Technology
Healthcare organisations are on a quest to embed innovation, streamline processes and use the latest technology. Technology, including RPA, however when the intended use includes health care and patients then an integral part of this journey, is the requirement of safety standards. One such standard gaining prominence is DCB0129. DCB0129 provides the framework for clinical risk management for the manufacturer of Health IT systems, including- development, deployment, and maintenance of digital health systems, placing patient safety at the forefront.

The Alignment of RPA with Safety Standards
Robotic Process Automation, a digital capability hailed for its efficiency, is not exempt from the scrutiny of safety standards. The alignment of RPA with DCB0129 middleware safety standards is crucial in establishing a robust foundation for its integration into healthcare workflows. From risk assessments to hazard identification, controls and continuous monitoring, RPA developers must align their practices to ensure compliance and mitigate potential risks from the use in health and care environments.

Procurement Considerations- A Varied Landscape
How healthcare organisations approach the procurement of technologies like RPA is diverse and influenced by several factors. Organisational policies, the regulatory environment, awareness, vendor accountability, and collaboration between project and clinical teams all play pivotal roles. Organisations at the forefront of patient safety are likely to prioritise vendors who actively demonstrate compliance, transparency, and a commitment to addressing safety concerns.

However, it is becoming more and more apparent in the work I support that compliance is either not considered or even worse not well known within procurement and the wider project teams. I am seeing more digital health products being procured and deployed without the rigour of DCB0160. DCB0160 is the clinical safety standard in which deployers of digital health IT systems should comply.

Creating a Culture of Safety in Technology Adoption
As the healthcare industry undergoes digital transformation, there’s a growing awareness of the need to create a culture of safety from the very inception of technology adoption.

The procurement process is a critical juncture where organisations can assess and prioritise the compliance readiness of a product or even the manufacturer. DTAC is a good way to assess this, however, again, many teams are not aware how to navigate through the assessment or what to look for, what’s right or what areas need further clarification. Once procured its then the project team or end users that MUST perform the Clinical Risk Management activities required to ensure a safe deployment. Appointing a Clinical Safety Officer (CSO) if they have one, working through tasks and assessments.

Recommendations may be formed following the analysis of the product and service area. However, teams are not fully informed of these crucial elements to ensure a safe deployment. Many do not have or even know what a CSO is, therefore we are seeing more and more deployments without the required compliance. Which is mandated under the Health and Social Care Act 2012. We need to create a safety culture, embedding the knowledge and awareness throughout all the teams, whether at a GP practice, Trust, or ICB. We must collectively be aware, engage in open communication with vendors, and make informed decisions that align with established safety standards.

The Ongoing Commitment to Patient Safety
Patient safety doesn’t end with technology procurement and deployment, it’s an ongoing commitment. The integration of RPA for example and other technologies should be accompanied by continuous monitoring, evaluation, and a willingness to learn from failures.

Therefore, establishing incident reporting mechanisms, fostering a culture of transparency, and actively addressing safety concerns contribute to a safer and more efficient healthcare ecosystem. Manufacturers of products and systems must have a clearly defined incident management process with timescales, this must be shared with deploying organisations to ensure there’s a feedback and mechanism in place to ensure any reported incidents are owned, thoroughly investigated, addressed and where required disseminated to others.

Integration of RPA relies on the careful implementation, consideration of intended use and compliance with clinical safety standards. Manufacturers must own that responsibility and not shy away. There are conflicting and confusing messages out there however, recent confirmation from the NHS England clinical safety team reinforces that RPA does fall under DCB0129 as middleware.

Therefore, if you’re a RPA manufacturer ensure you are complying with DCB0129, and if you’re a deployer then you should be asking for the manufacturers document set and ensuring DCB0160 compliance. As healthcare organisations navigate the deployments, patient safety and technological innovation must intertwine, creating a future where the benefits of RPA are maximized, and patient well-being is never compromised. It’s a journey toward a safer, more efficient healthcare ecosystem which shouldn’t be completed hastily.

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