Co-authored by Dean Mawson, Clinical Director / Founder, DPM Digital Healthm, and Tom Bradshaw, Clinical Safety Officer & GP and Founder of BMS Digital Safety.
Buying budget – not always buying best.
Ever regretted buying that knock-off detergent that left you with a nagging itch? Sometimes cost cutting isn’t worth it. The same goes for Clinical Safety Officers.
A Clinical Safety Officer’s (CSO) role is far more nuanced and significant than simply completing a set of predefined tasks or “ticking boxes.” CSOs are integral to ensuring the safe delivery of care through digital health technologies. Their work directly influences patient safety, clinical workflows, and the broader healthcare ecosystem.
Clinical Risk Management (CRM) isn’t a one-size-fits-all process; it demands a profound understanding of both clinical practice and digital health.
A qualified, knowledgeable, CSO brings invaluable know-how, engaging in every project phase—from design and development to clinical workflow analysis, testing, training, and governance.
They lead hazard workshops, drive reviews, and ensure risks are identified, assessed, and mitigated in alignment with clinical realities.
They are pivotal in bridging the gaps between cybersecurity, data management, and clinical safety—domains that must be harmonised for successful digital transformation.
Investing in a top-notch Clinical Safety Officer means investing in years of clinical experience, their professional credentials, and the enduring status their professional body brings. It’s an investment in their reputation, enhancing your product’s credibility.
While cost considerations are valid, reducing the role of a CSO to a commoditised service undermines their value and critical importance. A CSO is not just for DTAC and DCB compliance but embedding a culture of safety into your product; ensuring these frameworks are applied meaningfully, shaping safer, more reliable solutions for patients and clinicians.
Clinical risk management is not a cost-cutting exercise. Patient safety should never be reduced to a price point.
All involved in health-tech regulation must advocate for the ability and leadership that CSOs bring to digital health. They must elevate the CSO role, emphasising that Clinical Risk Management is a strategic investment in safety, quality, and trust.
NHS England’s review of DCB 0129 is a watershed moment for the digital health community. This consultation is the chance to strengthen clinical safety, elevate standards, and shape broader frameworks like DTAC. As regulations and technologies evolve, adapting standards, strengthening governance, and providing practical tools are crucial. We must shift from reactive to proactive risk management, focusing on prevention.
Accountability must be emphasised, with real consequences for non-compliance. This is not about punitive measures; it’s about fostering a culture of compliance and safety. CSOs are central to this effort, serving as ambassadors for safe digital health technology and guardians of the CRM process; vital for ensuring safe, effective digital health solutions. Establishing a national register of CSOs would underscore their critical importance.
Finally, and speaking directly to health tech manufacturers, the Health and Social Care Act mandates that you have a lawful responsibility to provide adequate resources to meet the rigours of clinical risk management. While bundled services may offer a cost-effective possibility for start-ups, it’s vital to understand your legal duties and the value of experienced CSOs who drive meaningful, lasting impact beyond compliance checklists.
Clinical Safety on a shoestring is not an option if you’re serious about your product, your company and the future of digital health-technologies.
As the saying goes – buy cheap – buy twice.
Let’s seize this opportunity to build a future where clinical safety is paramount, standards are robust, and the role of CSOs is recognised and respected. Together, we can ensure that digital health technologies deliver on their promise of safer, more effective patient care.
