Better to be safe than sorry

The role of clinical safety in transformative healthcare IT

Healthcare delivery can be a risky business

Progress is a great thing – and progress in healthcare technology is an amazing thing.

Throughout the world, technology is used to support healthcare professionals in the treatment of millions of patients. From EPRs and EHRs to medications management to telehealth to appointment and resource scheduling, and newer technologies like cloud, cybersecurity and mobility, practically every area of healthcare can benefit from technology.

When everything works, patient outcomes can be improved substantially, along with staff working conditions and morale, and healthcare organizations can operate more efficiently and effectively. But the potential consequences should anything go wrong can be almost too dreadful to contemplate.

Unfortunately, unrealistic expectations are sometimes placed on technology, with the assumption that healthcare IT systems will eliminate every problem. When they don’t, fingers are pointed, regardless of where the blame actually lies.

Take the United States for example. Last summer, Healthcare IT News reported that preventable medical errors were the third largest cause of death in the United States – after heart disease and cancer – claiming 400,000 lives each year and an average of 10,000 serious complications each day. The same article reported on a Subcommittee on Primary Health and Aging, where IT failures were identified as playing a major role in many of these instances, from missed/delayed diagnoses to incorrect test ordering and more.

This seems unfair, as human error is often part of the equation. However, no system or software can ever be totally risk-free, and while IT systems often have the ability to mitigate risks, unfortunately they can occasionally introduce problems of their own.

That’s why our industry has a duty to get it right as far as humanly possible and to minimize risk every step of the way.

Global Compliance

It’s stating the obvious to say that a safety culture should form the heart of any healthcare software development process – but what can we do to ensure risk is kept to a minimum?

Well, throughout many regions across the world, including the United States, the European Union, Asia, Canada, New Zealand and Australia, developers must classify and certify their software and/or medical device products in compliance with mandatory standards and requirements. Legal action will be taken in many countries for those that don’t.

Yet while these standards share the common aim of clinical safety, their composition varies widely from region to region, so suppliers operating in multiple countries must be equipped to understand the laws of each nation and ensure they conform. And to complicate matters further, in Europe for example, software suppliers must adhere to the Medical Devices Directives plus any legislation applicable to each home country, such as NHS England Safety Standards ISB 0129 and 0160, which make Clinical Risk Management activities mandatory.

How low can you go?

It is therefore obvious that every healthcare IT developer needs a comprehensive clinical safety strategy in place, ideally managed by a team of clinical safety experts, or several teams, depending on the number of countries where they are active.

An experienced clinical safety team will understand both global best practice and specific regional requirements. It’s vital work, and it’s a process that never ends, as they need to apply the principle of ALARP (As Low As Reasonably Practicable) to every stage of the software life cycle. From development, deployment, maintenance and the implementation of any additional functionality, their role is crucial in ensuring that software and devices are clinically safe and fit for purpose.

Safe and Secure

Clinical safety teams play a hugely important role in ensuring the success of healthcare IT suppliers.  No vendor wants to incur financial penalties or legal action, or experience the inevitable reputational damage that can arise when risk events occur.

But most importantly of all, they help us fulfil goals that everyone involved in healthcare aspires to: the ability to deliver products that will contribute to safe and effective patient care and improved outcomes by supporting healthcare professionals and organizations.

While CSC is not alone in developing, delivering and deploying a varied portfolio of healthcare products and services, the fact that we operate in 60 countries across six continents in the healthcare space gives us a particularly broad perspective. We also serve the Life Sciences industry, supplying software specifically designed to help facilitate accurate submissions and support regulatory compliance. This necessitates a thorough understanding of Food and Drug Administration (FDA) rules and regulations, and those of similar agencies across the world.

CSC’s clinical safety experts understand better than most that it is impossible to completely remove risk from the equation, but they continue to do everything in their power to eliminate risk wherever possible. I am particularly proud of our positive approach, always seeking ways to proactively use clinical safety as an enabler for improving healthcare systems rather than viewing these obligations as a costly overhead or necessary liability.

The bottom line is about minimizing risk though, and as long as the products we deliver have been rigorously reviewed by our experts, and are designed to improve clinical outcomes and support healthcare delivery then I think we are on the path to success.


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