7 Key questions to ask when thinking about Digital Clinical Safety for your product
As Digital Clinical products and services continue to gain popularity, ensuring clinical safety becomes paramount. In this article, we will explore the key questions to ask when thinking about digital clinical safety for your product/innovation in Healthtech.
What is Digital Clinical Safety?
Digital Clinical safety is an important component of developing all clinical digital products which impact patient care. It is key that startups within this space imbed clinical safety in existing functionalities and products, in addition into new functionality and product lifecycles.
Clinical safety is a structured process whereby the development of healthtech systems are assessed by a trained registered clinical professional known as a Clinical Safety Officer (CSO). This can include when building healthtech products in sectors such as community, primary, secondary and tertiary care.
The role of the clinical safety officer (CSO) is to identify any risks of a proposal to citizens and/or service users, allowing companies to make an informed decision before deploying a product.
CSO’s generally work within the wider company team to proactively discuss mitigations of risk and potential solutions to help keep risks low. They also ensure companies are complying with statutory and regulatory standards.
As discussed in the previous blog healthtech products and services continue to proliferate, it is crucial to prioritise clinical safety to ensure that these technologies are not only effective but also reliable and secure. Clinical safety is of paramount importance to avoid harmful outcomes and comply with regulation.
There are two main standards which are focussed on clinical safety in healthtech companies. These are DCB0129 and DC0160.
7 Key questions to think about:
1. How does the digital system impact patient safety?
2. Does the digital solution comply with relevant healthcare regulations and standards?
3. How is patient data protected from unauthorised access or breaches?
4. Does the digital system integrate with existing healthcare infrastructure and systems to ensure critical information is not missing?
5. Are user interfaces optimised for ease of use, minimising the risk of user error?
6. How are feedback and adverse events collected, analyzed, and used for continuous improvement?
7. How are healthcare professionals trained to use the digital tool?
This is not an exhaustive list of questions however it should provide the basis of questions to ask oneself when thinking about digital clinical safety. For more information and advice sign up to a free intro call to discuss further.
Dr Yasmin Karsan, MRPharmS, PhD, PGDip, MSc.
Founder of the Digital Clinical Safety agency.
Contact: yasmin@digitalclinicalsafety.com
www.digitalclinicalsafety.com
