The Beginners Guide to Digital Clinical Safety
The field of healthtech has experienced a large transformation in recent years. Through the use of technology women, men and families all now have the access to digital clinical products at the click of a button. This change is driven by an expanding industry known as Healthtech, which encompasses a range of digital health tools and technologies designed to address the patients within or remotely away from the traditional doctors office. In the United Kingdom, healthtech products are highly regulated through an area called Clinical Safety guided by NHS England. This topic area ensures risks associated with patients accessing digital clinical products are mitigated and the digital products are safe to use.
In this article, we will explore the role of clinical safety in Healthtech, highlighting the importance of it when developing innovations in improving healthcare technology.
What is Healthtech?
Healthtech is short for "healthcare technology” - It refers to a category of health-related technologies and products designed with a focus on health. These innovations leverage various technologies, including mobile apps, wearable devices, telemedicine platforms, and AI-driven diagnostics, to provide personalized and accessible healthcare solutions. The healthtech industry has witnessed substantial growth, with an array of products aimed at empowering patients to take control of their health.
The Importance of Clinical Safety in Healthtech
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.
What is Clinical Safety?
Clinical safety is a structured process whereby the development of healthtech systems are assessed by a registered clinical professional. 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 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. Here are some key reasons why clinical safety is of paramount importance in the healthtech space:
Avoiding Harmful Outcomes: Poorly designed or inadequately tested healthtech solutions can lead to harmful outcomes, causing physical, emotional, or psychological harm. Clinical safety measures help mitigate these risks.
Regulatory Compliance: In the UK, there are set standards which provide a set of requirements to promote and ensure ‘effective application of clinical risk management by those who develop and deploy Health IT Systems’. There are two main standards which are focussed on clinical safety in healthtech companies. These are DCB0129 and DC0160.
Startups which are building a product where you are the manufacturer and deployer you would have to cover both these standards.
Clinical Safety Measures in Healthtech
To ensure clinical safety in the healthtech industry, companies must adopt a multifaceted approach. This approach should include the following key measures:
User-Centric Design: Products and apps should be designed with user needs in mind, offering intuitive interfaces and clear, accurate information. Usability testing can help ensure that women can easily navigate and understand the technology.
Regular Updates and Maintenance: Continuous monitoring and maintenance are essential to ensure that healthtech solutions remain up-to-date, secure, and effective over time.
Collaboration with Healthcare Professionals: Engaging healthcare professionals, from diverse backgrounds, can help in creating healthtech solutions that align with best clinical practices and guidelines.
Healthtech is revolutionising digital healthcare by providing personalised and accessible care for patients. As outlined in this article clinical safety should feature in all stages of development and deployment. As the healthtech industry continues to expand, ensuring clinical safety will be a critical factor in empowering patients to take charge of their health and well-being.
Dr Yasmin Karsan, MRPharmS, PhD, PGDip, MSc.
Founder of the Digital Clinical Safety agency.
Contact: yasmin@digitalclinicalsafety.com
www.digitalclinicalsafety.com
