What's the role of clinical safety in FemTech?
Clinical safety is an important part of developing any clinical digital product which impacts patient care.
What does good look like when it comes to healthtech? Of course, any product needs to be effective, it needs to be easy to use, but most crucially of all it needs to be safe.
That’s where clinical safety comes into play.
In this article we’ve got Dr Yasmin Karsan, Clinical Safety Consultant at Any Rx to explain exactly why clinical safety is so important, what it is (through the lens of the UK regulatory system) and when startups need to be considering clinical safety.
Over to you, Dr Yasmin!…
Why clinical safety?
Clinical safety is an important part of developing any clinical digital product which impacts patient care. Of course, that goes for FemTech too. Imagine you are launching a period tracking app, for example. What if the patient logged emergency symptoms - how would they be signposted or that risk mitigated? If you offer prescriptions - how are any prescribers on your database verified?
Without well-thought through clinical safety you risk causing physical, emotional, or psychological harm to users, as well as reputational damage to your product and perhaps ultimately you may cause your business to fail too.
And while taking clinical safety seriously is the right thing to do, there’s also a regulatory reason to do so too: In the United Kingdom, healthtech products are highly regulated through an area called Clinical Safety, guided by NHS England (more on this later). This ensures risks associated with patients accessing Femtech products are mitigated and the digital products are safe to use.
How do you ensure clinical safety?
Clinical safety is a structured process where the development of healthtech systems, including FemTech products, is assessed by a registered clinical professional. Typically, 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. This then allows companies to make an informed decision before deploying a product.
If risks are identified, CSOs generally work within the wider company team to proactively discuss how to mitigate these risks and together plan some potential solutions to help keep risks low.
Another role of the CSO is to ensure companies are complying with statutory and regulatory standards. As mentioned earlier, 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 health tech companies. These are DCB0129 and DC0160. If you are a startup and building a product where you are the manufacturer and deployer you would have to cover both these standards.
What does good look like when it comes to clinical safety in FemTech?
Clinical safety in FemTech needs a multifaceted approach. All startups within this space need to embed clinical safety in existing functionalities and products, as well as into new functionality and product lifecycles.
Looking at clinical safety should include the following key measures:
User-centric design: Products and apps should be designed with the needs of the user. For example, making sure interfaces are intuitive and provide clear, accurate information. Usability testing can help ensure that women can easily navigate and understand the technology.
Regular updates and maintenance: Clinical safety is not just a ‘one and done’. Continuous monitoring and maintenance are essential to ensure that Femtech solutions remain up-to-date, secure, and effective over time.
Collaboration with healthcare professionals: Engaging healthcare professionals, such as gynaecologists and obstetricians, can make a big difference in creating Femtech solutions that align with best clinical practices and guidelines.
Conclusion
Femtech is revolutionising women's health by providing personalised and accessible care for women. As outlined in this article, clinical safety needs to feature at all stages of development and deployment.
As the Femtech industry continues to expand, ensuring clinical safety will be a critical factor in empowering women to take charge of their health and well-being.
This article was written by Dr Yasmin Karsan, MRPharmS, PhD, PGDip, MSc.
Dr Yasmin is Founder of AnyRx - Clinical Safety Consultancy Firm. You can get in touch with Yasmin: yasmin@anyrx.org or via her website: www.anyrx.org