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Navigating the Governance and Regulations of Digital Health
by Startacus Admin
Startacus is delighted to hear from Former children's nurse, PhD, adventurer, author, and sailor, Elin Haf Davies. Here she shares her experiences of founding a MedTech social enterprise! Is there anything this woman can't do?
"Founding a digital health social enterprise was never a goal or an ambition that I have always aspired towards. To be honest it was more of a chance meeting with co-founder Ed Freed and a complete frustration that the current system of monitoring paediatric patients was not fit for purpose.
I began my professional career as a children’s nurse and after years of clinical experience specialised in research – looking after children that were recruited onto clinical trials of new drugs.
After years of encouraging children to complete tests and assessments that were completely inappropriate for their age and/or disease I embarked on a PhD to try to develop new child-friendly, disease-specific endpoints.
I also went to work as a regulator at the European Medicine Agency – with the naïve view that I could positively influence the choice of test used in clinical trials before they reached children.
When neither approaches had the impact that I wanted, I decided that founding my own digital health social enterprise was the answer; with the simple approach of using wearable technology and smartphone apps to monitor patients passively, remotely, in real-time and capturing outcomes that are important to the patient and their family.
However even with a background of working as a regulator I have to admit that navigating the regulatory and governance aspect of digital health has been extremely daunting.
The main challenge is that a digital health initiative like ours, which combines a wearable technology to monitor ambulation and a mobile phone app to record patient reported outcomes straddles many different legal obligations and governance.
Data privacy and protection is paramount to ensure patient trust in our approach. Registering as a data controller with the Information Commissioner's Office and ensuring that we comply with the EU Data Protection Directive (95/46/EC) on the protection of individuals with regards to processing of personal data and on the free movement of such data. As our plans is to offer our services across Europe (and beyond) interpreting the demands in each Member State will become even more of a challenge.
As our product and service is also considered as a Medical Device (Directive 93/68/EEC) we also had to apply to the Medicine Healthcare Regulatory Authority (MHRA) here in the UK for the right to run a trial. This in addition to getting ethical approval and a contract in place with all the hospitals that will be running the trials for us.
This is all without even getting our device even close to a patient to try out! All in all it has taken the best part of eight months, with fees and insurance costs totaling near £8000, as well as pro bono legal support from Hogan Lovells. Not an insignificant amount for a startup like ours, and a clear reason why startups, SMEs and even larger companies are avoiding the health arena, and opting for lifestyle and fitness instead.
Having said all that we’re very aware, and grateful that George Freeman MP (First Minister for Life Science) is currently campaigning to improve the way the innovation can be adopted into health care systems. And the constant support and encouragement that we receive from the patient groups that we’re collaborating with tells us that these hurdles are worthwhile embarking upon and that the value of our approach can be foreseen.
I therefore remained completely committed to our initiative, in the genuine belief that digital health and better tools for patient reported outcomes will become an instrumental way for managing patients care and wellbeing. Even more so as our health care faces unprecedented shortages and crises."
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