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 clos
e 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."
Elin Haf Davies PhD is the founder of MedTech startup Aparito Health! Check them out on Twitter, or connect with Elin directly!
Subscribe to our newsletter
If you would like to receive our startup themed newsletter, full of the latest startup opportunities, events, news, stories, tips and advice, then sign up here.
Stashbee, the online sharing-economy platform for storage space, has announced a £1.6m funding round on leading European investment platform Seedrs.
The lowdown on Talentful, the startup that's using your cultural fit and personality to match you to a job and employer...
Hot flushes affect around 1.5 million women in the UK alone. Step forward Grace, the world's first automated tracking and cooling bracelet that counters menopausal hot flushes
The innovative startup that empowers restaurant managers and owners to measure and improve their customer experience.
upSTART, the startup pitch competition at Digital DNA 2019 will see over 20 disruptive NI-based startups pitch to determine who will win an all-expenses paid trip to explore the New York tech scene.
If you've not quite scraped the pounds together to get your 1st startup idea off the ground yet, don't fret! Here's a few top funding tips to consider.
If you are running a business, it’s important for you to understand financial matters, too, Here's some handy accounting reminders!
Holland-based startup Active Cues has created a simple product to engage children and adults with cognitive challenges...
The startup that's empowering people to participate in their health and wellbeing decisions with easy-to-understand health insights.
The startup that's aiming to reduce loneliness and social isolation through warm technology...
Published on: 3rd September 2015
If you would like to enable commenting via your Startacus account, please enable Disqus functionality in your Account Settings.
- Stashbee announces £1.6m funding round on Seedrs 17th Jun 2019 Stashbee, the online sharing-economy platform for storage space, has announced a £1.6m funding round on leading European investment platform Seedrs.
- The upSTART finalists at Digital DNA 2019 13th Jun 2019 upSTART, the startup pitch competition at Digital DNA 2019 will see over 20 disruptive NI-based startups pitch to determine who will win an all-expenses paid trip to explore the New York tech scene.
- Lloyd's Lab announces third round of applications 3rd Jun 2019 From data sharing to next generation claims, insurance industry focused tech startups are currently being sought after to join Lloyd's Lab cohort 3.
- Startup Exhibitor package at Digital DNA 2019 28th May 2019 New startup exhibitor package at Digital DNA 2019 gives startups access to 150 Speakers, an estimated 3,000 attendees, 121 investor meetings, a startup pod to exhibit and 4 x 1 full-access exhibition tickets!
