MEP Eva Kaili, a member of Parliament’s Industry, Research and Energy Committee and President of EU40, calls for greater cross-border collaboration to help deliver a European digital healthcare system
Ground-breaking digital advancements at all stages of patient care have triggered a radical shift in the way we think and deliver healthcare. The COVID-19 pandemic has significantly accelerated this process, leading to the acknowledgement that digital solutions are essential for patients and healthcare systems.
Digital solutions have helped people continue to carry out regular health check-ups and consultations and have made sure that those living with a long-term or chronic disease have access to care. In the European Union, we went from having 90,000 digital health apps in 2020, to 350,000 available today, and the number of people using digital health tools keeps growing.
The new Internet of Medical Things (IoMT) – the network of internet-connected medical devices, hardware infrastructure, and software applications that connects healthcare information technology – enables more accurate diagnoses with fewer mistakes and at lower cost, especially to the benefit of those living in the most distant regions. Paired with smartphone applications, the IoMT allows patients to send health information to doctors, ensuring better health checks and follow-up.
"Through the creation of a European Health Data Space (EHDS), we will promote better exchange and access to different types of health data, facilitate healthcare delivery, health research, and health policymaking”
Digital technologies also play a crucial role in the long-term by encouraging the policy-change needed to build more resilient healthcare systems in a way that is ethical, safe, secure, reliable, equitable and sustainable. Furthermore, the use of blockchain enables interoperability, supply chain traceability, identity verification, patient consent, data sharing and access permissions. For example, smart contracts protect patient anonymity, make research results available without any bias in human data collection and analytics, and curtail the burgeoning costs of clinical trials.
The combination of blockchain with AI promises to create a predictive system that will facilitate the clinical workflow and allow researchers, doctors, and scientists to harness the power of data to review, interpret, and suggest solutions to complex medical problems. To get there, blockchain and AI should be deployed in combination with a robust health information system and data infrastructure. This requires an appropriate governance framework, and the EU’s Digital Strategy to make Europe fit for the digital age and empower people with a new generation of technologies is an essential step towards the future.
Through the creation of a European Health Data Space (EHDS), we will promote better exchange and access to different types of health data, facilitate healthcare delivery, health research, and health policymaking. To achieve this, and successfully build an agile framework, we require strong cross-border collaboration among policymakers and stakeholders. Today, European digital health policy stands at a crossroads. It is up to us to point it in the right direction to the benefit of all Europeans and our healthcare systems.
In conversation with... Dr Shibeshih Belachew
Dr Shibeshih Belachew, Head of Biogen Digital Health Science, believes it is essential to align and advance policies to unlock transformative digital innovation in the healthcare space
What are the key trends you see in digital health?
The healthcare industry overall is transforming with the direct and indirect effect of technological innovation. For example, we are witnessing a rise in healthcare that directly relates to people’s lives, with increased personalisation, customer-orientation, and data-driven, mobile and remote care. We also see that the healthcare ecosystem overall is reshaping, in the context of global challenges such as the COVID-19 pandemic, and the emergence of non-traditional entrants including tech players that are revolutionising healthcare from R&D to patient experience. Third, we are experiencing unprecedented breakthroughs in computational automation and device technology, for example with machine learning and artificial neural networks, virtual reality solutions and digital therapeutics, that are changing the face of modern healthcare.
What potential do you see in digital health innovation in neuroscience specifically?
Neuroscience is a field of immense unmet medical need, and an area in which Biogen has been pioneering break-throughs for more than 40 years. Neurological diseases are highly complex, devastating, and there are significant challenges in how they are understood, in particular with respect to the underpinnings of their paramount heterogeneity. This is due in part to the structural and functional complexity of the human central nervous system, but also due to the limitations of how, as a society, we currently study, explore and monitor the brain and neurological diseases, by generally relying on largely subjective and human observation-based information. We believe we can improve our understanding of neurological diseases by bringing biology and technology together. Digital health in neuroscience may enable more prevention-focused, personalised medicine, and deepen our understanding of diseases to improve care for people living with neurological conditions, such as multiple sclerosis, Alzheimer’s or Parkinson’s disease. Digital measurement technologies may have the capability to unlock important insights into the truth of patient experience and improve our capacity to predict individual trajectories of disease progression. Data is at the centre of this – more data, but more importantly better data, and how we use computer science to process data, can enable more personalised decision-making and better patient outcomes.
“There is an increasing need for agile regulatory pathways to ensure the efficient review and acceptance of novel digital endpoints at scale in medicine development”
Given the importance of data in making progress in the field of digital health in neurology, how can policymakers help?
With the volume and diverse dimensions of data types generated within our healthcare environments increasing exponentially, there is an opportunity to create a more holistic body of knowledge to support decision-making by regulators and other stakeholders. This could transform the development of new medicines, as well as treatment decisions, and improve the patient journey. In Europe, the European Medicines Agency has taken a leading position in advancing the use and acceptability of digital endpoints, as demonstrated by the qualification opinion on a wearable device to measure stride velocity as a secondary endpoint in Duchenne’s Muscular Dystrophy. However, regulatory qualification of novel methodologies is a lengthy and involved procedure that may require refinement if it is to fit the pace of advancement for digital technologies. Indeed, there is an increasing need for agile regulatory pathways to ensure the efficient review and acceptance of novel digital endpoints at scale in medicine development.
True innovation in digital health requires robust evidence generation, often involving large-scale, multi-country, multi-language, and sometimes multi-device clinical trials. Biogen believes that optimising the use and applicability of these digital tools will require an agile, progressive regulatory framework for digital health technologies which may be enabled through the establishment of collaborative models and accompanied by the development of joint guidance by medicine and medical device regulators. Indeed, increasing harmonisation of medical device requirements for digital health technologies is essential across different Member States to minimise ambiguity and inconsistency for digital health research. Policymakers and regulators need to ensure that regulatory frameworks are standardised and future looking.
This content was commissioned by Biogen and produced by Dods