Digital Health and Self-Care
Digitalization is a great opportunity to improve the well-being of people. It can help them take ownership of their health, facilitate self-diagnosis, positively impact health habits or behaviors, facilitate treatment adherence, or allow for easy interaction with healthcare professionals or other people with similar health problems.
Paving the way for the digitalisation of healthcare
Due to the economic situation and, more recently, the COVID-19 crisis, developing Europe’s capabilities in the digital space has become even more necessary and urgent. The COVID-19 pandemic has led many governments to rethink the role of innovation and digital technology for health and wellbeing. It has also led to an accelerated shift in how companies have approached digital adoption strategies in response to increased people’s needs.
Harnessing the potential of new technologies in the field of self-care will facilitate the transition to more efficient and preventive healthcare systems and improve access to care while leading to an overall reduction in costs. To do this, Europe must ensure an appropriate and proportionate regulatory framework fostering the trust and security of European citizens so that they can safely benefit from the advantages brought by digital transformation and new technologies.
A digital strategy for self-care
AESGP supports the various initiatives undertaken at European level and is committed to playing its role in building an innovative digital health for Europe. To this end, we have developed a digital strategy for self-care. The paper identifies some regulatory gaps, highlights several requests for improvement, and offers enablers to drive needed regulatory changes and initiatives in five areas:
- Data, Real World Data / Real World Evidence (RWD/RWE)
- Artificial Intelligence (AI)
- Product and Disease Information
- Digital Workforce Capacity Building
Industry, regulators, legislators and society as a whole must work together to accelerate the effort if Europe is to become a leader in the digital health space.Discover our digital strategy for self-care
Data, Real-World Data and Real-World Evidence
The last decade has not only seen an explosion in the amount of data captured, shared and stored, but has also witnessed a change in the way data is processed. However, when it comes to self-care and healthcare, the permitted use of data for research, improving tools or assessing personal needs is rather limited.
While welcoming and strongly supporting initiatives already launched by regulators (e.g., General Data Protection Regulation – GDPR, European Data Strategy, European Health Data Space, etc.), the self-care industry is calling for more concrete authorized applications and data infrastructures for self-care developed and managed in the EU to unlock the potential of data.
In particular, data obtained from the real-world use of medicines and health products can be useful to regulators. In a pioneering article, AESGP experts shed light on the importance of existing and potential applications of real-world data (RWD) and real-world evidence (RWE) for non-prescription medicines and how they can help in regulatory decision-making throughout the lifecycle of self-care medicines.
In addition, AESGP’s position on the European Health Data Space initiative highlights the need to accompany improved data sharing with the necessary (digital) literacy programs.
Artificial intelligence can bring huge benefits to the healthcare sector. Specifically for self-care, artificial intelligence can help foster a personalized approach to self-care and empower people to better manage their health and well-being, particularly with regard to prevention and detection / early treatment of potential health problems.
By analyzing data shared by consenting individuals, artificial intelligence could help them practice self-assessment and self-care. The application of artificial intelligence in self-care currently includes the development of symptom checkers and mental wellness apps, for instance.
Product and Disease Information
Having good information about products and diseases is essential to properly manage our health. Medicines authorized in the EU come with a package leaflet which provides the information needed for the safe and effective use of the medicine.
However, the content of these leaflets currently has several shortcomings: language that is hard to understand; a design and layout that lacks readability and is not always user-friendly; too much emphasis on risks versus benefits of the medicinal product. People with low literacy are particularly disadvantaged, but generally these issues apply to all patient groups.
With the review of pharmaceutical legislation and health literacy becoming a priority, this is an opportunity to broaden the debate on how to make the package leaflet more fit for purpose.
Electronic product information (ePI), or e-leaflet, has the potential to address some of the limitations posed by the paper version. ePI can be more dynamic in presentation format with searchable menus, language change and links. It can integrate media tools to help accessibility and visual recommendations of use. It also presents the advantage of being able to have automatic updates. However, in the case of non-prescription medicines, as there may not be any interaction with a healthcare professional that can advise, a paper version of the product information should always remain available with the medicine if needed.
The development and public use of electronic product information (ePI), self-assessment and self-monitoring applications will help people easily access reliable sources of information and provide a solid foundation for more resilient healthcare systems.
Building Digital Workforce Capacity
The need to build digital workforce capabilities is already well recognized. It is important to train people specialized in the field of artificial intelligence or data science to operate in a regulated healthcare environment, as well as to give basic training to the general population on the use of digital solutions.
Fostering digital literacy in healthcare will not only ensure responsible and proper use of digital tools but will also build trust in the system.
E-commerce of self-care products is allowed in the EU and there is a harmonized approach to the registration of online pharmacies (e-pharmacies). However, national governments take different approaches as to product classification, which classes of products are allowed to be sold online, which entities can sell the different classes of products, as well as the requirement for online pharmacies to have a physical presence or not.
The main reasons people buy self-care products online are affordability and convenience. For obvious reasons, the COVID-19 pandemic has increased the popularity of e-commerce, including when it comes to buying self-care products. It is important to ensure that adequate resources are allocated and that the right framework is in place so that people who choose to buy their self-care products online can do so safely.Read our position paper on e-commerce