Accelerating Digitalisation – a healthy approach
A safe, secure and reliable system of monitoring and regulating the sharing of medical data between Member States of the European Union was on the table at the webinar ‘Accelerating Digitalisation – a healthy approach’ on Friday organised by American Chamber of Commerce Europe (AmCham Europe) and hosted by the American Chamber of Commerce in Portugal (AmCham Portugal).
To mark Portugal’s fourth presidency of the EU Council and the 70th anniversary of AmCham Portugal, this was the third in a series of five webinars whose main goals are to contribute to a constructive dialogue on the important issues that will be addressed under the Portuguese Presidency and discuss priorities and recommendations that it believes will make Europe more competitive and an attractive place to invest, and at the same time reinforce transatlantic relations.
AmCham EU has a dedicated health care committee, working across the full spectrum of healthcare and life sciences. A comprehensive approach to the current healthcare issues, ambition to look beyond the Covid-19 crisis and build a real European Health Union, European beating cancer and anti-microbial resistance plans, and working on treatments for rare and entoritic diseases are some of its areas of joint EU-US interest in health.
The webinar moderator Zeger Vercouteren (J&J), Chair, AmCham EU outlined that responding to issues requires long-term investment in European life sciences, simplified access to capital, a strong intellectual property incentives framework that entices innovation, but also a shifting mindset is needed to put the health of citizens at the head of the agenda. Another ambition is to leverage economic recovery to accelerate digitalisation and apply this to healthcare in a healthy approach.
Dr. Diogo Serra Lopes, Secretary of State for Health, Portugal, said in his introductory address that the key goal of Portugal’s EU presidency is to foster a better cooperation between the Member States on sharing information and services. Tele-healthcare, already used in monitoring glucose levels, heart and lung conditions and blood pressure, and other medical services, can now be easily accessed with the help of a smartphone.
The minister pointed out that remote medical appointments are today safer and more convenient for patients, while a variety of technologies that enable doctors to monitor a patient’s health remotely now exist that are technology and web based, and use mobile apps.
Home monitoring devices for older or more fragile people and that can pick up changes in normal activities, such as falls. “With the current crisis, it is very clear how these technologies can be very, very useful,” he said.
However, the need to prove the feasibility of these types of tele-health services cross-borders, between Member States, and the implications for sharing patient data means that a secure and harmonised framework needs to be constructed that is patient-centric and gives them a high degree of control over when, how and where their data is used and with whom it is shared.
“The need for a better data exchange between countries, not just because of new Covid-19 variants, but also track and trace approaches and genome sequencing, will remain the cornerstones of the response to these emerging variants,” he said.
“To achieve this we need to develop a harmonised framework for patients, diseases registries, and a strong health data system. We have made the promotion of digital health a priority, with a six-month programme focused on a health data sharing ecosystem which provides national governments with timely access and integrated insights into peoples health status and conditions,” added minister Serra Lopes.
The minister pointed to a legal and regulatory framework that allows healthcare data to be available for multiple uses.
“As the healthcare sector strongly relies on information to solve problems, digital healthcare solutions such as electronic health records and registers and higher levels of cooperation on cross-border exchange, artificial intelligence and blockchain are all seen as valuable assets to address the challenges that are currently placing our national health services under pressure,” he said.
“Long-standing barriers need to be removed at a national and international level, consistency across health systems and jurisdictions is instrumental to foster a European health union in which standardised, coherent and accessible records can be exchanged for the good of our communities,” suggested minister Serra Lopes.
Fragmented assessment processes
The panel heard that Health Technology Assessment (HTA) processes in Europe are currently fragmented, with different national approaches contributing to inequalities in health data access.
Yet, innovative technologies can generate efficiencies in healthcare systems to make them more accessible, safe and sustainable.
The regulatory environment needs to adapt, as the assessment of the added value of healthcare technologies is key to driving faster access to healthcare for patients across Europe.
AmCham Europe recommends supporting the Commission’s push to harmonise the assessment of clinical evidence and avoid the duplication of the process across Member States.
It also calls for a balanced approach and methodology to reflect the specificities of each healthcare sector while retaining Member State autonomy to perform country-specific socio-economic appraisals and make decisions regarding pricing and reimbursements.
Other recommendations are: limiting the scope of the regulation to joint clinical assessments for pharmaceutical products; and ensuring cross-stakeholder consultation with a formal stakeholder network being part of the process.
Intellectual property (IP) incentives for new medicines and the life sciences industry contributes significantly to Europe’s economic and social prosperity, strengthening EU industrial competitiveness and growth.
Intellectual property rights (IPR) are key to driving investment and innovation in Europe, and as the Commission reviews the IP incentives framework, it is critical to protect the current framework from erosion to safeguard investment in pharmaceutical research. To move backwards on IP incentives would send a negative message to the US and global investors as to the prospects of the European R&D sector.
Digital technology transforming healthcare
The minister highlighted that in the near future the EU Member States will be able to exchange data on medical imaging, lab results, discharge letters and rare diseases and will be in a much better position to solve cross border health challenges through cross-border sharing, standardised health records and e-prescriptions.
“Digital technology can help us transform healthcare systems into more sustainable ones, enhance the relations between medical professionals and patients, and provide cheaper and faster and more effective solutions for diseases. We know that technologies can help us win the battle against the current pandemic and help us to prevent and fight new ones. In the end the main goal is to help us have healthier citizens in a healthier community,” he said.
European Data Union – a robust legal framework
Monique Goyens, Director-General for the European Consumer Organisation (BEUC) said that a key priority for the digitalisation of healthcare is to provide a solid, robust legal framework for digital health services and products.
“There is a lot of digital healthcare technology out there, but we are missing the rollout of a safe, secure, trustworthy, and people-centric digital health system,” she said.
“When we speak about digital health, there is no definition of health data. We all agree that we need to fight the pandemic, and that digitalisation can help with data sharing, but a lot about digital health data and tools concerns the more frivolous developments, and there are blurred lines between health data covering blood pressure, and body mass index, for example, and that covering lifestyle data, such as weekly alcohol consumption, and we need to know who is going to use that data,” she said, referring to insurance companies and banks which could use the data to decide what level of insurance or the loan terms and at what cost an individual would receive it.
“There is a big difference between wellbeing and health data. There is a whole journey between the different types of data that needs to be addressed, and the European Data Union aims to bring clarity and a high level of consumer protection to certain technology-centric practices,” she said.
Goyens also pointed out that you cannot engage in the digitalisation of healthcare if you don’t have digital and healthcare skills, since 44% of Europeans don’t have basic digital skills.
Goyens also asked how customer trust in data sharing could be measured and achieved. Neither patients or doctors should have to have a PhD in quantum mathematics, she said, to understand the functions in telemedicine and suggested the need for help desks to explain to people their use.
“There is a huge problem of data protection and there is a big problem of cyber security and hacking, and at the moment we just take the risk and hope that it won’t happen to us as individuals. People accept technology, but it does not mean the underlying problems are not there,” she said.
Andrzej Jan Rys, Director Health systems, Medical Products and Innovation, Directorate-General for Health & Food Safety, European Commission, himself a patient who uses remote health monitoring applications, said that that sending data via mobile phones or even WhatsApp was “not the most secure way”.
“We often say that Covid-19 is a catalyser for change, and the most beneficial thing from this pandemic is digitalisation. Before, both patients and doctors didn’t like conducting consultations online because they preferred to have the face-to-face interaction. But there has to be a balance between what we can provide as a technological solution, and this much needed face-to-face interaction,” he said.
There also needs to be a legal framework so that doctors can send patients information from country to country in an automatic and already translated form, and this automation was already being developed.
Cross-borders tele-services need to be stimulated, and although there is still a relatively small number of tele-service providers, telemedicine and tele-technology are evolving.
“We have already proposed the Digital Governance Act which is being discussed in European parliamentary committees on enacting specific regulations for health. Data cannot travel without navigation assistance and there is the need for a more federated network regarding data control, storage and sharing — a navigation system by which we know who has got the data,” Jan Rys said.
Portugal – a tech development hub
Sónia Santos, Associate Director, Health and Public Administration, Accenture Portugal said that
Portugal is becoming a hub for technology development, explaining that it is an excellent country to pilot new solutions in a sustainable way. “It is an excellent technical showcase with the right features to develop pioneering projects. Its small size means that it can develop pilots from a sustainable economic point of view and with less risks,” she said.
“Portugal is very good at technology adoption. In 2019, online health information online was 51% (4% more than other OECD countries). Portugal, she said, is a pioneering country and a model of success in initiatives related to digital transformation in health and the mass adoption of the electronic clinical process is an excellent example of this, as well as the adoption of electronic medical prescriptions at a national level,” she explained.
“With the help of technology, we are able to relieve pressure on the system, freeing up doctors and nurses to dedicate their time to cases that really need their attention,”she added.
Sonia Santos gave the examples of telemedicine in heath centres or hospitals in post surgery situations where the doctor’s follow up could be performed remotely. This avoided trips to hospitals that saved discomfort and inconvenience to the patient and unnecessary costs.
Technology has become part of the everyday activities in Portuguese hospitals and a convenience. We believe that Portugal has the technological ability to contribute towards the digitalisation and sustainability of the health sector,” she said.
The conclusion was that while Digital health and Tele-healthcare have the potential to revolutionise people’s lives and transform healthcare systems for the convenience of all stakeholders; patients, doctors and researchers, as well as being cost-effective, agreement on a digital service infrastructure enabling secure cross-border access had to be reached, one which was safe and secure regarding data sharing protection policies and not open to wild interpretation from country to country. In effect, a secure and standardised medical records sharing policy within the EU.