Introduction and purpose of the Declaration
Estonia holds the Presidency of the Council of the European Union from July to December 2017. Its main focus is related to the Digital Society and the free movement of data in the European Union, as the fifth freedom of the European Union (pdf).
Today, healthcare systems are transformed by digital technologies, and most of the European policy makers have defined strategies to implement digital health solutions, even if some barriers are still to be overcome.
The Ministry of Social Affairs of Estonia, supported by the European Connected Health Alliance (ECHAlliance), is thus launching the present Digital Health Society (DHS) Declaration, as a call for actions on 'Health in the Digital Society and the Digital society for health'.
Because a holistic view is needed, this document has integrated input from all the stakeholders interested in the development of digital health, sharing a vision, between citizens and patients, policy makers, health professionals and healthcare services managers, scientists, companies, startups, insurers and mutual funds, investors, etc. about the strategies and actions to achieve the digital transformation of healthcare systems.
The free flow of data in healthcare makes difference through hitting a triple goal:
- increased access and safety in healthcare can be achieved through empowered citizens and adequate data availability at the point of care
- sustainability of health systems will be supported by a values-based approach
- new economic opportunities, jobs and investment will be created using data-driven healthcare innovation
The Estonian Presidency of the Council of the EU aims to advance digital innovation in healthcare, in particular focussing on:
- the right of citizens to access, manage and control their health data electronically in a convenient and secure manner; to better use health data, in particular for research and innovation purpose
- the better use of health data, in particular for research and innovation purposes
A public consultation has been engaged widely in Europe from July to September 2017. The present DHS Declaration is open to co-endorsement and co-signature to all interested organisations during and after the high level eHealth conference of the Estonian Presidency, 16-18 October 2017. The signatory organisations will then form a permanent multistake holders group (continuously open to new members), which will, in collaboration with the member states and the European Commission:
- initiate and coordinate European DHS task forces on key challenges for the DHS; four have already been created on:
- a convergence roadmap on interoperability standards
- citizen-controlled data governance and data donors
- a legal framework for the free flow and secondary use of health data
- digital transformation and change management in health and social care organisations
- generate and promote pan-European actions and projects, gathering the commitments of the stakeholders (all categories mentioned above) to progress tangibly on the listed challenges
- encourage voluntary cooperation by member states in the implementation of digital health innovations at the European scale
- monitor and measure the impact of these actions and commitments and the tangible progress of the digitalisation of healthcare systems across Europe.
The DHS Declaration, the fruit of the Digital Health Society movement and a consensus among all stakeholders, is designed to support the work of the European Commission in the framework of the Digital Single Market Strategy and the communication expected to be published by the end of the year. It also aims to support the discussions at the Council of the European Union, in view of the adoption of Council conclusions expected in December 2017.
Health empowered by digital opportunities
Improving the circulation and the sharing of health data could be beneficial for all stakeholders: citizens and patients, health and social care providers, professionals, policy makers and institutions, innovative companies, public/private payers and insurers, universities and other research institutions.
In a context of trust, privacy, confidentiality and security, the latest technologies related to data treatment, such as big data or artificial intelligence, could benefit existing practices and healthcare services, but could also drive a real transformation of our European systems, supporting a shift from a curative-oriented approach to more prevention (potentially prediction) and the better well-being for the EU population.
The European Commission has recognised the importance of eHealth and digital innovation in addressing the common challenges that the European health systems face in terms of increasing cost of healthcare and population ageing associated with a rise of chronic diseases and multi-morbidity. Through its eGovernment Action Plan, the Commission has declared its support to member states in the development of eHealth services that also enable the cross-border exchanges of e-prescriptions, telemedicine and telemonitoring solutions. In addition, the Commission will support the development of citizens' digital access to their health data.
Opportunities for citizens and patients
The benefits for citizens and patients from digital technologies cover several dimensions:
- Empowerment and health education: a better understanding of the health status (thanks to data) and the continuous monitoring of it, better understanding of treatments. Access to personal health data and information allows patients to take an active role and it enables them to become managers of their own health throughout their life cycle
- Inclusiveness and equality: better communication and access to healthcare services and professionals (using several channels physical or digital)
- Personalised health:
- innovative treatments and 'patient-centric' interventions, based on personal data (health, lifestyle, environment…)
- advice, motivations and incentives in order to improve their health status or change their health trajectory
Opportunities for health and social care providers and professionals
Digital technologies facilitate the integration of services and a holistic approach to health, combining health and social care services.
Health challenges and stakes have changed since the design of the European healthcare systems. When acute care was the major objective for hospital-centred systems, the current health conditions represented the major burden and the main challenges – such as preventable chronic diseases and ageing-related pathologies. So, when our current system is treating, for example, an exacerbation of a chronic heart failure, it is unable to anticipate the condition and deploy the intervention to avoid it in the first place. The use of health data allows our systems to switch from a purely curative model to a preventive one.
Meanwhile, when applied to health and healthcare services, information technology can increase the efficiency of service provision; by, for example, the optimisation of patient flows, as well as the management of medical personnel’s workload and workflows, and the coordination of care.
Opportunities for research
Health data should also be widely used for research and development in the health sector. Data analysis methods available today allow research to tackle complex issues that were not solvable in the past. Several centres can now share and compare data coming from several centres and countries around a same disease/case, and scientists and physicians can then create stronger models and, thanks to correlations, identify innovative treatments faster.
Also, an obvious benefit is related to rare diseases, as sharing data allows the development of new research projects, which were impossible in the past because of the tiny sample-sizes of a single centre.
Opportunities for business
The potential market for digital health solutions has been highly evaluated recently but it is still not always tangible for all European companies.
The European IT sector is highly skilled, employs millions of Europeans and generates growth across the EU. It could benefit from the massive integration of IT technologies in the healthcare sector. Here, a number of companies involved in other industries could find ways for diversification and business growth. There is also the opportunity to create a number of innovative and disruptive startups.
Moreover, digital health requires innovation across industry sectors and disciplines such as IT (big data, artificial intelligence, data analytics, algorithms, etc.), digital (web techs, virtual reality, games, etc.), design, social sciences (behaviour change, psychology), and more.
European industry should invest in the digital health sector, taking into account that the potential market is not limited to the EU, but also includes the rest of the world; from the Americas (north and south) to the Middle East and Asia.
Opportunities for governments and policy makers
Governments and policy makers have the opportunity, thanks to data-driven systems and solutions, to adapt their health and social care systems to modern challenges (demography, chronic diseases, etc.) by switching the model from mainly curative to preventive.
Digital technologies also offer tools to reorganise the system, improve its efficiency and continuously monitor and pilot public policies for health in a more precise and meaningful way.
Digital health requires innovation. By the implementation of innovative solutions, Governments and policy makers are no longer considering health expenditures as a pure cost, but as an investment, fostering the growth of companies by innovation, and supporting the creation of jobs and new businesses.
Challenges to tackle
To enjoy the full potential of innovation in health, the free flow of health data within the EU is a fundamental precondition. These data should also be readable and understandable both by humans and by machines. This is not the present case and current practices, such as citizens travelling with their own health information and data on paper, in USB sticks or through e-mail, introduce a number of issues related to privacy, security, confidentiality, and safety.
The present declaration and its promoters aims to overcome a number of barriers, and progress with the implementation of digital health in Europe. The main barriers may be described as follows:
Lack of awareness and meaning
Citizens are not well-enough informed about the benefits of using data for healthcare services or research. A lack of understanding (meaning) often leads to the non-acceptance of sharing data. We also observe a lack of co-design, which could lead to the better integration of digital health solutions. Nevertheless, several surveys launched on various EU countries show that EU citizens are globally willing to share data, if it is realised in a controlled manner.
Lack of confidence and trust
Citizens should be assured that their data are protected and that all precautions have been taken to guarantee issues around privacy, confidentiality, and security. Health professionals, and health and social care organisations should also benefit from the same guarantee in order to fully engage in a digital health society.
Lack of interoperability
In order to achieve the free flow of data, health data producers of European countries and regions should embrace a common strategy and a convergence roadmap regarding the interoperability of data, at the technical and semantic level.
Lack of clear legal framework
Related to confidence and trust, European countries and regions should clearly define the conditions for health data use, based on citizens informed consent, (indicating what the characteristics of data that could be used are, for what purpose, and by what types of stakeholders).
Lack of training for institutions, healthcare providers and professionals
Data will be correctly collected and used in the day-to-day practices of health professionals if specific training is provided (to students in medical school / nurses training and to the current workforce).
Lack of change management strategy in healthcare systems
As in all sectors, the implementation of digital technologies is not only equipping the on-going work process and organisation, it requires a re-design and re-organisation of the whole system, the role of the stakeholders and the approach for the healthcare service delivery. Digital brings a complete transformation.
Lack of meaningful and integrated solutions
Simple, rough and general data does not impact behaviours. Citizens need to understand the meaning of each set of data to have a view on the impact of their actions and choices on their health and so forth.
The basic quantified self, thanks to all personal devices and wearables currently on the market, does not trigger the behavioural changes they may be expected, because of a lack of meaningful information and the lack of integration within healthcare systems.
Lack of innovation in funding models
A lack of funds is also often indicated as one of the main barriers, but it is debatable. If we observe the allocation of resources in the area of digital health, particularly related to electronic health data deployment at the EU or the member state level, we realise that large sums have been or are being invested. The issue seems to identify creative and innovative funding models. As EU systems are widely based on a fee-for-service models, the added-value of data-based systems and solutions focused on integrated care, services quality, prevention and outcomes of the interventions don’t find their place in the current purchase processes and contracts model. The challenge is then to break down the budget silos between health and social care or between secondary and primary care, to incentivise stakeholders, to deploy more widely, innovative public procurement models and new types of contracts, as well as outcomes-based and risk sharing between the parties (suppliers-buyers-care providers).
Finding the solutions
The barriers listed above demonstrate that moving forward for the implementation and deployment of digital health in Europe means to adopt a systemic approach where all parts of the system, policy makers, citizens, health and social care providers and professionals, companies and startups, researchers, and payers, have to take a role and agree together around the directions to follow.
The Digital Health Society Declaration aims to bring together all stakeholders in Europe interested in moving this agenda forward, with each of them acting at their level, with a set of actions they have defined themselves, converging in a common and shared vision of digital health in the EU.
What should be done at the EU level?
At the EU level, although health competence remains the responsibility of each member state, this common understanding should be formed into an agreement that fixes common components and common infrastructure that enables the free flow of health data. While common components lay in grey areas, each member state has launched projects around the redesign of their systems. An agreement has to be achieved between member states around interoperability.
While the necessary legal framework already exists at the EU level, such as the 2016 General Data Protection Regulation (GDPR), legal uncertainty still remains. This is due to the large amount of relevant legal provisions in a variety of regulations and directives. It is paradoxical that the legal frameworks content is not a barrier, but that the format and amount of it has become a barrier. The clarity of these rules and their transparency for EU citizens should also be an objective, short and simple guidelines for the public could be created and made available.
What should be done at the member states level?
A number of European member states have already designed their healthcare system in order to digitalise data. The remaining member states should implement strategies and policies for the creation of electronic health records across their country in order to stimulate the innovation for health and exchanges data with other EU countries.
All member states should actively seek a common agreement at the EU level in order to develop the common components for the digitalisation of health and social care systems in a coordinated and interoperable way. A voluntary cooperation of like-minded member states could lead to the immediate start of such a cooperation.
As trust is a fundamentally important factor, member states should review their regulations and legal framework, in order to assure citizens, patients and health professionals that even in a digital format doctor-patient confidentiality is still guaranteed. If there is lack of trust, the quality of health data is questionable and therefore the use of this data is problematic and can result in faulty outcomes.
Member states should also raise societal awareness through communication campaigns targeted at citizens as well as health and social care professionals regarding successful existing eHealth solutions and their results.
What could be done by patients’ organisations?
Promote that patients are and should always be the centre of healthcare. The new systems created and the decisions that are made should all be from the patients’ perspective.
Make it clear that patients are aware of the possible value that can be created for them by using electronic health data. The value added can be of better quality or new technical solutions or entirely new health, healthcare, social or integrated services.
Demonstrate that patients are already using technology such as various apps for monitoring and/or improving their health; a number of patients are progressive, responsible, and volunteers in their use of technology, and are ready to become 'data donors'. EU governments should also be on the same level at the very least.
Demonstrate that patients are familiar with the need to use their health data, not only for their own interest but for public interest (research) too and willing to accept it, as long as the privacy and integrity of the patient is guaranteed in the process.
What could be done by health and social care professionals organisations?
Promote the belief that, thanks to big data and artificial intelligence technologies, having access to more relevant and pre-analysed information about patients’ conditions helps health and social care professionals make better decisions. The free flow of health data within and across member states' borders breaks down barriers, for instance, if the treatment of a patient needs to take place in more than one health institution. Therefore, treatment can be faster, and less tests and analyses need to be taken as the ones already taken can be reused.
However, care must be taken to protect professionals’ time. More and more information can actually be a problem unless data management tools convert information overload to meaningful data that supports professional decisions.
The Digital Health Society Declaration full text (PDF)
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