The current data-related situation hinders the development of innovative, new services. The General Data Protection Regulation (GDPR) provided important guarantees to data privacy in a context where data are handled in the main by third parties. The real take-off of a European Health Data Space (EHDS) should be now associated intrinsically with a citizen-centric approach. Many of EHTEL’s concrete proposals were therefore targeted at informing, engaging, and training fully equipped citizens to take on this new opportunity, which will affect them both individually and societally.
If you are interested in these four important topics, on 30 November - 1 December 2021 EHTEL is organising its annual Thought Leader Symposium, with a special focus on citizens' control of health data use. Save the date in your agendas!
| Want to know what EHTEL’s position on the four chief areas around the European Health Data Space were? These four quickie summaries each contain a background rationale and the proposals that EHTEL put forward: |
- Access to and exchange of data for healthcare
- Access to and exchange of personal data for research
- Digital health services and products
- Artificial Intelligence in healthcare
We heartily encourage you to offer your support to these actions. This is easy to do. You simply need to click the button on each of the sections below to support them.
Access to and exchange of data for healthcare
EHTEL supports access to and exchange of data for healthcare that would have the following rationale and proposed actions:
Background rationale
- Access and exchange of personal health data should draw on a citizen-centred approach that is complementary to the healthcare-centred one.
- Mobile phones act as important enablers to add value to data. (They can provide privacy and security in health data transactions and – that’s important – in an easy-to-use mode.)
- The data space provides access to a range of data repositories. (It can act as a platform for enabling new digital health services.)
- The direction is towards an operational framework that is based on the creation of trusted health data ecosystems that can foster public and private innovation initiatives on digital health. As a virtuous circle, the approach can also enable a citizen-centric approach to data use.
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Proposed actions
- The idea suggested by the European Commission of a European framework on the access and exchange of personal health data, provided it promotes and enables citizens’ control of their own health data either by themselves or by trusted third parties.
- The development of European health data interoperability guidelines which would ensure data portability, transferability, and re-use in a wider European context. These guidelines can capitalise on open standards and knowledge developed through European projects and national programmes. Example European projects include InteropEHRate and UNICOM. Example national programmes include the Dutch MedMij personal health environment.
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Curious to explore the topic? This action relates to a session of the 2021 EHTEL Symposium: Enabling citizens to be in better control of their own data.
Access to and exchange of data for research
EHTEL supports access to and exchange of data for research that would have the following rationale and proposed actions:
Background rationale
- Access to and exchange of data for research in healthcare should be based on already-available guidelines on real-world health data analytics, which may need to be updated. Examples include guidelines from agencies like the European Medicines Agency and the Federal Drugs Administration (in the USA).
- Public-private partnerships, when used, offer an important approach to data use for public health and clinical research. Example industrial sectors to engage involve mobile telecommunications and the pharmaceutical industry.
- Real-world data evidence gathering can be based on active involvement of citizens and/or trusted third parties in initiatives that take place through mobile phones (or other devices) that are connected to e.g., their electronic medical records or sensor data.
- Important areas of focus are several. They will include:
- national or public central or regional health authority data centre(s) located in nodes.
- additional and complementary data sources and other data streams. Some examples will come from citizens themselves.
- citizens’ facilitation of use of data; involvement in decentralised clinical trials; crowd-sourcing of data; and data donation.
- Besides data support for research, data’s support of policy-making and innovation in healthcare is equally important.
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Proposed actions
- Incentivisation of data sharing for research, policy-making and innovation in healthcare.
- Legitimate use of frameworks for data sharing and use. (This can include help that comes through private-public partnership(s), when appropriate.)
- Use of data from research that emerges from European pilots and projects related to research and innovation, so as to make more public use of their findings. Example European projects include, InteropEHRate and GATEKEEPER. (For further actions along these lines, see ‘Artificial Intelligence in healthcare’.)
- Promotion of a common semantic and interoperability framework to speed up and promote the objectives of the European Health Data Space.
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Curious to explore the topic? This action relates to a session of the 2021 EHTEL Symposium: Enabling citizens to be in better control of their own data.
Digital health services and products
EHTEL supports digital health services and products that would have the following rationale and proposed actions:
Background rationale
- Initiatives are needed to foster the uptake of data-driven digital health services and products at both European Union (EU) and national levels. (Example services and products include decision support aids, mHealth apps, virtual assistants, and chatbots.)
- For public (health and care) authorities, efficient, updated, and independent evaluation of digital health services and products is needed.
- Public publication of experiences and know-how emerging from good Member State-supported public and private initiatives for digital solutions (in health and care) is needed. (There should also be coverage of the reimbursement criteria used for relevant digital solutions.)
- Activities should be complementary to already-existing rules and regulations (e.g., ISO 82304-2 which proposes a quality label for health apps).
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Proposed actions
- An operational initiative supported by a European network of relevant authorities in the Member States that should develop a European framework for assessment of digital health products and the reimbursement of their use in e.g., a hybrid model of care.
- A harmonised, efficient and meaningful process of evaluation of digital solutions which is based on intervention on at least two levels of criteria (generic essential criteria, and advanced assessment).
- Expansion of evaluation of services/tools to a wider set of issues/fields e.g., contribution to multiple objectives the filling of market-related gaps; the assessment of medicinal products.
- Use of findings on services emerging from innovation projects, like InteropEHRate, on citizens' use of apps and mobile technologies in healthcare.)
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Curious to explore the topic? This action relates to a session of the 2021 EHTEL Symposium: Deploying Digital Health Services.
Artificial Intelligence in healthcare
EHTEL supports artificial intelligence (AI) that would have the following rationale and proposed actions:
Background rationale
- Measures to facilitate the access to data that is compliant with the 2018 General Data Protection Regulation (GDPR) health data are certainly more than welcome. Yet more needs to be done to provide adequate and sufficient data to train algorithms in terms of volume of quality data and data pertinence (context, service, gender, age).
- Awareness needs to be expanded about the limitations of (AI) data algorithms in terms of the types of services to be supported and the human-machine interactions.
- Digital solutions which are ‘totally under patients’ control’ (e.g., mobile phones or other devices) and that offer an important new opportunity to collect different types of (health and care) data should be promoted.
- Pro-active strategies for the collection of data need to be developed: they would draw on useful examples of European projects, such as Captain, vCare and OPEN DEI.
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Proposed actions
- A coordination and support action which could collect important knowledge and questions on innovation in AI-related projects related to care patterns.
- Funded projects – especially large-scale pilots – should be encouraged to:
- provide access to the data collected by the project in a format which would make those data re-usable by the wider community.
- invest time/resources in collecting data before algorithms are put to the test.
- consider the data as official deliverables.
- Projects which make use of AI should be provided with software engineering tools, like reference support environment(s), which can support them in producing quality data.
- The creation of a specific guideline (or ‘code of conduct’) which would consolidate the knowledge acquired in projects, services, and solutions which make active use of AI. Content should relate especially to the training of algorithms.
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Curious to explore the topic? This action relates to a session of the 2021 EHTEL Symposium: Artificial Intelligence for Health - Hitting the reality wall.
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