|
Brussels, |
|
EU Introduces Telemedicine: The Digital Healthcare Revolution
The European Union is poised to unveil a groundbreaking initiative, set to redefine healthcare across member states. This transformative approach promises enhanced access, control and use of digital health data, marking a significant leap towards an integrated, tech-driven healthcare ecosystem. What will change in our patient lives?
The agreement between European Parliament and EU Ministers on the European Health Data Space (EHDS) marks a epochal moment in the journey toward a European Health Union. By harnessing the power of health data, the EU is poised to enhance healthcare delivery, foster innovation, and improve public health outcomes. As we await the formal adoption of the new Regulation, the vision of a unified health data space that benefits all EU citizens is closer to becoming a reality.
The EHDS stands as a testament to the EU's commitment to leveraging technology for the betterment of its citizens' health and well-being.
The EHDS stands as a testament to the EU's commitment to leveraging technology for the betterment of its citizens' health and well-being.
By eEuropa Team
Brussels, 9 April 2024 - 4 MINUTES READ
Brussels, 9 April 2024 - 4 MINUTES READ
Last March, European Parliament and EU Ministers reached an agreement on the final text of the Commission's proposal for a EU Regulation on the European Health Data Space (EHDS).
EHDS is a significant initiative by the European Union designed to facilitate the digital transformation of healthcare within its member states. It represents a key component of the broader European Health Union strategy, aimed at enhancing health data exchange and usage across the EU for various purposes, including improved healthcare delivery, research, and policymaking. also transforming the landscape of health services and products within the single market.
The EHDS is designed to empower EU citizens by giving them unparalleled control over their electronic health data, thereby improving healthcare delivery across member states.
EHDS is a significant initiative by the European Union designed to facilitate the digital transformation of healthcare within its member states. It represents a key component of the broader European Health Union strategy, aimed at enhancing health data exchange and usage across the EU for various purposes, including improved healthcare delivery, research, and policymaking. also transforming the landscape of health services and products within the single market.
The EHDS is designed to empower EU citizens by giving them unparalleled control over their electronic health data, thereby improving healthcare delivery across member states.
Why EHDS is Important?
- Enhanced Patient Empowerment: The EHDS aims to put patients at the center of healthcare by giving them control over their personal health data. This means individuals can access their health data easily, share it with healthcare providers across the EU, and manage their health more effectively.
- Cross-border Health Data Exchange: It enables seamless sharing of health information across EU countries, which is particularly beneficial for mobile EU citizens or those seeking medical treatment in another member state. This ensures continuity of care and supports evidence-based decision-making in clinical settings.
- Boost to Research and Innovation: By facilitating the secondary use of health data (use of health data for purposes other than patient care, such as research), the EHDS will accelerate medical research, innovation, and the development of new treatments, including personalized medicine. This can lead to advancements in combating diseases and improving public health outcomes.
- Strengthening Health Systems: The initiative supports the digitalization of health systems, making them more efficient and sustainable. It also aims to improve the functioning of the internal market for digital health services and products, encouraging innovation and competition.
- Data Protection and Security: The EHDS is designed to ensure the highest standards of data protection and privacy, in line with the EU's General Data Protection Regulation (GDPR). This builds trust among patients and healthcare providers in the digital use and sharing of health data.
- Crisis Preparedness and Response: The COVID-19 pandemic highlighted the need for accessible and interoperable health data to respond to health emergencies. The EHDS will improve the EU's preparedness and capacity to manage health crises more effectively through better data availability and analysis.
Negotiations and final result
National Parliaments reviewed the initial Commission's proposal, with some endorsing it and others raising concerns, underlining the importance of aligning with the principles of subsidiarity and proportionality.
The European Parliament's committees on Civil Liberties and Environment took the lead, culminating in a first plenary vote that demonstrated the legislative body's commitment to the health data space.
After extensive negotiations last months, including several trilogues and technical meetings, a provisional agreement on a compromise text was reached. This agreement reflects a delicate balance between various interests and visions within the EU, paving the way for the EHDS's implementation.
The compromise introduces several crucial elements, including voluntary opt-out provisions for primary use and a mandatory opt-out for secondary use, with possible exceptions under specific conditions. It sets safeguards for data categories considered sensitive and outlines a self-certification scheme for Electronic Health Record (EHR) systems. Additionally, data localization requirements are stipulated for secondary use, with specific implementation timelines shortened to accelerate the EHDS's rollout.
The European Parliament's committees on Civil Liberties and Environment took the lead, culminating in a first plenary vote that demonstrated the legislative body's commitment to the health data space.
After extensive negotiations last months, including several trilogues and technical meetings, a provisional agreement on a compromise text was reached. This agreement reflects a delicate balance between various interests and visions within the EU, paving the way for the EHDS's implementation.
The compromise introduces several crucial elements, including voluntary opt-out provisions for primary use and a mandatory opt-out for secondary use, with possible exceptions under specific conditions. It sets safeguards for data categories considered sensitive and outlines a self-certification scheme for Electronic Health Record (EHR) systems. Additionally, data localization requirements are stipulated for secondary use, with specific implementation timelines shortened to accelerate the EHDS's rollout.
Advantages for Individuals
Where personal electronic health data is made available to a healthcare provider or a pharmacy by a natural person, or is transmitted by another data controller in the European electronic health record exchange format, the format should be accepted and the recipient should be able to read the data and use it for the provision of healthcare or for dispensation of a medicinal product, thus supporting the provision of the health care services or the dispensation of the electronic prescription.
Telemedicine is becoming an increasingly important tool that can provide patients with access to care and tackle inequities and has the potential to reduce health inequalities and reinforce the free movement of Union citizens across borders. Digital and other technological tools can facilitate the provision of care in remote regions. When digital services accompany the physical provision of a healthcare service, the digital service should be included in the overall care provision.
Under Article 168 of the Treaty on the Functioning of the European Union (TFEU), Member States are responsible for their health policy, in particular for the organisation and delivery of health services and medical care, including regulation of activities such as online pharmacies, telemedicine and other services that they provide and reimburse, in line with their national legislation. Different healthcare policies should not, however, constitute barriers to the free movement of electronic health data in the context of cross-border healthcare, including telemedicine, such as online pharmacy services.
The format of the data exchanged in the EU should be designed in a way that facilitates translation of electronic health data represented using it into the Union’s official languages, to the extent possible.
Telemedicine is becoming an increasingly important tool that can provide patients with access to care and tackle inequities and has the potential to reduce health inequalities and reinforce the free movement of Union citizens across borders. Digital and other technological tools can facilitate the provision of care in remote regions. When digital services accompany the physical provision of a healthcare service, the digital service should be included in the overall care provision.
Under Article 168 of the Treaty on the Functioning of the European Union (TFEU), Member States are responsible for their health policy, in particular for the organisation and delivery of health services and medical care, including regulation of activities such as online pharmacies, telemedicine and other services that they provide and reimburse, in line with their national legislation. Different healthcare policies should not, however, constitute barriers to the free movement of electronic health data in the context of cross-border healthcare, including telemedicine, such as online pharmacy services.
The format of the data exchanged in the EU should be designed in a way that facilitates translation of electronic health data represented using it into the Union’s official languages, to the extent possible.
Next Steps
European Parliament should confirm its agreement by a vote of its plenary in April 2024 and EU Council next months.
Read the inter-institutional agreement
© Copyright eEuropa Belgium 2020-2024
Source: © European Union, 1995-2024
Read the inter-institutional agreement
© Copyright eEuropa Belgium 2020-2024
Source: © European Union, 1995-2024
