Lack of interoperability is one of the main barriers to be overcome in order to achieve full implementation of digital health technologies and services, says MedTech Europe. The association representing the industry of medical devices has published a call to action position paper to improve interoperability, on the basis of four different targets: the development of a clear leadership and guidance by governments and healthcare authorities, the option of common standards and mandate adherence to them in all procurement activity run by payers and providers, investments from the EU Commission and member States to continue building digital health infrastructures and solutions, and convergence on interoperable data systems also from other types of industries, i.e. consumer devices and IT companies. “Patients will benefit from better interoperability of medical technologies through better quality of care and improved outcomes”, said Serge Bernasconi, CEO of MedTech Europe.

An ecosystem to inform and empower citizens, healthcare professionals and providers

The data ecosystem proposed by MedTech Europe should be fully compliant to applicable privacy and data protection principles and allow for the free and secure movement and sharing of health data across borders and vendors. The ultimate goal is to better inform patients, citizens, healthcare professional and providers, payers and authorities and to provide safer and more integrated services.
The initiative embraces the widely diffused patient-centric vision, and is expected to improve remote monitoring and self-management of chronic conditions, thus reducing the need to visit medical centres while increasing the availability of real world data to be analysed using the new tools made available by artificial intelligence.

Advanced connected devices and in vitro diagnostics are critical to achieve a better sustainability of healthcare, but their full implementation would require an improvement in interoperability, says MedTech Europe in its position paper. Interoperable devices and software are able to exchange information and use it for the correct execution of a specified function without changing the content of the data. They can also communicate with each other, and work together as intended, according to the definition given by the Medical Devices Regulation.

Overcome the current fragmentation of data

Data silos are still a strong reality in many cases, reducing the ability to share healthcare data between different stakeholders within the digital ecosystem. A situation resulting from market fragmentation, according to the “Blueprint – Digital Transformation of Health and Care for the Ageing Society in 2016” published by the European Innovation Partnership for Active and Healthy Ageing (EIP AHA).
MedTech Europe’s suggestion to overcome these barriers is to invest in the creation of open platforms and international widely adopted standards to develop digital health applications and devices, on the example of the harmonised principles of individual control over personal data and the importance of patient consent introduced with the adoption of the EU’s General Data Protection Regulation in May 2016. The industrial association endorses the adoption of the Electronic Health Record Exchange Format released by the EU Commission on 6 February 2019, and the specifications and profiles released by DICOM (Digital Imaging and Communications in Medicine), HL7 (Health Level 7), and IHE (Integrating the Healthcare Enterprise) initiatives.
Other proposed actions to overcome fragmentation include a better access of patients to their healthcare data – with the possibility to opt for their sharing with healthcare professionals -, the building of electronic health record (EHR) systems and other infrastructures for their management and conservation, and the facilitation of cross-border exchange of health data based on open, international standards. According to MedTech Europe, this effort should also support investments in digital health infrastructures, an essential feature of the value-based healthcare models. Small and medium size companies may also benefit from a wider adoption of interoperable systems, as they are often first line players in the development of new healthcare technologies, services and applications.

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