In order to live up to the expectations of the EHDS, the co-legislators will need to ensure that the current lack of interoperability and standards is overcome and that a broad set of stakeholders – such as the life science and healthcare industry as well as third countries – will be included in the scope of the EHDS.

The EHDS, which is the first initiative of its kind, needs to carefully balance the needs for both legal certainty and adaptability required in the rapidly-changing domain of data science, in order to ensure that all stakeholders – patients, clinicians, payors, regulators and industry partners — can fully engage in and benefit from the EHDS. This will be best achieved through open, transparent and structured stakeholder involvement throughout the development and implementation of the EHDS. Furthermore, in order to foster trust in the EHDS, citizens need to be supported in exercising their rights and guided on the implications of new concepts such as data altruism.

The EHDS should ensure a consistent and efficient framework for the reuse of health data in order to support the development, access to and adoption of innovative solutions in Europe’s health systems, advancing health equity in the EU and globally. This framework must consider and promote international collaboration including third-country access to health data, noting that health threats know no borders, as exemplified by the COVID pandemic. AmCham EU is committed to the success of the EHDS as an opportunity to achieve better health for all citizens and address existing and future global health challenges.