AIOTI White Paper IoT/Edge Computing and Health Data and Data Spaces

AIOTI WG Health has published a White Paper on IoT/Edge Computing and Health Data and Data Spaces.

The European Health Data Space proposal is one of the initiatives the Commission has put forward as part of the Health Union package adopted in November 2020. It is the outcome of the convergence of two major policy streams of the last decade: the data economy and eHealth. It can be read as a lex specialis and one of the first sectoral applications of the Data Governance Act (2022). It sets a data governance framework for data intermediaries that facilitate data exchanges and sharing between several parties.

There are several objectives the EHDS aims to pursue, but the main ones are the following: i) Empower individuals through better digital access to their health data; support the free movement by ensuring that health data follow people; ii) Unleash the data economy by fostering a genuine single market for digital health services and products; and iii) Set up strict rules for the use of individual’s non-identifiable health data for research, innovation, policy-making and regulatory activities. As such, the EHDS aims to improve and support healthcare delivery within Europe by allowing public health data to be accessible throughout Europe. The EHDS also aims to promote better access and exchange of different types of health data for research and policy purposes. The aim is to have the EHDS up and running in 2025.

The EHDS is expected to bring great benefits, but it also brings challenges related to technology, governance and privacy as such EU approaches to health data have struggled due to several key limitations:

1. Uncertain demand on the part of patients for cross-border delivery of eHealth services;
2. Impediments posed by the simultaneous need to maintain the privacy and confidentiality of sensitive health data;
3. Insufficient incentives for Member States and institutions to participate in data-pooling arrangements;
4. Lack of a strong mandate to proceed at the EU level (subsidiarity); and
5. The risk of problematic interactions with other EU and national legal instruments.

These limitations manifest differently for primary use versus secondary use, and they have different implications for the degree to which the proposed EHDS Regulation can be expected to be effective, efficient, coherent, and add European value.

This paper aims to shed light on some key elements of the EHDS Regulation, its relationship and comparison with international big players such as the USA and China, and the vision, expectations, use cases, and best practices provided by AIOTI WG Health members.

The full paper can be found here.