Legal-Ethical Challenges and Technological Solutions to e-Health Data Consent in the EU

peer reviewede-Health data is sensitive and consenting to the collection, processing, and sharing involves compliance with legal requirements, ethical standards, and appropriate digital tools. We explore two legal-ethical challenges: 1) What are the scope and requirements of digital health data consent? 2) What are the legal-ethical reasons for obtaining consent beyond the GDPR’s legal basis, and how might such consent be obtained? We then propose human-centered solutions to help navigate standards of ethical and legal consent across the EU, purposefully addressing those use cases to compensate for human difficulties in managing consent without clear guidelines. These solutions – including ISO standards, ontologies, consent mechanisms, value-centered privacy assistants, and layered dynamic consent platforms – complement and aid humans to help uphold ethical and rigorous consent.LeADS, KnowGraphs, d-Rea