Safeguarding privacy and efficacy in e-mental health: policy options in the EU and Australia

Autor(en)

Elisabeth Steindl

Abstrakt

Digital technologies have made a significant impact on the mental health sector, and they are likely to continue doing so. Despite the increasing demand for e-mental health solutions, there are concerns regarding poor privacy and data protection practices, as well as a lack of evidence to support their effectiveness. Both are considered impediments to fully reaping the benefits of digital technologies in mental health.
European Union (EU) policymakers are currently developing actions for a comprehensive mental health strategy. It would be prudent to incorporate a robust regulatory framework for e-mental health from the outset in order to encourage a sustainable European industry for e-mental health. Partially, this framework can take recourse to existing legal instruments available under current EU data protection law, while also taking inspiration from recent regulatory efforts in Australia.
The focus of this article is on the grey zone between classified medical devices and simple consumer health products. Whereas the EU adheres to a strict distinction between these two categories, Australia adapts the regulations for medical devices to the needs and specificities of e-mental health tools by assigning them their own niche within the medical devices systematics under a ‘conditioned exemption’. With regard to devices beyond the scope of the medical devices legislation, Australia is implementing a coordinated regime of complementary regulation of sectoral standards combined with an accreditation scheme. To a certain extent and its data protection-related aspects, this coordinated regime shows conceptual similarities with co-regulatory instruments under EU data protection law, such as a sector-specific data protection code of conduct and a data protection certificate.

Organisation(en)

Institut für Innovation und Digitalisierung im Recht, Forschungsplattform Governance of digital practices

Journal

International Data Privacy Law

Band

13

Seiten

207-224

Anzahl der Seiten

18

ISSN

2044-3994

DOI

https://doi.org/10.1093/idpl/ipad009

Publikationsdatum

06-2023

Peer-reviewed

Ja

ÖFOS 2012

505002 Datenschutz

ASJC Scopus Sachgebiete

Law

Sustainable Development Goals

SDG 3 – Gesundheit und Wohlergehen

Link zum Portal

https://ucrisportal.univie.ac.at/de/publications/ecf329ad-c6e3-47dd-a019-bc74cd691e89