Health Apps for YEPPs – Forget about regulations?

July 2019 / updated April 2020. YEPPs, the Young, Energetic, Passionate, Personality-driven consumers, pick up lightheartedly digital products which promise health benefits. Blanket consent to use private data is widespread among devices. Do consumers really care for privacy protection? So, why should developers, their investors, or vendors care for regulators, in particular when acting from outside a single jurisdiction such as the EU? Can developers invoke blanket consent displaying regulatory compliance? What about cunning investors and manufacturers who bet on exceptional returns by exploiting regulatory loopholes in single jurisdictions? Facing the upcoming Medical Device Directive revised by the EU.

Ulrich Gassner, Professor of Public Law at Universität Augsburg (DE) has been dealing with business strategies in grey zones where non-regulated applications for health overlap with medical devices. 2020 the revision EU Medical Device Directive will decisively change prevailing carelessness by developers of apps (wellness, healthcare, and other uses). An interview with B2Bioworld on Do’s and Dont’s, and about opportunities beyond regulatory compliance. Includes an updated introduction by the editor on GAFA manoeuvering, and a discussion of opinion polls among  app consumers. updated April 2020.Reading time: 18 min

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