From the magazine LSR 1/2020 | S. 20-27 The following page is 20

Digital Medical Applications: Legal and Compliance Risks

Addressing the Challenges of Patient-Facing Digital Medicine

Medical Device Law, Data Protection Law


While digital medical applications targeted at improving the treatment of severe chronic diseases present novel opportunities for enhanced patient engagement and better care, their development and roll-out raise difficult legal and ethical issues. This is due to the complex and evolving nature of the relevant rules, particularly in the area of privacy, but also to the fact that digital medical applications involve and affect stakeholders with different mindsets and interests, from patients over pharma companies and technology providers to physicians and payers. The present contribution discusses the role of these different actors and identifies key legal and compliance challenges for patient-facing digital medical applications, concluding that proper data governance frameworks and a clear allocation of responsibilities are crucial for creating trust in digital solutions and paving the way to their broader adoption.
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