It is a fact that lifestyle, healthcare and medical apps are developing at a fast rate. From fitness apps and cardiometers to drug-dose calculators and glycemia controllers, m-Health is slowly becoming a part of our daily lives. It is also affecting healthcare professionals in their day-to-day practices.
m-Health provides a platform for pharmaceutical companies, the medical devices industry and IT developers and service providers to converge. This Lunch Special intends to provide those players involved in this technical evolution with a legal insight into those aspects which should be considered as a result of this new and innovative platform.
From a regulatory perspective, medical apps can be regarded as medical devices where they meet certain conditions and present certain characteristics. In addition, certain functionalities may raise questions with respect to medical practice and the regulatory constraints attached thereto. While technology offers a potentially unlimited array of possibilites, certain acts are reserved by law to specific healthcare professionals.
From a data protection perspective, m-Health solutions raise concerns regarding the appropriate manner in which the large quantities of sensitive information can be collected, and how such sensitive data can be used. We will discuss compliance with privacy legislation, and how the revisions being made at European level have recently come into force or are due to come into force in the near future.
From an IT perspective, mobile applications - whether or not in the medical sector - necessarily raise numerous issues. In particular, the relationships governing the various players involved, such as the application stores, developers and users. In this respect we will be examining more closely the contractual and liability issues which may arise.
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