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ARTICLE · 24 FEBRUARY 2019

GDPR And Digital Health

The GDPR identifies three specific examples where a DPIA would be required.

European UnionPrivacy

Introduction

Most of us are by now aware of the changes to data protection regulation which came into force on 25 May of this year by virtue of the General Data Protection Regulation (GDPR).

The GDPR introduced several key changes to the previous data protection regulation. Although most of the new regulations apply to digital health companies in the same way as they apply to other types of businesses, there are certain provisions which are more challenging for digital health companies. These are as follows:

1. Consent - Under the GDPR, the processing of health data (defined as: personal data related to the physical or mental health of a natural person, including the provision of health care services, which reveal information about his or her health status), which is considered a "special category" of data, is prohibited unless one of several conditions is met. The most common condition is receipt of explicit consent. Digital health companies must therefore

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