Health app compliance

The eHealth market is one of the fastest growing in the world. Users want to access the benefits of personalised healthcare, but in doing so, they are entrusting you with their most valuable and personal data. Mess up and you risk losing that trust and killing your market.

The MDR will be enforced from May 2020. To help companies prepare for it, the EU has published a step-by-step implementation plan. Here we explain how the 12 step plan applies to eHealth companies.

The Data Protection Officer (DPO), is a corporate figure introduced by the General Data Protection Regulation GDPR, the EU's new law on Data Protection and Privacy matters.

Under GDPR law, sensitive data is in a much higher risk category than other types of personal data. Businesses that store sensitive health data should focus on GDPR administrative and technical recuirenments.

Under GDPR, anonymous data is not treated as personal data, therefore no user consent and no particular protection is required. However, it is very difficult to ensure that the data is truly anonymous.

Some time ago we attended the Frontiers Health, the healthcare innovation edition of Frontiers Conferences. Designed to provide a unique platform to learn, exchange and get inspired on the topics of digital disruption and technologies in healthcare.

The General Data Protection Regulation (GDPR) unifies the legal framework at the EU level and focuses on new technologies to establish the lawful processing of users' data.

Digital Health applications collecting personal and sensitive data must comply with Data Protection Laws. For application developers identifying relevant laws, extracting rules and obligations and implementing them within their applications could be extremely challenging, expensive and risky.