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The new General Data Protection Regulation (GDPR) has been in force since May 25, 2018. A good reason for health apps to finally take data protection seriously.
With the new EU GDPR, many data protection aspects are subject to stricter requirements than before, this applies above all to the transparency and information obligations towards those affected. Manufacturers and operators of health and fitness apps are threatened with high fines for violations.
Privacy by design
The GDPR requires privacy-friendly, technical default settings for devices and software in accordance with the principles of privacy by design and privacy by default. Mainly due to the sensitive nature of health data, health app manufacturers should be particularly careful and, if in doubt, secure themselves with legal advice. The health app should be built so that data processing does not go beyond what the user has approved.
EU-US Privacy Shield
Many health app providers are based in the U.S. and store the data on U.S. servers. It is currently unclear how the legal situation regarding the EU-US Privacy Shield will develop and whether the European Court of Justice (ECJ) will find data transfers to the USA to be lawful. It does not matter whether the company has a registered office or only service centers in Germany. The GDPR applies whenever personal data is collected within the EU or with reference to the EU.
Privacy Seal
Since there is still no general seal of approval for medical devices, it is all the more important for operators to have their health app certified with a data protection seal of approval by an independent body. This is what, for example ePrivacy seal of approval or that Data protection seal of approval from the Independent State Center for Data Protection on.
Health apps and data protection
The challenges that health apps have to face in terms of data protection, cyber security and cloud technology have only recently been discussed by the Health Working Group of the Cyber Security Council Germany e.V. among other things with the head of innovation, strategic analysis and IT consulting at the National Association of Statutory Health Insurance Physicians and of course with the working group leader and HealthDataSpace Business Development Manager Marc Pickardt.
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