04/05/15

WP 29 defines the scope of Health Data collected by mobile apps and devices

In light of the Internet of Things, mobile apps that are installed in smartphones, other portable electronic devices, and smartwear devices collect and process increasingly large quantities of data - especially personal data. Among these mobile apps, an increasing number of lifestyle apps are currently available. They collect a variety of data about the user's day-to-day activities (e.g., one's health and physical conditions, eating, sleeping, and workout habits). These mobile app users are often not aware of the kinds of data that are being processed and the adverse effects the processing could have on their private life and reputation. Therefore, the category health data is considered a special category of sensitive data to which a higher level of protection applies.

As a response to the request of the European Commission in the light of its mobile Health or mHealth initiative, the Article 29 Working Party ("WP 29") gave its clarification on the scope of health data, as set out in Article 8 of the Data Protection Directive (Directive 95/46/EC). The WP 29 clarifies that personal data is qualified as health data if it falls within the broad scope of one of the following categories or description:

  1. The data is inherently/clearly medical data;
  2. The data are raw sensor data that can be used in itself or in combination with other data to draw a conclusion about the actual health status or health risk of a person;
  3. Conclusions are drawn about a person's health status or health risk (irrespectively of whether these conclusions are accurate or inaccurate, legitimate or illegitimate, or otherwise adequate or inadequate).

Although not all information collected through lifestyle apps constitutes health data within the meaning of Article 8 of the Data Protection Directive, e.g., an app that registers the number of steps one takes during a walk does not collect enough information to draw conclusions on the health status of the user, the opinion of the WP 29 warns of the processing of data that are in the "grey zone", i.e., where it is not directly obvious in determining if the data collected can be considered health data. The WP 29 emphasizes accordingly that not only the type of data but especially the intended use of data must be considered when assessing whether personal data qualifies as health data. In that way, even low impact data can be considered health data when used (especially in combination with other data) to determine the health status of the user. For example, an app for runners (e.g., Nike +) might only collect limited information about a user (i.e., the blood pressure level and speed), but such information collected over a long period of time, combined with data on the user's age and gender can be used to draw conclusions on the user's health status.

Because of the prohibition of processing health data under Article 8 of the Data Protection Directive, a data controller who intends to process health data needs to rely on one of the derogations laid down in the same provision. According to the WP 29, the derogation that would most likely apply to this scenario would be when there is explicit consent of the data subject for such processing, provided that the data subject is clearly informed about the intended use of his or her data. In addition, the opinion focuses on additional obligations (e.g., principle of purpose limitation and security obligations) that will need to be taken into account by data controllers (i.e., lifestyle app developers) when processing health data.

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