Regulation 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (“GDPR”):
- rules for processing personal data.
Act of 18 July 2002 on Electronically Supplied Services (“ESS Act”):
- obligations of the service provider relating to Electronically Supplied Services, rules for exempting the service provider from liability for Electronically Supplied Services, rules for protecting personal data of natural persons using Electronically Supplied Services.
Act of 16 July 2004 – Telecommunications Law (“Telecommunications Law”)
- in particular with respect to storing of or gaining access to information already stored in the telecommunications terminal equipment (e.g., smartphone) of a subscriber or end user.
Act of 4 February 1994 on Copyright and Related Rights (“Copyright Act”):
- in principle, computer programs have the same protection as literary works; and
- economic rights belong to employer of the author, unless agreement between them states otherwise.
As a side note, certain aspects of digital health software may be governed by the Polish Act on Competition and Consumer Protection. This act may apply, in particular, where digital health software is designed in such a way that it requires consumers to give access to their data, e.g., phone book, camera, exact location, making it a necessary condition to download the software. In addition, it is often the case that the software providers use the acquired data in unspecified or unknown ways.
Pursuant to Polish law, undertakings are obliged to provide consumers with reliable, truthful and comprehensive information on the products and services sold. In the case of digital health software, consumers should be provided with clear information about which parts of their data will be used and how. More importantly, consumers should be informed of this fact prior to downloading the app.