POLAND Trends and Developments Contributed by: Barbara Kiełtyka, Jakub Gładkowski and Małgorzata Kiełtyka, Kieltyka Gladkowski KG Legal
New Regulations for Health Apps (Digital Therapeutics) The Polish Ministry of Health is currently promot- ing free apps for monitoring the health of patients. Apps will be eligible to receive the “Ministry of Health-Certified Application” accreditation for a period of 24 months. According to the new regu- lations, the aim of the certification programme is to recognise health apps that can not only provide information about health but also safely store data, where their software will be classi- fied as “medical device” . A health app is an app that is used to monitor health. Some apps may be recognised as medical devices if they meet the requirements of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017. The certification is designed to show that the app is a safe and reliable tool that can be used by patients and medical personnel. For developers, the certification may be useful for promoting apps by providing proof of their effectiveness. Currently, two apps in the health app portfolio have been certified: the first was created by doctors to assess symptoms and their causes, and the second was designed for people struggling with allergies. Through the certification programme, apps are verified in terms of their content, functionality, ease of use, innovation and information secu- rity. The programme is scheduled to finish in November 2026 and, according to the Ministry’s announcements, may be the first step towards medical apps in Poland being issued to patients on prescription. Current Problems in Creating and Distributing Life Sciences Products: Selected Examples Concerning the creation and distribution of medicines (including OTC medicines), medical devices for treatment and in vitro diagnosis, dietary supplements, novel foods and “border-
line” products, challenges are arising in relation to the rapid changes in regulations and the need to adapt production to a relatively short vacatio legis. For example, the regulations that help ensure products are fit for use over the long term are changing in relation to specific chemical com- pounds and food preservatives. The large distri- bution chains of functional foods, such as ener- gy bars, are not keeping up with the bans on the use of preservatives and certain colorants. Cur- rent trends point to poor labelling practices and the use of substances included in the Rapid Alert System for Food and Feed (RASFF) database. Under Article 50 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002, the RASFF was established as a notification system for foods that pose a direct or indirect danger to human health. Based on product testing and notifications via the RASFF, non-compliant products posing a risk to humans are withdrawn from the market. The RASFF is thus an important source of information on prod- uct safety, identifying substances in imported products that, if consumed by humans, may have serious negative health effects. In Poland, in accordance with Article 85 of the Act of 25 August 2006 on food and nutrition safety, the Chief Sanitary Inspectorate manages the RASFF. It should be remembered that the producer (or other entity, such as the importer) that intro- duces a product to the market is responsible for food safety in Poland. It is their responsibility to ensure procedures and safeguards that minimise the risk of contamination are in place. When a food that may pose a health risk is in cir- culation and/or in the possession of consumers, the Chief Sanitary Inspectorate informs the pub-
233 CHAMBERS.COM
Powered by FlippingBook